+(,121/,1(

Citation: 73 Fed. Reg. 66759 2008 

Content downloaded/printed from 

HeinOnline (http://heinonline.org)

Wed Jun 16 17:36:12 2010

-- Your use of this HeinOnline PDF indicates your acceptance

 of HeinOnline's Terms and Conditions of the license

 agreement available at http://heinonline.org/HOL/License

-- The search text of this PDF is generated from 

 uncorrected OCR text.
Federal Register/Vol. 73, No. 219/Wednesday, November 12, 2008/Rules and Regulations 66759

E. Executive Order 13211 (Energy

Effects)

This rulemaking is not a significant

energy action under Executive Order

13211 because this rulemaking is not

likely to have a significant adverse effect

on the supply, distribution, or use of

energy. Therefore, a Statement of Energy

Effects is not required under Executive

Order 13211 (May 18, 2001).

F. Executive Order 12988 (Civil Justice

Reform)

This rulemaking meets applicable

standards to minimize litigation,

eliminate ambiguity, and reduce burden

as set forth in sections 3(a) and 3(b)(2)

of Executive Order 12988 (Feb. 5, 1996).

G. Executive Order 13045 (Protection of

Children)

This rulemaking does not concern an

environmental risk to health or safety

that may disproportionately affect

children under Executive Order 13045

(Apr. 21, 1997).

H. Executive Order 12630 (Taking of

Private Property)

This rulemaking will not effect a

taking of private property or otherwise

have taking implications under

Executive Order 12630 (Mar. 15, 1988).

I. Congressional Review Act

Under the Congressional Review Act

provisions of the Small Business

Regulatory Enforcement Fairness Act of

1996 (5 U.S.C. 801 et seq.), prior to

issuing any final rule, the United States

Patent and Trademark Office will

submit a report containing this final rule

and other required information to the

U.S. Senate, the U.S. House of

Representatives and the Comptroller

General of the Government

Accountability Office. The changes in

this final rule are not expected to result

in an annual effect on the economy of

100 million dollars or more, a major

increase in costs .or prices, or significant

adverse effects on competition,

employment, investment, productivity,

innovation, or the ability of United.

States-based enterprises to compete

with foreign-based enterprises in

domestic and export markets. Therefore,

this final rule is not a "major rule" as

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

J. Unfunded Mandates Reform Act bf

1995

The changes in this final rule do not

involve a Federal intergovernmental

mandate that will result in the

expenditure by State, local, and tribal

governments, in the aggregate, of 100

million dollars (as adjusted) or more in

any one year, or a Federal private sector

mandate that will result in the

expenditure by the private sector of 100

million dollars (as adjusted) or more in

any one year, and will not significantly

or uniquely affect small governments.

Therefore, no actions are necessary

under the provisions of the Unfunded

Mandates Reform Act of 1995. See 2

U.S.C. 1501 et seq.

K. National Environmental Policy Act

This rulemaking will not have any

effect on the quality of environment and

is thus categorically excluded from

review under the National

Environmental Policy Act of 1969. See

42 U.S.C. 4321 et seq.

L. National Technology Transfer and

Advancement Act

The requirements of section 12(d) of

the National Technology Transfer and

Advancement Act of 1995 (15 U.S.C.

272 note) are inapplicable because this

rulemaking does not contain provisions

which involve the use of technical

standards.

M. Paperwork Reduction Act

The changes in this final rule involve

information collection requirements

which are subject to review by the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995 (44 U.S.C. 3501 et seq.). The

collection of information involved in

this notice has been reviewed and

approved by OMB under OMB control

number 0651-0021. The Office did not

resubmit an information collection

-package to OMB for its review and

approval because the changes in this

final rule concern revised fees for

existing information collection

requirements associated with the

information collection under OMB

control number 0651-0021. The Office

will submit fee revision changes to the

* inventory of the information collection

under OMB control number 0651-0021.

Notwithstanding any other provision

of law, no person is required to respond

to nor shall a person be subject to a

penalty for failure to comply with a

collection of information subject to the

requirements of the Paperwork

Reduction Act unless that collection of

information displays a currently valid

OMB control number.

List of Subjects

37 CFR Part 1

Administrative practice and

procedure, Courts, Freedom of

Information, Inventions and patents,

Reporting and record keeping

requirements, Small Businesses.

PART 1.-RULES OF PRACTICE IN

PATENT CASES

E 1. The authority citation for 37 CFR

Part 1 continues to read as follows:

Authority: 35 U.S.C. 2(b)(2).

0 2. The authority citation for subpart is

revised to read as follows:

Authority: Secs. 1.401 to 1.499 also issued

under 35 U.S.C. 41 and 351 through 376.

7 3. Section 1.445 is amended by

revising paragraphs (a)(1), (a)(2) and

(a)(3) to read as follows:

§1.445 International application filing, processing and search fees.

(a) * * *

(1) A transmittal fee (see 35

U.S.C. 361(d) and PCT Rule

14) ........................................

$24

(2) A search fee (see 35 U.S.C.

361(d) and PCT Rule 16) ......... -$2,08

(3) A supplemental search fee

when required, per additional

invention .................................. $2,08

0.00

0.00

0.00

Dated: October 21, 2008.

Jon W. Dudas,

Under Secretary of Commerce for Intellectual

Property and Director of the United States

Potent and Trademark Office.

[FR Doc. E8-26711 Filed 11-10-08; 8:45 am]

BILLING CODE 3510-16-P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 52 and 81

(EPA-R09-OAR-2008-0306; FRL-8724-7]

Approval and Promulgation of

Implementation Plans; Designation of

Areas for Air Quality Planning

Purposes; State of California; PM-10;

Revision of Designation;

Redesignation of the San Joaquin

Valley Air Basin PM-10 Nonattainment

Area to Attainment; Approval of PM-10

Maintenance Plan for the San Joaquin

Valley Air Basin; Approval of

Commitments for the East Kern PM-10

Nonattainment Area

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is approving the State of

California's request under the Clean Air

Act (CAA or the Act) to revise the

designation for the San Joaquin Valley

(SJV) serious nonattainment area for

particulate matter of ten microns or less

(PM-IO) (SJV nonattainment area) by

splitting the area into two separate

nonattainment areas: The San Joaquin

HeinOnline -- 73 Fed. Reg. 66759 2008
66760 Federal Register/Vol. 73, No. 219/Wednesday, November 12, 2008/Rules and Regulations

Valley Air Basin (SJVAB) serious PM-10

nonattainment area and the East Kern

serious PM-10 nonattainment area. EPA

is also redesignating the SJVAB

nonattainment area to attainment for the

PM-10 national ambient air quality

standard (NAAQS) and approving the

PM-10 maintenance plan, motor vehicle

emissions budgets and conformity

trading mechanism for the area. EPA is

also excluding from use in determining

that the area has attained the standard

exceedances on July 4, 2007, and

January 4, 2008, that EPA has concluded

were caused by exceptional events.

Finally, EPA is approving enforceable

commitments by the Kern County Air

Pollution Control District and the

California Air Resources Board to install

a PM-10 monitor in the East Kern

nonattainment area and to address CAA

requirements under section 189(d) as

necessary for the area.

DATE: This rule is effective on December

12, 2008. The motor vehicle emission

budgets are applicable as of November

12, 2008.

ADDRESSES: EPA has established docket

number EPA-R09-OAR-2008-0306 for

this action. The docket is available

electronically at www.regulations.gov

and in hard copy at EPA Region IX, 75

Hawthorne Street, San Francisco,

California. While all documents in the

docket are listed in the index, some

information may be publicly available

only at the hard copy location (e.g.,

copyrighted material), and some may

not be publicly available in either

location (e.g., CBI). To inspect the hard

copy materials, please schedule an

appointment during normal business

hours with the contact listed in the FOR

FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT:

Doris Lo, EPA Region IX, (415) 972-

3959, lo.doris@epa.gov.

SUPPLEMENTARY INFORMATION:

Throughout this document, "we," "us"

and "our" refer to EPA.

Table of Contents

I. Background

II. Public Comments and EPA Responses

A. Area Has Attained

B. Fully Approved SIP

C. Improvements in Air Quality are Due to

Permanent and Enforceable Emission

Reductions

D. Area Has Met All Applicable CAA

Section 110 and Part D Requirements

E. Maintenance Plan

F. Revision of Boundary Designation

G. Miscellaneous Comments

I. Final Actions

IV. Statutory and Executive Order Reviews

I. Background

On April 25, 2008 (73 FR 22307), EPA

proposed the following actions:

* Approval of the State of California's

request to revise the designation for the

SJV serious PM-1 nonattainment area

by splitting the area into two separate

nonattainment areas, the SJVAB serious

PM-10 nonattainment area and the East

Kern serious PM-10 nonattainment

area.

* Redesignation of the SJVAB

nonattainment area to attainment for the

PM-l0 NAAQS and approval of the

maintenance plan, motor vehicle

emissions budgets and conformity

trading mechanism for the SJVAB area.

* Exclusion froi use in determining

that the SJVAB area has attained the

standard two exceedances that EPA has

concluded were caused by exceptional

events that occurred on July 4, 2007,

and January 4, 2008.

* Approval of enforceable

commitments by the Kern County Air

Pollution Control District (KCAPCD)

and the California Air Resources Board

(CARB) to install a PM-10 monitor in

the East Kern nonattainment area and to

address CAA requirements under

section 189(d) as necessary for the East

Kern area.

Subsequently, On May 23, 2008, EPA

extended the public comment period for

two weeks, until June 10, 2008. 73 FR

30029. EPA issued the extension in

order to notify the public of a minor

change in the motor vehicle emissions

budgets and to provide the public with

the opportunity to consider these

technical corrections.

Under section 107(d)(3)(D) of the

CAA, the Governor of any state may, on

the Governor's own motion, submit to

EPA a revised designation of any area or

portion thereof within the state.1 EPA is

required to approve or deny the revised.

designation within 18 months of receipt.

On January 31, 2008, the State

submitted to EPA a revised designation

that involves a boundary change only

and not a change in status (e.g., from

"nonattainment," to "attainment" or "unclassifiable") of any area.

Section 107(d)(3)(E) of the CAA states

that an area can be redesignated to

attainment if the following conditions

are met:

(1) EPA has determined that the area

has attained the NAAQS.

(2) The applicable implementation

plan has been fully approved by EPA

under section 110(k) of the CAA.

(3) EPA has determined that the

improvement in air quality is due to

permanent and enforceable reductions

in emissions.

' Boundary changes are an inherent part of a

designation or redesignation of an area under the

CAA. See CAA section 107(d)1](B](ii].

(4) The State has met all applicable

requirements for the area under section

110 and Part D of the CAA.

(5) EPA has fully approved a

maintenance plan, including a

contingency plan, for the area under

section 175A of the CAA. These

requirements are discussed in more

detail in a September 4, 1992, EPA

memorandum, "Procedures for

Processing Request To Redesignate

Areas to Attainment," John Calcagni,

Director, Air Quality Management

Division (Calcagni memorandum).

The proposed rule provides a more

detailed discussion of the background

pertinent to this final action.

H. Public Comments and EPA

Responses

EPA received one letter in support of

EPA's proposed actions from the San

Joaquin Valley Air Pollution Control

District (SJVAPCD or the District) and

two letters with adverse comments. As

EPA sets forth in detail in its responses

to comments below, in taking final

action EPA has fully considered all data

pertinent for regulatory use in

determining attainment in the SJVAB

area and EPA continues to believe that

the area has attained the PM-10

standard. EPA has also determined that

the State's request for redesignation and

the maintenance plan for the SJVAB

area meet the applicable requirements of

the CAA. In addition, EPA is granting

the State's request for a boundary

revision for the area based on a

multiplicity of factors. The available

monitoring data for the East Kern area,

while limited, also indicate that

concentrations are well below the

NAAQS. Thus, for the reasons set forth

in the responses to comments below, as

well as in the proposed rule, EPA is

finalizing its proposed determinations

as fully meeting the requirements of the

CAA.

A. Area Has Attained

Comment 1: Earthjustice (EJ) states

that the first condition that a

nonattainment area must meet in order

to be'redesignated to attainment under

CAA section 107(d)(3)(E) is that EPA

has determined that the area has

actually attained the NAAQS. EJ alleges

that the SJV nonattainment area has

recorded multiple exceedances of the

standard during the period that EPA is

relying on to demonstrate attainment

and that EPA is thus ignoring a serious

air quality problem and the health

impacts associated with it. EJ

incorporates by reference and attaches

its previous comments on EPA's

attainment determination that claim the

problem EPA is ignoring has existed for

HeinOnline -- 73 Fed. Reg. 66760 2008
Federal Register/Vol. 73, No. 219/Wednesday, November 12, 2008/Rules and Regulations 66761

many years, is part of what led EPA to

designate the SJV area nonattainment in

the first place and is caused by ongoing

human activity that is not reasonably

controlled.

Response 1: The previous comments

to which EJ refers in its June 10, 2008

comment letter on the proposed rule are

contained in its August 18, 2006

comment letter with attachments A-I,

October 26, 2007 comment letter,

December 29, 2006 Petition for

Reconsideration and March 21, 2007

Petition for Withdrawal, with attached

declarations from Sarah Jackson and Jan

Null. EJ raised the same issues as it

raises here during EPA's rulemakings

regarding the 2006 determination of

attainment for the SJV nonattainment

atea and 2008 affirmation of that

determination. EPA fully responded to

EJ's comments at that time. See the final

rules at 71 FR 63642 (October 30, 2006)

and 73 FR 14687 (March 19, 2008). See

also the proposed rules for these actions

at 71 FR 40952 (July 19, 2006) and 72

FR 49046 (August 27, 2007). As we

explained in our responses to EJ's

comments in the final rules, EPA

believes that the SJV area has attained

the PM-10 NAAQS and that the

exceedances noted by EJ were properly

excluded from consideration under the

Agency's Exceptional Events Rule

(EER)(72 FR 13560; March 22, 2007).

EJ subsequently filed petitions for

review of the October 2006 and March

2008 final rules in the U.S. Court of

Appeals for the Ninth Circuit. Latino

Issues Forum, et a]. v. EPA, Nos. 06-

75831 and 08-71238.2 In its opening

brief in these cases, filed on June 16,

2008, EJ again raises these issues. In its

brief in opposition, filed on September

3, 2008, EPA again responds to EJ's

arguments. EJ was required to raise any

issues regarding the 2006 attainment

determination and 2008 affirmation of

that determination during those

rulemakings and in the Ninth Circuit in

Latino Issues Forum and cannot

relitigate the same issues here.

Moreover, in the proposed rule for

today's final action we proposed to

exclude under the EER data showing

exceedances in the SJV nonattainment

area on July 4, 2007 and January 8,

2008, and concluded that the area

continued to attain the PM-10 standard

through February 2008. We did not

receive any adverse comments on this

aspect of our proposed rule. In this final

action, for the reasons set forth in the

proposed rule and in EPA's concurrence

letters to which it refers, we are

concurring with the State's flagging of

2 The Ninth Circuit has consolidated the two

petitions for review.

those data as caused by fireworks and

high wind exceptional events, and

excluding those data from consideration

in determining that the SJVAB area

continues to attain the standard.

Finally, EPA is aware of PM-10

exceedances recorded on May 21, 2008

at the Corcoran and Bakersfield Federal

Equivalent Method (FEM) monitors and

the Corcoran Federal Reference Method

(FRM) monitor, and on May 22, 2008 at

the Corcoran FEM. On June 24, 2008,

the District posted on its website

documentation that these exceedances

were caused by a natural event, i.e.,

high winds. The comment period ended

on July 24, 2008 and no public

comments were received. The

documentation was submitted to EPA

on August 12, 2008 and EPA has

concurred that these exceedances

should be flagged as exceptional events.

Letter from Wayne Nastri, EPA to Mary

D. Nichols, CARB, September 24, 2008.

EPA is not taking comment on

whether the May 2008 exceedances

should be excluded from the

determination in this final rule that the

SJVAB area continues to attain the PM10 standard. The determination of

whether an area has attained the PM-10

standard is based on the most recent

three consecutive calendar years of data.

As mentioned above and in other EPA

actions, the SJVAB area has attained the

PM-10 standard based on data for the

three-year period from 2003 through

2005 and the three-year period from

2005 through 2007. See 71 FR 63642

and 73 FR 14687. Because 2008 has not

ended, EPA cannot determine whether

the area has attained the standard based

on the three-year period from 2006

through 2008. We can, however,

determine with less than three years of

data whether the SJVAB area has failed

to attain in the period from 2006 to date.

See 40 CFR part 50, appendix K, section

2.3(c) and 71 FR 63642, footnote 26.

Because the May 21 and 22, 2008

exceedances are the only exceedances at

the Corcoran monitors since 2006 not

excluded through notice and comment

rulemaking from regulatory

consideration, the expected number of

exceedances recorded at the FRM

monitor, based on the May 21

exceedance, is three and the expected

number of exceedances recorded at the

FEM monitor on May 21 and May 22 is

two. 3 Similarly, because the May 21,

3 Note that the Corcoran FRM operates on a onein-three day schedule and that EPA does not

combine PM-10 data collected with different

monitoring methods, i.e., FRMs and FEMs. See

Memorandum from Gerald A. Emisdn, EPA, to EPA

Regional Division Directors, "Revision to Policy on

the Use of PM-la Measurement Data," November

21, 1988 at 3.

2008 exceedance is the only exceedance

recorded at the Bakersfield monitor

since 2006 not excluded from regulatory

consideration through notice and

comment rulemaking, the expected

number of exceedances at the

Bakersfield monitor is one. Thus, even

if EPA does not exclude the May 21 and

22, 2008 exceedances from regulatory

consideration, the SJVAB area continues

to attain the PM-10 NAAQS to date

because both Corcoran and Bakersfield

have an expected number of

exceedances of less than or equal to one

per year, averaged over the three year

period 2005-2007 and through 2008 to

date. All Other monitors in the SJV area

had an expected number of exceedances

of less than or equal to one per year

during these periods. EPA thus

determines that the SJVAB area has

attained the PM-10 NAAQS as required

by section 107(d)(3)(E)(i).

B. Fully Approved SIP

Comment 2: EJ states that the second

condition for redesignation under

section CAA section 107(d)(3)(E) is that

an area seeking redesignation must have

a fully approved state implementation

plan (SIP) and must satisfy all

requirements that apply to the area and

that the SJV nonattainment area does

not have such a SIP. EJ argues that while

EPA concedes that it has never

approved contingency measures for the

area and has instead suspended this

requirement under the Agency's Clean

Data Policy, neither the policy nor the

cases EPA cites addresses PM-10

nonattainment areas and therefore do

not square EPA's action with the

mandate under CAA section 189(c) that

such areas continue to achieve the

milestones for emission reductions in

order to demonstrate reasonable further

progress (RFP) "until the area is

redesignated to attainment." EJ believes

that because contingency measures are

also necessary to ensure this progress is

achieved, EPA cannot suspend the

requirement for these measures. Citing

Engine Mfrs. Ass'n v. EPA, 88 F.3d

1075, 1089 (D.C. Cir. 1996), EJ asserts

that EPA does not have the authority to

waive statutory requirements and

circumvent redesignation provisions

because it believes compliance with

those requirements is unnecessary.

Response 2: In 2006 EPA approved

the entire nonattainment plan for the

SJV area,4 including the CAA section

189(c)(1) reasonable further progress

milestones, except for the CAA section

172(c)(9) contingency measures, on

4 "2003 PM10 Plan, San Joaquin Valley Plan to

Attain Federal Standards for Particulate Matter 10

Microns and Smaller" (2003 PM-10 Plan).

