Azoxystrobin; Pesticide Tolerance

revisit the tolerances assigned to

these commodities, has concluded that the commentors are correct in

their concerns, and here proposes to increase the tolerances for

residues of azoxystrobin and its Z isomer in or on pistachios to 0.02

ppm and in or on tree nuts to 0.02 ppm.

DATES: Comments, identified by docket control number OPP-300951, must

be received by EPA on or before March 6, 2000.

ADDRESSES: Comments may be submitted by mail, electronically, or in

person. Please follow the detailed instructions for each method as

provided in Unit I. of the ``SUPPLEMENTARY INFORMATION.'' To ensure

proper receipt by EPA, it is imperative that you identify docket

control number OPP-300951 in the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By mail: Cynthia L. Giles-Parker,

Registration Division (7505C), Office of Pesticide Programs,

Environmental Protection Agency, 401 M St., SW., Washington, DC 20460;

telephone number: (703) 305-7740; and e-mail address: giles-

[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an

agricultural producer, food manufacturer, or pesticide manufacturer.

Potentially affected categories and entities may include, but are not

limited to:

------------------------------------------------------------------------

Examples of

Categories NAICS codes Potentially

Affected Entities

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Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide

manufacturing

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o:

------------------------------------------------------------------------

Examples of

Categories NAICS codes Potentially

Affected Entities

------------------------------------------------------------------------

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide

manufacturing

------------------------------------------------------------------------

This listing is not intended to be exhaustive, but rather provides

a guide for readers regarding entities likely to be affected by this

action. Other types of entities not listed in the table could also be

affected. The North American Industrial Classification System (NAICS)

codes have been provided to assist you and others in determining

whether or not this action might apply to certain entities. If you have

questions regarding the applicability of this action to a particular

entity, consult the person listed under ``FOR FURTHER INFORMATION

CONTACT.''

B. How Can I Get Additional Information, Including Copies of this

Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this

document, and certain other related documents that might be available

electronically, from the EPA Internet Home Page at http://www.epa.gov/.

To access this document, on the Home Page select ``Laws and

Regulations'' and then look up the entry for this document under the

``Federal Register--Environmental Documents.'' You can also go directly

to the Federal Register listings at http://www.epa.gov/fedrgstr/.

2. In person. The Agency has established an official record for

this action under docket control number OPP-300951. The official record

consists of the documents specifically referenced in this action, and

other information related to this action, including any information

claimed as Confidential Business Information (CBI). This official

record includes the documents that are physically located in the

docket, as well as the documents that are referenced in those

documents

docket control number OPP-300951. The official record

consists of the documents specifically referenced in this action, and

other information related to this action, including any information

claimed as Confidential Business Information (CBI). This official

record includes the documents that are physically located in the

docket, as well as the documents that are referenced in those

documents. The public version of the official record does not include

any information claimed as CBI. The public version of the official

record, which includes printed, paper versions of any electronic

comments submitted during an applicable comment period is available for

inspection in the Public Information and Records Integrity Branch

(PIRIB), Rm. 119, Crystal Mall 2 (CM #2), 1921 Jefferson Davis Hwy.,

Arlington, VA, from 8:30 a.m. to 4 p.m., Monday

through Friday, excluding legal holidays. The PIRIB telephone number is

(703) 305-5805.

C. How and to Whom Do I Submit Comments?

You may submit comments through the mail, in person, or

electronically. To ensure proper receipt by EPA, it is imperative that

you identify docket control number OPP-300951 in the subject line on

the first page of your response.

1. By mail. Submit your comments to: Public Information and Records

Integrity Branch (PIRIB), Information Resources and Services Division

(7502C), Office of Pesticide Programs (OPP), Environmental Protection

Agency, 401 M St., SW., Washington, DC 20460.

2. In person or by courier. Deliver your comments to: Public

Information and Records Integrity Branch (PIRIB), Information Resources

and Services Division (7502C), Office of Pesticide Programs (OPP),

Environmental Protection Agency, Rm. 119, Crystal Mall 2, 1921

Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m.

to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB

telephone number is (703) 305-5805.

3. Electronically

nformation and Records Integrity Branch (PIRIB), Information Resources

and Services Division (7502C), Office of Pesticide Programs (OPP),

Environmental Protection Agency, Rm. 119, Crystal Mall 2, 1921

Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m.

to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB

telephone number is (703) 305-5805.

3. Electronically. You may submit your comments electronically by

e-mail to: [email protected], or you can submit a computer disk as

described above. Do not submit any information electronically that you

consider to be CBI. Avoid the use of special characters and any form of

encryption. Electronic submissions will be accepted in WordPerfect 6.1/

8.0 or ASCII file format. All comments in electronic form must be

identified by docket control number OPP-300951. Electronic comments may

also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI that I Want to Submit to the Agency?

