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Citation: 73 Fed. Reg. 66759 2008

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-- 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, oruse of energy. Therefore, a Statement ofEnergy Effects is not required under Executive Order 13211 (May 18, 2001).

F.Executive Order12988(CivilJustice 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) ofExecutive Order 12988 (Feb. 5, 1996).

G.

Executive Order 13045 (Protectionof Children)

This rulemaking does not concern an environmental riskto health or safety that may disproportionately affect children under Executive Order 13045 (Apr.21, 1997).

H.Executive Order 12630 (Takingof Private Property)

This rulemaking willnot effect a taking ofprivate property orotherwise have taking implications under Executive Order 12630 (Mar. 15, 1988).

I. Congressional ReviewAct
Under the Congressional Review Act provisions ofthe 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 finalrule and other required information to the U.S. Senate, the U.S. House of Representatives and the Comptroller General ofthe Government Accountability Office. The changes in this final rule are not expected to result inan annual effect on the economy of 100 million dollars or more, a major increase in costs .orprices, or significant adverse effects on competition, employment, investment, productivity, innovation, orthe ability ofUnited. States-based enterprises to compete with foreign-based enterprises in domestic and export markets. Therefore, this final rule is nota "major rule" as defined in 5 U.S.C. 804(2). 

### J. UnfundedMandates ReformAct bf 1995

The changes in this final rule do not involve a Federal intergovernmental mandate that will resultin the expenditure by State, local, and tribal governments, in the aggregate, of100 million dollars (asadjusted) or more in
any oneyear, or a Federal private sector mandate that will resultin the expenditure by the private sector of100 million dollars (as adjusted) ormore in any one year, and will not significantly

or uniquely affect small governments. Therefore, no actions are necessary under the provisions ofthe Unfunded Mandates Reform Act of1995. See2 U.S.C. 1501 etseq.
K.National EnvironmentalPolicyAct

Thisrulemaking will nothave any effect on the quality ofenvironment and is thus categorically excluded from review under the National Environmental Policy Act of1969. See 42 U.S.C. 4321 etseq.
L. NationalTechnologyTransferand AdvancementAct

The requirements ofsection 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 oftechnical standards.

M.Paperwork ReductionAct

The changes in this finalrule involve information collection requirements which are subject to review by the Office ofManagement and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 etseq.). The collection ofinformation 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 -packageto OMB for itsreview and approval because the changes inthis finalrule 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 ofthe information collection under OMB control number 0651-0021.

Notwithstanding any other provision oflaw, no person isrequired to respond
to nor shall a person be subject to a penalty for failure to comply with a collection ofinformation subject to the requirements ofthe Paperwork Reduction Act unless that collection of information displays acurrently valid OMB control number.

List ofSubjects

37 CFRPart1

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 citationfor 37CFR Part 1 continues to read as follows:

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

0 2.The authority citationforsubpart is revised to read asfollows:

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

.................................. $2,080.00

0.00

0.00

Dated: October 21, 2008.
Jon W. Dudas, UnderSecretaryofCommerce forIntellectual PropertyandDirector ofthe UnitedStates PotentandTrademarkOffice. [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 forAir Quality Planning Purposes; State of California; PM-10; Revisionof 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 forthe 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 often microns orless (PM-IO) (SJVnonattainment area) by splitting the area into two separate nonattainment areas: The San Joaquin

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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 emissionsbudgets and conformity trading mechanism for the area. EPA is also excluding from use in determining that the area has attained the standard exceedances onJuly 4, 2007, and January 4, 2008, that EPA has concluded

were caused byexceptional events. Finally, EPA is approving enforceable commitments by the Kern County Air Pollution ControlDistrict 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 onDecember 12, 2008. The motor vehicle emission budgets are applicable as ofNovember 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 inthe 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 ofContents

I.Background II.PublicComments and EPA Responses

A. Area Has Attained B.FullyApproved SIP C.Improvements in Air Quality are Due to

Permanent and Enforceable Emission Reductions D. Area Has Met AllApplicable CAA

Section 110 and PartD Requirements E. Maintenance Plan F.Revision ofBoundary 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 ofthe State ofCalifornia's request to revise the designation for the SJV seriousPM-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-10nonattainment

area.

* Redesignation ofthe SJVAB nonattainment area to attainment for the PM-l0 NAAQS and approval ofthe maintenance plan, motor vehicle emissionsbudgets and conformity trading mechanism forthe SJVAB area.

* Exclusion froi use in determining thatthe SJVAB areahas attained the standard two exceedances that EPA has concluded were causedby exceptional
events that occurred onJuly 4, 2007, and January 4, 2008.

* Approval ofenforceable commitments bythe Kern County Air Pollution Control District (KCAPCD) and the California AirResources Board (CARB) to install aPM-10 monitor in the East Kern nonattainment area and to address CAA requirements under section 189(d) as necessary forthe 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 orderto notify the public ofaminor change inthe motor vehicle emissions budgets and to provide the public with the opportunity to consider these technical corrections.

Under section 107(d)(3)(D) ofthe CAA, the Governor ofany state may, on theGovernor's own motion, submit to EPA arevised designation of any area or portion thereofwithin the state.1 EPA is required to approve or deny the revised. designation within 18months ofreceipt. 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") ofany area.

Section 107(d)(3)(E) ofthe CAA states that an area canbe redesignated to attainment ifthe 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) ofthe CAA.

(3)EPA has determined that the improvement in air quality is due to permanent and enforceable reductions in emissions.

' Boundary changes arean inherentpart ofa designation orredesignation of an areaunderthe 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 Dofthe CAA.

(5) EPA has fully approved a maintenance plan, including a contingency plan, for the area under section 175A ofthe CAA. These requirements are discussed in more detail in aSeptember 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 ofthe 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 tobelieve 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

areameet the applicable requirements of the CAA. In addition, EPA is granting the State's request for aboundary revision forthe area based on a multiplicity offactors. The available monitoring data for the East Kern area, while limited, also indicate that concentrations are well below the NAAQS. Thus, forthe reasons set forth inthe responses to comments below, as well asin the proposed rule, EPA is finalizing its proposed determinations

as fully meeting the requirements ofthe CAA.

A. AreaHasAttained
Comment1:Earthjustice (EJ) states that the firstcondition 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. EJalleges 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 airquality problem and the health impacts associated with it. EJ incorporates byreference and attaches its previous comments on EPA's attainment determination that claim the problem EPA is ignoring has existed for

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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 EJrefers 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 forWithdrawal, with attached declarations from Sarah Jackson and Jan Null. EJ raised the same issues asit raises here during EPA's rulemakings regarding the 2006 determination of attainment for the SJV nonattainment
atea and 2008 affirmation ofthat determination. EPA fully responded to EJ's comments at that time. See the final rules at 71 FR63642 (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 inour 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 byEJ 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 ofthe October 2006 and March 2008 final rules in the U.S. Court of Appeals forthe Ninth Circuit. Latino IssuesForum,et a].v. EPA,Nos. 06- 75831 and 08-71238.2 In its opening brief inthese cases, filed onJune 16, 2008, EJ againraises these issues.In its briefin opposition, filed on September 3, 2008, EPA againresponds to EJ's arguments. EJ was required to raise any issuesregarding the 2006 attainment determination and 2008 affirmation of that determination during those rulemakings and in the Ninth Circuit in LatinoIssuesForumand 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 July4, 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 ofour proposed rule. In this final action, forthe reasons set forth inthe proposed rule and in EPA's concurrence letters to which itrefers, we are concurring with the State's flagging of

2The NinthCircuithas consolidated thetwo petitionsfor 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 ofPM-10 exceedances recorded on May 21, 2008
atthe Corcoran and Bakersfield Federal Equivalent Method (FEM)monitors and the Corcoran Federal Reference Method (FRM) monitor, and onMay 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 nopublic comments were received. The documentation was submitted to EPA

on August 12, 2008 andEPA 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 inthis final rule that the SJVAB area continues to attain the PM10 standard. The determination of whether an area has attained the PM-10 standard isbased on the most recent three consecutive calendar years ofdata. As mentioned above and in other EPA actions, the SJVAB area has attained the PM-10 standard based on data forthe 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 2008has not ended, EPA cannot determine whether the area has attained the standard based

onthe three-year period from 2006 through 2008. We can, however, determine with less than three years of data whether the SJVAB areahas failed
to attain in the period from 2006 to date. See40 CFR part50, 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 onthe May 21 exceedance, is three and the expected number ofexceedances recorded atthe FEM monitor on May 21 and May 22 is two. 3 Similarly, because the May 21,

3Note thatthe Corcoran FRM operates on a onein-three day schedule andthat EPA does not combine PM-10 data collected with different monitoring methods, i.e., FRMs andFEMs. See Memorandum from Gerald A. Emisdn, EPA, to EPA Regional Division Directors, "Revision to Policyon the Use ofPM-la Measurement Data," November 21, 1988 at 3. 2008 exceedance is the only exceedance recorded atthe Bakersfield monitor since 2006 not excluded from regulatory consideration through notice and comment rulemaking, the expected number ofexceedances at the Bakersfield monitor is one. Thus, even ifEPA doesnot 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 ofless than or equal to one per year, averaged overthe three year period 2005-2007 and through 2008 to date. All Other monitors in the SJV area had an expected number ofexceedances ofless than or equal to one per year during these periods. EPA thus determines that the SJVAB area has attained the PM-10 NAAQS asrequired by section 107(d)(3)(E)(i).

B. Fully ApprovedSIP
Comment2: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 ithas never approved contingency measures forthe

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 demonstratereasonable further progress (RFP) "until the area is redesignated to attainment." EJbelieves that because contingency measures are alsonecessary to ensure this progress is achieved, EPA cannot suspend the requirement for these measures. Citing EngineMfrs.Ass'n v.EPA, 88 F.3d 1075, 1089 (D.C. Cir. 1996), EJ asserts that EPA does nothave the authority to waive statutory requirements and circumvent redesignation provisions because it believes compliance with those requirements is unnecessary.

Response2:In 2006 EPA approved the entire nonattainment plan forthe
SJV area,4 including the CAA section 189(c)(1) reasonable further progress milestones, except forthe CAA section 172(c)(9) contingency measures, on

4 "2003 PM10 Plan, San Joaquin Valley Plan to AttainFederal Standards for Particulate Matter 10 Microns and Smaller" (2003 PM-10 Plan).