HeinOnline -- 73 Fed. Reg. 66761 2008
66762 Federal Register/Vol. 73, No. 219/Wednesday, November 12, 2008/Rules and Regulations

which EPA deferred action. 69 FR 30006

(May 26, 2004). EPA subsequently

determined that the contingency

measures requirement for the SJV area

was suspended as a result of its October

2006 determination that the area has

attained the PM-10 standard. 71 FR

63642, 63663. During that rulemaking,

EJ raised the same issues with regard to

EPA's Clean Data Policy 5 and statutory

construction as it raises here. EPA

responded to EJ's arguments in the final

rule. See id. at 63643-63647. EJ again

raises these issues in its opening brief in

Latino Issues Forum. EPA again

responds to EJ's arguments in its brief in

opposition. EJ was required to raise any

issues regarding the suspension of the

contingency measures requirement

during EPA's 2006 attainment

determination rulemaking and in Latino

Issues Forum. EJ did so and cannot

relitigate the same issues here. Because

EPA has approved SIP provisions

submitted by talifornia for the SJVAB

area that address all applicable CAA

requirements, EPA has concluded that

the CAA section 107(d)(3)(E)

requirement for a fully approved SIP has

been met.

In addition, in the context of

evaluating the area's eligibility for

redesignation, there is a separate and

additional justification for finding that

the section 172(c)(9) contingency

measures are not an applicable SIP

requirement for purposes of

redesignation. Prior to and

independently of that policy, and

specifically in the context of

redesignations, EPA interpreted the

contingency measure requirement as not

applicable for purposes of

redesignation. In the General Preamble

EPA stated that:

[t]he section 172(c)(9) requirements are

directed at ensuring RFP and attainment by

5EPA has long interpreted the CAA to provide

that certain nonattainment area requirements, the

purpose of which are to ensure attainment of the

relevant NAAQS by the applicable deadline, will no

longer apply once an area has attained that NAAQS,

and for as long it continues to do so until it is

redesignated to attainment status. While referred to

as the Clean Data Policy, it is more accurately

described as EPA's interpretations of the relevant

provisions of Title 1, Part D of the CAA. See Sierra

Club v. EPA, 375 F.3d 537, 541-42 (7th Cir. 2004);

Sierra Club v. EPA, 99 F.3d 1551, 1156-57 (loth

Cir. 1996). EPA first set forth this interpretation in

its "General Preamble for the Interpretation of Title

I of the Clean Air Act Amendments of 1990,"

(General Preamble) thereafter reiterated it in several

policy memoranda and since codified the policy

with respect to ozone and PM-2.5 nonattainment

areas. 57 FR 13498. 13564 (April 16.1992). 40 CFR

51.918 (ozone) and 51.1004(c) fM ,,). EPA has

applied the policy to numerous PM-lo

nnnattaimnent areas, including the SW area. For an

expi nded duscription of the policy and uiu

appliuation of it, see' Respondent EPA's Merits Brief

in Latino Issues Forum at 7-8. 71 FR 40952, 40954

and 71 FR b3642, 63644.

the applicable date. These requirements no longer apply when an area has attained the

standard and is eligible for redesignation.

Furthermore, section 175A for maintenance

plans * * * provides specific requirements

for contingency measures that effectively

supersede the requirements of section

172(c)(9) for these areas.

See also Calcagni memorandum at 6

("The requirements for reasonable

further progress and other measures

needed for attainment will not apply for

redesignations because they only have

meaning for areas not attaining the

standard."). Thus, even-if the

contingency measure requirement had

not previously been suspended, it

would not apply for purposes of

evaluating whether an area that ha&

attained the standard qualifies for

redesignation. EPA has enunciated and

held this position since the General

Preamble was published more than

sixteen years ago and represents the

Agency's interpretation of what

constitutes applicable requirements

under section 107(d)(3)(E). The Courts

have recognized the scope of EPA's

authority to interpret "applicable

requirements" in the redesignation

context. See Sierra Club v. EPA, 375

F.3d 537 (7th Cir. 2004).

C. Improvements in Air Quality Must Be

Due to Permanent and Enforceable

Emission Reductions

Comment 3: EJ states that a 1992

guidance memorandum from John

Calcagni lays out the steps that an area

must take to show that the improvement

in air quality is attributable to

permanent and enforceable reductions

in emissions, the third condition for

redesignation to attainment under CAA

section 107(d)(3)(E). EJ claims that this

analysis should include estimating the

percentage reductions achieved from the

federal and state controls implemented

in the area, taking into account

permitted emission rates, production

capacities and other related information.

EJ states that EPA, banking on its waiver

of all the violations during the period of

interest, neglected to perform the proper

analyses in the Calcagni memorandum

and merely repeats the District's belief,

based on four observations (comments 4

through 7 below), that the area is

attaining the standard.

Response 3: As discussed in our

proposed rule, the Calcagni

memorandum states that the state must

be able to reasonably attribute the

improvement in air quality to emission

reductions which are permanent and

enforceable, and the improvement

should not be a result of temporary

reductions (e.g., economic downturns or

shutdowns) or unusually favorable

meteorology. The Calcagni

memorandum also states that in making

this showing the state should estimate

the emission reductions from adopted

and implemented federal, state and

local control measures, and consider the

emission rates, production capacities,

and other related information to show

that the air quality improvements are

the result of implemented controls. Our

proposed rule discusses how each of

these factors is addressed by the State in

the "2007 PM10 Maintenance Plan and

Retuest for Redesignation," September

20, 2007, SJVAPCD (2007 Plan). 73 FR

22307; 2008, footnote 8; 22311-22312.

In general, the 2007 Plan shows that

there has been a significant

improvement in PM-10 air quality since

1990, noting that there were 33

estimated exceedance days during

1990-1992 and 2.9 exceedance days

during 2002-2004. This decrease in

exceedance days (and emissions)

occurred during a period of rapid

economic growth in the SJVAB area as

indicated by the increases in population

and vehicle miles traveled (VMT). The

2007 Plan did not find any evidence of

significant shutdowns that would cause

the decline in exceedance days. The

2007 Plan analyzed the meteorology in

the SJVAB area during 2003-2006 by

comparing the average annual wind

speeds, precipitation levels and stability

levels to long-term averages and found

that there was no consistent pattern to

show that there was favorable

meteorology leading to the improvement

in PM-10 levels during 2003-2006.

The 2007 Plan states that over 500

new rules and rule amendments have

been adopted, reducing NOx and PM-10

emissions from a wide range of source

categories, and'it shows decreases in the

overall emissions of NOx and PM-Ia

(which include all emissions from area

sources as well as from permitted major

sources) since 2000. A more detailed

discussion of these analyses can be

found in our proposed rule and in the

2007 Plan. EPA's analysis is based on

the State's assessment and EPA

continues to believe that the State has

demonstrated that the improvement in

PM-10 air quality in the SJVAB area is

a result of permanent and enforceable

reductions in emissions and has

adequately addressed the provisions of

the Calcagni memorandum.

Finally, as discussed in the response

to comment I above, EPA has

determined that the SJV area has

attained the PM-10 standard. 71 FR

63642; 73 FR 14687. These

determinations included EPA's

concurrence with the State's and Santa

Rosa Rancheria Tribe's conclusion that

a number of exceedances were caused

HeinOnline -- 73 Fed. Reg. 66762 2008
Federal. Register/ Vol. 73, No. 219/Wednesday, November 12, 2008/Rules and Regulations 66763

by exceptionaL events and thus should

be excluded from regulatory

consideration. Id. EJ seems to suggest

that EPA's analyses should include

these exceedances even though they

have been properly excluded from

regulatory consideration. EPA disagrees.

Comment 4: EJ claims that the District

provides a chart (2007 Plan at 24, Figure

2) showing a downward trend in air

pollution levels that is completely

misleading because it does not include

EPA-acknowledged exceedances in 2004

and 2005, let alone the many

exceedances EPA has ignored in its

attainment determination.

Response 4: The District's chart (2007

Plan at 24, Figure 2) shows a long-term

downward PM-10 trend from 1990 to

2006 for the SJVAB area by plotting the

estimated exceedance days over the

NAAQS. The estimated exceedance

days in this chart are based on

exceedances recorded with FRMs and

not FEMs such as continuous beta

attenuation monitors (BAMs). EPA

believes that the District's chart is not

misleading and provides a general

picture of the long-term trend for PM10 and that 1990 is a reasonable year to

begin the analysis because that was the

year the CAA was amended.

EJ's comment letter (page 4) includes -a chart, "PM-IO Trend," that appears to

revise the 2007 Plan's chart by adding

the exceedances from BAMs that

occurred in 2004 and 2005 and by

removing the data for 1990 in order to

show a less precipitous decline in PM10 levels. However, even with the

exclusion of the 1990 data and the

addition of the exceedances from the

BAMs, EJ's "PM-10 Trend" chart still

shows a decline in PM-10 levels.

Moreover, the 2007 Plan provides a

summary in Table 10 of the declining

annual average emissions inventories

from 1990 through 2005 which is

consistent with the District's trends

chart. Table 10 shows PM-10 emissions

decreasing by 46 tons per day (tpd) and

NOx emissions decreasing by 228 tpd

during this time period.

Finally, as discussed above, EPA has

not ignored any recorded exceedances

but rather has followed its regulations to

exclude from regulatory consideration

any exceedances that are caused by

exceptional events. 73 FR 14687;

response to comment 3 above. EPA also

set forth in its 2006 attainment

determination its conclusions as to prior

monitored data. 71 FR 63642.

Comment 5: EJ claims that while the

District asserts that growth in the SJV

nonattainment area has been rapid since

1990 but that emissions have decreased,

the sources of these claimed reductions

do not support redesignation.

Response 5: See responses to

comments 1, 3 and 4 above, and 7 and

8 below.

Comment 6: EJ alleges that the District

and EPA conclude without justification

that the District's meteorological

analysis shows that favorable

meteorology did not lead to the

improvements in air quality. Instead, EJ

argues, the analysis shows that from

2004 to 2006, the SJV nonattainment

area experienced some of the wettest

years on record and that 2003 through

2006 experienced lower than average

stability levels, which EPA and the

District concede would lead to better

dispersion conditions and lower PM-Ia

levels. As a result, EJ claims the data

provided undercut any claim that the

alleged air quality improvement is likely

to be maintained.

Response 6: Our proposed rule

summarizes the meteorological analysis

provided in the 2007 Plan whichincludes an examination of the

precipitation, temperature wind speeds

and atmospheric stability during the

period 2003 through 2006. The

summary was based on data presented

in Appendix C to the 2007 Plan. As EJ

comments, there were some conditions

that favored lower PM-10 levels;

however, there were also conditions that

favored higher PM-10 levels.

Conditions that favored higher PM-10

levels included no variation in annual

average wind speeds (which are

generally quite low for the SV area),

warmer than average temperatures and

two dry years ranking 98th and 112th in

wetness (with the 1st year being the

wettest year) during a 128 year period.

Since there were conditions that both

favored and did not favor higher PM-10

levels, the conclusion of the 2007 Plan

and EPA's analysis is that there was no

consistent pattern to show that

attainment was a result of unusually

favorable meteorology. 73 FR 22307,

22312.

Finally we note that the Calcagni

memorandum makes clear that

"[a]ttainment resulting from * * *

unusually favorable meteorology would

not qualify as an air quality

improvement due to permanent and

enforceable emission reductions."

Calcagni memorandum at 4. Therefore

EPA disagrees with EJ's comment that

the meteorological data indicate that the

air quality improvement will not likely

be maintained.

In addition, EPA obtained available

information on precipitation, average

monthly temperatures and wind speeds

for 2007 and compared the 2007 data to

the averages presented in Appendix C to

the 2007 Plan at Tables C-1, C-2 and C3. (Atmospheric stability data for 2007

was not available.) The total

precipitation for 2007 was 7.03 inches

(http://www.wrh.noaa.gov/hnx/fat

norma1s/fatrnyr.htm) which is lower

than the average precipitation of 10.13

inches for 1878 through 2006 (2007 Plan

at Table C-1) and would favor higher

PM-10 levels. The average monthly

temperatures in degrees Celcius for 2007

were 4.6 for January, 9.5 for February,

14.3 for March, 15.9 for April,-20.7 for

May, 24 for June, 26.3 for July, 26.3 for

August, 21.7 for September, 16.1 for

October, 11.9 for November and 5.5 for

December. (http://www.weather.gov/

climate/xmacis.php?wfo=hnx) When

compared to the average monthly

temperatures from 1900 through 2005

(2007 Plan at Table C-2), the average

temperatures for the months of March,

May, June and August were higher in

2007 than average and would favor

higher PM-10 levels. Finally, the

average wind speed for 2007 was 3.7

miles per hour (mph) (http://

www.cimis.water.ca.gov) which is

consistent with the average wind speed

of 3.72 mph for 1984 through 2006

(2007 Plan at Table C-3) and would

favor high PM-10 levels. Since the

available 2007 meteorological data favor

higher PM-10 levels, EPA continues to

believe that there is no consistent

pattern that would establish that

attainment has resulted from unusually

favorable meteorology.

Comment 7: EJ disputes EPA's

conclusion that improvements in air

quality are the result of permanent and

enforceable reductions in emissions

from rules adopted by the District since

1992. EJ claims that most of these rules

were adopted only in the last few years

and therefore any trend in emission

reductions that can be inferred from the

chart provided by the District (2007

Plan at 24, Figure 2) cannot be

attributed to these rules. EJ suggests that

the drop in exceedance days between

1990 and 1992 might be due to a

difference in the methodologies for

measuring exceedances for the TSP and

PM-10 standards. EJ provides its own

chart, "PM-10 Trend," adjusted to

include the exceedance days that it says

EPA has acknowledged, that purports to

show only minimal changes in the

recurring pattern of PM-10 violations

over the last 15 years.

Response 7: On July 1, 1987, EPA

revised the NAAQS for particulate

matter by replacing the standards for

total suspended particulate matter (TSP)

with new standards applying only to

PM-lO. 52 FR 24672. While PM-10

monitoring data have been collected

since 1987 (see 71 FR 63642, 63653), the

District and CARB have not reported

TSP data to EPA's Air Quality System

HeinOnline -- 73 Fed. Reg. 66763 2008
66764 Federal Register/Vol. 73, No. 219/Wednesday, November 12, 2008/Rules and Regulations

(AQS) database since 1989. Therefore

any difference in measurement

methodologies for the two pollutants

could not be the cause of the drop in

exceedance days between 1990 and

1992.

Since enactment of the 1990 CAA

Amendments, the State has adopted and

submitted several PM-10 plans. These

include a moderate area plan under

CAA section 189(a), a serious area plan

under section 189(b) and a serious area

plan under section 189(d) (i.e., the 2003

PM-10 Plan approved by EPA in 2004

and discussed above). The 2003 PM-10

Plan provides a summary of the many

State, District and EPA rules adopted

from 1990 through 2003. See 2003 PM10 Plan at Tables 4-1, 4-2, 4-3 and 4-

4. The 2003 PM-10 Plan also includes

commitments for additional PM-10 and

NOx measures, all of which were

adopted by the District and State after

2003 and most of which have been

approved by EPA. See response to

comment 8 below.

The District's chart (2007 Plan, Figure

2) shows that PM-10 levels have

declined from 1990 through 2006 while

these PM-10 plans and rules have been

adopted and implemented. We note that

even EJ's own "PM-10 Trend" chart

shows a general decrease in PM-10

levels since 1992 and since early 2000.

Furthermore, the 2007 Plan shows

that significant reductions in PM-10

and NOx emissions occurred from the

year 2000 to the year 2005, the time

period during which the SJV area

attained the PM-10 standard. NOx

emissions have declined from 673 tpd

in 2000 to 606 tpd in 2005 and PM-10

emissions have declined from 324 tpd

in 2000 to 284 tpd in 2005. 2007 Plan;

Staff Report, Air Resources Board,

"Analysis of the San Joaquin Valley

2007 PM10 Maintenance Plan," (ARB

Staff Report for 2007 Plan) Appendix

B. 6

As can be seen from the above

discussion and our responses to

previous comments, PM-10 exceedance

days and PM-tO and NOx emission

levels have declined while at the same

time the SJV area has exhibited

significant growth in population and

vehicle miles traveled. 2007 Plan at 24,

Figure 2 and at 26, Figures 3 and 4.

Thus EPA continues to believe that it is

reasonable to attribute the improvement

in PM-10 air quality to the emission

reductions from adopted rules that are

permanent and enforceable.

Comment 8: EJ argues that the

District's failure to estimate the tons or

percent reduction from the baseline year

achieved by its PM-10 control measures

makes it difficult to assert that any

improvements in air quality are the

result of such controls. Further, while

EPA claims that the District has adopted

all of its rule commitments in the 2003

PM-10 Plan, only 2 of the 14

commitments have received EPA

approval according to EJ. The

maintenance plan identifies 8 additional

rules, only 3 of which have been

approved by EPA. EJ states that of the

22 rules the District identified during its

PM-10 planning process to help reduce

PM-tO in the SJV nonattainment area,

only 5 are enforceable elements of the

SIP.

Response 8: The 2007 Plan provides

a summary of overall NOx and PM-1O

emissions and shows that emissions

have decreased from approximately

1177 tpd in 1990 to approximately 1000

tpd in 2000 to approximately 900 tpd in

2005 and estimates that they will

continue to decrease to approximately

800 tpd in 2010. 2007 Plan at Table 10

and 73 FR 22307, 22312. These

declining emissions levels have

occurred as population and VMT have

increased and are due to the emissions

reductions from rules and control

measures that have been adopted and

implemented since 1990. 2007 Plan at

26 through 27 and 2003 PM-10 Plan at

Tables 4-1, 4-2, 4-3 and 4-9.

The 2003 PM-10 Plan summarizes the

numerous rules and control measures

adopted by the SJVAPCD, the State and

EPA prior to 2003. 2003 PM-10 Plan at

Tables 4-1, 4-2 and 4-3. The 2003 PM10 Plan also includes District

commitments to achieve additional

reductions. 2003 PM-10 Plan at Table

4-9. As discussed below, the

commitments have all been converted to

adopted rules. The emissions reductions

from all of the 2003 PM-10 Plan's rules,

control measures and adopted

commitments are reflected in the 2007

Plan's emissions inventory. ARB Staff

Report for 2007 Plan at Appendix B.

It is not clear what year EJ considers

to be the baseline year; however, the

2007 Plan provides emissions

inventories for the years 1990, 2000,

2005 and 2010 which include the

estimated tpd of reductions achieved by

the PM-10 rules, control measures and

rules adopted pursuant to commitments.

2007 Plan at Table 10 and ARB Staff

Report for 2007 Plan at Appendix B.

Thus, EPA believes that the State and

District have estimated the tpd

reductions from several baseline years

(1990, 2000 and 2005) achieved by its

PM-10 control measures and have

shown that the improvements in air

quality are the result of such controls.

Regarding EJ's comment that only five

of the 22 rules the District identified

during its PM-10 planning process are

enforceable elements of the SIP, EPA

notes that this information was updated

in the 2007 Plan. See "Errata, 2007

PM10 Maintenance Plan and Request for

Redesignation," October 9, 2007,

included in the 2007 Plan submittal to

EPA. Table 1 below summarizes the

EPA-approved rules from the 2003 PM10 Plan commitments and provides the

EPA approval dates for these rules as

applicable. EPA has approved all but

three of the submitted rules (Rules 4694,

4401 and 9510)..

TABLE 1-SUMMARY OF EPA ACTIONS ON 2003 PM-10 PLAN COMMITMENTS

2003 PM-10 plan commitment 7 (pollutants Adopted rule number and title EPA action

covered by commitment) Adopted rule number and title EPA action

A. Agriculture (Conservation Management

Practice Program) (PM-10, VOC).

B. Cotton Gins (PM-10) .............................

C. Dryers (NOx) .........................................

D. Fugitive PM-10 (Regulation VIII) (PM-10)

4550--Conservation Management Practices ...

4204- Cotton G ins ...........................................

4309-Dryers, Dehydrators, and Ovens ..........

8011--General Requirements ..........................

8021-Construction, Demo, Excavation

8031-Bulk Materials.

8041-Carryout and Trackout.

8051 -Open Areas.

8061-Paved and Unpaved Roads.