Do not submit any information electronically that you consider to

be CBI. You may claim information that you submit to EPA in response to

this document as CBI 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. In addition to one complete

version of the comment that includes any information claimed as CBI, a

copy of the comment that does not contain the information claimed as

CBI must be submitted for inclusion in the public version of the

official record. Information not marked confidential will be included

in the public version of the official record without prior notice. If

you have any questions about CBI or the procedures for claiming CBI,

please consult the person listed under ``FOR FURTHER INFORMATION

CONTACT.''

E. What Should I Consider as I Prepare My Comments for EPA?

mitted for inclusion in the public version of the

official record. Information not marked confidential will be included

in the public version of the official record without prior notice. If

you have any questions about CBI or the procedures for claiming CBI,

please consult the person listed under ``FOR FURTHER INFORMATION

CONTACT.''

E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your

comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used

that support your views.

4. If you estimate potential burden or costs, explain how you

arrived at the estimate that you provide.

5. Provide specific examples to illustrate your concerns.

6. Offer alternative ways to improve the proposed rule or

collection activity.

7. Make sure to submit your comments by the deadline in this

document.

8. To ensure proper receipt by EPA, be sure to identify the docket

control number assigned to this action in the subject line on the first

page of your response. You may also provide the name, date, and Federal

Register citation.

II. Background and Statutory Findings

A. What Action is the Agency Taking?

In the Federal Register of March 17, 1999 (64 FR 13106) (FRL-6064-

6), EPA issued a final rule pursuant to section 408(b)(2)(A)(i) of the

Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food

Quality Protection Act of 1996 (FQPA) (Public Law 104-170), announcing

the establishment of tolerances for residues of azoxystrobin and its Z

isomer on several commodities, including pistachio nuts at 0.01 ppm and

tree nuts at 0.01 ppm, as had been proposed by Zeneca Ag Products in

tolerance petition number (PP) 7F4864. This final rule included a

detailed discussion of the risk assessment and of residue and other

considerations that lay behind EPA's decision to establish the

tolerances

rances for residues of azoxystrobin and its Z

isomer on several commodities, including pistachio nuts at 0.01 ppm and

tree nuts at 0.01 ppm, as had been proposed by Zeneca Ag Products in

tolerance petition number (PP) 7F4864. This final rule included a

detailed discussion of the risk assessment and of residue and other

considerations that lay behind EPA's decision to establish the

tolerances. Telephone comments were received from two parties in

California immediately after completion of the rule. In both cases the

parties believed that the pistachios and tree nuts tolerances were too

low, considering the data submitted in support of the tolerances and

the use directions on the label, and might lead to adulterated

commodities even when the use directions on the label were accurately

followed. EPA agreed to revisit the tolerances assigned to these

commodities. If the commentor's comments were substantiated, a

reassessment of the risk from the use of azoxystrobin would also be

necessary. The Agency has concluded that the commentors' concerns are

justified and that the appropriate tolerances for these commodities are

0.02 ppm in or on pistachios and 0.02 ppm in or on tree nuts.

This document proposes to amend 40 CFR 180.507 by increasing the

tolerances for combined residues of the fungicide azoxystrobin and its

Z isomer, in or on pistachios at 0.02 ppm and tree nuts at 0.02 ppm.

B. What is the Agency's Authority for Taking this Action?

ustified and that the appropriate tolerances for these commodities are

0.02 ppm in or on pistachios and 0.02 ppm in or on tree nuts.

This document proposes to amend 40 CFR 180.507 by increasing the

tolerances for combined residues of the fungicide azoxystrobin and its

Z isomer, in or on pistachios at 0.02 ppm and tree nuts at 0.02 ppm.

B. What is the Agency's Authority for Taking this Action?

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide chemical residue in or on a

food) only if EPA determines that the tolerance is ``safe.'' Section

408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable

certainty that no harm will result from aggregate exposure to the

pesticide chemical residue, including all anticipated dietary exposures

and all other exposures for which there is reliable information.'' This

includes exposure through drinking water and in residential settings,

but does not include occupational exposure. Section 408(b)(2)(C)

requires EPA to give special consideration to exposure of infants and

children to the pesticide chemical residue in establishing a tolerance

and to ``ensure that there is a reasonable certainty that no harm will

result to infants and children from aggregate exposure to the pesticide

chemical residue....''

EPA performs a number of analyses to determine the risks from

aggregate exposure to pesticide residues. For further discussion of the

regulatory requirements of section 408 and a complete description of

the risk assessment process, see the final rule on Bifenthrin Pesticide

Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

C. Aggregate Risk Assessment and Determination of Safety

Consistent with section 408(b)(2)(D), EPA has reviewed the

available scientific data and other relevant information in support of

this action. EPA has sufficient data to assess the hazards of and to

make a determination on aggregate exposure, consistent with section

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

2961, November 26, 1997) (FRL-5754-7).