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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 aresult ofits 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 Policy5 and statutory construction as itraises here. EPA responded to EJ's arguments in the final rule. See id. at 63643-63647. EJagain raises these issues in its opening briefin LatinoIssuesForum.EPA again responds to EJ's arguments in its briefin opposition. EJ was required to raise any issues regarding the suspension ofthe contingency measures requirement during EPA's 2006 attainment determination rulemaking and in Latino IssuesForum.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 additionaljustification forfinding that the section 172(c)(9) contingency

measures are not an applicable SIP requirement for purposes of redesignation. Prior to and independently ofthat 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 ensuringRFP andattainment by

5EPA haslong interpreted the CAA toprovide that certain nonattainment area requirements, the purpose of which are to ensure attainment ofthe relevant NAAQS by the applicable deadline, will no longer apply once an area has attained that NAAQS, and foras long itcontinues to do so until it is redesignated to attainment status. Whilereferred to

asthe Clean Data Policy, it is more accurately described as EPA's interpretations ofthe relevant provisions ofTitle 1, Part D ofthe CAA. See Sierra Clubv. EPA, 375 F.3d 537, 541-42 (7th Cir. 2004); SierraClubv. EPA, 99F.3d 1551, 1156-57 (loth Cir. 1996). EPA first set forth this interpretation in its "General Preamble forthe Interpretation ofTitle I ofthe Clean Air Act Amendments of1990," (General Preamble) thereafter reiterated it in several policy memoranda and since codified the policy with respect to ozone and PM-2.5 nonattainment

areas. 57FR 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 ofthe policy and uiu appliuation ofit, see'Respondent EPA's Merits Brief in LatinoIssuesForumat 7-8. 71 FR 40952,40954 and 71 FR b3642, 63644. the applicable date.These requirements no longer applywhen an area has attained the standard and is eligible forredesignation. Furthermore, section 175A for maintenance plans * * *provides specific requirements for contingency measures that effectively supersede therequirements ofsection 172(c)(9) for these areas. See also Calcagni memorandum at 6 ("Therequirements for reasonable further progress and other measures needed forattainment will notapply for redesignations because they onlyhave meaning for areas notattaining the standard."). Thus, even-ifthe 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 ofwhat constitutes applicable requirements under section 107(d)(3)(E). The Courts have recognized the scope ofEPA's authority to interpret "applicable requirements" inthe redesignation
context. See SierraClubv. EPA, 375 F.3d 537 (7th Cir. 2004).

C.ImprovementsinAir Quality MustBe DuetoPermanent andEnforceable EmissionReductions

Comment 3:EJ states that a 1992 guidance memorandum from John Calcagni lays outthe stepsthat an area must take to show that the improvement in air quality is attributable to permanent and enforceable reductions inemissions, the third condition for redesignation to attainment under CAA section 107(d)(3)(E). EJclaims 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. EJstates that EPA, banking on its waiver ofallthe 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 fourobservations (comments 4 through 7 below), that the area is attaining the standard.

Response3:As discussed in our proposed rule, theCalcagni memorandum states that the state must beable to reasonably attribute the improvement in air quality to emission reductions which are permanent and enforceable, and the improvement should notbe a result oftemporary 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 andimplemented 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 ofimplemented controls. Our proposed rule discusses how each of these factors is addressed by the State in the "2007 PM10 Maintenance Plan and Retuest forRedesignation," September 20, 2007, SJVAPCD (2007Plan). 73 FR 22307; 2008, footnote 8; 22311-22312.

Ingeneral, 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 (andemissions) occurred during a period ofrapid economic growth in the SJVAB area as indicated by the increases in population and vehicle miles traveled (VMT). The 2007 Plan didnot 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 ofsource categories, and'it shows decreases inthe overall emissions ofNOx and PM-Ia (whichinclude all emissions from area
sources as wellas from permitted major sources) since 2000. A more detailed discussion ofthese analyses can be found in our proposed rule andin 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 ofpermanent 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-10standard. 71 FR 63642; 73 FR 14687. These determinations included EPA's

concurrence with the State's and Santa Rosa Rancheria Tribe's conclusion that

anumber ofexceedances were caused

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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:EJclaims thatthe District provides a chart (2007Plan at 24, Figure 2) showing a downward trend in air pollution levels that is completely misleadingbecause it does not include EPA-acknowledged exceedances in 2004 and 2005, let alone the many exceedances EPA has ignored in its attainment determination.

Response4:The District's chart (2007 Plan at 24, Figure 2) shows a long-term downward PM-10 trend from 1990 to 2006 forthe SJVAB area byplotting the estimated exceedance days over the NAAQS. The estimated exceedance days inthis chart are based on exceedances recorded withFRMs and notFEMs such as continuous beta attenuation monitors (BAMs). EPA believes that the District's chart is not misleading and provides ageneral picture ofthe long-term trend forPM10 andthat 1990 is areasonable 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," thatappears to revise the 2007 Plan's chartby 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 PM10levels. However, even with the exclusion ofthe 1990 data and the addition ofthe 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 ofthe 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 thistime period.

Finally, as discussed above, EPA has
notignored 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. EPAalso
set forth in its 2006 attainment determination its conclusions as to prior monitored data. 71 FR 63642. Comment5:EJ claims that while the District asserts that growth inthe SJV nonattainment area has been rapid since 1990 but that emissions have decreased, the sources ofthese claimed reductions do not support redesignation. Response5: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 SJVnonattainment

area experienced some ofthe 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 inthe 2007 Plan whichincludes an examination ofthe precipitation, temperature wind speeds and atmospheric stability during the period 2003 through 2006. The summary wasbased 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 inannual 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 yearbeing the wettest year) during a 128 yearperiod. Since there were conditions that both favored and didnot favor higher PM-10 levels, the conclusion ofthe 2007 Plan and EPA's analysis is that there was no consistent pattern to show that attainment was a result ofunusually favorable meteorology. 73 FR 22307, 22312.

Finally we note that the Calcagni memorandum makes clearthat "[a]ttainment resulting from * * * unusually favorable meteorology would
not qualify as an air quality improvement due to permanent and enforceable emission reductions." Calcagni memorandum at4. Therefore EPA disagrees with EJ's comment that the meteorological data indicate that the air qualityimprovement will notlikely 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 atTables 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 of10.13 inches for 1878 through 2006 (2007Plan at Table C-1) and would favor higher PM-10 levels. The average monthly temperatures in degrees Celcius for 2007

were 4.6forJanuary, 9.5 for February, 14.3 for March, 15.9 for April,-20.7 for May, 24 forJune, 26.3 for July, 26.3 for August, 21.7 for September, 16.1 for October, 11.9 forNovember 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 (2007Plan atTable C-2), the average temperatures forthe months ofMarch, 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 perhour (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 atTable 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 ofpermanent and enforceable reductions in emissions from rules adopted by the District since 1992. EJ claims that most ofthese rules

were adopted only inthe last few years and therefore any trend in emission reductions that canbe 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 inthe methodologies for measuring exceedances forthe TSP and PM-10 standards. EJprovides its own chart, "PM-10 Trend," adjusted to include the exceedance days that it says EPAhas acknowledged, that purports to show only minimal changes in the recurring pattern ofPM-10 violations

overthe 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

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(AQS) database since 1989. Therefore
any difference inmeasurement methodologies for the two pollutants could notbe the cause ofthe drop in exceedance daysbetween 1990 and 1992.

Since enactment ofthe 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 byEPA in 2004 and discussed above). The 2003 PM-10 Plan provides a summary ofthe many State, Districtand EPA rules adopted from 1990 through 2003. See 2003 PM10 Plan atTables 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 ofwhich were adopted by the District and State after 2003 and most ofwhich have been approved byEPA. See response to comment 8 below.

The District's chart (2007Plan, Figure 2) shows that PM-10 levels have declined from 1990 through 2006 while these PM-10 plans andrules 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; StaffReport, Air Resources Board, "Analysis ofthe San Joaquin Valley 2007 PM10 Maintenance Plan," (ARB StaffReport for 2007 Plan)Appendix
B. 6

As can be seen from the above discussion andour 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 ofsuch controls. Further, while EPA claims that the District has adopted all ofits rule commitments inthe 2003 PM-10 Plan, only 2 ofthe 14 commitments have received EPA approval according to EJ. The maintenance plan identifies 8 additional rules, only 3 ofwhich have been approved by EPA. EJ states that ofthe 22 rules the District identified during its PM-10 planning process to help reduce PM-tO inthe SJV nonattainment area, only 5are enforceable elements of the SIP.

Response8:The 2007 Plan provides

a summary ofoverall 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 atTable 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 26through 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 atTable 4-9.As discussed below, the commitments have allbeen converted to adopted rules. The emissions reductions from all ofthe 2003 PM-10 Plan's rules, control measures and adopted commitments are reflected inthe 2007 Plan's emissions inventory. ARB Staff Report for 2007 Plan at Appendix B.

Itis not clear what year EJ considers
to be the baselineyear; however, the 2007 Plan provides emissions inventories for the years 1990, 2000, 2005 and 2010 which include the estimated tpd ofreductions achieved by the PM-10 rules, control measures and rules adopted pursuant to commitments. 2007 Plan atTable 10and ARB Staff Report for 2007 Plan atAppendix 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 ofsuch controls.

Regarding EJ's comment that only five ofthe 22 rules the District identified during its PM-10 planning process are enforceable elements ofthe SIP, EPA
notes thatthis information was updated inthe 2007 Plan. See "Errata, 2007 PM10 Maintenance Plan and Request for Redesignation," October 9, 2007, included in the 2007 Plan submittal to EPA. Table 1below 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 ofthe submitted rules (Rules4694, 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 Gins

........................................... 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 ofthe proposed rule. 73 FR
22307,22308.

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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 Notadopted 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 2.0to 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.Wineries (VOC)

............................................. 4694- Wineries

................................................ 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 thosefound inthe version ofthe 2003 PM-10 Plan adopted bythe District on December 18, 2003.

8In 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 itinour Table for completeness inaddressing EJ's comments.

In addition to the rules in Table 1, the 2007 Plan cites reductions from additional rules that were notincluded in the 2003 PM-10 Plan's commitments. All ofthese 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 ofEPA 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 ofthe rules identified in the 2007 Plan have been approved by EPA as federally enforceable elements ofthe SIP. EPA is continuing to process the remainder of the State's submitted rules.

Comment9:EJ concludes thatbecause the air quality improvements are premised on ignoring multiple violations ofthe PM-10 standard and fewer than one quarter ofthe rules the District relies on forreductions are an enforceable part ofthe SIP, EPAcannot reasonably attribute air quality improvements to permanent and enforceable emission reductions. Response9:See above responses to comments 1,3, 4, 6, 7 and 8.

D.AreaHasMetAllApplicableCAA Section 110andPartDRequirements

Comment10: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 partD. EJ says that in addition to the contingency measure requirement, the District has notmet the section 189(b)(1)(B) BACM requirement because BACM wererequired to be implemented byJanuary 8, 1993 and EPA has still not approved most ofthe PM-10 rules relied on (as a result ofthe 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 resultit is no longer an applicable partD requirement. 71 FR 63642, 63663; 73 FR 22307, 22313. In any event, as set forth above (seeresponse to comment 2), independent ofits suspension, the contingency measure requirement is not

an applicable requirement for purposes ofredesignation.