8071-Unpaved Vehicle/Equip Traffic Areas.

Approved 2/14/06, 71 FR 7683.

Approved 11/9/06, 71 FR 65740.

Approved 5/30/07, 72 FR 29886.

Approved 2/17/06, 71 ER 8461.

, See footnote 2 of the proposed rule. 73 FR

22307, 22308.

HeinOnline -- 73 Fed. Reg. 66764 2008
Federal Register/Vol. 73, No. 219/Wednesday, November 12, 2008/Rules and Regulations 66765

TABLE 1-SUMMARY OF EPA ACTIONS ON 2003 PM-10 PLAN COMMITMENTS-Continued

2003 PM-10 plan commitment 7 (pollutants covered by commitment) Adopted rule number and title EPA action

8081-Agricultural Sources.

E. Glass-Melting Furnaces (SOx) ..................... 4354--Glass Melting Furnaces ........................ Approved 8/1/07, 72 FR 41894.

F. Gas-Fired Oilfield Steam Generators (SOx) 4406-Suffur Compounds From Oilfield Steam Not adopted by District.

Generators-Kem County. G. Indirect Source Review, and Indirect Source 9510-Indirect Source Review ......................... Under EPA Review.

Mitigation Fee (NOx, PM-10). H. Solid Fuel Boilers, Steam Generators, and 4352-Solid Fuel Fired Boilers, Steam Gen- Approved 5/30/07, 72 FR 29886.

Process Heaters (NOx, SOx). erators, and Process Heaters.

I. Small Boilers, Steam Generators, and Proc- 4307-Boilers, Steam Generators, and Proc- Approved 5/30/07, 72 FR 29886.

ess Heaters (NOx, SOx). ess Heaters 2.0 to 5.0 mmBtu.

J. Water Heaters (Industrial, Commercial, and 4308-Boilers, Steam Generators, and Proc- Approved 5/30/07, 72 FR 29886.

Institutional) (NOx). ess Heaters 0.075 to 2.0 mmBtu.

K. W ineries (VOC) ............................................. 4694- W ineries ................................................ Under EPA Review.

L. Steam Enhanced Crude Oil Production Well 4401-Steam Enhanced Crude Oil Production Under EPA Review.

Vents (VOC). Well Vents.

M. Residential Space Heating (NOx) ................ 4905-Natural Gas Fired, Fan-type, Residen- Approved 5/30/07, 72 FR 29886.

tial Central Furnaces..

N. Agricultural Internal Combustion Engines 4702-Internal Combustion Engines Phase 2 Approved 1/10/08, 73 FR 1819.

(PM-10, NOx). Residential Wood Combustion 8 ........................ 4901-Residential Wood Burning .................... Approved 9/30/03, 68 FR 56181.

7On May 26, 2004, EPA approved the 2003 PM-10 Plan including commitments for new District rules. See 2003 PM-10 Plan, Table 4-9 List of New District Commitments. The commitments for PM-10 and NOx reductions were approved as meeting BACM and the commitments for

other pollutants (SOx, VOC) were approved as SIP strengthenings. See 69 FR 30006, 30035 and 69 FR 5412, 5423. The District subsequently amended the 2003 PM-10 Plan and revised Chapter 4 Control Strategy in May 2005; however, the amendments were not submitted to EPA. The EPA-approved commitments are those found in the version of the 2003 PM-10 Plan adopted by the District on December 18, 2003.

8 In its comment letter, EJ lists Residential Wood Combustion as a commitment from the 2003 PM-10 Plan; however, it was an adopted measure and not a commitment. We have included it in our Table for completeness in addressing EJ's comments.

In addition to the rules in Table 1, the

2007 Plan cites reductions from

additional rules that were not included

in the 2003 PM-10 Plan's commitments.

All of these additional rules have been

adopted and submitted to EPA by the

State and most have been approved by

EPA. Table 2 below provides a summary

of EPA actions on these additional rules

based on the "Errata, 2007 PM-10

Maintenance Plan and Request for

Redesignation."

TABLE 2-SUMMARY OF EPA ACTION ON ADDITIONAL RULES IDENTIFIED BY 2007 PLAN

Rule # Rule title EPA action

4103 ............................. Open Burning (VOC & NOx) ................................................................. Approved 4/11/06, 71

FR 18216.

4305 ............................. Boilers, Steam Generators, and-Process Heaters (NOx) ........................................................... Approved 5/18/04, 69

FR 28061.

4409 ............................. Components Serving Light Crude Oil or Gases at Production Facilities (VOC) ........................ Approved 3/23/06, 71

FR 14652.

4451 & 4452 ................ Components at Petroleum Refineries (VOC).

4570 .............. Confined Animal Feeding Operations (VOC) ............................................................................. Under EPA Review.

4604 ............................. Can and Coil Coating Operations (VOC) .................................................................................... Approved 5/19/0_6, 70

FR 28826.

9310 ............................. School Bus Fleets (NOx) ............................................................. Under EPA Review.

Thus, contrary to EJ's comment, most

of the rules identified in the 2007 Plan

have been approved by EPA as federally

enforceable elements of the SIP. EPA is

continuing to process the remainder of

the State's submitted rules.

Comment 9: EJ concludes that because

the air quality improvements are

premised on ignoring multiple

violations of the PM-10 standard and

fewer than one quarter of the rules the

District relies on for reductions are an

enforceable part of the SIP, EPA cannot

reasonably attribute air quality

improvements to permanent and

enforceable emission reductions.

Response 9: See above responses to

comments 1, 3, 4, 6, 7 and 8.

D. Area Has Met All Applicable CAA

Section 110 and Part D Requirements

Comment 10: EJ asserts that the

District fails to comply with CAA

section 107(d)(3)(E) because it has not

met all applicable requirements under

section 110 and part D. EJ says that in

addition to the contingency measure

requirement, the District has not met the

section 189(b)(1)(B) BACM requirement

because BACM were required to be

implemented by January 8, 1993 and

EPA has still not approved most of the

PM-10 rules relied on (as a result of the

2003 PM-10 Plan commitments) as

being BACM-level controls.

Response 10: As noted above, in its

October 30, 2006 attainment

determination EPA suspended the

172(c)(9) contingency measure

requirement and as a result it is no

longer an applicable part D requirement.

71 FR 63642, 63663; 73 FR 22307,

22313. In any event, as set forth above

(see response to comment 2),

independent of its suspension, the

contingency measure requirement is not

an applicable requirement for purposes

of redesignation.

With respect to the section

189(b)(1)(B) BACM requirement, as

HeinOnline -- 73 Fed. Reg. 66765 2008
66766 Federal Register/Vol. 73, No. 219/Wednesday, November 12, 2008/Rules and Regulations

discussed in our proposed rule, EPA

determined that this requirement was

met for the SJV nonattainment area in

our approval of the 2003 PM-10 Plan.

See 69 FR 30006, 30035. ("EPA is

approving the RACM/BACM

demonstration for all significant PM-10

and NOx sources in the SJV as meeting

the requirements of sections 189(a)(1)(C)

and 189(b)(1)(B)"). In the 2003 PM-10

Plan the District addressed the BACM

requirement by providing enforceable

commitments to implement BACM rules

in the future rather than already

adopted rules. During the rulemaking on

the 2003 PM-10 Plan, EJ argued that

until the relevant BACM requirements

are adopted and no longer subject to

change in the rule development process

for each of these source categories, EPA

could not conclusively determine that

the plan provides for the

implementation of BACM/BACT for all

significant sources of PM-l0 and PM10 precursors. In rejecting that argument

we stated that:

[s]ection 189(b)(1)(B) requires that serious area PM-10 plans include '[plrovisions to assure that the best available control measures for the control of PM-10 shall be

implemented no later than 4 years after the

date the area is classified (or reclassified) as a Serious Area.' Nothing in this language

either requires a state to have adopted

controls in place before a SIP revision can be

approved into its PM-10 plan or forbids the

adoption of an enforceable commitment to

meet the statute's BACM [footnote omitted]

requirement.

Id. at 30013. We further stated, in fully

approving commitments as meeting the

Act's BACM requirement that:

[c]onsistent with this statutory language,.

EPA has historically determined that an enforceable commitment to adopt and

implement BACM in a SIP meets this

statutory requirement since it constitutes a 'provision to assure that BACM.is

implemented' by a fixed deadline. As a result, the commenters' complaint that '[bly

definition the plan fails to implement BACM/

BACT for all source categories for which no developed control measures exist has no merit since the statute itself does not impose

such a requirement. Because the statute does

not define what is a 'provision to assure BACM is implemented,' EPA may adopt an

interpretation reasonably accommodated to

the purpose of the statutory provision.

Chevron U.S.A., Inc. v. Natural Resources

Defense Council, 467 U.S. at 842-44.

Id. at 30013-30014. In conclusion we

stated that:

In accepting enforceable commitments to

meet the requirements of section 189(b](1)B),

however, EPA has required states to

undertake an analysis to ensure that the

regulation ultimately adopted pursuant to the

commitment will represent a BACM level of

control. As we describe in our proposed rule,

a state must determine the technical and

economic feasibility of potential control

measures for each of the significant source

categories. 69 FR 5412, 5418. Thus the

measure that is the subject of a commitment

must describe generally the type and level of

control to be adopted.

Moreover, once the ultimate control

measure is adopted and submitted to EPA,

the Agency undertakes an additional

evaluation to ensure that that measure meets

the statute's BACM requirements. See, e.g.,

the Arizona rulemakings in which EPA

initially approved as RACM [footnote

omitted] a requirement in a state statute to

adopt and implement best management

practices for agricultural operations and

subsequently determined that the rules

adopted pursuant to the statute represented

RACM/BACM. 64 FR 34726 (June 29, 1999);

66 FR 51869 (October 11, 2001); 67 FR 48718

(July 25, 2002).

Id. at 30014. EPA's interpretation and its

full SIP approval of the BACM

requirement was not challenged. EPA

may rely on prior SIP approvals in

approving a redesignation request.

Calcagni memorandum at 3;

Southwestern Pennsylvania Growth

Alliance v. Browner, 144 F.3d. 984. 989-

990 (6th Cir. 1998); and Wall v. EPA,

265 F.3d 526 (6th Cir. 2001). Finally we

note that EPA has approved many of the

rules submitted by the State as meeting

a BACM level of control. See the Federal

Register notices listed in Tables 1 and

2 above in which we approve SJVAPCD

PM-10 and NOx rules.

Comment 11: EJ also claims that the

District has failed to submit to EPA a

demonstration that the quantitative

milestones as required by CAA section

189(c)(1) and (c)(2) and the section

189(d) 5 percent requirement have been

met. EJ also claims that the District has

not met its commitment to update and

improve the 2003 PM-10 Plan by March

2006.

Response 11: CAA section

107(d)(3)(E)(v) requires that a state

seeking redesignation of an area to

attainment must have met all

requirements applicable to the area

under section 110 and part D. In

interpreting this requirement EPA has

stated that "any requirements that came

due prior to submittal of the

redesignation request must be fully

approved into the plan at or before the

time EPA redesignates the area."

Calcagni memorandum at 5. Sierra Club

v. EPA, 375 F.3d 537 (7th Cir. 2004).

EPA has approved the 2003 PM-10

Plan's RFP demonstration as meeting

the requirements of 172(c)(2) and

189(c)(1) and has approved the plan as

meeting the quantitative milestones

requirement in section 189(c)(1). 69 FR

30006, 30034. Also, as we explained in

our 2006 attainment finding, we believe

that once an area attains the NAAQS the

requirements of section 189(c)(2) with

respect to milestones no longer applies

under the Agency's Clean Data Policy.

71 FR 63642, 63646-63647. We'also

explained in that rulemaking the

application of the Clean Data Policy to

PM-10. See 71 FR 40952, 40954-40955

and 71 FR 63642, 63643-63645. Apart

from the Clean Data Policy, for an area

that has attained the standard and is

eligible for redesignation, the

requirements for milestone

demonstrations under section 189(c)

have no further meaning or function.

Therefore the District was not required

to submit milestone demonstrations

pursuant to section 189(c).

In addition, EPA approved a

commitment in the 2003 PM-10 Plan by

the State to submit a SIP revision by

March 31, 2006 based on a mid-course

review to determine whether the level of

emission reductions in the plan is

sufficient to attain the PM-10 standards.

69 FR 30006, 30035. EPA approved this

commitment as part of the Plan's

attainment demonstration. See 69 FR

5412, 5429. While the SJVAPCD

adopted a mid-course review SIP

addressing the quantitative milestone

reporting requirement and mid-course

review SIP commitment and submitted

the SIP to the State, the State has not

submitted the mid-course review SIP to

EPA. Nevertheless, EPA's full approval

of the attainment demonstration in the

2003 PM-10 Plan fully satisfies therequirement of CAA section

107(d)(3)(E)(v).

Moreover, EPA has determined that

the SJV area attained the PM-10

standard in 2005, and continues to

attain the standard. The mid-course

review requirement is not a requirement

under section 110 or Part D, and

therefore is not an applicable CAA

requirement for purposes of

redesignation. Furthermore, even if it

were, the requirement for a mid-course

review was approved as part of the

attainment demonstration. Therefore,

because EPA has determined that the

SJV area is attaining the PM-10

standard, a submission under the midcourse review provision would not be

required for purposes of redesignation.

57 FR. 13498, 13564; Clean Data Policy.

Comment 12: EJ claims that EPA

misinterprets an October 14, 1994

memorandum from Mary Nichols, EPA,

entitled "Part D NSR Requirements for

Areas Requesting Redesignation to

Attainment" as allowing the District to

replace its new source review (NSR)

program with a prevention of significant

deterioration (PSD) program. EJ quotes

the memorandum as saying that "the

part D program may be replaced by the

corollary PSD program, if it is shown

HeinOnline -- 73 Fed. Reg. 66766 2008
No. 219/Wedhesday, November 12, 2008/Rules and Regulations 66767

through the maintenance demonstration

that the area will maintain without part

D NSR." EJ asserts that here neither EPA

nor the District has.made any such

demonstration and claims that this is

especially worrisome in light of EPA's

recent proposed appioval of revisions to

the District's NSR program exempting "so-called minor agricultural sources

such as industrial dairy operations."

Response 12: First, the commenter

overlooks the fact, enunciated in our proposed rule, that EPA has previously

fully approved the NSR program for the

SJV area. We also noted that EPA has

recently proposed approval of some

revisions to the NSR rule. 73 FR 22307,

22313. EJ's citation to the October 14,

1994 memorandum from Mary Nichols,

EPA, entitled "Part D NSR

Requirements for Areas Requesting

Redesignation to Attainment" (Nichols

memorandum) is misdirected. The

Nichols memorandum's discussion of

the need to demonstrate maintenance

without fully approved NSR addressed

the situation, not the case here, where

an area's NSR rule has not been

approved. Moreover, as our proposed

rule explained, even though EPA

previously approved the NSR rule, such

approval is not a prerequisite to

finalizing our approval of the State's

redesignation request. Id. If an area does

not have a fully approved NSR program,

it can still be redesignated if it shows

maintenance without NSR in effect. The

2003 PM-i0 Plan and 2007 Plan do not

rely on reductions from the area's NSR

program. Nothing in the plans'

inventories or estimated emissions

reductions indicates any reliance on

NSR program reductions. Thus, the

SJVAB area will maintain the NAAQS

without NSR. This is consistent with the

provisions of the Nichols memorandum.

Finally, we note that while the PSD

requirements will apply once the area

has been redesignated to attainment, the

District's SIP-approved NSR rule will

continue to apply with respect to PM10 until EPA approves a revised NSR

rule.

E. Maintenance Plan

Comment 13: EJ maintains that even

if all bf the other issues it has raised

with respect to the redesignation were

remedied, EPA cannot approve the

redesignatioin request because the

maintenance plan is flawed and cannot

be approved. EJ concludes that EPA's

decision to approve the maintenance

plan without the requisite analysis and

without meeting the basic requirements

laid out in the Calcagni memorandum

leaves little for EJ to comment upon

and, as such, is the very definition of

arbitrary and capricious. EJ believes that

EPA's obligation is to provide not just

its legal conclusions but the facts and

rationale that support them.

Response 13: EPA disagrees. Our

proposed rule lays out all of the

requirements for maintenance plans

found under the CAA and the Calcagni

memorandum and sets forth the

Agency's analysis of how the 2007 Plan

meets each of those requirements. 73 FR

22307, 22313-22315. In addition, the

2007 Plan itself addresses in detail the

requirements in the Calcagni

memorandum. Thus EJ's contention that

EPA's discussion of the maintenance

plan'left them "very little" to comment

on is without basis.

Comment 14: EJ asserts that the 2005

emissions inventory is insufficient to

identify the level of emissions in the

area because the continuing PM-ia

problem is the result of direct PM-10

emissions during the fall rather than

secondary wintertime NOx emissions

and the direct PM-10 inventory is

expected to increase over the next 10

years. EJ states that EPA's claim that

increasing direct PM-IO emissions are

offset by a larger decrease in the NOx

inventory demonstrates a lack of

understanding of the PM-10 problem in

the SJV nonattainment area because

reducing secondarily formed PM-10

does nothing to reduce the ongoing

direct PM-ia problems. EJ concludes

that since the maintenance

demonstration is based on an inventory

that is insufficient to attain the NAAQS,

EPA cannot find that the plan will

maintain healthful air for 10 years

following redesignation.

In a footnote to its comment above

regarding the emissions inventory for

the maintenance plan, EJ claims that

prior to 2004 the District had never

asked EPA to waive PM-Ia data but in

the past 4 years it has been asked to

waive 11 separate events, 10 of them

after the Agency's original attainment

finding. EJ states that if windy days are

this common EPA and the District must

accept that the SJV nonattainment area

has a windblown dust problem and they

must do more to control it. EJ states that

an event is only exceptional if it is not

expected to recur on a regular basis.

Response 14: As discussed in our

proposed rule, the Calcagni

memorandum provides that a state

should provide an attainment emissions

inventory to identify the level of

emissions in the area sufficient to attain

the NAAQS and, where the state as here

has made an adequate demonstration

that air quality has improved as a result

of the SIP (see above responses to

comments 3 through 4 and 6 through 8),

the attainment inventory will generally

be an inventory of actual emissions at

the time the area attained.

The 2007 Plan does exactly what the

Calcagni memorandum recommends

and selects the 2005 PM-10 and NOx

inventories as the attainment emission

inventories because the SJV area

attained the standard in 2005. 73 FR

22307, 22314 and 71 FR 63642. The SJV

area relies on reductions of both NOx (a

PM-10 precursor) and directly emitted

PM-10 sources to achieve attainment.

2003 PM-10 Plan at ES-9 through ES10, Chapters 2, 4 and 5; 69 FR 5412,

5414 and 69 FR 30006, 30007. Analysis

of ambient air quality data for the SJV

area shows that it experiences the most

frequent and severe exceedances from

October through January during

stagnant weather conditions (i.e., low

wind speeds that are unable to disperse

the PM-10). 9 Both direct PM-10 and

secondary PM-10 (formed by reactions

with NOx ) occur during this time.

October and November exceedances are

dominated by direct PM-10 emissions

and December and January are

dominated by secondary PM-10 such as

ammonium nitrate (formed when NOx

reacts with ammonia and other

components); however, the reduction of

both direct PM-10 and NOx is necessary

for reducing ambient PM-10 levels

throughout the year. 2003 PM-IO Plan

at ES-9 through ES-10 and 5-6 through

5-7. Thus, EPA's belief that the slight

increase in PM-10 emissions of 284 tpd

in 2005 to 290 tpd in 2020 is

insignificant when compared to the

substantial NOx decreases of 606 tpd in

2005 to 328 tpd in 2020 is based on an

understanding that high PM-10 levels

in the SJV area are caused by both direct

PM-10 and precursor NOx emissions. In

addition, consistent with the Calcagni

memorandum, the modeled

maintenance demonstration is primarily

based on modeling similar to the

modeling used for the 2003 PM-10 Plan.