C. Aggregate Risk Assessment and Determination of Safety

Consistent with section 408(b)(2)(D), EPA has reviewed the

available scientific data and other relevant information in support of

this action. EPA has sufficient data to assess the hazards of and to

make a determination on aggregate exposure, consistent with section

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

combined residues of azoxystrobin and its Z isomer in or on pistachios

at 0.02 ppm and in or on tree nuts at 0.02 ppm. EPA's assessment of the

dietary exposures and risks associated with establishing the tolerances

were published in 64 FR 13106 (March 17, 1999), the final rule that

established the initial tolerances for residues of azoxystrobin in or

on pistachios at 0.01 ppm and in or on tree nuts at 0.01 ppm. In that

rule the Agency concluded that there was a reasonable certainty that no

harm would result from the establishment of azoxystrobin tolerances for

several other commodities. A reassessment of the risk associated with

increasing the azoxystrobin tolerances for pistachios and tree nuts to

0.02 ppm demonstrated that the calculated risk increases were so small

(generally at the fourth decimal place) that the risk assessment values

(rounded) reported in 64 FR 13106 (March 17, 1999) were not changed.

That is, the risk increase resulting from this proposed rule will be

negligible. Accordingly, EPA concludes that modifying these tolerances

as described will be safe for the general population, including infants

and children. EPA reaffirms its specific risk findings set forth in the

March 1999 azoxystrobin tolerance action.

D. International Residue Limits

There are no Codex, Canadian or Mexican Maximum Residue Limits

(MRL) established for azoxystrobin for pistachios or tree nuts. Thus,

harmonization is not an issue.

III. Regulatory Assessment Requirements

the general population, including infants

and children. EPA reaffirms its specific risk findings set forth in the

March 1999 azoxystrobin tolerance action.

D. International Residue Limits

There are no Codex, Canadian or Mexican Maximum Residue Limits

(MRL) established for azoxystrobin for pistachios or tree nuts. Thus,

harmonization is not an issue.

III. Regulatory Assessment Requirements

This proposed rule seeks to establish a tolerance under FFDCA

section 408(e). 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 action 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) (Public Law 104-4). Nor does it require any prior consultation

as specified by Executive Order 13084, entitled Consultation and

Coordination with Indian Tribal Governments (63 FR 27655, May 19,1998);

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 or any Agency action under Executive Order 13045,

entitled Protection of Children from Environmental Health Risks and

Safety Risks (62 FR 19885, April 23, 1997). This action does not

involve any technical standards that would require Agency consideration

of voluntary consensus standards pursuant to section 12(d) of the

National Technology Transfer and Advancement Act of 1995 (NTTAA),

Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Pursuant to the

Regulatory Flexibility Act (RFA) (5 U.S.C

h Risks and

Safety Risks (62 FR 19885, April 23, 1997). This action does not

involve any technical standards that would require Agency consideration

of voluntary consensus standards pursuant to section 12(d) of the

National Technology Transfer and Advancement Act of 1995 (NTTAA),

Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Pursuant to the

Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), 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. In addition, the Agency

has determined that this action will not have a substantial direct

effect on States, on the relationship between the national government

and the States, or on the distribution of power and responsibilities

among the various levels of government, as specified in Executive Order

13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive

Order 13132 requires EPA to develop an accountable process to ensure

``meaningful and timely input by State and local officials in the

development of regulatory policies that have federalism implications.''

``Policies that have federalism implications'' is defined in the

Executive Order to include regulations that have ``substantial direct

effects on the States, on the relationship between the national

government and the States, or on the distribution of power and

responsibilities among the various levels of government.'' This rule

directly regulates growers, food processors, food handlers and food

retailers, not States

alism implications'' is defined in the

Executive Order to include regulations that have ``substantial direct

effects on the States, on the relationship between the national

government and the States, or on the distribution of power and

responsibilities among the various levels of government.'' This rule

directly regulates growers, food processors, food handlers and food

retailers, not States. This action does not alter the relationships or

distribution of power and responsibilities established by Congress in

the preemption provisions of FFDCA section 408(n)(4).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,

Agricultural commodities, Pesticides and pests, Reporting and

recordkeeping requirements.

Dated: December 16, 1999.

James Jones,

Director, Registration Division, Office of Pesticide Programs.

Therefore, it is proposed that 40 CFR chapter I shall be amended as

follows:

PART 180--[AMENDED]

1. The authority citation for part 180 continues to read as

follows:

Authority: 21 U.S.C. 321(q), (346a) and 371.

2. In Sec. 180.507, the table to paragraph (a)(1), by revising the

entries for pistachios and tree nuts to read as follows:

Sec. 180.507 Azoxystrobin; tolerances for residues.

(a) General. (1) * * *

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Commodity Parts per million

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* * * * *

Pistachios..................................... 0.02

* * * * *

Tree nuts...................................... 0.02

* * * * *

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* * * * *

[FR Doc. 00-75 Filed 1-4-00; 8:45 am]

BILLING CODE 6560-50-F