Withrespect to the section 189(b)(1)(B) BACM requirement, as

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discussed in our proposed rule, EPA determined that this requirement was met for the SJV nonattainment area in

our approval ofthe 2003 PM-10 Plan. See 69 FR 30006, 30035. ("EPA is approving the RACM/BACM demonstration forall significant PM-10 andNOx sources in the SJV as meeting the requirements ofsections 189(a)(1)(C) and 189(b)(1)(B)"). In the 2003 PM-10 Plan the District addressed theBACM 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 ofthese source categories, EPA could not conclusively determine that the planprovides forthe implementation ofBACM/BACT for all significant sources ofPM-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 bestavailable control

measures forthe control ofPM-10 shallbe implemented no laterthan4 years after the date the area is classified (orreclassified) as
a Serious Area.' Nothing inthis language either requires a state tohave adopted controls inplace before a SIPrevision canbe approved intoits PM-10 plan or forbids the adoption ofan 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,. EPAhas historically determined thatan enforceable commitment to adoptand implement BACM ina SIP meets this statutory requirement since it constitutes a 'provision to assure thatBACM.is implemented' by a fixed deadline. As a result, the commenters' complaint that '[bly definitionthe plan failsto implement BACM/ BACT for all source categories forwhich no developed control measures exist hasno merit since the statute itselfdoes notimpose such arequirement. Because the statute does not definewhat is a 'provision to assure BACM isimplemented,' EPA may adoptan interpretation reasonably accommodated to thepurpose ofthe statutory provision. Chevron U.S.A., Inc.v. NaturalResources Defense Council,467 U.S. at842-44. Id. at 30013-30014. In conclusion we stated that:

In accepting enforceable commitments to meetthe requirements ofsection 189(b](1)B), however,EPAhas required states to undertake an analysis to ensurethat the regulation ultimately adopted pursuant tothe commitment will represent aBACM level of control. As we describe in ourproposed rule,

a state must determine the technical and economic feasibility ofpotential control

measures for each ofthe significant source categories. 69 FR 5412, 5418. Thus the

measure that is the subject ofa 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 thatmeasure meets the statute's BACM requirements. See, e.g., the Arizona rulemakings in whichEPA 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); 66FR 51869 (October 11, 2001); 67 FR 48718 (July 25, 2002).
Id. at 30014. EPA's interpretation and its full SIP approval ofthe BACM requirement was not challenged. EPA
may rely on prior SIP approvals in approving aredesignation request. Calcagni memorandum at 3; SouthwesternPennsylvaniaGrowth 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 ofthe rules submitted by the State as meeting

a BACM level ofcontrol. 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 submitto 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 ofan 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 ofthe redesignation request mustbe fully approved into the plan at or before the time EPA redesignates the area." Calcagni memorandum at 5. SierraClub

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 ofsection 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 inthat rulemaking the application ofthe Clean Data Policyto 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 forredesignation, the requirements for milestone demonstrations under section 189(c) have no further meaning or function. Therefore theDistrict was not required
to submit milestone demonstrations pursuant to section 189(c).

Inaddition, EPA approved a commitment in the 2003 PM-10 Planby the State to submit a SIPrevision by March 31, 2006based on amid-course review to determine whether the level of emission reductions inthe plan is sufficient to attain the PM-10 standards. 69 FR 30006, 30035. EPA approved this commitment aspart ofthe 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 ofthe attainment demonstration in the 2003 PM-10 Plan fully satisfies therequirement ofCAA 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 arequirement under section 110 or PartD, and therefore is not an applicable CAA requirement for purposes of redesignation. Furthermore, even if it
were, the requirement fora mid-course review was approved aspart ofthe attainment demonstration. Therefore, because EPA has determined that the

SJV area is attaining the PM-10 standard, a submission underthe midcourse review provision would notbe required forpurposes ofredesignation. 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 NSRRequirements 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. EJquotes the memorandum as saying that "the part Dprogram may be replaced by the corollary PSDprogram, ifit is shown

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through the maintenance demonstration that the area will maintain without part D NSR." EJasserts that here neither EPA

nor the District has.made any such demonstration and claims that this is especially worrisome in light ofEPA's recent proposed appioval ofrevisions 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 NSRprogram forthe
SJV area. We also noted that EPA has recently proposed approval ofsome revisions to the NSRrule. 73 FR 22307, 22313. EJ's citation to the October 14, 1994 memorandum from Mary Nichols, EPA, entitled "Part D NSR Requirements forAreas 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 notbeen 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 ofthe State's redesignation request. Id. Ifan area does not have a fully approved NSR program, it can still be redesignated ifit 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 inthe 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 ofthe Nichols memorandum. Finally,we note that while the PSD requirements will apply once the area has beenredesignated 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.MaintenancePlan
Comment 13:EJ maintains that even ifall bfthe other issues ithas raised with respect to the redesignation were remedied, EPA cannot approve the redesignatioin requestbecause 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 outin the Calcagni memorandum leaves littlefor EJ to comment upon and, as such, is the very definition of arbitrary and capricious. EJbelieves that EPA's obligation is to provide notjust its legal conclusions but the facts and rationale that support them.

Response 13:EPA disagrees. Our proposed rulelays out all ofthe requirements formaintenance plans found under the CAA and the Calcagni memorandum and sets forth the Agency's analysis ofhow the 2007 Plan
meets eachofthose requirements. 73 FR 22307, 22313-22315. In addition, the 2007 Plan itselfaddresses in detail the requirements in the Calcagni memorandum. Thus EJ's contention that EPA's discussion ofthe maintenance plan'left them "very little" to comment

onis without basis.

Comment 14:EJ asserts that the 2005 emissions inventory is insufficient to identifythe level ofemissions 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 ofthe PM-10problem in the SJVnonattainment 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.

Ina footnote to its comment above regarding the emissions inventory for the maintenance plan, EJ claims that prior to 2004 the District hadnever asked EPA towaive PM-Ia data but in the past 4 years ithasbeen asked to waive 11 separate events, 10 ofthem after the Agency's original attainment finding. EJ states that ifwindy days are this common EPA and the District must accept that the SJV nonattainment area has awindblown dust problem and they
must do more to control it. EJstates that

an event is only exceptional ifitis 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 aresult ofthe SIP (see above responsesto comments 3through 4 and 6 through 8), the attainment inventory will generally be an inventory ofactual emissions at the timethe 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

arearelies on reductions ofboth NOx (a PM-10 precursor) and directly emitted PM-10 sources to achieve attainment. 2003 PM-10 Plan atES-9 through ES10, Chapters 2, 4 and 5; 69 FR 5412, 5414 and 69 FR 30006, 30007. Analysis ofambient airquality data for the SJV

area shows that it experiences the most frequent and severe exceedances from October throughJanuary during stagnant weather conditions (i.e.,low wind speeds that are unable to disperse the PM-10).9 Both directPM-10 and secondary PM-10 (formedby reactions with NOx )occur duringthis time. October and November exceedances are dominated by direct PM-10 emissions and December andJanuary are dominated by secondary PM-10 such as ammonium nitrate (formed when NOx
reacts with ammonia and other components); however, the reduction of both directPM-10 and NOx is necessary forreducing ambient PM-10 levels throughout the year. 2003 PM-IO Plan at ES-9through ES-10 and5-6 through 5-7. Thus, EPA's beliefthat 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 of606 tpd in 2005 to 328 tpd in 2020 is based on an understanding that high PM-10 levels in the SJV areaare caused byboth 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 directPM-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 ofits letter does not appear to be related tothe inventory or any other provision ofthe 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 ofEJ's argument that the SJV area has not in fact attained the PM-ia standard. In this

9As discussed in our attainment affirmation and proposed rule, unusually high winds can also cause exceedances. 73 FR14687 and 73 FR 22307, 22311. Federal Register /Vol. 73,

v

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regard, see response to comment 1 above. Notwithstanding, EPAnotes that
not all ofthe exceptional event days in the past five years in the SJV area have been due to high winds. Ofthe 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 ifit does not then the modeling for the maintenance plan is flawedbecause it fails to include these higher values in its projections.

Response 15:As discussed in our proposed rule, a state maygenerally demonstrate maintenance ofthe NAAQS by either showing that future emissions ofa pollutant or its
precursors will not exceed the level of the attainment inventory, or by modeling to show that the future anticipated mix ofsources and emission
rates will not cause aviolation ofthe NAAQS. 73 FR 22307, 22314-22315. See also Calcagni memorandum at 9 and Wallv. EPA, 265 F.3d426 (6thCir. 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 fortheir attainment demonstrations, the same level of modeling should be used for the maintenance demonstrations. The 2007 Planuses Chemical Mass Balance (CMB) and rollback to demonstrate maintenance ofthe 24-hour PM-10 standard until 2020 which is consistent with the modelingperformed for the 2003 PM-10 Plan. 73 FR 22307, 22314; 2007 Plan at 6-11. The modeling involves selecting arepresentative day for each location, determining the speciation data for the site based on analysis ofthe 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 basedon the highest episodes during the most recent attainmewt year at the time, 2006. The District selected representative peak winter days foreach ofthe monitors in the SJVAB formodeling, and used the observed values from those days as the basis ofits modeling exercise. In addition, fall episode days were included for several monitors. Table 2 of the 2007 Plan summarizes the episode values and the 2020projections.

One ofthe 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 inthis case, 2004 through 2006, and depends on the frequency and completeness ofrecorded values. Inaddition, forPM-IO, the design values are generally based on FRM data, butFEM data can also be used; however, as noted infootnote 3 above, data from different monitoring instruments are not combined.

The representative days selected for modeling are consistent with the design values forthe'Corcoran and Bakersfield sites where the September 2004 and November 2005 values were measured. Forthe Corcoran FRM, the design value is 140 gg/m 3

,based on a calculation that includes and explicitly accounts for the 217 gg/m 3measured in September 2004.10 This value is very closeto, and supports the selection of,the two representative high episode values in the 2007 Plan for Corcoran: A 136 gg! M3 forthe winter episode and a 137 gg/ M3 forthe 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 of150 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 timeperiod cannotbe calculated based on the FEM data. However, the 2004-2006 PM-10 design value forBakersfield using the data collected with the FRM monitor would be 154 ug/m 3

. 1 This concentration is consistent withthe 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

1oIfwe assume that theSeptember 2004
exceedance is not flagged, thehighest recorded PM10 values from 2004 through 2006 are: (1)217 jig/

m3on 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, thedesign value is based on the secondhighest recorded PM-IOvalue, or 140 pg/

M 3

.

11

The design value forBakersfield is calculated using theFRM data set from 2004-2006.The design value in thiscase would be thehighest non-flagged value forthe three year period. 154 pg/m 3 measured

onDecember 7, 2006. taken into account inthe 2007 Plan's maintenance demonstration modeling. Comment 16:While EJ is glad that the District plans to continue operation of its PM-10monitoring network, EJ is troubled that the District suggests in its 2008 "Ambient AirMonitoring Network Plan" that it may reduce the frequency ofits monitoring. EJhopes that the District will strengthen its network because EJ continues tobelieve that the
current network does not adequately represent the west side communities andthe near-highway areas ofhigh concentration and that more monitoring is required.

Response 16:In 2003, EPA evaluated the adequacy ofthe 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 ofthe Adequacy ofthe 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 ofthe network in our 2006 determination ofattainment for the SJV

area. 71 FR 63642, 63648-63658.

With regard specifically tomonitoring frequency, EPA regulations require minimum frequencies formanual PM10 and PM-2.5 samplers at designated
state orlocal air monitoring stations (SLAMS) sites. See40 CFR 58.12. On October 17, 2006 EPA revised its monitoring regulations to require air monitoring agencies to perform an assessment oftheir 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 mustbe submitted to EPA by July 1,2010. Agencies are directed to make changes to theirmonitoring networks based inpart on the results of these network assessments. Such an assessment in the SJVAB area may result in a requirement thatthe District increase the sampling frequency of certain PM-10 monitors sitedto record the maximum concentrations ofPM-10 pollution. See40 CFR 58.12(e).