73 FR 22307, 22314. Finally, contrary to

EJ's comments, there is no ongoing

direct PM-iO problem in the SJVAB as

we have determined that the area has

attained the PM-IO standard. 71 FR

63642 and 73 FR 14687. See also

response to comment 1.

EJ's comment in footnote 3 of its letter

does not appear to be related to the

inventory or any other provision of the

maintenance plan in the 2007 Plan or

the maintenance plan requirement of

CAA section 107(d)(3)(E)(iv). Rather it

appears to be an expansion of EJ's

argument that the SJV area has not in

fact attained the PM-ia standard. In this

9 As discussed in our attainment affirmation and

proposed rule, unusually high winds can also cause

exceedances. 73 FR 14687 and 73 FR 22307, 22311.

Federal Register /Vol. 73, v

HeinOnline -- 73 Fed. Reg. 66767 2008
66768 Federal Register/Vol. 73, No. 219/Wednesday, November 12, 2008/Rules and Regulations

regard, see response to comment 1

above. Notwithstanding, EPA notes that

not all of the exceptional event days in

the past five years in the SJV area have

been due to high winds. Of the eleven

exceptional event days, seven were

caused by high wind events and the

remaining four by construction,

improper monitor siting and fireworks.

Comment 15: EJ states that it is not

clear whether the modeling takes into

account the September 2004 and

November 2005 exceedances EPA has

conceded but if it does not then the

modeling for the maintenance plan is

flawed because it fails to include these

higher values in its projections.

Response 15: As discussed in our

proposed rule, a state may generally

demonstrate maintenance of the

NAAQS by either showing that future

emissions of a pollutant or its

precursors will not exceed the level of

the attainment inventory, or by

modeling to show that the future

anticipated mix of sources and emission

rates will not cause a violation of the

NAAQS. 73 FR 22307, 22314-22315.

See also Calcagni memorandum at 9 and

Wall v. EPA, 265 F.3d 426 (6th Cir.

2001). While only required to use one of

these methods, the SJVAPCD showed

both with emissions inventory and

modeling that the area would maintain

the standard for at least ten years after

redesignation, in accordance with

section 175A. For areas such as the SJV

that used modeling for their attainment

demonstrations, the same level of

modeling should be used for the

maintenance demonstrations. The 2007

Plan uses Chemical Mass Balance (CMB)

and rollback to demonstrate

maintenance of the 24-hour PM-10

standard until 2020 which is consistent

with the modeling performed for the

2003 PM-10 Plan. 73 FR 22307, 22314;

2007 Plan at 6-11. The modeling

involves selecting a representative day

for each location, determining the

speciation data for the site based on

analysis of the monitoring filters and

sources in the area and determining the

emissions reductions that are necessary

or that will be achieved due to

emissions reductions from implemented

rules.

The 2007 Plan's maintenance

demonstration modeling was based on

the highest episodes during the most

recent attainmewt year at the time, 2006.

The District selected representative peak

winter days for each of the monitors in

the SJVAB for modeling, and used the

observed values from those days as the

basis of its modeling exercise. In

addition, fall episode days were

included for several monitors. Table 2 of

the 2007 Plan summarizes the episode

values and the 2020 projections.

One of the objectives in determining

appropriate representative episodes is to

choose those days that are

approximately as severe as the design

value for the modeled pollutant. The

design value is based on three years of

monitoring data, or in this case, 2004

through 2006, and depends on the

frequency and completeness of recorded

values. In addition, for PM-IO, the

design values are generally based on

FRM data, but FEM data can also be

used; however, as noted in footnote 3

above, data from different monitoring

instruments are not combined.

The representative days selected for

modeling are consistent with the design

values for the'Corcoran and Bakersfield

sites where the September 2004 and

November 2005 values were measured.

For the Corcoran FRM, the design value

is 140 gg/m 3, based on a calculation that

includes and explicitly accounts for the

217 gg/m 3 measured in September

2004.10 This value is very close to, and

supports the selection of, the two

representative high episode values in

the 2007 Plan for Corcoran: A 136 gg!

M3 for the winter episode and a 137 gg/

M3 for the fall episode. The small

differences between the design value of

140 jg/m3 and the selected winter and

fall episode values is not an issue

because the projected maintenance

levels are well below the 24-hour PM10 standard of 150 jg/m3. 2007 Plan at

Table 2. The Bakersfield FEM does not

have a complete set of data from 2004

through 2006, and therefore a design

value for this time period cannot be

calculated based on the FEM data.

However, the 2004-2006 PM-10 design

value for Bakersfield using the data

collected with the FRM monitor would

be 154 ug/m 3.

1 This concentration is

consistent with the values of 153 ug/m3

and 154 ig/im3 measured during the

representative modeled episodes

included in the 2007 Plan for

Bakersfield. Therefore, the September

2004 and November 2005 exceedances

to which EJ refers in its comment were

1o If we assume that the September 2004

exceedance is not flagged, the highest recorded PM10 values from 2004 through 2006 are: (1) 217 jig/

m3 on September 3, 2004-; (2) 140 hg/m3 on October

26, 2006; and (3) 139 pg/m 3 on October 15, 2004.

Since the Corcoran FRM operates on a one-in-three

day schedule, the design value is based on the

second highest recorded PM-IO value, or 140 pg/

M 3

.

11 The design value for Bakersfield is calculated

using the FRM data set from 2004-2006. The design

value in this case would be the highest non-flagged

value for the three year period. 154 pg/m 3 measured

on December 7, 2006.

taken into account in the 2007 Plan's

maintenance demonstration modeling.

Comment 16: While EJ is glad that the

District plans to continue operation of

its PM-10 monitoring network, EJ is

troubled that the District suggests in its

2008 "Ambient Air Monitoring Network

Plan" that it may reduce the frequency

of its monitoring. EJ hopes that the

District will strengthen its network

because EJ continues to believe that the

current network does not adequately

represent the west side communities

and the near-highway areas of high

concentration and that more monitoring

is required.

Response 16: In 2003, EPA evaluated

the adequacy of the monitoring network

for the SJV area and concluded that it

meets all the applicable statutory and

regulatory requirements. See 69 FR

30006, 30033 and "Evaluation of the

Adequacy of the Monitoring Network

for the San Joaquin Valley, California for

the Annual and 24-Hour PM-10

Standards," Bob Pallarino, EPA,

September 22, 2003. We reaffirmed the

adequacy of the network in our 2006

determination of attainment for the SJV

area. 71 FR 63642, 63648-63658.

With regard specifically to monitoring

frequency, EPA regulations require

minimum frequencies for manual PM10 and PM-2.5 samplers at designated

state or local air monitoring stations

(SLAMS) sites. See 40 CFR 58.12. On

October 17, 2006 EPA revised its

monitoring regulations to require air

monitoring agencies to perform an

assessment of their monitoring networks

every five years according to guidance

issued by EPA. See 71 FR 61299 and 40

CFR 58.10(d). The first monitoring

network assessment required by this

regulation must be submitted to EPA by

July 1, 2010. Agencies are directed to

make changes to their monitoring

networks based in part on the results of

these network assessments. Such an

assessment in the SJVAB area may

result in a requirement that the District

increase the sampling frequency of

certain PM-10 monitors sited to record

the maximum concentrations of PM-10

pollution. See 40 CFR 58.12(e).

Most manual PM-10 samplers in the

SJV monitoring network currently

operate at the minimum required

frequency of once every six days, except

for Corcoran which operates-manual

PM-10 samplers once every three days.

The District has exceeded this required

sampling frequency by operating

continuous FEM monitors, which

produce a 24-hour average PM-10

concentration every day, at three

locations in the SJVAB area, Tracy,

Corcoran and Bakersfield. According to

the District's 2008 "Ambient Air

HeinOnline -- 73 Fed. Reg. 66768 2008
Federal Register/Vol. 73, No. 219/Wednesday, November 12, 2008/Rules and Regulations 66769

Monitoring Network Plan," the

Corcoran and Bakersfield-Golden State

Highway sites are two of the four PM10 monitoring sites located to record the

highest PM-10 concentrations in the

SJVAB area.12 Therefore, the District has

already proactively increased the

sampling frequency at two high

concentration sites to the maximum

frequency possible.

Comment 17: EJ believes that the

contingency measure provision in the

maintenance plan is much too weak and

cannot be approved. EJ states that the

provision relies first and foremost on

trying to excuse any future violation

under the EER and then, in the event of

any post-redesignation violations, on

seeing if there are any estimated

reductions achieved that were not

counted towards the attainment

demonstration that can be used to

"cover" the violation. EJ does not

believe this approach makes sense

because if an area is violating the

standard, there are no "extra"

reductions because all of the reductions

are by definition not working. EJ

believes that while EPA may accept this

gaming in the context of RFP

demonstrations such an approach

would be illegal and arbitrary when real

ambient violations are being monitored.

EJ believes that the District should

adopt the approach suggested in the

Calcagni memorandum which sets

indicators that trigger contingency

provisions before a violation occurs

which would avoid NAAQS violations

and not just come up with on-paper "covers" for those violations.

Response 17: Under CAA section

175A(d), maintenance plans must

contain "such contingency provisions as

the Administrator deems necessary to

assure thAt the State will promptly

correct any violation of the standard."

The Calcagni memorandum states that

"EPA will review-what constitutes a

contingency plan on a case-by-case

basis. At a minimum, it must require

that the State will implement all

measures contained in the Part D

nonattainment plan for the area prior to

redesignation. * * * " Calcagni

memorandum at 12-13. The

memorandum also makes clear that a

monitored violation of the standard is

appropriate to serve as the indicator or

trigger for contingency measures.

Id. at 12.

EJ's statement that the contingency

provisions of the 2007 Plan "relies first

and foremost" on trying to excuse any

future violation under the EER is

misleading. The 2007 Plan selects an

12"The other two sites are the Fresno-First Street

site and the Stockton-Hazelton site.

action level or trigger based on an

exceedance of the PM-10 NAAQS of

155 micrograms per cubic meter (gg/ m 3

). 1 3 2007 Plan at 16. In addition, the

District may also consider other factors

such as a succession of values just

below but near the level of the PM-10

standard. In our proposed rule we

explained why we believe that an

exceedance of 155 jig/m 3 is an

appropriate trigger:

The SJVAB has several continuous PM-10

monitors, and a single measurement of 155

jg/m3 at one of these monitors would not

constitute a violation of the PM-10 NAAQS.

Even if a measurement of 155 gg/m 3 is

recorded at a one-in-six day FEM, a violation

is not necessarily being recorded as the State

might need to evaluate the possibility that

the measurement is due to an exceptional

event.

73 FR 22307, 22315. Thus the

contingency plan makes clear that

determining whether an exceedance of

the PM-l0 standard is due to an

exceptional event is part of determining

whether a violation of the standard

actually occurred, which would require

corrective actions. In other words, we

concluded that the 2007 Plan's action

level or trigger, including the exclusion

of exceedances caused by exceptional

events, meets the statutory mandate that

the contingency provisions "correct any

violation of the standard." Because it is

clearly part of the action level or trigger,

and not the corrective actions to be

undertaken in the event of a violation,

it is not accurate to conclude, as EJ does,

that the contingency plan relies "first

and foremost" on the use of the EER.

Moreover, since an exceedance, which

is not necessarily a violation, triggers

the contingency measure provision, the

provision may also be used to prevent

violations of the NAAQS, and at a

minimum provides for a violation that

is determined not to be due to an

exceptional event to trigger a measure. Once the contingency plan is

triggered, the District would determine

the possible causes of the exceedance

and determine if emissions reductions

from adopted measures that are not

needed to maintain the PM-10 NAAQS

are available to serve as contingency

measures. 2007 Plan at 16. EJ objects to

the use of these excess reductions (i.e.,

those not relied on in the maintenance

demonstration) when ambient

concentrations are being monitored.

13 An exceedance is defined as a daily value that

is above the level of the 24-hour standard (150 pg/

m3) after rounding to the nearest 10 jg/m3 (i.e.

values ending in 5 or greater are to be rounded up).

Thus, a recorded value of 154 ig/m 3 would not be

an exceedance since it would be rounded to 150 Vg/

M 3 whereas a recorded value of 155 gig/m 3 would

be an exceedance since it would be rounded to 160

ig/m3. See 40 CFR part 50, appendix K, section 1.0.

Initially we note that EPA has long

approved contingency provisions that

rely on reductions from measures that

are already in place but are over and

above those relied on in the attainment

and RFP demonstrations under CAA

section 172(c)(9). See, e.g., 62 FR 15844

(April 3, 1997); 62 FR 66279 (December

18, 1997); 66 FR 30811 (June 8, 2001);

66 FR 586 and 66 FR 634 (January 3,

2001). We discussed this interpretation

of section 172(c)(9) in our final PM-2.5

implementation rule. See 72 FR 20586,

20642-20643 (April 25, 2007). This

interpretation has also been upheld in

LEANv. EPA, 382 F.3d 575 (5th Cir.

2004), and the court in that case set

forth in detail the reasoning for

accepting excess reductions from

already adopted measures as

contingency measures. In addition to being triggered by a

failure to meet RFP, contingency

measures under section 172(c)(9) are

triggered when EPA determines that an

area has failed to attain a NAAQS.

Determinations of whether an area has

attained a NAAQS (see, e.g., section

188(b)(2); 71 FR 40952) are based on

monitored concentrations. Likewise,

here, a determination of whether the

action level has been reached is based

on monitored concentrations. Therefore

our interpretation that excess emission

reductions can appropriately serve as

section 172(c)(9) contingency measures

is equally applicable to section 175A(d)

contingency measures. Furthermore, section 172(c)(9) is

considerably less flexible than section

175A(d) in that under the former

provision contingency measures are

required to be fully adopted measures

that will take effect without further

action by the state, whereas this is not

a requirement in order for the

maintenance plan to be approved.

Moreover, section 175A(d) grants

considerably more discretion to EPA in

determining whether to accept

contingency provisions in maintenance

plans (maintenance plans must contain

"such contingency provisions as the

Administrator deems necessary to

assure that the State will promptly

correct any violation of the standard."

(Emphasis added). In addition, the

Calcagni memorandum at 12-13 states

that a contingency plan under section

175A(d) "[alt a minimum must require

that the State will implement all

measures contained in the Part D

nonattainment plan for the area prior to

redesignation. * * * " The 2007 Plan so

provides and goes well beyond this

minimum threshold.

The U.S. Court of Appeals for the

Sixth Circuit addressed the issue of the

adequacy of reductions from already

HeinOnline -- 73 Fed. Reg. 66769 2008
No. 219/Wednesday, November 12, 2008/Rules and Regulations

adopted measures in the context of

section 175A(d) contingency measures

in a maintenance plan for Cuyahoga

County, Ohio. Greenbaum v. EPA, 370

F.3d 527 (6th Cir. 2004). 14 There EPA

had approved section 172(c)(9)

contingency measures into the SIP in

1996 as part of the State's moderate area

PM-10 nonattainment plan. In

approving these measures EPA found

that they provided for emission

reductions following any prospective

determination that the SIP failed to

provide for timely attainment of the

NAAQS. In 2000, Ohio submitted a

redesignation request with a

maintenance plan that included. as

section 175A(d) contingency provisions

the already approved section 172(c)(9)

contingency measures. Among other

things, the petitioners argued that the

CAA does not authorize EPA to use

other measures outside the maintenance

plan to assure correction of a violation.

In upholding EPA's approval of the

redesignation, the court found that:

[tihe Administrator has been granted broad

discretion by Congress in determining what

is 'necessary to assure' prompt correction.

The EPA has approved Ohio's maintenance

plan, concluding that its contingency measures provide a means to deal with likely

violations. We do not believe that thisdetermination is 'arbitrary, capricious, or manifestly contrary to the statute.' Chevron,

467 U.S. at 844.

The Sixth Circuit in Greenbaum further

noted that Congress contemplated that

contingency measures need not be

sufficient to correct all violations and

that EPA and the state could rely on a

combination of factors to correct

violations. See the extensive discussion

of contingency measures in Greenbaum.

Here, the 2007 Plan looks first to

emission reductions from adopted

measures that are not needed to

maintain the PM-10 NAAQS to serve as

section 175A(d) contingency measures.

If these emission reductions prove to be

insufficient to correct the violation, the

District commits to proceed with

identifying control measures from

feasibility studies such as those found

in its 2007 Ozone Plan and Proposed

2008 PM2.5 Plan 15 (see 2007 Ozone

Plan at Table 6-2 and 2008 PM2.5 Plan

at Table 6-4) and with prioritizing

measures most relevant for reducing

PM-10 emissions. 2007 Plan at 16-17.

14 As early as 1995, EPA approved a maintenance

plan under section 175A that included contingency

provisions that relied in part on measures to be

implemented prior to any post-redesignation

NAAQS violation. See 60 FR 27028, 27029 (May 22,

1995).

1

3 The 2008 PM2.5 Plan was adopted by the

District on April 30, 2008, approved by the State on

May 22, 2008, and submitted to EPA on June 30,

2008.

The SJVAPCD ha§ also provided

clarification that if additional control

measures are necessary, the SJVAPCD

will adopt and implement such

measures. Letter from Seyed Sadredin,

SJVAPCD, to Deborah Jordan, EPA,

April 17, 2008. EPA believes that the

2007 Plan's contingency provisions

which rely in part on emissions

reductions from adopted measures not

neededto maintain the PM-10 NAAQS

to correct any PM-10 violation are

consistent with the Agency's policies

and with the statute. As the court in

Greenbaum observed, Congress has

expressly delegated to EPA the authority

to determine what contingency

measures are necessary. Here, EPA has

determined that the contingency

measures, which include both the

potential for emission reductions from

already adopted measures and from

measures to be adopted, clearly are

sufficient.

Finally, with respect to EJ's

preference, suggested in the Calcagni

memorandum, that the contingency

plan for the SJVAB area set indicators

that trigger contingency provisions

before a violation occurs, we note again

that the memorandum provides that

contingency provisions are to be judged

on a case by case basis. See also

Greenbaum. With the exception of the

minimum requirement mentioned

above, the Calcagni memorandum is not

prescriptive and allows for considerable

latitude as to what constitutes an

adequate contingency plan. The

Calcagni memorandum itself provides

that a violation of the standard is an

appropriate trigger for contingency measures. Calcagni memorandum at 12.

See also Greenbaum. It is a common

practice in maintenance plans to

provide that a violation will trigger the

requirement for a contingency measure

to be implemented. Moreover, as

pointed out above, under the

contingency measure provisions, a

monitored exceedance of the standard

that does not itself constitute a violation

(e.g., at a continuous monitor or a onein-three day FRM monitor) could trigger

a contingency measure prior to a

violation occurring.

F. Revision of Boundary Designation

Comment 18: EJ maintains that the

portion of the San Joaquin Valley that

EPA now proposes to split off was

designated as part of the SJV

nonattainrnent area because, as

provided in CAA section 107(d)(1)(A), it was part of the geographic area "that

does not meet (or that contributes to

ambient air quality in a nearby area that

does not meet) the national primary or

secondary air quality standard for that

pollutant." EJ states that EPA makes no

attempt to explain how circumstances

have changed to justify the removal of

this portion of the designated

nonattainment area. EJ notes that the

SJV area includes other high-elevation

areas that are located above the

inversion layer and that whether a

community is above or below the

inversion layer is irrelevant because

these areas are part of the Valley and

part of the same air basin polluted by

emissions generated in the Valley.

Response 18: As discussed in our

proposed rule, on January 31, 2008

California requested a boundary

redesignation splitting the SJV

nonattainment area into two separate

nonattainment areas, the SJVAB and

East Kern. Section 107(d)(3)(D) of the

CAA authorizes the State to submit to

EPA a revised designation of any area

and EPA is required to approve or deny

it within 18 months of receipt of a

complete State submittal. The type of

revised designation that the State of

California requested involves a

boundary change only and does not

involve a change in status (e.g., from "nonattainment" to "attainment" or "unclassifiable") of any area. Our

criteria for evaluating the State's request

are discussed in our proposed rule.