Most manual PM-10 samplers in the

SJV monitoring network currently operate at the minimum required frequency ofonce 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

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Monitoring Network Plan," the Corcoran and Bakersfield-Golden State Highway sites are two ofthe four PM10 monitoring sites located to record the highest PM-10 concentrations inthe
SJVAB area. 12 Therefore, the District has already proactively increased the sampling frequency at two high concentration sites to the maximum frequency possible.

Comment17:EJ believes that the contingency measure provision in the maintenance plan is much too weak and
cannotbe approved. EJ states thatthe provisionrelies first and foremost on trying toexcuse any future violation under the EER and then, inthe event of
any post-redesignation violations, on seeing ifthere are any estimated reductions achieved that were not counted towards theattainment demonstration that canbe used to "cover" the violation. EJ does not believe this approach makes sense because ifan area is violatingthe standard, there are no "extra" reductions because all ofthe reductions

areby definition notworking. EJ believes that while EPA may accept this gamingin the context ofRFP demonstrations such an approach would be illegal and arbitrary when real ambient violations arebeing monitored. EJbelieves that the District should adopt the approach suggested inthe Calcagni memorandum which sets indicators that trigger contingency provisions before a violation occurs which would avoid NAAQS violations and notjust 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 ofthe standard." The Calcagni memorandum states that "EPA willreview-what constitutes a contingency plan on a case-by-case basis. At a minimum, it mustrequire that the State will implement all

measures contained inthe PartD nonattainment plan for the area prior to redesignation. * * * " Calcagni memorandum at 12-13. The memorandum also makes clearthat a monitored violation ofthe standard is appropriate to serve as the indicator or trigger for contingency measures. Id.at 12.

EJ's statement that the contingency provisions ofthe 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 othertwo sites arethe Fresno-First Street site and the Stockton-Hazelton site. action level ortrigger based on an exceedance ofthe 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 ofvaluesjust below but near the level ofthe 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, anda single measurement of 155 jg/m3at one ofthese monitors wouldnot constitute aviolation ofthePM-10 NAAQS. Even ifameasurement of 155 gg/m 3is recorded at a one-in-six dayFEM, aviolation is notnecessarily being recorded as the State might need to evaluate the possibilitythat themeasurement is dueto 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 ofdetermining whether a violation ofthe standard actually occurred, which would require corrective actions. In other words, we concluded that the 2007 Plan's action level ortrigger, including the exclusion ofexceedances causedby exceptional events, meets the statutory mandate that the contingency provisions "correct any violation ofthe standard." Because it is clearly part ofthe action level ortrigger, and not the corrective actionsto be undertaken in the event ofa violation, itis not accurate to conclude, as EJ does, that the contingency plan relies "first and foremost" on theuse ofthe 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 oftheNAAQS, and at a minimum provides for aviolation that is determined notto be due to an exceptional event to trigger a measure.

Once the contingency plan is triggered, theDistrict would determine the possible causes ofthe exceedance and determine ifemissions 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 ofthese excess reductions (i.e., those notrelied on in themaintenance demonstration) when ambient concentrations arebeing monitored.

13An exceedance is defined as a dailyvalue that is above the level ofthe 24-hour standard (150pg/ m3

) after rounding to thenearest 10jg/m 3(i.e. values ending in 5 or greater are to berounded up). Thus, arecorded value of 154 ig/m 3 would not be

an exceedance since itwould berounded to 150 Vg/
M3 whereas arecorded valueof 155 gig/m 3would be an exceedance since itwould berounded to 160 ig/m3

. See 40CFR 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 inthe attainment and RFP demonstrations under CAA section 172(c)(9). See, e.g., 62 FR 15844 (April3, 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 ofsection 172(c)(9) in our finalPM-2.5 implementation rule. See 72 FR 20586, 20642-20643 (April 25, 2007). This interpretation has also beenupheld in LEANv. EPA, 382 F.3d 575 (5th Cir. 2004), andthe court inthat 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 ofwhether an area has attained aNAAQS (see, e.g., section 188(b)(2); 71 FR40952) arebased on monitored concentrations. Likewise, here, a determination ofwhether the action level hasbeen 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) inthat 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

arequirement in order forthe 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 asthe Administrator deemsnecessaryto

assure thatthe State will promptly
correct any violation ofthe standard." (Emphasis added). In addition, the Calcagni memorandum at 12-13 states that a contingency plan under section 175A(d) "[alt aminimum mustrequire that the State will implement all

measures contained in the Part D nonattainment plan forthe area prior to redesignation. * * * " The 2007 Plan so provides and goes well beyond this minimum threshold.

The U.S. Court ofAppeals for the Sixth Circuit addressed the issue ofthe adequacy ofreductions from already

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adopted measures in the context of section 175A(d) contingency measures in a maintenance plan for Cuyahoga County, Ohio. Greenbaumv. EPA, 370 F.3d 527 (6thCir. 2004). 14 There EPA had approved section 172(c)(9) contingency measures into the SIP in 1996 as part ofthe 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 fortimely attainment ofthe 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 EPAto use other measures outside the maintenance plan to assure correction ofaviolation. In upholding EPA's approval ofthe redesignation, the court found that:

[tihe Administrator hasbeen granted broad discretion by Congress indetermining what is 'necessary to assure' prompt correction. The EPA hasapproved Ohio'smaintenance plan, concluding that its contingency

measures provide ameans to deal with likely violations. We donotbelieve that thisdetermination is 'arbitrary, capricious, or manifestly contrary to the statute.' Chevron, 467 U.S.at844.
The Sixth Circuitin Greenbaumfurther noted that Congress contemplated that contingency measures need not be sufficient to correct all violations and that EPA andthe state could rely on a combination offactors to correct violations. See the extensive discussion ofcontingency measures in Greenbaum.

Here, the 2007 Plan looks first to emission reductions from adopted

measures that are notneeded to maintain the PM-10 NAAQS to serve as section 175A(d) contingency measures. Ifthese 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 andProposed 2008 PM2.5 Plan 15 (see 2007 Ozone Plan atTable 6-2 and 2008 PM2.5 Plan at Table 6-4) and with prioritizing

measures most relevant for reducing PM-10 emissions. 2007Plan at 16-17.

14As early as 1995,EPA approved a maintenance plan undersection 175A that included contingency provisions that relied in part on measures to be implemented priorto anypost-redesignation NAAQS violation. See60 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 EPAon June 30, 2008. The SJVAPCD ha§ also provided clarification that ifadditional 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-10NAAQS to correct anyPM-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 inthe Calcagni memorandum, that the contingency plan for the SJVAB area setindicators thattrigger contingency provisions before a violation occurs, we note again thatthe memorandum provides that contingency provisions are to bejudged

on a case by case basis. See also Greenbaum.With the exception ofthe 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 itselfprovides that a violation ofthe 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 acontingency measure to be implemented. Moreover, as pointed outabove, under the contingency measure provisions, a monitored exceedance ofthe standard that does not itselfconstitute aviolation (e.g., ata continuous monitor ora onein-three day FRM monitor) could trigger

a contingency measure prior to a violation occurring.

F.RevisionofBoundaryDesignation

Comment 18:EJ maintains that the portion ofthe San Joaquin Valley that EPA now proposes to splitoffwas designated as part ofthe SJV nonattainrnent area because, as provided in CAA section 107(d)(1)(A), it

was part ofthe geographic area "that does notmeet (orthat contributes to ambient air quality in anearby area that does notmeet) the national primary or secondary air quality standard forthat pollutant." EJ states that EPA makesno attempt to explain how circumstances have changed tojustify the removal of this portion ofthe designated nonattainment area. EJ notes that the SJV area includes other high-elevation

areas that are located above the inversion layer and thatwhether a community is above orbelow the inversion layer is irrelevant because these areas are part ofthe Valley and part ofthe same airbasin polluted by emissions generated in the Valley.

Response 18:As discussed in our proposed rule, onJanuary 31, 2008 California requested aboundary redesignation splitting the SJV nonattainment area into two separate nonattainment areas, the SJVAB and East Kern. Section 107(d)(3)(D) ofthe CAA authorizes the State to submit to EPA arevised designation ofany area andEPA is required to approve or deny itwithin 18months ofreceipt ofa complete State submittal. The type of revised designation thatthe State of California requested involves a boundary change only anddoes not involvea change in status (e.g., from "nonattainment" to "attainment" or "unclassifiable") ofany area. Our criteria for evaluating the State's request

are discussed in our proposed rule.

In general, the State has provided a compelling technicaljustification for splitting the nonattainment area which includes an evaluation ofthe differences injurisdiction, geography, population and degree ofurbanization, employment and traffic/commuting patterns, emissions and air quality. 73 FR 22307, 22308-22310. EJnotes that there are other high elevation areas inthe 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 airbasins and do'not have the

same mix ofairpollution 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 andthe East Kern area for the reasons set forth inthe proposed rule and in this response.

Comment 19:A commenter states that while the proposal to separate the
western portion ofthe KCAPCD is clear andcompelling, the commenter is concerned about environmental justice issues forthe East Kern area. The
commenter states that ifthe purpose of the separation is to clean-up one area andignore the other industrialized area with the State prison, then EPA is not following its ethics concerning 

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environmental justice. The commenter states that communities with prisons

serve as a target ofenvironmental neglect and should notbe abandoned from environmental laws and attainment requirements and should not be forgotten by EPA.

Response 19:EPA's final action to splitthe SJV nonattainment area into
two nonattainment areas does notrelax any requirements. EPA is also approving enforceable commitments forthe East Kern area that willensure progress in meeting CAA requirements for the area. These commitments include the installation ofa FRM/FEM 16 and submittal of a SIP addressing applicable CAA requirements ifthe monitor violates the PM-10 standard. 73 FR 22307, 22317. Inthe meantime, the existing data from the IMPROVE monitor, although not a FRM orFEM, do notindicate an air quality problem inEast Kern-rather they showlevels 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 forfair treatment ofthe inhabitants ofEast Kern, EPA is taking steps to assure that the East Kern area will not be forgotten by EPA, and no community inthat area will be "abandoned from environmental laws and attainment requirements." EPA is committed to meeting the goals of environmental justice and is equally concerned forthe populations ofboth the SJVAB and East Kern areas. There is

nobasis for concluding that the population ofEast Kern is exposed to ongoing levels above the standard, and EPA and the State have worked to provide assurances that the area willbe required to conduct more comprehensive monitoring and to adopt additional requirements ifneeded. Thus EPA recognizes the role of environmental justice and is observing its principles.

Comment20:A commenter disagrees with the proposed rule's statement that the boundary redesignation makes sense because ofthe difference inchemical composition ofPM-10 between the two

areas. The commenter believes this is
not avalid statement because there are

16Currently there is no FRM orFEM monitoring
ofPM-IO in the East Kern area. However, there is

an Interagency Monitoring ofProtected Visual Environments (IMPROVE) monitor located in the Kern RiverValley. Pursuant to its commitment, CARB has purchased the new monitor and has secured permission from the Bureau ofLand Management to install itnext to the existing IMPROVE monitor. noFRMs orFEMs inthe East Kern area. Furthermore, the commenter states that the one IMPROVE monitor in the East Kern area is inadequate and the chemical composition ofthe SWAB and East Kern should notbe compared until there is an adequate monitoring system inEast Kern. In addition, the
commenter concludes that a reanalysis ofreported data mustbe performed before considering attainment for the SWAB.

Response20:Webased our conclusion that the SVAB and East Kern should be separate nonattainment

areas onmultiple factors, only one of which relates to the difference inthe types ofairpollutants inthe two areas. See 73 FR 22307, 22310. Whilethe
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 theEast Kern area. Pending data from this new monitor, the IMPROVE monitor doesprovide useful information regarding the composition ofPM-10 in the area. See id. and Attachments B andC 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 willretain its nonattainment designation until the State can demonstrate, following assessment of data from thenew monitor, that all the applicable CAA requirements forredesignation ofthe East Kern area are met.

EPA does notagree that areanalysis ofthe 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 ofthe Monitoring Network for the SanJoaquin Valley, California forthe Annual and 24-Hour PM-l0 Standards," Bob Pallarino, EPA, September 22, 2003. To demonstrate attainment, an areamust show that it
meets the standard over athree-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. MiscellaneousComments

Comment22:A commenter states that there are several gaps in evaluating the PM-10 data for the SJVAB from 1990 to 2004 and thatgiven the cyclical nature ofPM-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 ofthe higher exposures.

Response21: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

atrend that accounts for any cyclical changes inPM-10 data. In addition, an evaluation ofthe seasonal conditions causing PM-10 is provided in the 2003 PM-10 Plan. 2003 PM-IO Plan atES-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 iftherewere any unusually favorable meteorological conditions that would cause PM-10 exceedances. EPA determined that overall there was no consistent pattern offavorable meteorology. 73 FR 22307, 22312; responses to comments 3and 6 above.

Forthe SWAB area, it has been determined that on an annual average basis, unstable conditions (orlow stability) result in dispersion of pollutants and lower PM-10 levels and stable conditions (orhigh stability) result in a temperature inversion which keeps emissions atthe surface and leads
to higher PM-10 levels. 2007 Plan at Appendix C. During the attainment period of2003 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 ofall 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) inthe SW area can lead to

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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. 73FR 22307, 22310-22311 and 73 FR 14687.

Comment22: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 forMerced County for 2005. The SJVAPCD states that the budget shouldread 39.4 tons per day and not 39.2 tonsper day.

Response22:EPA appreciates the comments and has made the correction in today's final action. III.FinalActions

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 arevised boundary designation, EPA is approving the State's request under section 107(d)(3)(D) to revise the boundary designation forthe 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 ofsection 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 forthe PM-10 NAAQS and approving the 2007 maintenance plan for the area.

EPA is also approving the conformity trading mechanism forthe 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 budgetreplaces 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

Fresno .............................................................................................................................. 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 Madera

.......................................... 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 Tulare ............................................................................................................................... 7.3 25.1 9.4 10.9

Total

.......................................................................................................................... 60.5 314.9 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 ithas concluded were caused by exceptional events onJuly 4, 2007 andJanuary 4, 2008, and is determining that the SJVAB area continues to attain the PM-la standard.

Finally, EPA is approving commitments from KCAPCD andCARB
to install a FRM or FEM inthe newly created East Kern serious PM-10 nonattainment area and to address section 189(d) CAA requirements forthe

area ina SIP revision in the event the FRM or FEM records aviolation ofthe PM-10 standard.

1740 CFR 93.118(f)(2) applies when EPAreviews the adequacy ofan implementation plan simultaneously withEPA's approval ordisapproval ofthe implementation plan.as is the case here. IV. Statutory andExecutive 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 bythe Office ofManagement and Budget. For this reason,this action is also not subject to Executive Order 13211, "Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, orUse" (66 FR 28355, May 22, 2001). This action merely approves
a revised boundary designation, a redesignation to attainment forthe 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 "liifEPA makes
an adequacy finding through a final rulemaking that approves theimplementation plan submission, such afinding willbecome effective upon the ofwhich were either requested or submitted by the State. Accordingly,'the Administrator certifies that this rule willnot have a significant economic impact on a substantial number ofsmall entities under the Regulatory Flexibility Act (5 U.S.C. 601 etseq.). Because this rule does notimpose any additional enforceable duty, it does not contain any unfunded mandate or significantly

oruniquely affect small governments, as described in the Unfunded Mandates Reform Act of1995 (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 ofEPA's approval inthe Federal Register."

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reservations located within the boundaries ofthe SJVAB. EPA has consulted with representatives ofthe tribes and will continue to work with the tribesas 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 implicationsbecause it does not have substantial direct effects on the States,

onthe relationship between the national government and the States, or on the distribution ofpower and responsibilities among the various levels ofgovernment, as specified in Executive Order 13132 (64FR 43255, August 10, 1999). This action merely approves requests or submittals from the State and does not alter therelationship

orthe distribution ofpower 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 oftheirprograms, policies, and activities onminority and low-income populations. Today's action involves approvals of arevised 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 forthe

area and commitments forthe East Kern

area. Itwill nothave disproportionately high and adverse effects on any communities inthe area, including minority and low-income communities.

This rule also is not subjectto 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 ofsection 12(d) ofthe National Technology Transfer and Advancement Act of1995 (15 U.S.C. 272 note) do not apply because it would be inconsistent with applicable law for EPA, when determining theattainment
status ofan area, to use voluntary

consensus standards in place of promulgated air quality standards and monitoring procedures that otherwise satisfy the provisions ofthe Clean Air. This rule does not impose an information collection burden under the provisions ofthe Paperwork Reduction Act of 1995 (44 U.S.C. 3501 etseq.).

The Congressional Review Act, 5 U.S.C. 801 etseq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rulemay take effect, the
agency promulgating the rule must submit arule report, which includes a copy ofthe rule, to each House ofthe Congress andto the Comptroller General ofthe United States. EPA will submit a report containing thisrule and other required information to the U.S. Senate, the U.S. House ofRepresentatives, and the Comptroller General ofthe United States prior topublication ofthe rule in the Federal Register. Amajor rule
cannot take effect until 60 days afterit is published inthe Federal Register. This action is not a "major rule" as definedby 5 U.S.C. 804(2).

Under section 307(b)(1) ofthe Clean Air Act, petitions forjudicial review of this action must be filed inthe United States Court ofAppeals forthe appropriate circuitbyJanuary 12, 2009. Filing a petition forreconsideration by the Administrator ofthis final rule does
not affect the finality ofthis rule forthe
purposes of judicial review nor does it extend the time within which a petition forjudicial review maybe filed, and shall not postpone the effectiveness of such rule oraction. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

List ofSubjects

40 CFRPart 52
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Particulate matter, Reporting and recordkeeping requirements.

40 CFRPail81

Environmental protection, Airpollution control, National parks, Wilderness areas.

Authority: 42 U.S.C. 7401 etseq. Dated: September 24, 2008. Wayne Nastri, Regional Administrator, RegionIX. * Parts 52 and 81 ofChapter I, Title 40 oftheCode ofFederal Regulations are -amendedas follows:

PART52-fAMENDED]

m 1.The authority citation forPart52 continues toread as follows:

Authority: 42 U.S.C. 7401 etseq. Subpart F-California

* 2.*Section 52.220is amended by adding paragraphs (c)(356) and (357) to read as follows: §52.220 Identification ofplan.

* * * * *

(c) * * * (356)The following plan was submitted on November 16, 2007, bythe Governor's Designee. (i) Incorporation byreference. (A) San Joaquin Valley Air Pollution Control District.

(1) 2007 PM10 Maintenance Plan and Request forRedesignation, adopted by the SanJoaquin Valley Air Pollution

. Control District on September 20, 2007, section 6. Contingency Plan onpages 16

to 17.

(ii) Additional materials. (A) San Joaquin Valley Air Pollution Control District. (1) 2007 PM10 Maintenance Plan and Request forRedesignation, adopted by the SanJoaquin Valley Air Pollution Control District on September 20, 2007, except for Appendices A through F. (2)State ofCalifornia, AirResources Board, StaffReport, Analysis ofthe 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, bythe Governor's Designee:

(i) Incorporation byreference. (A) Commitments for the installation and operation ofa FRM orFEM PM-10 monitor and SIP development and submittal.

(1) ResolutionNo. 2008-001-02, adopted by theAir Pollution Control Board, Kern County AirPollution Control Districton February 27, 2008. (2) Executive Order S-08-004, adopted by the California AirResources Board onMarch 3, 2008.

PART 81--AMENDED]

* 3. Thqauthority citation forPart 81 continues toread 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.

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### 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 WellsValley):

(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.

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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; PesticideTolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule.

SUMMARY: This regulation establishes a time-limited tolerance for combined residues ofthe insecticide avermectin B, and its delta-8,9-isomer in or on bean, lima, seed. This action is in
response to EPA's granting ofan emergency exemption under section 18 ofthe Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use ofthe pesticide on large lima beans. This regulation establishes a maximum permissible level forresidues ofavermectin inthis food commodity. The time-limited tolerance expires and is revoked onDecember 31, 2010. DATES: This regulation is effective November 12, 2008. Objections and requests for hearings mustbe received

on orbefore January 12, 2009, and must be filed in accordance with the instructions provided in 40 CFRpart 178 (see also Unit I.C. ofthe 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 inthe 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 willbe publicly available only in hardcopy form. Publicly available docket materials are available inthe electronic docket at http://www.regulations.gov, or, ifonly available in hard copy, atthe OPP Regulatory Public Docket in Rm. S4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility isopen 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 ofPesticide 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 thisAction 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 notlimited 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. Ifyou have any questions regarding the applicability of this action to aparticular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. 

### 66775

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### 66776 Federal Register/Vol. 73, No. 219/Wednesday, November 12, 2008/Rules and Regulations

B.HowCanIAccessElectronicCopies ofthisDocument?

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 of40 CFRpart 180 through the Government Printing Office's e-CFR site at http:// www.gpoaccess.gov/ecfr.

C. CanIFilean ObjectionorHearing Request?

Under section 408(g) ofthe Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect ofthisregulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission ofobjections and requests for hearings appear in 40 CFRpart 178. You must file your objection orrequest

a hearing on thisregulation in accordance with the instructions provided in 40 CFRpart 178. To ensure. proper receipt by EPA, you must identify docket ID number EPA-HQOPP-2008-0175 inthe subject line on the first page ofyour submission.All requests mustbe in writing, and mustbe 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 in40 CFRpart 178, please submit a copy ofthe filing that doesnot contain any CBI forinclusion 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 eRulemakingPortal:http:// www.regulations.gov. Follow the on-line instructions for submitting comments.

*Mail:Office ofPesticide 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 ofoperation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries ofboxed 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) ofFFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing a timelimited tolerance for combined residues ofthe insecticide avermectin B, and'its delta-8,9-isomer in oron 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 inthe Federal Register to remove the revoked tolerances from the CFR.