In general, the State has provided a

compelling technical justification for

splitting the nonattainment area which

includes an evaluation of the differences

in jurisdiction, geography, population

and degree of urbanization, employment

and traffic/commuting patterns,

emissions and air quality. 73 FR 22307,

22308-22310. EJ notes that there are

other high elevation areas in the SJV

nonattainment area; however, the State

has not made a request to revise any

other boundaries. In addition, as

discussed in our proposed rule, the

SJVAB and East Kern areas are in

separate air basins and do'not have the

same mix of air pollution sources. Id.

EPA continues to believe that it should

grant the State's request for a revised

designation splitting the SJV

nonattainment area into two PM-10

nonattainment areas, the SWAB area

and the East Kern area for the reasons set forth in the proposed rule and in this

response.

Comment 19: A commenter states that

while the proposal to separate the

western portion of the KCAPCD is clear

and compelling, the commenter is

concerned about environmental justice

issues for the East Kern area. The

commenter states that if the purpose of

the separation is to clean-up one area

and ignore the other industrialized area

with the State prison, then EPA is not

following its ethics concerning

66770 Federal Register /Vol. 73,

HeinOnline -- 73 Fed. Reg. 66770 2008
Federal Register/Vol. 73, No. 219/Wednesday, November 12, 2008/Rules and Regulations 66771

environmental justice. The commenter

states that communities with prisons

serve as a target of environmental

neglect and should not be abandoned

from environmental laws and

attainment requirements and should not

be forgotten by EPA.

Response 19: EPA's final action to

split the SJV nonattainment area into

two nonattainment areas does not relax

any requirements. EPA is also approving

enforceable commitments for the East

Kern area that will ensure progress in

meeting CAA requirements for the area.

These commitments include the

installation of a FRM/FEM 16 and

submittal of a SIP addressing applicable

CAA requirements if the monitor

violates the PM-10 standard. 73 FR

22307, 22317. In the meantime, the

existing data from the IMPROVE

monitor, although not a FRM or FEM,

do not indicate an air quality problem

in East Kern-rather they show levels

that are consistently significantly below

the standard. See id. at 22310 ("* * *

IMPROVE monitor has, since February

2000, consistently measured PM-10

concentrations far below the PM-10

standard.").

With respect to the commenter's

concerns for fair treatment of the

inhabitants of East Kern, EPA is taking

steps to assure that the East Kern area

will not be forgotten by EPA, and no

community in that area will be "abandoned from environmental laws

and attainment requirements." EPA is

committed to meeting the goals of

environmental justice and is equally

concerned for the populations of both

the SJVAB and East Kern areas. There is

no basis for concluding that the

population of East Kern is exposed to

ongoing levels above the standard, and

EPA and the State have worked to

provide assurances that the area will be

required to conduct more

comprehensive monitoring and to adopt

additional requirements if needed. Thus

EPA recognizes the role of

environmental justice and is observing

its principles.

Comment 20: A commenter disagrees

with the proposed rule's statement that

the boundary redesignation makes sense

because of the difference in chemical

composition of PM-10 between the two

areas. The commenter believes this is

not a valid statement because there are

16 Currently there is no FRM or FEM monitoring

of PM-IO in the East Kern area. However, there is

an Interagency Monitoring of Protected Visual

Environments (IMPROVE) monitor located in the

Kern River Valley. Pursuant to its commitment,

CARB has purchased the new monitor and has

secured permission from the Bureau of Land

Management to install it next to the existing

IMPROVE monitor.

no FRMs or FEMs in the East Kern area.

Furthermore, the commenter states that

the one IMPROVE monitor in the East

Kern area is inadequate and the

chemical composition of the SWAB and

East Kern should not be compared until

there is an adequate monitoring system

in East Kern. In addition, the

commenter concludes that a reanalysis

of reported data must be performed

before considering attainment for the

SWAB.

Response 20: We based our

conclusion that the SVAB and East

Kern should be separate nonattainment

areas on multiple factors, only one of

which relates to the difference in the

types of air pollutants in the two areas.

See 73 FR 22307, 22310. While the

commenter is correct that there is no

FRM or FEM in the East Kern area, as

stated above, the State and the District

have committed to install an FRM/FEM

in the East Kern area. Pending data from

this new monitor, the IMPROVE

monitor does provide useful

information regarding the composition

of PM-10 in the area. See id. and

Attachments B and C to letter from

James N. Goldstene, CARB, to Deborah

Jordan, EPA, January 31, 2008. See also

response to comment 19. The newly

created East Kern area will retain its

nonattainment designation until the

State can demonstrate, following

assessment of data from the new

monitor, that all the applicable CAA

requirements for redesignation of the

East Kern area are met.

EPA does not agree that a reanalysis

of the reported data must be performed

before considering whether the SWAB

area has attained the PM-10 standard.

As noted above, EPA has found that the

SWAB area has an adequate monitoring

system on which to base such a

determination. See 69 FR 30006, 30033,

71 FR 63642, 63648 and "Evaluation of

the Adequacy of the Monitoring

Network for the San Joaquin Valley,

California for the Annual and 24-Hour

PM-l0 Standards," Bob Pallarino, EPA,

September 22, 2003. To demonstrate

attainment, an area must show that it

meets the standard over a three-year

period. The SJVAB area has

demonstrated attainment over three

separate 3-year periods-2003-2005,

2004-2006, and 2005-2007, and it

continues to attain the standard.

G. Miscellaneous Comments

Comment 22: A commenter states that

there are several gaps in evaluating the

PM-10 data for the SJVAB from 1990 to

2004 and that given the cyclical nature

of PM-10 the downward trend should.

be considered inconclusive until all

yearly averages are taken into account as

well as seasonally weighted averages.

The commenter also states that in the

proposed rule's discussion of

meteorological conditions a lower

stability level would more likely lead to

less dispersion and higher PM-10

values. The commenter believes the

lower stability means the PM-l0 levels

were overestimated and provides

information as to the unequal

distribution in the surrounding

community and who is bearing the

brunt of the higher exposures.

Response 21: In our proposed rule we

reference the expected PM-10

exceedances from 1990-1992, 1998-

2000 and 2002-2004 to show that there

has been a significant decline in

NAAQS exceedances over the past 17

years, i.e., from 1990 through 2006.

There are no data gaps; the 2007 Plan

includes data for each year. 2007 Plan

at 23-24, Figure 2. EPA believes that a

17 year period is sufficient to establish

a trend that accounts for any cyclical

changes in PM-10 data. In addition, an

evaluation of the seasonal conditions

causing PM-10 is provided in the 2003

PM-10 Plan. 2003 PM-IO Plan at ES-4

to ES-10 and Chapter 2.

EPA examined meteorological data,

including information about

atmospheric stability, wind speeds,

precipitation and temperature in order

to determine if there were any

unusually favorable meteorological

conditions that would cause PM-10

exceedances. EPA determined that

overall there was no consistent pattern

of favorable meteorology. 73 FR 22307,

22312; responses to comments 3 and 6

above.

For the SWAB area, it has been

determined that on an annual average

basis, unstable conditions (or low

stability) result in dispersion of

pollutants and lower PM-10 levels and

stable conditions (or high stability)

result in a temperature inversion which

keeps emissions at the surface and leads

to higher PM-10 levels. 2007 Plan at

Appendix C. During the attainment

period of 2003 through 2006, the SJVAB

area experienced somewhat low

stability which allowed for dispersion of

pollutants and lower PM-10 levels;

however, as discussed in response to

comment 6 above, based on the analysis

of all the meteorological parameters,

EPA determined that there was no

overall pattern which favored improved

PM-10 levels.

It is not completely clear to EPA what'

point the commenter is trying to make

regarding stability. EPA acknowledges,

however, that unstable conditions

combined with other factors (e.g.,

emissions) in the SW area can lead to

HeinOnline -- 73 Fed. Reg. 66771 2008
66772 Federal Register/Vol. 73, No. 219/Wednesday, November 12, 2008/Rules and Regulations

high PM-10 levels on a daily basis, as has been seen with exceedances that

occur during high wind events. Such

exceedances however have been

excluded from regulatory consideration

under EPA's Exceptional Events Rule.

73 FR 22307, 22310-22311 and 73 FR

14687.

Comment 22: The SJVAPCD provided

comments supporting EPA's proposed

actions and also notes a minor

typographical error for the proposed

transportation conformity budgets found

in Table 4 for Merced County for 2005.

The SJVAPCD states that the budget

should read 39.4 tons per day and not

39.2 tons per day.

Response 22: EPA appreciates the

comments and has made the correction

in today's final action.

III. Final Actions

For the reasons set forth in the

proposed rule and in the responses to

comments above, EPA i$ taking the final

actions summarized below:

Having concluded that the State has

addressed all the necessary

requirements for a revised boundary

designation, EPA is approving the

State's request under section

107(d)(3)(D) to revise the boundary

designation for the SJV PM-10

nonattainment area by splitting the area

into two separate serious PM-10

nonattainment areas, the SJVAB PM-10

nonattainment area and the East Kern

PM-10 nonattainment area.

Having concluded that the CAA

requirements of section 107(d)(3)(E) for

redesignations and section 175A for

maintenance plans have been met for

the SJVAB area, EPA is approving the

State's request to redesignate the newly

created serious SJVAB nonattainment

area to attainment for the PM-10

NAAQS and approving the 2007

maintenance plan for the area.

EPA is also approving the conformity

trading mechanism for the SJVAB area

and the motor vehicle emissions subarea

budgets for the attainment year, 2005,

and the maintenance year, 2020, found

in Table 3 below. The 2005 attainment

year budget replaces the current

attainment budgets from the approved

2003 PM-10 Plan. These budgets are

approved as of November 12, 2008

1ursuant to section 93.118(f)(2)(iii). 17

TABLE 3-MOTOR VEHICLE EMISSIONS SUBAREA BUDGETS 2007 PLAN*

[Tons per day]

2005 2020

County

PM-10 NOx PM-10 NOx

F resno .............................................................................................................................. 13.5 59 .2 16 .1 23.2

Kern ** ................... ......................................... 12.1 88.3 14.7 39.5

Kings ...... ......................................................... 3.1 16.7 3.6 6.8

M adera .......................................... 3.6 13.9 4.7 6.5

Merced*** ...... ...................................................... 6.2 39.4 6.4 12.9

San Joaquin .................... ................... 9.1 42.6 10.6 17.0 Stanislaus ..................... .................................. 5.6 29.7 6.7 10.8

T u la re ............................................................................................................................... 7 .3 25 .1 9 .4 10.9

T otal .......................................................................................................................... 60 .5 3 14 .9 72 .2 127 .6

*The budgets are based on attainment and maintenance of the 24-hour PM-10 NAAQS. The annual standard was revoked on December 18,

2006. See 71 FR 61144.

•* MVEBs in Table 3 are only for the SJVAB portion of Kern County. *** EPA's April 25 and May 23, 2008 proposed rules (73 FR 22307 and 73 FR 30029) incorrectly include 39.2 tons per day for the Merced 2005 NOx subarea budget. This was a typographical error. The number provided in the State's submittal of the 2007 Plan is 39.4 tons per day, which is reflected in Table 3 above.

EPA is excluding from use in

determining that the SJVAB area has

attained the PM-10 NAAQS two

exceedances that it has concluded were

caused by exceptional events on July 4,

2007 and January 4, 2008, and is

determining that the SJVAB area

continues to attain the PM-la standard.

Finally, EPA is approving

commitments from KCAPCD and CARB

to install a FRM or FEM in the newly

created East Kern serious PM-10

nonattainment area and to address

section 189(d) CAA requirements for the

area in a SIP revision in the event the

FRM or FEM records a violation of the

PM-10 standard.

1740 CFR 93.118(f)(2) applies when EPA reviews

the adequacy of an implementation plan

simultaneously with EPA's approval or disapproval

of the implementation plan. as is the case here.

IV. Statutory and Executive Order

Reviews

Under Executive Order 12866 (58 FR

51735, October 4, 1993), this action is

not a "significant regulatory action" and

therefore is not subject to review by the

Office of Management and Budget. For

this reason,this action is also not

subject to Executive Order 13211,

"Actions Concerning Regulations That

Significantly Affect Energy Supply,

Distribution, or Use" (66 FR 28355, May

22, 2001). This action merely approves

a revised boundary designation, a redesignation to attainment for the

SJVAB, a maintenance plan for the

SJVAB area, motor vehicle emissions

budgets and conformity trading

mechanism for the area and

commitments for the East Kern area, all

Subsection (f)(2)(iii) provides that "liif EPA makes

an adequacy finding through a final rulemaking that

approves the implementation plan submission,

such a finding will become effective upon the

of which were either requested or

submitted by the State. Accordingly,'the

Administrator certifies that this rule

will not have a significant economic

impact on a substantial number of small

entities under the Regulatory Flexibility

Act (5 U.S.C. 601 et seq.). Because this

rule does not impose any additional

enforceable duty, it does not contain

any unfunded mandate or significantly

or uniquely affect small governments, as

described in the Unfunded Mandates

Reform Act of 1995 (Pub. L. 104-4).

Executive Order 13175 (65 FR 67249,

November 9, 2000) requires EPA to

develop an accountable process to

ensure "meaningful and timely input by

tribal officials in the development of

regulatory policies that have tribal

implications." Seven Indian tribes have

publication date of EPA's approval in the Federal

Register."

HeinOnline -- 73 Fed. Reg. 66772 2008
Federal Register/Vol. 73, No. 219/Wednesday, November 12, 2008/Rules and Regulations 66773

reservations located within the

boundaries of the SJVAB. EPA has

consulted with representatives of the

tribes and will continue to work with

the tribes as provided for in Executive

Order 13175. Accordingly, EPA has

addressed Executive Order 13175 to the

extent that it applies to this action. This

action also does not have Federalism

implications because it does not 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, as specified in

Executive Order 13132 (64 FR 43255,

August 10, 1999). This action merely

approves requests or submittals from the

State and does not alter the relationship

or the distribution of power and

responsibilities established in the Clean

Air Act.

Executive Order 12898 establishes a

Federal policy for incorporating

environmental justice into Federal

agency actions by directing agencies to

identify and address, as appropriate,

disproportionately high and adverse

human health or environmental effects

of their programs, policies, and

activities on minority and low-income

populations. Today's action involves

approvals of a revised boundary

designation, a redesignation to

attainment for the SJVAB area, a

maintenance plan for the SJVAB area,

motor vehicle emissions budgets and.

conformity trading mechanism for the

area and commitments for the East Kern

area. It will not have disproportionately

high and adverse effects on any

communities in the area, including

minority and low-income communities.

This rule also is not subject to

Executive Order 13045 "Protection of

Children from Environmental Health

Risks and Safety Risks" (62 FR 19885,

April 23, 1997), because it is not

economically significant. The

requirements of section 12(d) of the

National Technology Transfer and

Advancement Act of 1995 (15 U.S.C.

272 note) do not apply because it would

be inconsistent with applicable law for

EPA, when determining the attainment

status of an area, to use voluntary

consensus standards in place of

promulgated air quality standards and

monitoring procedures that otherwise

satisfy the provisions of the Clean Air.

This rule does not impose an

information collection burden under the

provisions of the Paperwork Reduction

Act of 1995 (44 U.S.C. 3501 et seq.).

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit 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 United

States prior to publication of the rule in

the Federal Register. A major rule

cannot take effect until 60 days after it

is published in the Federal Register.

This action is not a "major rule" as

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

Under section 307(b)(1) of the Clean

Air Act, petitions for judicial review of

this action must be filed in the United

States Court of Appeals for the

appropriate circuit by January 12, 2009.

Filing a petition for reconsideration by

the Administrator of this final rule does

not affect the finality of this rule for the

purposes of judicial review nor does it

extend the time within which a petition

for judicial review may be filed, and

shall not postpone the effectiveness of

such rule or action. This action may not

be challenged later in proceedings to

enforce its requirements. (See section

307(b)(2)).

List of Subjects

40 CFR Part 52

Environmental protection, Air

pollution control, Incorporation by

reference, Intergovernmental relations,

Particulate matter, Reporting and

recordkeeping requirements.

40 CFR Pail 81

Environmental protection, Airpollution control, National parks,

Wilderness areas.

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

Dated: September 24, 2008.

Wayne Nastri,

Regional Administrator, Region IX.

* Parts 52 and 81 of Chapter I, Title 40

of the Code of Federal Regulations are

-amended as follows:

PART 52-fAMENDED]

m 1. The authority citation for Part 52

continues to read as follows:

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

Subpart F-California

* 2.*Section 52.220 is amended by

adding paragraphs (c)(356) and (357) to

read as follows:

§52.220 Identification of plan. * * * * *

(c) * * *

(356) The following plan was

submitted on November 16, 2007, by the

Governor's Designee.

(i) Incorporation by reference.

(A) San Joaquin Valley Air Pollution

Control District.

(1) 2007 PM10 Maintenance Plan and

Request for Redesignation, adopted by

the San Joaquin Valley Air Pollution .

Control District on September 20, 2007,

section 6. Contingency Plan on pages 16

to 17.

(ii) Additional materials.

(A) San Joaquin Valley Air Pollution

Control District.

(1) 2007 PM10 Maintenance Plan and

Request for Redesignation, adopted by

the San Joaquin Valley Air Pollution

Control District on September 20, 2007,

except for Appendices A through F.

(2) State of California, Air Resources

Board, Staff Report, Analysis of the San

Joaquin Valley 2007 PM1O Maintenance

Plan, Release Date: October 12, 2007,

Appendix B Emission Inventory.

(3) Letter dated May 13, 2008, from

James N. Goldstene, California Air

Resources Board, to Wayne Nastri, EPA,

providing revised motor vehicle

emission budgets for the 2007 San

Joaquin Valley PM10 Maintenance Plan.

(357) The following commitments

were submitted on February 29, 2008,

by the Governor's Designee:

(i) Incorporation by reference.

(A) Commitments for the installation

and operation of a FRM or FEM PM-10

monitor and SIP development and

submittal.

(1 ) Resolution No. 2008-001-02,

adopted by the Air Pollution Control

Board, Kern County Air Pollution

Control District on February 27, 2008.

(2) Executive Order S-08-004,

adopted by the California Air Resources

Board on March 3, 2008.

PART 81--AMENDED]

* 3. Thq authority citation for Part 81

continues to read as follows:

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

n 4. In § 81.305 the "California-PM10" table is amended under Fresno,

Kern, Kings, Madera, Merced, San

Joaquin, Stanislaus, Tulare Counties by

revising the entry for the "San Joaquin

Valley planning area" to read as follows:

§81.305 California.

HeinOnline -- 73 Fed. Reg. 66773 2008
66774 Federal Register/Vol. 73, No. 219/Wednesday, November 12, 2008/Rules and Regulations

CALIFORNIA-PM-1 0

Designation Classification

Designated Area Date Type Date Type

Fresno, Kern, Kings, Madera, Merced, San Joaquin, Stanislaus, Tulare

Counties:

East Kern; that portion of Kern County which lies between the following

two lines (with the exception of that portion in Hydrologic Unit Number

18090205-the Indian Wells Valley):

(1) West and north of a line described as follows: Beginning at the

southwest corner of section 31, T. 10 N. 16 W. and running east to

the northwest boundary of the Rancho La Liebre Land Grant; then

running north and east along the northwest boundary of the Rancho

La Liebre Land Grant to the point of intersection with the range line

common to R. 15 W. and R. 16 W., San Bemardino Base and Meridian; then north along the range line to the northwest corner of

section 2, T. 32 S., R. 32 E., Mount Diablo Base and Meridian; then

east along the township line common to T. 32 S. and T. 31 S.; then

north along the range line common to R. 35 E. and R. 34 E.; then

east along the township line common to T. 29 S. and T. 28 S.; then

north along the range line common to R. 36 E. and R. 35 E.; then

east along the township line common to T. 28 S. and T. 27 S.; then

north along the range line common to R. 37 E. and R. 36 E. to the

Kem-Tulare County boundary.