Section 408(l)(6) ofFFDCA requires EPA to establish atime-limited tolerance orexemption from the requirement fora tolerance forpesticide chemical residues in food that will result from the use ofa pesticide under

an emergency exemption granted by EPA under section 18 ofFIFRA. Such tolerances canbe established without providing notice or period for public
comment. EPA does not intend forits actions on section 18 related timelimited tolerances to setbinding precedents forthe application ofsection 408 ofFFDCA and the new safety standard to other tolerances and exemptions. Section 408(e) ofFFDCA allows EPA to establish a tolerance or an exemption from the requirement ofa tolerance on its own initiative, i.e., without having received any petition from an outside party.

Section 40B(b)(2)(A)(i) ofFFDCA allows EPA to establish a tolerance (the legal limit fora pesticide chemical residue in or on afood) only ifEPA determines thatthe tolerance is "safe." Section 408{b)(2)(A)(ii) ofFFDCA defines "safe" to mean that "there is a reasonable certainty that noharm 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 waterand in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) ofFFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue inestablishing a tolerance and to "ensure that there is a reasonable certainty that noharm will result to infants and children from aggregate exposure to the pesticide chemical residue

......

Section 18 ofFIFRA authorizes EPA
to exempt any Federal orState agency from any provision ofFIFRA, ifEPA determines that "emergency conditions exist whichrequire such exemption." EPA has established regulations governing such emergency exemptions in 40 CFRpart 166.

IIM. Emergency Exemption for Avermectin on Large Lima Beans and FFDCA Tolerances

The state ofCalifornia asserts that large lima bean growers have few miticides to work with for controlling spider mites.Confirmed resistance to dicofol hasbeen 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 ofthe available registered alternatives. After having reviewed the submission,EPA determined that emergency conditions exist forthis State, and that the criteria for an emergency exemption are met. EPA has authorized under FIFRA section 18the use ofavermectin on large lima beans for control ofspider mites in California.

As part ofits evaluation ofthe emergency exemption application, EPA assessed the potential risks presented by residues ofavermectin in oron large lima beans. In doing so, EPA considered the safety standard in section 408(b)(2) ofFFDCA, and EPA decided that the necessary tolerance under section 408(l)(6) ofFFDCA 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 forpublic comment as provided in section 408(l)(6) ofFFDCA. Although thistimelimited tolerance expires and is revoked

on December 31, 2010, under section 408(l)(5) ofFFDCA, residues ofthe pesticide not inexcess ofthe amounts specified in the tolerance remaining in

or onlarge 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 notexceed a levelthat was authorized by this time-limited tolerance atthe time ofthat application. EPA will take action to revoke this timelimited tolerance earlier ifany experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because thistime-limited tolerance is being approved under emergency conditions, EPA has not made any decisions about whether avermectin
meets FIFRA's registration requirements

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for use on large lima beans or whether permanent tolerances for this usewould be appropriate. Underthese circumstances, EPA does notbelieve that this time-limited tolerance decision

serves as a basis forregistration of avermectin by a State for special local needs under FIFRA section 24(c). Nor does this tolerance serve asthe basis for persons in any State other than California to use this pesticide on this crop under FIFRA section 18 absent the issuance ofan emergency exemption applicable within that State. For additional information regarding the emergency exemption for avermectin,
contact the Agency's Registration Division atthe address provided under
FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination ofSafety Section 408(b)(2)(A)(i) ofFFDCA allows EPA to establish atolerance (the legal limit for apesticide chemical residue in oron a food) only ifEPA determines that the tolerance is "safe." Section 408(b)(2)(A)(ii) ofFFDCA defines "safe" to mean that "there is a reasonable certainty that no harm will result from aggregate exposure tothe 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) ofFFDCA requires EPA to give special consideration to exposure ofinfants and childrento the pesticide chemical residue in establishing a tolerance and to "ensure thatthere 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 inFFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support ofthis action. EPA has. sufficient data to assess the hazards of and to make a determination on aggregate exposure expected as aresult ofthis emergency exemption request and the time-limited tolerance for combined residues ofavermectin BI and its delta-8,9-isomer in or onbean, lima, seed at 0.005 ppm. EPA's assessment of exposures 'andrisks associated with establishing the time-limited tolerance follows.

A. ToxicologicalEndpoints

For hazards thathave a threshold below which there is no appreciable risk, a toxicological point ofdeparture (POD) is identified as the basisfor derivation ofreference values for risk
assessment. The POD maybe defined as the highest dose atwhich no adverse effects are observed (theNOAEL) in the toxicology studyidentified as appropriate for use in riskassessment. However, ifa NOAEL cannotbe determined, thelowest dose at which adverse effects ofconcern 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 andin the variations in sensitivity among members ofthe human population as wellas other unknowns. Safety is assessed foracute and chronic dietary risks bycomparing aggregate food and water exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD andcPAD are calculated by dividing the POD by all applicable UFs. Aggregate short-, intermediate-, and chronic-term risks are evaluated by comparing food, water, andresidential exposure to the POD to ensure that the margin of exposure (MOE) called forby the product ofall applicable UFs is not exceeded. This latter value is referred to

asthe Level ofConcern (LOC).

For non-threshold risks, the Agency

assumes that any amount ofexposure will lead to some degree ofrisk. Thus, the Agency estimates risk in terms ofthe probability ofan occurrence ofthe adverse effect greater than that expected in a lifetime. For more information on the general principles EPA uses in risk characterization and acomplete description ofthe risk assessment process, see http://www.epa.govl pesticides/factsheets/riskassess.h tin. A summary ofthe toxicological endpoints for avermectin used for human riskassessment is discussed in

a tolerance document entitled AvermectinB, anditsdelta-8,9-isomer; PesticideTolerance(70FR 7876, FRL7695-7, February 16, 2005).

B.ExposureAssessment

1. Dietaryexposure fromfoodand feed uses.In evaluating dietary
exposure to avermectin, EPA considered
exposure under the time-limited tolerance established by this action as well as allexisting avermectin tolerances in (40 CFR 180.449). EPA assessed dietary exposures from avermectin in food asfollows:

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 ofFood Intake byIndividuals (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 drinkingwater. Acute anticipated residues for many foods were derived using market basket survey and new field trial studies. Estimated concentrations ofavermectin in drinking water were incorporated directly into the acute assessment.

ii. Chronicexposure.Inconducting the chronic dietary exposure assessment EPA used theDEEM/FCID which incorporates food consumption data as reportedby respondents in theUSDA 1994-1996 and 1998 Nationwide CSFII, and accumulated exposure to the chemical for each commodity. Percent crop treated and anticipated residues refinements were used. Arefined chronic dietary exposure assessment

was conducted for the general U.S. population and various population subgroups. The assumptions ofthe
assessment were anticipated residue estimates, PCT estimates for most ofthe commodities, and default DEEM processing factors when necessary. Estimated concentrations ofavermectin in drinkingwater were incorporated directly into the chronic assessment.

iii. Cancer. An aggregate exposure assessment forthe purpose ofassessing

cancer risk was notperformed because avermectin has been classified as "not likely to be carcinogenic to humans."

iv.AnticipatedresidueandPCT information.Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels ofpesticide residues in food and the actual levels ofpesticide residues that have been measured in food. IfEPA relies on such information, EPA mustrequire pursuant to FFDCA section 408(f)(1) that data be provided 5
years after the tolerance is established, modified, or left ineffect, demonstrating that the levels infood are not above the levels anticipated. For the present action,EPA will issue such data call-ins

as arerequired by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submittedno laterthan 5 years from the date ofissuance ofthis tolerance.

Section 408(b)(2)(F) ofFFDCA states that the Agency may use data on the actual percent offood treated for assessing chronic dietary risk only if:

*Condition a: The data used are reliable and provide avalid basis to show what percentage ofthe food Federal Register/Vol. 73,

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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 ofany estimates used.To provide for the periodic evaluation ofthe estimate ofPCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data onPCT.

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 UseDatabase forthe chemical/crop combination forthe most recent 6 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure foreach 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 forthose 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 ofavailable public and private market survey data for the existing use and rounded up to the nearest multiple of5%.

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 ofthis consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does notunderstate exposure for any significant subpopulation group and allows the Agency to bereasonably 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 theregional consumption offood to which avermectin may be applied in a particular area.

2. Dietaryexposure 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 ofavermectin. Further information regarding EPA drinkingwater models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefedi/models/ water/index.htm.Tier II screening models PRZM (Pesticide RootZone Model) and EXAMS (ExposureAnalysis Modeling System) were used to determine estimated surface water concentrations ofavermectin based on the modeled scenario ofone seed treatment to cucumbers followed by 3 aerial applications at a 7-day interval in Florida. This use ofavermectin 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 forthe acute dietary assessment, and the one inten year annual mean concentration of0.190 ppm was used for chronic dietary estimates. Modeled estimates ofdrinking water concentrations were directly entered into the dietary exposure model.

3. Fromnon-dietaryexposure.The
term "residential exposure" is used in this document to refer to nonoccupational, non-dietary exposure (e.g., forlawn and garden pest control, indoor pest control, termiticides, and flea and tickcontrol onpets).

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 ofcontinuous exposure) to avermectin is not expected. Adults may be exposed through handling the pesticide andboth adults and children may be exposed through contact with treated areas following application. Accordingly, handler and postapplication exposures were assessed for two major categories ofresidential 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. Cumulativeeffectsfrom substances with acommonmechanism oftoxicity. Section 408(b)(2)(D)(v) ofFFDCA requires that, when considering whether
to establish, modify, orrevoke a tolerance, the Agency consider "available information" concerning the cumulative effects of aparticular pesticide's residues and "other substances that have acommon mechanism oftoxicity."

EPA has not found avermectin to share a common mechanism oftoxicity with any other substances, and avermectin does not appear to produce

a toxic metabolite produced by other substances. For the purposes ofthis tolerance action, therefore, EPA has assumed that avermectin does not have

a common mechanism oftoxicity with other substances. For information regarding EPA's efforts to determine whichchemicals have a common mechanism oftoxicity andto evaluate the cumulative effects ofsuch chemicals, see the policy statements released by EPA's Office ofPesticide 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.SafetyFactor forInfantsandChildren
1. Ingeneral.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 ofthreshold effects to account for prenatal and postnatal toxicity and the completeness ofthe database ontoxicity and exposure unless EPA determines based on reliable data that a different margin ofsafety willbe 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, oruses 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:

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eThere 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 tobe steep.

eSevere effects were seen atthe LOAELs in several studies (death, neurotoxicity, and developmental toxicity). Although increased susceptibility ofthe young was observed in several studies, the degree ofconcern 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
uteroexposure to avermectin B1.There

was also an increase inquantitative and qualitative susceptibility inthe rat reproductive toxicity study. The

concern for susceptibility seen in the developmental study with rabbits and in the reproductive toxicity study inthe rat is lowbecause the lowest NOAEL obtained (0.12 mg/kg/day) was used as the basis forthe chronic RfD and other non-dietary riskassessment scenarios, which is protective ofall ofthe 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 inthe CD-1 mouse.

D.AggregateRisks andDetermination of Safety

EPA determines whether acute and chronic pesticide exposures are safeby comparing aggregate exposure estimates
to the aPAD andcPAD. 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 forby the product ofall 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% ofthe aPAD forall infants less than 1year old, the population group receiving the greatest exposure.

2. Chronicrisk.Using the exposure assumptions described in thisunit for chronic exposure, EPA has concluded that chronic exposure to avermectin from food and water willutilize 20% of the cPAD for children 1-2 years old,the population group receiving the greatest
exposure. Based onthe explanation in the unit regarding residential use patterns, chronic residential exposure to residues ofavermectin isnot expected.

3. Short-termandintermediate-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 inthis unit for short-term and intermediate-term exposures, EPA has concluded the combined'short-term food, water, and residential exposures aggregated result inaggregate MOEs of 3,000 forthe U.S. population, and 1,700 for children 1-2 years old. These aggregate MOEs are greater than the Agency's level ofconcern of 1,000 for aggregate exposure to food, water and residential uses and therefore acceptable.

4.Aggregatecancerrisk 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 riskto humans.

5. Determinationofsafety.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. OtherConsiderations

A. AnalyticalEnforcementMethodology

Adequate enforcement methodology is available to enforce the tolerance expression. The method maybe 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 ResidueLimits
There are no CODEX residue limits for residues ofavermectin onbean, lima, seed.

VI. Conclusion

Therefore, a time-limited tolerance is established for combined residues ofthe insecticide avermectin B, and its delta8,9-isomer in or onbean,.lima, seed at .0.005 ppm.This time-limited tolerance expires and isrevoked on December 31, 2010.

VII. Statutory and Executive Order Reviews

This final rule establishes atolerance 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 ofactions from review under Executive Order 12866, entitled RegulatoryPlanning and Review(58 FR 51735, October 4, 1993). Because this finalrule has been * exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled ActionsConcerningRegulations ThatSignificantly Affect EnergySupply, Distribution,or Use (66 FR 28355, May 22, 2001) orExecutive Order 13045, entitled ProtectionofChildren from EnvironmentalHealthRisks andSafety 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 toAddressEnvironmentalJusticein MinorityPopulationsandLow-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) ofFFDCA, such as the tolerance inthis final rule, do not require the issuance ofa proposed rule, the requirements ofthe Regulatory Flexibility Act (RFA) (5 U.S.C. 601 etseq.) do not apply.

This final rule directly regulates growers, food processors, food handlers, and foodretailers, not States ortribes,

nor does this action alterthe relationships or distribution ofpower andresponsibilities established by Congress inthe preemption provisions ofsection 408(n)(4) ofFFDCA.As such, the Agency has determined that this action will not have a substantial direct effect on States ortribal governments,

on the relationship between the national government and the States ortribal

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### 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 ofgovernment orbetween the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism(64.FR 43255, August 10, 1999) andExecutive Order 13175, entitled ConsultationandCoordination with IndianTribalGovernments(65 FR 67249, November 9, 2000) do notapply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate

as described under Title Hofthe Unfunded Mandates Reform Actof 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration ofvoluntary

consensus standards pursuant to section 12(d) ofthe 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; PesticideTolerances
AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule.

SUMMARY: This regulation establishes tolerances for combined residues offree 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: Thisregulation is effective November 12, 2008. Objections and requests for hearings mustbe 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. ofthe
SUPPLEMENTARY INFORMATION). ADDRESSES: EPA has established a docket forthis action under docket identification (ID) number EPA-HQVIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 etseq.,generally provides that before arule may take effect, the agency promulgating the rulemust submit a rule reportto each House of the Congress andto the Comptroller General ofthe 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 ofthe United States prior to publication ofthis finalrule in the Federal Register. This final rule is not

a "major rule" as defined by 5U.S.C. 804(2).

List of Subjects in40 CFRPart180

Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

OPP-2007-0945. All documents inthe docket are listed in the docket index available athttp://www.regulations.gov. Although listed inthe 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 inthe electronic docket at http://www.regulations.gov, or, ifonly available inhard copy, atthe 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 ofPesticide 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,Officeof Pesticide Programs.

E Therefore, 40CFR chapter Iis amended as follows:

PART 180-[AMENDED]

M1. The authority citation forpart 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 acommodity to the table inparagraph (b)to read as follows:
§180.449 Avermectin Bl and itsdelta-8,9- isomer; tolerances for residues.

(b)* *

I. General Information

A. DoesthisActionApply toMe?

You maybe potentially affected by this action ifyou are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged inthe following activities:

eCrop production (NAICS code 111).

• Animal production (NAICS code 112).

aFood manufacturing (NAICScode 311).

ePesticide manufacturing (NAICS code 32532).

-

This listing is not intended to be exhaustive, butrather to provide aguide forreaders regarding entities likely to be affectedby this action. Other types of entities notlisted in thisunit 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. Ifyou have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

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B.HowCanIAccessElectronicCopies ofthisDocument?

In addition to accessing electronically available documents at http:// www.regulations.gov,you may access thisFederal 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 ofEPA'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.CanIFilean ObjectionorHearing Request?

Under section 408(g) ofFFDCA, 21 U.S.C. 346a, any person may file an objection to any aspect ofthis regulation and may also request a hearing on those objections. You must file your objection

or request ahearing on thisregulation in accordance with the instructions provided in 40 CFR part 178.To ensure proper receipt by EPA, you must identify docket IDnumber EPA-HQOPP-2007-0945 in the subject line on the first page ofyour submission. All requests mustbe in writing, and must be mailed ordelivered to the Hearing Clerk

as required by 40 CFRpart 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 acopy ofthe filing that doesnot contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFRpart 2 maybe disclosed publicly byEPA without prior notice. Submit this copy, identifiedby docket ID number EPAHQ-OPP-2007-0945, by one ofthe following methods:

9FederaleRulemakingPortal:http:// www.regulations.gov.Follow the on-line instructions for-submitting comments.

*Mail:Office ofPesticide Programs (OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC20460-0001.

9Delivery-OPPRegulatory 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 ofoperation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries ofboxed information. The Docket Facility telephone numberis (703) 305-5805. H. Petitionfor Tolerance
In the Federal Register ofOctober 24, 2007 (72 FR60369) (FRL-8150-8), EPA issued a notice pursuant to section 408(d)(3) ofFFDCA, 21 U.S.C. 346a(d)(3), announcing the filing ofa pesticide petition (PP 7E7257) by Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W., Princeton, NJ08540. The petition requested that 40 CFR 180.318 be amended by establishing a tolerance for residues ofthe herbicide MCPB, 4-(2- methyl-4-chlorophenoxy) butyric acid, in oron minttops (leaves and stems) at 0.25 parts permillion (ppm). That notice referenced a summary ofthe petition prepared by Nufarm, Inc., the registrant, onbehalf ofIR-4, which is available to the public in the docket, http://www.regulations.gov. There were

no comments received in response to the notice offiling.

Based upon review ofthe data supporting the petition, EPA has revised the commodity terms and tolerance level. EPA has also revised the tolerance expression to include combined residues offree and conjugated MCPB and its metabolite MCPA. The reasons for these changes are explained in Unit IV.C.

HI. Aggregate Risk Assessment and Determination ofSafety

Section 408(b)(2)(A)(i) ofFFDCA allows EPA to establish atolerance (the legal limit fora pesticide chemical residue in or on a food) only ifEPA determinesthat thetolerance is "safe." Section 408(b)(2)(A)(ii) ofFFDCA defines "safe" tomean that "there isa reasonable certainty that noharm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures forwhich there is reliable information." This includes
exposure through drinking waterand in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) ofFFDCA requires EPA to give special consideration toexposure ofinfants and children to the pesticide chemical residue inestablishing a tolerance and to "ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure tothe pesticide chemical residue

......

Consistent with section 408(b)(2)(D) ofFFDCA, and the factors specified in section 408(b)(2)(D) ofFFDCA,EPA has reviewed the available scientific data and otherrelevant information in support ofthis action. EPA has sufficient data to assess the hazards of and tomake a determination on aggregate exposure for the petitioned-for tolerahces for combined residues offree and conjugated MCPB and its metabolite MCPA onpeppermint, tops and spearmint, tops at 0.20 ppm. EPA's
assessment ofexposures and risks associated with establishing tolerances follows.

A. ToxicologicalProfile

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability aswell as the relationship ofthe results ofthe studies to human risk. EPA has also considered available information concerning the variability ofthe sensitivities ofmajor identifiable subgroups ofconsumers, including infants and children.

The currently available toxicological database for MCPB is limited; thus it

was supplemented with data on the closelyrelated compound, 4-(chloro-2- methylphenoxy)acetic acid (MCPA). Structurally, MCPB and MCPA differ only inthat MCPB contains two additional carbon atoms.In both animal andplant metabolism studies, the data indicate that MCPB is readily converted
to MCPA. Therefore, EPA has concluded that the toxicity ofthese compounds is similar at sub-lethal dose levels.

MCPB has low to moderate acute toxicity via the oral, dermal and inhalation routes ofexposure. Itis mildly to moderately irritating to the eye but is not adermal irritant or skin sensitizer. Inlonger-term studies, nephrotoxicity and hepatotoxicity
appear tobe the most prevalent hazard

concerns forMCPB, based on the effects

seen throughout the MCPA database and the limited toxicity data set available for MCPB. Signs ofneurotoxicity (decreased arousal, impaired coordination and gait, reduced motor activity and reduced grip strength) were also reported after MCPB orMCPA exposure. Developmental and reproduction toxicity studies conducted with MCPB and/or MCPA did not indicate an enhanced sensitivity or susceptibility ofthe young,as developmental effects (delayed ossifications and decreased fetal or pup body weight) occurred atthe 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 MCPAhave been classified as "not likely tobe carcinogenic to humans" based on the absence ofincreased numbers oftumors inthe rat and mouse carcinogenicity studies and no evidence of mutagenicity.

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Specific information on the studies received and the nature ofthe adverse effects caused byMCPB and MCPA, as well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies, canbe found athttp:// www.regulations.govin the document 4- (4-chloro-2-methylphenoxy)butanoic acid(MCPB);Human-Health Risk Assessment forProposedSectionaNew Useon Mint,page 29 in docket ID number EPA-HQ-OPP-2007-0945.

B. ToxicologicalEndpoints

For hazards that have athreshold below which there is no appreciable risk, a toxicological point ofdeparture (POD) is identified asthe basis for derivation ofreference values forrisk
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 foruse inrisk assessment. However, ifaNOAEL cannot be determined, the lowest dose atwhich adverse effects ofconcern are identified (theLOAEL) 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 ofthe human population as well as other unknowns. Safety is assessed for acute and chronic dietary risks bycomparing 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, andresidential
exposure to thePOD to ensure that the margin ofexposure (MOE) called forby the product ofall 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 ofexposure will lead to some degree ofrisk. Thus, the Agency estimates risk interms ofthe probability ofan occurrence ofthe adverse effect greater than that expected in a lifetime. For more information on the gefieral principles EPA uses in risk characterization and -acomplete description ofthe risk assessment process, see http://www.epa.gov/ pesticides/factsheets/riskassess.htm.

A summary ofthe toxicological endpoints forMCPB used forhuman riskassessment 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 kidneytoxicity. FOPA SF = lox (UFDB)

Dermal short-term Dermal study LOC for MOE = 100 21-Day dermal toxicity (MCPA), rabbit (1to 30 days) and NOAEL = 25 mg/kg/day NOAEL = 100

intermediate-term UFA = lOx LOAEL = 1,000 mg/kg/day based on kidney tox- (1to 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- (1to 30 days) and lation absorption rate = tality

intermediate-term 100%) (1to 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%) kidneytoxicity UFA = lox UFH =lox [

_ __FQPA SF = lx. 