(2) East and south of a line of a line described as follows: Beginning

at the southwest comer of section 31, T. 10 N. 16 W. and running

north along the range line common to R. 16 W. and R. 17 W., San

Bernardino Base and Meridian; north along the range line to the

point of intersection with the Rancho El Tejon Land Grant boundary;

then southeast, northeast, and northwest along the boundary of the

Rancho El Tejon Land Grant to the northwest comer of S. 3, T. 11

N., R. 17 W.; then west 1.2 miles; then north to the Rancho El

Tejon Land Grant boundary; then northwest along the Rancho El

Tejon line to the southeast comer of S. 34, T. 32 S., R. 30 E.,

Mount Diablo Base and Meridian; then north to the northwest corner

of S. 35, T. 31 S., R. 30 E.; then northeast along the boundary of

the Rancho El Tejon Land Grant to the southwest corner of S. 18,

T. 31 S., R. 31 E.; then east to the southeast comer of S. 13, T. 31

S., R. 31 E.; then north along the range line common to R. 31 E.

and R. 32 E., Mount Diablo Base and Meridian, to the northwest

comer of S. 6, T. 29 S., R. 32 E.; then east to the southwest comer

of S. 31, T. 28 S., R. 32 E.; then north along the range line com- mon to R. 31 E. and R. 32 E. to the northwest corner of S. 6, T. 28

S., R. 32 E., then west to the southeast corner of S. 36, T. 27 S., R.

31 E., then north along the range line common to R. 31 E. and R.

32 E. to the Kern-Tulare County boundary.

11/15/1990 ........... Nonattainment ..... 11/15/1990 Serious.

HeinOnline -- 73 Fed. Reg. 66774 2008
Federal Register / Vol. 73, No. 219 / Wednesday, November 12, 2008 / Rules and Regulations

CALIFORNIA-PM-1 0-Continued

Designation Classification Designated Area Date Type Date Type

San Joaquin Valley Air Basin; Fresno County, Kings County, Madera December 12, Attainment.

County, Merced County, San Joaquin County, Stanislaus County, Tulare 2008.

County, and that portion of Kern County which lies west and north of a

line described as follows: Beginning at the Kern-Los Angeles County

boundary and running north and east along the northwest boundary of

the Rancho La Libre Land Grant to the point of intersection with the

range line common to R. 16 W. and R. 17 W., San Bemardino Rase and

Meridian; north along.the range line to the point of intersection with the

Rancho El Tejon Land Grant boundary; then southeast, northeast, and

northwest along the boundary of the Rancho El Tejon Land Grant to the

northwest corner of S. 3, T. 11 N., R. 17 W.; then west 1.2 miles; then

north to the Rancho El Tejon Land Grant boundary; then northwest

along the Rancho El Tejon line to the southeast corner of S. 34, T. 32

S., R. 30 E., Mount Diablo Base and Meridian; then north to the northwest corner of S. 35, T. 31 S., R. 30 E.; then northeast along the

boundary of the Rancho El Tejon Land Grant to the southwest comer of

S. 18, T. 31 S., R. 31 E.; then east to the southeast comer of S. 13, T.

31 S., R. 31 E.; then north along the range line common to R. 31 E. and

R. 32 E., Mount Diablo Base and Meridian, to the northwest corner of S.

6, T. 29 S., R. 32 E.; then east to the southwest corner of S. 31, T. 28

S., R. 32 E.; then north along the range line common to R. 31 E. and R.

32 E. to the northwest corner of S. 6, T. 28 S., R. 32 E., then west to

the southeast comer of S. 36, T. 27 S., R. 31 E., then north along the

range line common to R. 31 E. and R. 32 E. to the Kern-Tulare County

boundary.

[FR Doc. E8-26500 Filed 11-10-08; 8:45 am]

BILLING CODE 6560-50-P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[EPA-HO-OPP-2008-0175; FRL-8387-8]

Avermectin; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for combined

residues of the insecticide avermectin

B, and its delta-8,9-isomer in or on

bean, lima, seed. This action is in

response to EPA's granting of an

emergency exemption under section 18

of the Federal Insecticide, Fungicide,

and Rodenticide Act (FIFRA)

authorizing use of the pesticide on large

lima beans. This regulation establishes a

maximum permissible level for residues

of avermectin in this food commodity.

The time-limited tolerance expires and

is revoked on December 31, 2010.

DATES: This regulation is effective

November 12, 2008. Objections and

requests for hearings must be received

on or before January 12, 2009, and must

be filed in accordance with the

instructions provided in 40 CFR part

178 (see also Unit I.C. of the

SUPPLEMENTARY INFORMATION.

ADDRESSES: EPA has established a

docket for this action under docket

identification (ID) number EPA-HQOPP-2008-0175. All documents in the

docket are listed in the docket index

available in http://www.regulations.gov.

Although listed in the index, some

information is not publicly available,

e.g., Confidential Business Information

(CBI) or other information whose

disclosure is restricted by statute.

Certain other material, such as

copyrighted material, is not placed on

the Internet and will be publicly

available only in hard copy form.

Publicly available docket materials are

available in the electronic docket at

http://www.regulations.gov, or, if only

available in hard copy, at the OPP

Regulatory Public Docket in Rm. S4400, One Potomac Yard (South Bldg.),

2777 S. Crystal Dr., Arlington, VA. The

Docket Facility is open from 8:30 a.m.

to 4 p.m., Monday through Friday,

excluding legal holidays. The Docket

Facility telephone number is (703) 305-

5805.

FOR FURTHER INFORMATION CONTACT:

Andrew Ertman, Registration Division

(7505P), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460-0001; telephone number:

(703) 308-9367; e-mail address:

ertman.andrew@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Applylo Me?

You may be potentially affected by

this action if you are an agricultural

producer, food manufacturer, or

pesticide manufacturer. Potentially

affected entities may include, but are

not limited to:

" Crop production (NAICS code 111).

" Animal production (NAICS code

112).

* Food manufacturing (NAICS code

311).

e Pesticide manufacturing (NAICS

code 32532).

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 this unit could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether this action might apply to

certain entities. If you have any

questions regarding the applicability of

this action to a particular entity, consult

the person listed under FOR FURTHER

INFORMATION CONTACT.

66775

HeinOnline -- 73 Fed. Reg. 66775 2008
66776 Federal Register/Vol. 73, No. 219/Wednesday, November 12, 2008/Rules and Regulations

B. How Can I Access Electronic Copies

of this Document?

In addition to accessing electronically

available documents at http:!!

www.regulations.gov, you may access

this Federal Register document

electronically through the EPA Internet

under the "Federal Register" listings at

http://www.epa.gov/fedrgstr. You may

also access a frequently updated

electronic version of 40 CFR part 180

through the Government Printing

Office's e-CFR site at http://

www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing

Request?

Under section 408(g) of the Federal

Food, Drug, and Cosmetic Act (FFDCA),

21 U.S.C. 346a, any person may file an

objection to any aspect of this regulation

and may also request a hearing on those

objections. The EPA procedural

regulations which govern the

submission of objections and requests

for hearings appear in 40 CFR part 178.

You must file your objection or request

a hearing on this regulation in

accordance with the instructions

provided in 40 CFR part 178. To ensure.

proper receipt by EPA, you must

identify docket ID number EPA-HQOPP-2008-0175 in the subject line on

the first page of your submission. All

requests must be in writing, and must be

mailed or delivered to the Hearing Clerk

on or before January 12, 2009.

In addition to filing an objection or

hearing request with the Hearing Clerk

as described in 40 CFR part 178, please

submit a copy of the filing that does not

contain any CBI for inclusion in the

public docket that is described in

ADDRESSES. Information not marked

confidential pursuant to 40 CFR part 2

may be disclosed publicly by EPA

without prior notice. Submit your

copies, identified by docket ID number

EPA-HQ-OPP-2008-0175, by one of

the following methods:

* Federal eRulemaking Portal: http://

www.regulations.gov. Follow the on-line

instructions for submitting comments.

* Mail: Office of Pesticide Programs

(OPP) Regulatory Public Docket (7502P),

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460-0001.

e Delivery- OPP Regulatory Public

Docket (7502P), Environmental

Protection Agency, Rm. S-4400, One

Potomac Yard (South Bldg.), 2777 S.

Crystal Dr., Arlington, VA. Deliveries

are only accepted during the Docket

Facility's normal hours of operation

(8:30 a.m. to 4 p.m., Monday through

Friday, excluding legal holidays).

Special arrangements should be made

for deliveries of boxed information. The

Docket Facility telephone number is

(703) 305-5805.

II. Background and Statutory Findings

EPA, on its own initiative, in

accordance with sections 408(e) and

408(l)(6) of FFDCA, 21 U.S.C. 346a(e)

and 346a(1)(6), is establishing a timelimited tolerance for combined residues

of the insecticide avermectin B, and'its

delta-8,9-isomer in or on bean, lima,

seed at 0.005 parts per million (ppm).

This time-limited tolerance expires and

is revoked on December 31, 2010. EPA

will publish a document in the Federal

Register to remove the revoked

tolerances from the CFR.

Section 408(l)(6) of FFDCA 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. Such

tolerances can be established without

providing notice or period for public

comment. EPA does not intend for its

actions on section 18 related timelimited tolerances to set binding

precedents for the application of section

408 of FFDCA and the new safety

standard to other tolerances and

exemptions. Section 408(e) of FFDCA

allows EPA to establish a tolerance or an

exemption from the requirement of a

tolerance on its own initiative, i.e.,

without having received any petition

from an outside party.

Section 40B(b)(2)(A)(i) of 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) of FFDCA

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) of FFDCA 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."

EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

IIM. Emergency Exemption for

Avermectin on Large Lima Beans and

FFDCA Tolerances

The state of California asserts that

large lima bean growers have few

miticides to work with for controlling

spider mites. Confirmed resistance to

dicofol has been demonstrated in fields

located in Stanislaus County. In 2006,

two-spotted spider mite infestations

were pervasive on some ranches and

some growers experienced 30% crop

losses despite use of the available

registered alternatives. After having

reviewed the submission, EPA

determined that emergency conditions

exist for this State, and that the criteria

for an emergency exemption are met.

EPA has authorized under FIFRA

section 18 the use of avermectin on

large lima beans for control of spider

mites in California.

As part of its evaluation of the

emergency exemption application, EPA

assessed the potential risks presented by

residues of avermectin in or on large

lima beans. In doing so, EPA considered

the safety standard in section 408(b)(2)

of FFDCA, and EPA decided that the

necessary tolerance under section

408(l)(6) of FFDCA would be consistent

with the safety standard and with

FIFRA section 18. Consistent with the

need to move quickly on the emergency

exemption 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 as provided in section

408(l)(6) of FFDCA. Although this timelimited tolerance expires and is revoked

on December 31, 2010, under section

408(l)(5) of FFDCA, residues of the

pesticide not in excess of the amounts

specified in the tolerance remaining in

or on large lima beans after that date

will not be unlawful, provided the

pesticide was applied in a manner that

was lawful under FIFRA, and the

residues do not exceed a level that was

authorized by this time-limited

tolerance at the time of that application.

EPA will take action to revoke this timelimited tolerance earlier if any

experience with, scientific data on, or

other relevant information on this

pesticide indicate that the residues are

not safe.

Because this time-limited tolerance is

being approved under emergency

conditions, EPA has not made any

decisions about whether avermectin

meets FIFRA's registration requirements

HeinOnline -- 73 Fed. Reg. 66776 2008
No. 219_/Wednesday, November 12, 2008/Rules and Regulations 66777

for use on large lima beans or whether

permanent tolerances for this use would

be appropriate. Under these

circumstances, EPA does not believe

that this time-limited tolerance decision

serves as a basis for registration of

avermectin by a State for special local

needs under FIFRA section 24(c). Nor

does this tolerance serve as the basis for

persons in any State other than

California to use this pesticide on this

crop under FIFRA section 18 absent the

issuance of an emergency exemption

applicable within that State. For

additional information regarding the

emergency exemption for avermectin,

contact the Agency's Registration

Division at the address provided under

FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and

Determination of Safety

Section 408(b)(2)(A)(i) of 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) of FFDCA

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) of FFDCA 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...."

Consistent with the factors specified

in FFDCA 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 expected as a result

of this emergency exemption request

and the time-limited tolerance for

combined residues of avermectin BI and

its delta-8,9-isomer in or on bean, lima,

seed at 0.005 ppm. EPA's assessment of

exposures 'and risks associated with

establishing the time-limited tolerance

follows.

A. Toxicological Endpoints

For hazards that have a threshold

below which there is no appreciable

risk, a toxicological point of departure

(POD) is identified as the basis for

derivation of reference values for risk

assessment. The POD may be defined as

the highest dose at which no adverse

effects are observed (the NOAEL) in the

toxicology study identified as

appropriate for use in risk assessment.

However, if a NOAEL cannot be

determined, the lowest dose at which

adverse effects of concern are identified

(the LOAEL) or a Benchmark Dose

(BMD) approach is sometimes used for

risk assessment. Uncertainty/safety

factors (UFs) are used in conjunction

with the POD to take into account

uncertainties inherent in the

extrapolation. from laboratory animal

data to humans and in the variations in

sensitivity among members of the

human population as well as other

unknowns. Safety is assessed for acute

and chronic dietary risks by comparing

aggregate food and water exposure to

the pesticide to the acute population

adjusted dose (aPAD) and chronic

population adjusted dose (cPAD). The

aPAD and cPAD are calculated by

dividing the POD by all applicable UFs.

Aggregate short-, intermediate-, and

chronic-term risks are evaluated by

comparing food, water, and residential

exposure to the POD to ensure that the

margin of exposure (MOE) called for by

the product of all applicable UFs is not

exceeded. This latter value is referred to

as the Level of Concern (LOC).

For non-threshold risks, the Agency

assumes that any amount of exposure

will lead to some degree of risk. Thus,

the Agency estimates risk in terms of the

probability of an occurrence of the

adverse effect greater than that expected

in a lifetime. For more information on

the general principles EPA uses in risk

characterization and a complete

description of the risk assessment

process, see http://www.epa.govl

pesticides/factsheets/riskassess.h tin.

A summary of the toxicological

endpoints for avermectin used for

human risk assessment is discussed in

a tolerance document entitled

Avermectin B, and its delta-8,9-isomer;

Pesticide Tolerance (70 FR 7876, FRL7695-7, February 16, 2005).

B. Exposure Assessment

1. Dietary exposure from food and

feed uses. In evaluating dietary

exposure to avermectin, EPA considered

exposure under the time-limited

tolerance established by this action as

well as all existing avermectin

tolerances in (40 CFR 180.449). EPA

assessed dietary exposures from

avermectin in food as follows:

i. Acute exposure. In estimating acute

dietary exposure, EPA used food

consumption information from the

United States Department of Agriculture

(USDA) 1994-1996 and 1998

Nationwide Continuing Surveys of Food

Intake by Individuals (CSFII). The

following assumptions were made for

the acute exposure assessments: A Tier

3, acute probabilistic dietary exposure

assessment was conducted for all

supported food uses and drinking water.

Acute anticipated residues for many

foods were derived using market basket

survey and new field trial studies.

Estimated concentrations of avermectin

in drinking water were incorporated

directly into the acute assessment.

ii. Chronic exposure. In conducting

the chronic dietary exposure assessment

EPA used the DEEM/FCID which

incorporates food consumption data as

reported by respondents in the USDA

1994-1996 and 1998 Nationwide CSFII,

and accumulated exposure to the

chemical for each commodity. Percent

crop treated and anticipated residues

refinements were used. A refined

chronic dietary exposure assessment

was conducted for the general U.S.

population and various population

subgroups. The assumptions of the

assessment were anticipated residue

estimates, PCT estimates for most of the

commodities, and default DEEM

processing factors when necessary.

Estimated concentrations of avermectin

in drinking water were incorporated

directly into the chronic assessment.

iii. Cancer. An aggregate exposure

assessment for the purpose of assessing

cancer risk was not performed because

avermectin has been classified as "not

likely to be carcinogenic to humans."

iv. Anticipated residue and PCT

information. Section 408(b)(2)(E) of

FFDCA authorizes EPA to use available

data and information on the anticipated

residue levels of pesticide residues in

food and the actual levels of pesticide

residues that have been measured in

food. If EPA relies on such information,

EPA must require pursuant to FFDCA

section 408(f)(1) that data be provided 5

years after the tolerance is established,

modified, or left in effect, demonstrating

that the levels in food are not above the

levels anticipated. For the present

action, EPA will issue such data call-ins

as are required by FFDCA section

408(b)(2)(E) and authorized under

FFDCA section 408(f)(1). Data will be

required to be submitted no later than

5 years from the date of issuance of this

tolerance.

Section 408(b)(2)(F) of FFDCA states

that the Agency may use data on the

actual percent of food treated for

assessing chronic dietary risk only if:

* Condition a: The data used are

reliable and provide a valid basis to

show what percentage of the food

Federal Register /Vol. 73,

HeinOnline -- 73 Fed. Reg. 66777 2008
66778 Federal Register/Vol. 73, No. 219/Wednesday, November 12, 2008/Rules and Regulations

derived from such crop is likely to

contain the pesticide residue.

* Condition b: The exposure estimate

does not underestimate exposure for any

significant subpopulation group. . Condition c: Data are available on

pesticide use and food consumption in

a particular area, the exposure estimate

does not understate exposure for the

population in such area.

In addition, the Agency must provide

for periodic evaluation of any estimates

used. To provide for the periodic

evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F),

EPA may require registrants to submit

data on PCT.

The Agency used PCT information as

follows:

Almonds 21%; avocado 20%; balsam

pear 1%; cantaloupe 7%; casabas 1%;

chayote fruit 1%; Chinese waxgourd

1%; cotton 3%; cress (garden, upland)

1%; cucumber 1%; grape 6%; hops

82%; honeydew melon 1%; plum 1%;

pumpkin 1%; squash 1%; strawberry

44%; walnut 2%; watermelon 7%.

In most cases, EPA uses available data

from United States Department of

Agriculture/National Agricultural

Statistics Service (USDA/NASS),

proprietary market surveys, and the

National Pesticide Use Database for the

chemical/crop combination for the most

recent 6 years. EPA uses an average PCT

for chronic dietary risk analysis. The

average PCT figure for each existing use is derived by combining available

public and private market survey data

for that use, averaging across all

observations, and rounding to the

nearest 5%, except for those situations

in which the average PCT is less than

one. In those cases, 1% is used as the

average PCT and 2.5% is used as the

maximum PCT. EPA uses a maximum

PCT for acute dietary risk analysis. The

maximum PCT figure is the highest

observed maximum value reported

within the recent 6 years of available

public and private market survey data

for the existing use and rounded up to

the nearest multiple of 5%.

The Agency believes that the three

conditions discussed in Unit III.C.1.iv.

have been met. With respect to

Condition a, PCT estimates are derived

from Federal and private market survey

data, which are reliable and have a valid

basis. As to Conditions b and c, regional

consumption information and

consumption information for significant

subpopulations is taken into account

through EPA's computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups. Use of this

consumption information in EPA's risk

assessment process ensures that EPA's

exposure estimate does not understate

exposure for any significant

subpopulation group and allows the

Agency to be reasonably certain that no

regional population is exposed to

residue levels higher than those

estimated by the Agency. Other than the

data available through national food

consumption surveys, EPA does not

have available reliable information on

the regional consumption of food to

which avermectin may be applied in a

particular area. 2. Dietary exposure from drinking

water. The Agency used screening level

water exposure models in the dietary

exposure analysis and risk assessment

for avermectin,in drinking water. These

simulation models take into account

data on the physical, chemical, and fate/

transport characteristics of avermectin.