### 66782 Federal Register/Vol. 73,

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

### Continued

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 likelyto be carcinogenicto humans.

mal, inhalation) 

### .t
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members ofthe human population (intraspecies). UFL = use of a LOAELto extrapolate a NOAEL. UFs = use of a short-term study for long-term risk assessment. UFDB = to accountfor 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.ExposureAssessment

Whilethe Agency has concluded that MCPB converts to MCPA inthe environment, andthat MCPA maybe present in crops, residues ofMCPA resulting from the existing use ofMCPB

on peas and the new use on mint are expected tobe negligible, and significantly below analytical method limits ofdetection. 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 ofaggregate risks associated with MCPA canbe found inthe MCPA Reregistration Eligibility Decision (RED), available on the Office ofPesticide Programs web site at http://www.epa.gov/oppsrrdl/ REDs/mcpa-red.pdf

1.Dietaryexposure fromfoodand 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 forwhich a tolerance currently exists. EPA assessed dietary exposures from MCPB in food as follows:

i.Acute exposure.Quantitative acute dietary exposure and risk assessments

areperformedtfor afood-use pesticide, ifa toxicological study has indicated the possibility ofan effect ofconcern occurring as aresult ofa 1-day or single
exposure.

In estimating acute dietary exposure, EPA used food consumption information from the United States Department ofAgriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys ofFood Intakes by Individuals (CSFII). As to residue levels in food, EPA assumed that allpea and mint commodities contain tolerancelevel residues and that 100 percent of
pea and mint commodities are treated with MCPB.

ii. Chronicexposure.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) forall pea and mint commodities.

iii. Cancer.Based on the results of carcinogenicity studies inrats and mice, EPA classified MCPB as "not likely to be carcinogenic to humans." Therefore,

an exposure assessment for evaluating

cancer risk is unnecessary.

iv. AnticipatedresidueandPCT 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. Dietaryexposure from drinking
water.The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment forMCPB in drinking water. These simulation models take into account data on the physical, chemical, and fate/ transport characteristics ofMCPB. Furtherinformation regarding EPA drinking water models used in pesticide
exposure assessment canbe found at http://www.epa.gov/oppefedl/modelsl water/index.htm.

Based on the FirstIndex Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCIGROW) models, the estimated drinking
water concentrations (EDWCs) ofMCPB for acute exposures are estimated to be54.7 parts perbillion (ppb) for surface
water and 2.1 ppb for ground water. The EDWCs for chronic exposures fornoncancer assessments are estimated to be 13.5 ppb for surface water and 2.1 ppb for ground water.

Modeled estimptes ofdrinking water concentrations were directly entered into the dietary exposure model. For
acute dietary riskassessment, the water concentration value of54.7 ppb was used to assess the contribution to drinking water.-Forchronic dietary risk assessment, the water concentration of value 13.5 ppb was used to assess the contribution to drinking water.

3. Fromnon-dietaryexposure.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 tickcontrol on pets).

MCPB is notregistered for any specific use patterns that would result in residential exposure.

4. Cumulativeeffectsfrom substances witha common mechanismoftoxicity. Section 408(b)(2)(D)(v) ofFFDCA requires that, when considering whether
to establish, modify, orrevoke a tolerance, the Agency consider "available information" concerning the cumulative effects of aparticular pesticide's residues and "other substances that have a common mechanism oftoxicity."

EPA has not found MCPB to share a

common mechanism oftoxicity with
any other substances, and MCPB does
not appear to produce atoxic metabolite produced by other substances. For the
purposes ofthistolerance action, therefore, EPA has assumed that MCPB does not have acommon mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a

common mechanism oftoxicity and to evaluate the cumulative effects ofsuch chemicals, see EPA's website athttp:// www.epa.govpesticides/cumulative.

D.SafetyFactor forInfantsand Children

1.In general.Section 408(b)(2)(c) of FFDCA provides that EPA shall apply

an additional tenfold (1OX) margin of safety forinfants and children inthe

case ofthresholdeffects to account for prenatal and postnatal toxicity and the completeness ofthe database on toxicity and exposure unless EPA determines based on reliable data that a different margin ofsafety willbe 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 ofIOX, oruses a different additional safety factor when reliable data available to EPA support the choice ofa different factor.

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2. Prenatal andpostnatalsensitivity. The prenatal and postnatal toxicology database for MCPB includes rat and rabbit developmental toxicity studies; for MCPA itincludes rat and rabbit developmental toxicity studies and a 2- generation reproduction toxicity study in rats.There was noevidence of increased quantitative or qualitative susceptibility of fetuses or offspring to MCPA orMCPB 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 weightgain and food consumption). No toxicity to fetuses occurred inthe MCPB and MCPA rabbit developmental studies at doses resulting in maternal toxicity (mortality, decreased body weight and food consumption). In the ratreproduction study forMCPA, 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 ofthe uncertainties arising from these data deficiencies follows:

a.Developmentalneurotoxicity: 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 canbe 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 forMCPB. Given these findings ofneurotoxicity and sensitivity ofthe 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) ofall food and non-food use pesticides onDecember 26, 2007. Since the requirement went into effect after thistolerance petition

was submitted, these studies are notyet available for MCPB. In the absence of specific immunotoxicity studies, EPA has evaluated the available toxicity data forMCPB and MCPAregarding potential immunotoxic effects. Evidence ofpotential immunotoxicity was observed in subchronic 28-day oral toxicity studies in the mouse and dog with MCPA. Involution ofthe spleen due to lymphocytic depletion was observed inboth sexes at the highest dose tested (HDT) and LOAEL of453.7/ 223.9 milligrams kilogram day (mg/kg/ day) male/female (M/F) in the mouse, and decreased thymus weights were

seen inthe dog at a dose of30 mg/kg/ day HDT. Lymphoid depletion was observed inthe subchronic toxicity study inthe dog ata dose of44 mg/kg/ day (HDT) ofMCPB. The NOAEL inthe

mouse and dogfor 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 ofthe 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 ofchloropheroxy compounds such asMCPB due to their decreased ability to excrete organic acids, and thus the effect levels inthe 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 nothave such

concerns forimmunotoxicity. The immunotoxic effects with most relevance to humans had a NOAEL over 1oX greater than the NOAEL used in establishing the cRfD. Onthe 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 lacksreliable data to remove the FQPA children's safety factor.

ii. There is no evidence that MCPB or MCPAresults inincreased susceptibility in in uterorats orrabbits inthe prenatal developmental studies or inyoung rats inthe 2-generation reproduction study.

iii. There are no residual uncertainties identified inthe exposure databases. The dietary food exposure assessments

wereperformed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumption's inthe ground and surface water modeling used to assess exposure to MCPB in drinking water, and residential exposures are not expected. These
assessments will notunderestimate the
exposure and risks posed by MCPB.

E.AggregateRisks andDetermination 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 ofall applicable UFs is not exceeded.

1.Acute risk.An acute aggregate risk
assessment takes into account exposure "estimatesfrom acute dietary consumption offood and drinking water. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food andwater to MCPB will occupy 5.4% ofthe aPAD for infants, less than one year old, the population
group receiving the greatest exposure.

2. Chronicrisk.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% ofthe cPAD for infants, less than one year old, the population group receiving the greatest exposure. There are no residential uses forMCPB. 3. Short-termrisk.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 notregistered for any use patterns that would result in residential exposure. Therefore, the short-term aggregate risk is the sum of the riskfrom exposure to MCPB through food and water and will not begreater 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 ofthe riskfrom• exposure to MCPB through food and

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water, which has already been addressed, and will notbe greater than the chronic aggregate risk.

5. Aggregatecancerrisk 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. Determinationofsafety.Based on these riskassessments, EPA concludes that there is areasonable certainty that

no harm will resultto the general population, orto infants and children from aggregate exposure to MCPB residues.

IV. OtherConsiderations

A. AnalyticalEnforcementMethodology

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 ReidueLimits
There are no established orproposed Codex, Canadian, or Mexican maximum residue limits (MRLs) forMCPB.

C.Revisionsto Petitioned-For Tolerances

IR-4 proposed a tolerance for residues ofMCPB perse on mint tops (leavesand stems) at0.25 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 withthe preferred commodity terms in the Agency's Food and Feed Commodity Vocabulary. EPA determined the appropriate tolerance level for mint tops based on analysis ofthe residue field trial data using theAgency's Tolerance Spreadsheet in accordance with the Agency's Guidance forSettingPesticide TolerancesBasedon FieldTrialData. Finally, EPA revised the residues of

concern to be included in thetolerance expression based on the results ofplant metabolism studies.

V. Conclusion

Therefore, tolerances are established for combined residues offree and conjugated MCPB and MCPAin or on peppermint, tops and spearmint, tops at 0.20 ppm. VI. StatutoryandExecutive Order Reviews

This final rule establishes tolerances under section 408(d) ofFFDCA in
response to apetition submitted to the Agency. The Office ofManagement and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning andReview (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, entitledActions Concerning Regulations ThatSignificantly Affect EnergySupply, Distribution, or Use(66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ProtectionofChildren from EnvironmentalHealthRisks andSafety Risks (62FR 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 AddressEnvironmentalJusticein MinorityPopulations andLow-Income Populations (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that

are established on the basis ofa petition under section 408(d) ofFFDCA, such as the tolerance inthis final rule, do not require the issuance ofaproposed rule, the requirements ofthe Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.

This finalrule directly regulates
growers, food processors, food handlers, and food retailers, notStates ortribes,

nor does this action alter the relationships or distribution ofpower and responsibilities established by Congress inthe preemption provisions of section 408(n)(4) ofFFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States ortribal governments,

on the relationship between the national government and the States ortribal governments, or onthe distribution of
power and responsibilities among the various levels ofgovernment 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 ConsultationandCoordination with Indian TribalGovernments(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 IIofthe Unfunded Mandates Reform Actof 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration ofvoluntary

consensus standards pursuant to section 12(d) ofthe 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 etseq., generally provides that before a rule may take effect, the
agency promulgating the rule must submit arule report to each House of the Congress and to the Comptroller General ofthe United States. EPA will submit areport containing thisrule and other required information to the U.S. Senate, the U.S. House of Representatives, andthe Comptroller General ofthe United States prior to publication ofthis final rule in the FederalRegister. This final rule is not

a "major rule" as defined by 5 U.S.C. 804(2).

ListofSubjects in40 CFRPart180

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.

mTherefore, 40 CFR chapter Iis amended as follows:

PART 180-[AMENDED]

m 1. Theauthority citation forpart 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 existingtext as paragraph (a)(1) and by adding paragraph (a)(2) to read as -follows: 180.318 4-(2-Methyl-4-chlorophenoxy) butyricacid;tolerances for residues.

(a) General.(1) * * * (2) Tolerances are established for the combined residues, free and conjugated, ofthe herbicide MCPB, 4-(4-chloro-2- methylphenoxy)butanoic acid, andits metabolite MCPA, (4-chloro-2- methylphenoxy)acetic acid, in or on the following food commodities: Federal Register/Vol. 73,

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