Further information regarding EPA

drinking water models used in pesticide

exposure assessment can be found at

h ttp://www.epa.gov/oppefedi/models/

water/index.htm. Tier II screening

models PRZM (Pesticide Root Zone

Model) and EXAMS (Exposure Analysis

Modeling System) were used to

determine estimated surface water

concentrations of avermectin based on

the modeled scenario of one seed

treatment to cucumbers followed by 3

aerial applications at a 7-day interval in

Florida. This use of avermectin

represents the worst case potential

contribution of avermectin to drinking

water when considering currently

registered uses, including this one. The

full PRZM/EXAMS distribution was

used for the acute dietary assessment,

and the one in ten year annual mean concentration of 0.190 ppm was used

for chronic dietary estimates. Modeled

estimates of drinking water

concentrations were directly entered

into the dietary exposure model.

3. From non-dietary exposure. The

term "residential exposure" is used in

this document to refer to nonoccupational, non-dietary exposure

(e.g., for lawn and garden pest control,

indoor pest control, termiticides, and

flea and tick control on pets).

Avermectin is currently registered for

use on the following residential nondietary sites: Residential lawn

application for fire ant control and

residential indoor crack and crevice

application for cockroaches and ants.

These registered residential uses may

result in short- to intermediate-term

exposures; however, based on- current use patterns, long-term exposure (6 or more months of continuous exposure) to

avermectin is not expected. Adults may

be exposed through handling the

pesticide and both adults and children

may be exposed through contact with

treated areas following application.

Accordingly, handler and postapplication exposures were assessed for

two major categories of residential

avermectin use which are considered to

represent the reasonable high-end

residential exposure potential:

i. Granular baits used to treat lawns,

and

ii. Indoor crack and crevice dust

products.

4. Cumulative effects from substances

with a common mechanism of toxicity.

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

requires that, when considering whether

to establish, modify, or revoke a

tolerance, the Agency consider "available information" concerning the

cumulative effects of a particular

pesticide's residues and "other

substances that have a common

mechanism of toxicity."

EPA has not found avermectin to

share a common mechanism of toxicity

with any other substances, and

avermectin does not appear to produce

a toxic metabolite produced by other

substances. For the purposes of this

tolerance action, therefore, EPA has

assumed that avermectin does not have

a common mechanism of toxicity with

other substances. For information

regarding EPA's efforts to determine

which chemicals have a common

mechanism of toxicity and to evaluate

the cumulative effects of such

chemicals, see the policy statements

released by EPA's Office of Pesticide

Programs concerning common

mechanism determinations and

procedures for cumulating effects from

substances found to have a common

mechanism on EPA's website at http://

www.epa.gov/pesticides/cumulative.

C. Safety Factor for Infants and Children

1. In general. Section 408(b)(2)(C) of

FFDCA provides that EPA shall apply

an additional tenfold (10X) margin of

safety for infants and children in the

case of threshold effects to account for

prenatal and postnatal toxicity and the

completeness of the database on toxicity

and exposure unless EPA determines

based on reliable data that a different

margin of safety will be safe for infants

and children. This additional margin of

safety is commonly referred to as the

FQPA safety factor (SF). In applying this

provision, EPA either retains the default

value of 1OX, or uses a different

additional SF when reliable data

available to EPA support the choice of

a different factor. For avermectin BI

EPA retained the default 1OX factor

based on the following combination of

factors:

HeinOnline -- 73 Fed. Reg. 66778 2008
Federal Register/Vol. 73, No. 219/Wednesday, November 12, 2008/Rules and Regulations 66779

e There is residual uncertainty due to

a data gap for a developmnental

neurotoxicity study (DNT), as well as

data gaps for acute and subchronic

neurotoxicity studies. These studies are

required because avermectin B1 has

been shown to be neurotoxic, with

multiple neurotoxic clinical signs

(including head and body tremors and

limb splay) seen in multiple studies

with multiple species.

* For several species, the doseresponse curve appears to be steep.

e Severe effects were seen at the

LOAELs in several studies (death,

neurotoxicity, and developmental

toxicity). Although increased

susceptibility of the young was observed

in several studies, the degree of concern

with that susceptibility was judged to be

low. Increased susceptibility (qualitative

and/or quantitative) was seen in

prenatal developmental toxicity studies

in CD-1 mice and rabbits following in

utero exposure to avermectin B1. There

was also an increase in quantitative and

qualitative susceptibility in the rat

reproductive toxicity study. The

concern for susceptibility seen in the

developmental study with rabbits and in

the reproductive toxicity study in the rat

is low because the lowest NOAEL

obtained (0.12 mg/kg/day) was used as

the basis for the chronic RfD and other

non-dietary risk assessment scenarios,

which is protective of all of the

developmental/offspring effects seen in

those studies. Similarly, the concern for

susceptibility seen at the LOAEL in the

CD-1 mouse developmental toxicity

study is low, since the NOAEL in the rat

reproductive toxicity study is lower

than the dose at which effects were seen

in the CD-1 mouse.

D. Aggregate Risks and Determination of

Safety

EPA determines whether acute and

chronic pesticide exposures are safe by

comparing aggregate exposure estimates

to the aPAD and cPAD. The aPAD and

cPAD represent the highest safe

exposures, taking into account all

appropriate SFs. EPA calculates the

aPAD and cPAD by dividing the POD by

all applicable UFs. For linear cancer

risks, EPA calculates the probability of

additional cancer cases given the

estimated aggregate exposure. Short-,

intermediate-, and chronic-term risks

are evaluated by comparing the

estimated aggregate food, water, and

residential exposure to the POD to

ensure that the MOE called for by the

product of all applicable UFs is not

exceeded.

1. Acute risk. Using the exposure

assumptions discussed in this unit for

acute exposure, the acute dietary

exposure from food and water to

avermectin will occupy 93% of the

aPAD for all infants less than 1 year old,

the population group receiving the

greatest exposure.

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that chronic exposure to avermectin

from food and water will utilize 20% of

the cPAD for children 1-2 years old, the

population group receiving the greatest

exposure. Based on the explanation in

the unit regarding residential use

patterns, chronic residential exposure to

residues of avermectin is not expected.

3. Short-term and intermediate-term

risk. Short-term aggregate exposure

takes into account short-term residential

exposure plus chronic exposure to food

and water (considered to be a

background exposure level).

Avermectin is currently registered for

uses that could result in short-term and

intermediate-term residential exposure

and the Agency has determined that it

is appropriate to aggregate chronic

exposure through food and water with

short-term and intermediate-term

residential exposures to avermectin.

Using the exposure assumptions

described in this unit for short-term and

intermediate-term exposures, EPA has

concluded the combined'short-term

food, water, and residential exposures

aggregated result in aggregate MOEs of

3,000 for the U.S. population, and 1,700

for children 1-2 years old. These

aggregate MOEs are greater than the

Agency's level of concern of 1,000 for

aggregate exposure to food, water and

residential uses and therefore

acceptable.

4. Aggregate cancer risk for U.S.

population. Avermectin has been

classified as "not likely to be

carcinogenic to humans". and therefore

is not expected to pose a cancer risk to

humans.

5. Determination of safety. Based on

these risk assessments, EPA concludes

that there is a reasonable certainty that

no harm will result to the general

population, or to infants and children,

from aggregate exposure to avermectin

residues.

V. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology

is available to enforce the tolerance

expression. The method may be

requested from: Chief, Analytical

Chemistry Branch, Environmental

Science Center, 701 Mapes Rd., Ft.

Meade, MD 20755-5350; telephone

number: (410) 305-2905; e-mail address:

residuemethods@epa.gov.

B. International Residue Limits

There are no CODEX residue limits

for residues of avermectin on bean,

lima, seed.

VI. Conclusion

Therefore, a time-limited tolerance is

established for combined residues of the

insecticide avermectin B, and its delta8,9-isomer in or on bean,.lima, seed at

.0.005 ppm. This time-limited tolerance

expires and is revoked on December 31,

2010.

VII. Statutory and Executive Order

Reviews

This final rule establishes a tolerance

under sections 408(e) and 408(l)(6) of

FFDCA 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).

Because this final rule has been

* exempted from review under Executive

Order 12866, this final rule is not

subject to Executive Order 13211,

entitled Actions Concerning Regulations

That Significantly Affect Energy Supply,

Distribution, or Use (66 FR 28355, May

22, 2001) or Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

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., nor does it require any special

considerations under Executive Order

12898, entitled Federal Actions toAddress Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994).

Since tolerances and exemptions that

are established in accordance with

sections 408(e) and 408(l)(6) of FFDCA,

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.

This final rule directly regulates

growers, food processors, food handlers,

and food retailers, not States or tribes,

nor does this action alter the

relationships or distribution of power

and responsibilities established by

Congress in the preemption provisions

of section 408(n)(4) of FFDCA. As such,

the Agency has determined that this

action will not have a substantial direct

effect on States or tribal governments,

on the relationship between the national

government and the States or tribal

HeinOnline -- 73 Fed. Reg. 66779 2008
66780 Federal Register/Vol. 73, No. 219/Wednesday, November 12, 2008/Rules and Regulations

governments, or on the distribution of

power and responsibilities among the

various levels of government or between

the Federal Government and Indian

tribes. Thus, the Agency has determined

that Executive Order 13132, entitled

Federalism (64.FR 43255, August 10,

1999) and Executive Order 13175,

entitled Consultation and Coordination

with Indian Tribal Governments (65 FR

67249, November 9, 2000) do not apply

to this final rule. In addition, this final

rule does not impose any enforceable

duty or contain any unfunded mandate

as described under Title H of the

Unfunded Mandates Reform Act of 1995

(UMRA) (Public Law 104-4).

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).

[FR Doc. E8-26876 Filed 11-12-08; 8:45 am]

BILLING CODE 6560-50-S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0945; FRL-8387-1]

MCPB; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for combined residues of free

and conjugated MCPB and its metabolite

MCPA in or on peppermint, tops and

spearmint, tops. Interregional Research

Project Number 4 (IR-4) requested these

tolerances under the Federal Food,

Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective

November 12, 2008. Objections and

requests for hearings must be received

on or before January 12, 2009, and must

be filed in accordance with the

instructions provided in-40 CFR part

178 (see also Unit I.C. of the

SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket

identification (ID) number EPA-HQVIII. Congressional Review Act

The Congressional Review Act, 5

U.S.C. 801 et seq., generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report to each House of

the Congress and to the Comptroller

General of the United States. EPA will

submit 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 United States prior to

publication of this final rule in the

Federal Register. This final rule 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.

OPP-2007-0945. All documents in the

docket are listed in the docket index

available at http://www.regulations.gov.

Although listed in the index, some

information is not publicly available,

e.g., Confidential Business Information

(CBI) or other information whose

disclosure is restricted by statute.

Certain other material, such as

copyrighted material, is not placed on

the Internet and will be publicly

available only in hard copy form.

Publicly available docket materials are

available in the electronic docket at

http://www.regulations.gov, or, if only

available in hard copy, at the OPP

Regulatory Public Docket in Rm. S4400, One Potomac Yard (South Bldg.),

2777 S. Crystal Dr., Arlington, VA. The

Docket Facility is open from 8:30 a.m.

to 4 p.m., Monday through Friday,

excluding legal holidays. The Docket

Facility telephone number is (703) 305-

5805.

FOR FURTHER INFORMATION CONTACT:

Susan Stanton, Registration Division

(7505P), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460-0001; telephone number:

(703) 305-5218; e-mail address:

stanton.susan epa.gov.

SUPPLEMENTARY INFORMATION:

Dated: October 31, 2008.

Lois Rossi,

Director, Registration Division, Office of

Pesticide Programs.

E Therefore, 40 CFR chapter I is

amended as follows:

PART 180-[AMENDED]

M 1. The authority citation for part 180

continues to read as follows:

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

M 2.-Section 180.449 is amended by

alphabeticallyadding a commodity to

the table in paragraph (b) to read as

follows:

§180.449 Avermectin Bl and its delta-8,9-

isomer; tolerances for residues.

(b)* *

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 entities may include, but are

not limited to those engaged in the

following activities:

e Crop production (NAICS code 111).

• Animal production (NAICS code

112).

a Food manufacturing (NAICS code

311).

e Pesticide manufacturing (NAICS

code 32532). -

This listing is not intended to be

exhaustive, but rather to provide a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in this unit could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether this action might apply to

certain entities. If you have any

questions regarding the applicability of

this action to a particular entity, consult

the person listed under FOR FURTHER

INFORMATION CONTACT.

HeinOnline -- 73 Fed. Reg. 66780 2008
Federal Register/Vol. 73, No. 219/Wednesday, November 12, 2008/Rules and Regulations 66781

B. How Can I Access Electronic Copies

of this Document?

In addition to accessing electronically

available documents at http://

www.regulations.gov, you may access

this Federal Register document

electronically through the EPA Internet

under the "Federal Register" listings at

http://www.epa.gov/fedrgstr. You may

also access a frequently updated

.electronic version of EPA's tolerance

regulations at 40 CFR part 180 through

the Government Printing Office's pilot

e-CFR site at http://www.gpoaccess.govl

ecfr.

C. Can I File an Objection or Hearing

Request?

Under section 408(g) of FFDCA, 21

U.S.C. 346a, any person may file an

objection to any aspect of this regulation

and may also request a hearing on those

objections. You must file your objection

or request a hearing on this regulation

in accordance with the instructions

provided in 40 CFR part 178. To ensure

proper receipt by EPA, you must

identify docket ID number EPA-HQOPP-2007-0945 in the subject line on

the first page of your submission. All

requests must be in writing, and must be

mailed or delivered to the Hearing Clerk

as required by 40 CFR part 178 on or

before January 12, 2009.

-In addition to filing an objection or

hearing request with the Hearing Clerk

as described in 40 CFR part 178, please

submit a copy of the filing that does not

contain any CBI for inclusion in the

public docket that is described in

ADDRESSES. Information not marked

confidential pursuant to 40 CFR part 2

may be disclosed publicly by EPA

without prior notice. Submit this copy,

identified by docket ID number EPAHQ-OPP-2007-0945, by one of the

following methods:

9 Federal eRulemaking Portal: http://

www.regulations.gov. Follow the on-line

instructions for-submitting comments.

* Mail: Office of Pesticide Programs

(OPP) Regulatory Public Docket (7502P),

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460-0001.

9 Delivery- OPP Regulatory Public

Docket (7502P), Environmental

Protection Agency, Rm. S-4400, One

Potomac Yard (South Bldg.), 2777 S.

Crystal Dr., Arlington, VA. Deliveries

.are only accepted during the Docket

Facility's normal hours of operation

(8:30 a.m. to 4 p.m., Monday through

Friday, excluding legal holidays).

Special arrangements should be made

for deliveries of boxed information. The

Docket Facility telephone number is

(703) 305-5805.

H. Petition for Tolerance

In the Federal Register of October 24,

2007 (72 FR 60369) (FRL-8150-8), EPA

issued a notice pursuant to section

408(d)(3) of FFDCA, 21 U.S.C.

346a(d)(3), announcing the filing of a

pesticide petition (PP 7E7257) by

Interregional Research Project Number 4

(IR-4), 500 College Road East, Suite 201

W., Princeton, NJ 08540. The petition

requested that 40 CFR 180.318 be

amended by establishing a tolerance for

residues of the herbicide MCPB, 4-(2-

methyl-4-chlorophenoxy) butyric acid,

in or on mint tops (leaves and stems) at

0.25 parts per million (ppm). That

notice referenced a summary of the

petition prepared by Nufarm, Inc., the

registrant, on behalf of IR-4, which is

available to the public in the docket,

http://www.regulations.gov. There were

no comments received in response to

the notice of filing.

Based upon review of the data

supporting the petition, EPA has revised

the commodity terms and tolerance

level. EPA has also revised the tolerance

expression to include combined

residues of free and conjugated MCPB

and its metabolite MCPA. The reasons

for these changes are explained in Unit

IV.C.

HI. Aggregate Risk Assessment and

Determination of Safety

Section 408(b)(2)(A)(i) of 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) of FFDCA

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) of FFDCA 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 ......

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

of FFDCA, and the factors specified in

section 408(b)(2)(D) of FFDCA, 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 for the petitioned-for

tolerahces for combined residues of free

and conjugated MCPB and its metabolite

MCPA on peppermint, tops and

spearmint, tops at 0.20 ppm. EPA's

assessment of exposures and risks

associated with establishing tolerances

follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies 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.

The currently available toxicological

database for MCPB is limited; thus it

was supplemented with data on the

closely related compound, 4-(chloro-2-

methylphenoxy)acetic acid (MCPA).

Structurally, MCPB and MCPA differ

only in that MCPB contains two

additional carbon atoms. In both animal

and plant metabolism studies, the data

indicate that MCPB is readily converted

to MCPA. Therefore, EPA has concluded

that the toxicity of these compounds is

similar at sub-lethal dose levels.

MCPB has low to moderate acute

toxicity via the oral, dermal and

inhalation routes of exposure. It is

mildly to moderately irritating to the

eye but is not a dermal irritant or skin

sensitizer. In longer-term studies,

nephrotoxicity and hepatotoxicity

appear to be the most prevalent hazard

concerns for MCPB, based on the effects

seen throughout the MCPA database and

the limited toxicity data set available for

MCPB. Signs of neurotoxicity

(decreased arousal, impaired

coordination and gait, reduced motor

activity and reduced grip strength) were

also reported after MCPB or MCPA

exposure. Developmental and

reproduction toxicity studies conducted

with MCPB and/or MCPA did not

indicate an enhanced sensitivity or

susceptibility of the young, as

developmental effects (delayed

ossifications and decreased fetal or pup

body weight) occurred at the same doses

eliciting toxicity in the parental animals

(mortality, decreased body weight, body

weight gain and food consumption and

increased absolute and relative ovary

weights). MCPB and MCPA have been

classified as "not likely to be

carcinogenic to humans" based on the

absence of increased numbers of tumors

in the rat and mouse carcinogenicity

studies and no evidence of

mutagenicity.

HeinOnline -- 73 Fed. Reg. 66781 2008
No. 219/Wednesday, November 12, 2008/Rules and Regulations

Specific information on the studies

received and the nature of the adverse

effects caused by MCPB and MCPA, as

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the

toxicity studies, can be found at http://

www.regulations.gov in the document 4-

(4-chloro-2-methylphenoxy)butanoic

acid (MCPB); Human-Health Risk

Assessment for Proposed Section a New

Use on Mint, page 29 in docket ID

number EPA-HQ-OPP-2007-0945.

B. Toxicological Endpoints

For hazards that have a threshold

below which there is no appreciable

risk, a toxicological point of departure

(POD) is identified as the basis for

derivation of reference values for risk

assessment. The POD may be defined as

the highest dose at which no adverse

effects are observed (the NOAEL) in the

toxicology study identified as

appropriate for use in risk assessment.

However, if a NOAEL cannot be

determined, the lowest dose at which

adverse effects of concern are identified

(the LOAEL) or a Benchmark Dose

(BMD) approach is sometimes used for

risk assessment. Uncertainty/safety

factors (UFs) are used in conjunction

with the POD to take into account

uncertainties inherent in the

extrapolation from laboratory animal

data to humans and in the variations in

sensitivity among members of the

human population as well as other

unknowns. Safety is assessed for acute

and chronic dietary risks by comparing

aggregate food and water exposure to

the pesticide to the acute population

adjusted dose (aPAD) and chronic

population adjusted dose (cPAD). The

aPAD and cPAD are calculated by

dividing the POD by all applicable UFs.

Aggregate short-term, intermediate-term,

and chronic-term risks are evaluated by

comparing food, water, and residential

exposure to the POD to ensure that the

margin of exposure (MOE) called for by

the product of all applicable UFs is not

exceeded. This latter value is referred to

as the Level of Concern (LOC).

For non-threshold risks, the Agency

assumes that any amount of exposure

will lead to some degree of risk. Thus,

the Agency estimates risk in terms of the

probability of an occurrence of the

adverse effect greater than that expected

in a lifetime. For more information on

the gefieral principles EPA uses in risk

characterization and -a complete

description of the risk assessment

process, see http://www.epa.gov/

pesticides/factsheets/riskassess.htm.

A summary of the toxicological

endpoints for MCPB used for human

risk assessment is shown in the

following Table.

TABLE 1.-SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR MCPB FOR USE IN HUMAN RISK ASSESSMENT

Exposure/Scenario Point of Departure and Un- RfD, PAD, LOG for Risk Assessment Study and Toxicological Effects certainty/Safety Factors

Acute dietary NOAEL = 200 milligrams/ Acute RfD = 0.2 mg/kg/day Acute neurotoxicity (MCPA), rat

(General population kilograms/day (mg/kg/day) aPAD = 0.2 mg/kg/day LOAEL = 400 mg/kg/day based on gait impair- including infants UFA = lOx ment in males

and children; and UFH = lOx

females 13-50 FQPA SF = lox (UFDB)

years of age)

Chronic dietary NOAEL= 4.4 mg/kg/day Chronic RfD = 0.0044 mg/kg/day Chronic toxicity (MCPA), rat

(All populations) UFA = lOx cPAD = 0.0044 mg/kg/day LOAEL = 17.6 mg/kg/day based on liver and

UFH = lOx kidney toxicity.

FOPA SF = lox (UFDB)

Dermal short-term Dermal study LOC for MOE = 100 21-Day dermal toxicity (MCPA), rabbit

(1 to 30 days) and NOAEL = 25 mg/kg/day NOAEL = 100

intermediate-term UFA = lOx LOAEL = 1,000 mg/kg/day based on kidney tox-

(1 to 6 months) UFH = lOx icity and decreased body weight gain FOPA SF = lx Dermal absorption of MCPB is 4x that of

MCPA.

Dermal long-term Oral study LOG for MOE = 100 Chronic toxicity.(MCPA), rat

(> 6 months) NOAEL = 4.4 mg/kg/day LOAEL = 17.6 mg/kg/day based on liver and

(dermal absorption rate = kidney toxicity.

31%)

UFA = lOx

UFH = lOx

FQPA SF = lx

Inhalation short- Oral study LOC for MOE = 100 Developmental toxicity (MCPB), rabbit

term NOAEL= 5 mg/kg/day (inha- LOAEL = 20 mg/kg/day based on maternal mor- (1 to 30 days) and lation absorption rate = tality

intermediate-term 100%)

(1 to 6 months) UFA = lOx

UFH = lOx

FQPA SF = lx

Inhalation long-term Oralstudy NOAEL = 4.4 mg/ LOC for MOE = 100 Chronic toxicity (MCPA), rat

(> 6 months) kg/day (inhalation absorp- i LOAEL = 17.6 mg/kg/day based on liver and

tion rate = 100%) kidney toxicity

UFA = lox

UFH =lox

[ _ __FQPA SF = lx.

66782 Federal Register/Vol. 73,

HeinOnline -- 73 Fed. Reg. 66782 2008
Federal Register/Vol. 73, No. 219/Wednesday, November 12, 2008/Rules and Regulations 66783

TABLE 1.-SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR MCPB FOR USE IN HUMAN RISK ASSESSMENTContinued

Exposure/Scenanio Point of Departure and Un- RfD, PAD, LOC for Risk Assessment Study and Toxicological Effects certainty/Safety Factors I

Cancer (oral, der- Classification: Not likely to be carcinogenic to humans.

mal, inhalation) .t

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population

(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFs = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FOPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern.

C. Exposure Assessment

While the Agency has concluded that

MCPB converts to MCPA in the

environment, and that MCPA may be

present in crops, residues of MCPA

resulting from the existing use of MCPB

on peas and the new use on mint are

expected to be negligible, and

significantly below analytical method

limits of detection. These residues will

not contribute significantly to the

aggregate exposure to MCPA from other

sources, and, therefore, EPA did not

conduct an aggregate assessment

combining MCPA exposures from

MCPA and MCPB uses. The exposure

assessments presented here are for

MCPB only. A discussion of aggregate

risks associated with MCPA can be

found in the MCPA Reregistration

Eligibility Decision (RED), available on

the Office of Pesticide Programs web

site at http://www.epa.gov/oppsrrdl/

REDs/mcpa-red.pdf

1. Dietary exposure from food and

feed uses. In evaluating dietary

exposure to MCPB, EPA considered

exposure under the petitioned-for

tolerances as well as the existing MCPB

tolerance in 40 CFR 180.318 on peas,

the only commodity for which a

tolerance currently exists. EPA assessed

dietary exposures from MCPB in food as

follows:

i. Acute exposure. Quantitative acute

dietary exposure and risk assessments

are performedtfor a food-use pesticide,

if a toxicological study has indicated the

possibility of an effect of concern

occurring as a result of a 1-day or single

exposure.

In estimating acute dietary exposure,

EPA used food consumption

information from the United States

Department of Agriculture (USDA)

1994-1996 and 1998 Nationwide

Continuing Surveys of Food Intakes by

Individuals (CSFII). As to residue levels

in food, EPA assumed that all pea and

mint commodities contain tolerancelevel residues and that 100 percent of

pea and mint commodities are treated

with MCPB.

ii. Chronic exposure. In conducting

the chronic dietary exposure assessment

EPA used the food consumption data

from the USDA 1994-1996 and 1998

CSFII. As in the acute exposure

assessment, EPA assumed tolerancelevel residues and 100 percent crop

treated (PCT) for all pea and mint

commodities.

iii. Cancer. Based on the results of

carcinogenicity studies in rats and mice,

EPA classified MCPB as "not likely to

be carcinogenic to humans." Therefore,

an exposure assessment for evaluating

cancer risk is unnecessary.

iv. Anticipated residue and PCT

information. EPA did not use

anticipated residue or PCT information

in the dietary assessment for MCPB.

Tolerance level residues and/or 100 PCT

were assumed for all food commodities.

2. Dietary exposure from drinking

water. The Agency used screening level

water exposure models in the dietary

exposure analysis and risk assessment

for MCPB in drinking water. These

simulation models take into account

data on the physical, chemical, and fate/

transport characteristics of MCPB.

Further information regarding EPA

drinking water models used in pesticide

exposure assessment can be found at

http://www.epa.gov/oppefedl/modelsl

water/index.htm.

Based on the First Index Reservoir

Screening Tool (FIRST) and Screening

Concentration in Ground Water (SCIGROW) models, the estimated drinking

water concentrations (EDWCs) of MCPB

for acute exposures are estimated to be54.7 parts per billion (ppb) for surface

water and 2.1 ppb for ground water. The

EDWCs for chronic exposures for noncancer assessments are estimated to be

13.5 ppb for surface water and 2.1 ppb

for ground water.

Modeled estimptes of drinking water

concentrations were directly entered

into the dietary exposure model. For

acute dietary risk assessment, the water

concentration value of 54.7 ppb was

used to assess the contribution to

drinking water. -For chronic dietary risk

assessment, the water concentration of

value 13.5 ppb was used to assess the

contribution to drinking water.

3. From non-dietary exposure. The

term "residential exposure" is used in

this document to refer to nonoccupational, non-dietary exposure

(e.g., for lawn and garden pest control,

indoor pest control,termiticides, and

flea and tick control on pets).

MCPB is not registered for any

specific use patterns that would result

in residential exposure.

4. Cumulative effects from substances

with a common mechanism of toxicity.

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

requires that, when considering whether

to establish, modify, or revoke a

tolerance, the Agency consider

"available information" concerning the

cumulative effects of a particular

pesticide's residues and "other

substances that have a common

mechanism of toxicity."

EPA has not found MCPB to share a

common mechanism of toxicity with

any other substances, and MCPB does

not appear to produce a toxic metabolite

produced by other substances. For the

purposes of this tolerance action,

therefore, EPA has assumed that MCPB

does not have a common mechanism of

toxicity with other substances. For

information regarding EPA's efforts to

determine which chemicals have a

common mechanism of toxicity and to

evaluate the cumulative effects of such

chemicals, see EPA's website at http://

www.epa.govpesticides/cumulative.

D. Safety Factor for Infants and

Children

1. In general. Section 408(b)(2)(c) of

FFDCA provides that EPA shall apply

an additional tenfold (1OX) margin of

safety for infants and children in the

case of threshold effects to account for

prenatal and postnatal toxicity and the

completeness of the database on toxicity

and exposure unless EPA determines

based on reliable data that a different

margin of safety will be safe for infants

and children. This additional margin of

safety is commonly referred to as the

FQPA safety factor (SF). In applying this

provision, EPA either retains the default

value of IOX, or uses a different

additional safety factor when reliable

data available to EPA support the choice

of a different factor.

HeinOnline -- 73 Fed. Reg. 66783 2008
66784 Federal Register/Vol. 73, No. 219/Wednesday, November 12, 2008/Rules and Regulations

2. Prenatal and postnatal sensitivity.

The prenatal and postnatal toxicology

database for MCPB includes rat and

rabbit developmental toxicity studies;

for MCPA it includes rat and rabbit

developmental toxicity studies and a 2-

generation reproduction toxicity study

in rats. There was no evidence of

increased quantitative or qualitative

susceptibility of fetuses or offspring to

MCPA or MCPB exposure in any of

these studies. In the developmental rat

studies with MCPB and MCPA,

decreased ossification and decreased

fetal body weights occurred at the same

dose causing maternal effects (decreased

body weight gain and food

consumption). No toxicity to fetuses

occurred in the MCPB and MCPA rabbit

developmental studies at doses resulting

in maternal toxicity (mortality,

decreased body weight and food

consumption). In the rat reproduction

study for MCPA, the only offspring

toxicity was decreased weight gain

while nursing, which occurred at the

same dose causing maternal toxicity

(increased absolute and relative ovary

weights).

3. Conclusion. EPA has determined

that the FQPA safety factor of 1oX must

be retained as a database uncertainty

factor for MCPB acute and chronic risk

assessments. This decision is based on

the following findings:

i. The toxicity database for MCPB is

not complete. Additional data

pertaining to MCPB's potential to cause

developmental neurotoxicity (DNT) or

immunotoxicity are outstanding. EPA's

assessment of the uncertainties arising

from these data deficiencies follows:

a. Developmental neurotoxicity: EPA

has required a developmental

neurotoxicity study to be submitted

because neurotoxicity was found in

acute and subchronic neurotoxicity

studies with MCPA in rats (decreased

arousal, impaired coordination and gait,

reduced motor activity, reduced grip

strength), and similar signs of

neurotoxicity can be expected with

MCPB. The neurotoxic effects seen in

the acute neurotoxicity studies were the

most sensitive acute effect identified

and therefore were used in calculating

the aRfD for MCPB. Given these findings

of neurotoxicity and sensitivity of the

neurotoxic effects, EPA has concluded

that it lacks reliable data to remove the

FQPA lOX safety factor.

b. Immunoto.i city: EPA began

requiring functional immunotoxicity

testing (series 870.7800) of all food and

non-food use pesticides on December

26, 2007. Since the requirement went

into effect after this tolerance petition

was submitted, these studies are not yet

available for MCPB. In the absence of

specific immunotoxicity studies, EPA

has evaluated the available toxicity data

for MCPB and MCPA regarding

potential immunotoxic effects. Evidence

of potential immunotoxicity was

observed in subchronic 28-day oral

toxicity studies in the mouse and dog

with MCPA. Involution of the spleen

due to lymphocytic depletion was

observed in both sexes at the highest

dose tested (HDT) and LOAEL of 453.7/

223.9 milligrams kilogram day (mg/kg/

day) male/female (M/F) in the mouse,

and decreased thymus weights were

seen in the dog at a dose of 30 mg/kg/

day HDT. Lymphoid depletion was

observed in the subchronic toxicity

study in the dog at a dose of 44 mg/kg/

day (HDT) of MCPB. The NOAEL in the

mouse and dog for potential

immunotoxic effects was 173.4/69.2 mg/

kg/day M/F and 20 mg/kg/day,

respectively. The NOAEL being used for

calculation of the chronic reference dose

(cRfD) is 4.4 mg/kg/day. The NOAEL

from the mouse study (173.4/69.2 mg/

kg/day (M/F)) provides the more

appropriate reference for evaluating

potential immunotoxic effects in

humans. Unlike rodents and humans,

dogs are uniquely sensitive to the toxic

effects of chloropheroxy compounds

such as MCPB due to their decreased

ability to excrete organic acids, and thus

the effect levels in the mouse are more

relevant to potential immunotoxicity in

humans.

After weighing this evidence, EPA

retains significant uncertainty regarding

potential neurotoxic effects in infants

and children but does not have such

concerns for immunotoxicity. The

immunotoxic effects with most

relevance to humans had a NOAEL over

1oX greater than the NOAEL used in

establishing the cRfD. On the other

hand, neurotoxic effects were the most

sensitive acute effects seen in the

database. Additionally, the DNT study

specifically addresses potential risks to

developing animals. Given these

considerations, EPA has concluded that

it lacks reliable data to remove the

FQPA children's safety factor.

ii. There is no evidence that MCPB or

MCPA results in increased

susceptibility in in utero rats or rabbits

in the prenatal developmental studies or

in young rats in the 2-generation

reproduction study.

iii. There are no residual uncertainties

identified in the exposure databases.

The dietary food exposure assessments

were performed based on 100 PCT and

tolerance-level residues. EPA made

conservative (protective) assumption's

in the ground and surface water

modeling used to assess exposure to

MCPB in drinking water, and residential

exposures are not expected. These

assessments will not underestimate the

exposure and risks posed by MCPB.

E. Aggregate Risks and Determination of

Safety

EPA determines whether acute and

chronic pesticide exposures are safe by

comparing aggregate exposure estimates

to the aPAD and cPAD. The aPAD and

cPAD represent the highest safe

exposures, taking into account all

appropriate SFs. EPA calculates the

aPAD and cPAD by dividing the POD by

all applicable UFs. For linear cancer

risks, EPA calculates the probability of

additional cancer cases given the

estimated aggregate exposure. Shortterm, intermediate-term, and chronicterm risks are evaluated by comparing

the estimated aggregate food, water, and

residential exposure to the POD to

ensure that the MOE called for by the

product of all applicable UFs is not

exceeded.

1. Acute risk. An acute aggregate risk

assessment takes into account exposure

"estimates from acute dietary

consumption of food and drinking

water. Using the exposure assumptions

discussed in this unit for acute

exposure, the acute dietary exposure

from food and water to MCPB will

occupy 5.4% of the aPAD for infants,

less than one year old, the population

group receiving the greatest exposure.

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that chronic exposure to MCPB from

food and water will utilize 22% of the

cPAD for infants, less than one year old,

the population group receiving the

greatest exposure. There are no

residential uses for MCPB.

3. Short-term risk. Short-term

aggregate exposure takes into account

short-term residential exposure plus

chronic exposure to food and water

(considered to be a background

exposure level). MCPB is not registered

for any use patterns that would result in

residential exposure. Therefore, the

short-term aggregate risk is the sum of

the risk from exposure to MCPB through

food and water and will not be greater

than the chronic aggregate risk.

4. Intermediate-term risk.

Intermediate-term aggregate exposure

takes into account intermediate-term

residential exposure plus chronic

exposure to food and water (considered

to be a background exposure level).

MCPB is not registered for any use

patterns that would result in

intermediate-term residential exposure.

Therefore, the intermediate-term

aggregate risk is the sum of the risk from•

exposure to MCPB through food and

HeinOnline -- 73 Fed. Reg. 66784 2008
No. 219/Wednesday, November 12, 2008/Rules and Regulations 66785

water, which has already been

addressed, and will not be greater than

the chronic aggregate risk.

5. Aggregate cancer risk for U.S.

population. EPA has classified MCPB

into the category "Not Likely to be

Carcinogenic to Humans". MCPB is not

expected to pose a cancer risk.

6. Determination of safety. Based on

these risk assessments, EPA concludes

that there is a reasonable certainty that

no harm will result to the general

population, or to infants and children

from aggregate exposure to MCPB

residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology

(Gas chromatography/Mass

Spectrometry) is available to enforce the

tolerance expression. The method may

be requested from: Chief, Analytical

Chemistry Branch, Environmental

Science Center, 701 Mapes Rd., Ft.

Meade, MD 20755-5350; telephone

number: (410)-305-2905; e-mail address:

residuemethods@epa.gov.

B. International Reidue Limits

There are no established or proposed

Codex, Canadian, or Mexican maximum

residue limits (MRLs) for MCPB.

C. Revisions to Petitioned-For

Tolerances

IR-4 proposed a tolerance for residues

of MCPB per se on mint tops (leaves and

stems) at 0.25 ppm. EPA has determined

that separate tolerances at 0.20 ppm

should be established for combined

residues of free and conjugated MCPB

(4-(4-chloro-2-methylphenoxy)butanoic

acid) and MCPA (4-chloro-2-

methylphenoxy)acetic acid) on the

commodities "spearmint, tops" and

"peppermint, tops. The commodity

terms were revised to agree with the

preferred commodity terms in the

Agency's Food and Feed Commodity

Vocabulary. EPA determined the

appropriate tolerance level for mint tops

based on analysis of the residue field

trial data using the Agency's Tolerance

Spreadsheet in accordance with the

Agency's Guidance for Setting Pesticide

Tolerances Based on Field Trial Data.

Finally, EPA revised the residues of

concern to be included in the tolerance

expression based on the results of plant

metabolism studies.

V. Conclusion

Therefore, tolerances are established

for combined residues of free and

conjugated MCPB and MCPA in or on

peppermint, tops and spearmint, tops at

0.20 ppm.

VI. Statutory and Executive Order

Reviews

This final rule establishes tolerances

under section 408(d) of FFDCA 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). Because this final rule

has been exempted from review under

Executive Order 12866, this final rule is

not subject to Executive Order 13211,

entitled Actions Concerning Regulations

That Significantly Affect Energy Supply,

Distribution, or Use (66 FR 28355, May

22, 2001) or Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

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., nor does it require any special

considerations under Executive Order

12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994).

Since tolerances and exemptions that

are established on the basis of a petition

under section 408(d) of FFDCA, 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.

This final rule directly regulates

growers, food processors, food handlers,

and food retailers, not States or tribes,

nor does this action alter the

relationships or distribution of power

and responsibilities established by

Congress in the preemption provisions

of section 408(n)(4) of FFDCA. As such,

the Agency has determined that this

action will not have a substantial direct

effect on States or tribal governments,

on the relationship between the national

government and the States or tribal

governments, or on the distribution of

power and responsibilities among the

various levels of government or between

the Federal Government and Indian

tribes. Thus; the Agency has determined

that Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999) and Executive Order 13175,

entitled Consultation and Coordination

with Indian Tribal Governments (65 FR

67249, November 9, 2000) do not apply

to this final rule. In addition, this final

rule does not 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).

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).

VH. Congressional Review Act

The Congressional Review Act, 5

U.S.C. 801 et seq., generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report to each House of

the Congress and to the Comptroller

General of the United States. EPA will

submit 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 United States prior to

publication of this final rule in the

Federal Register. This final rule 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 31, 2008.

Lois Rossi,

Director, Registration Division, Office of

Pesticide Programs.

m Therefore, 40 CFR chapter I is

amended as follows:

PART 180-[AMENDED]

m 1. The authority citation for part 180

continues to read as follows:

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

* 2. Section 180.318 is amended in

paragraph (a) by redesignating the

existing text as paragraph (a)(1) and by

adding paragraph (a)(2) to read as

-follows:

180.318 4-(2-Methyl-4-chlorophenoxy)

butyric acid; tolerances for residues.

(a) General. (1) * * *

(2) Tolerances are established for the

combined residues, free and conjugated,

of the herbicide MCPB, 4-(4-chloro-2-

methylphenoxy)butanoic acid, and its

metabolite MCPA, (4-chloro-2-

methylphenoxy)acetic acid, in or on the

following food commodities:

Federal Register /Vol. 73,

HeinOnline -- 73 Fed. Reg. 66785 2008