40750 Federal Register / Vol. 74, No. 155 / Thursday, August 13, 2009 / Rules and Regulations 

EPA-APPROVED NON-REGULATORY OR QUASI-REGULATORY MATERIAL

Name of non-regulatory SIP 

revision Applicable geographic area State submittal date EPA approval date Additional explanation 

* * * * * * * 

8-Hour Ozone Maintenance 

Plan for the York-Adams, 

PA Area.

York-Adams Counties Area ... 6/14/07 1/14/08, 73 FR 2163.

5/23/08 8/13/09 [Insert page number 

where the document begins].

* * * * * * * 

* * * * * 

[FR Doc. E9–18864 Filed 8–12–09; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2008–0566; FRL–8939–2] 

Revisions to the California State 

Implementation Plan, Great Basin 

Unified Air Pollution Control District, 

Kern County Air Pollution Control 

District, Mohave Desert Air Quality 

Management District 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is finalizing the 

following actions: A disapproval of 

revisions to the Great Basin Unified Air 

Pollution Control District (GBUAPCD) 

portion of the California State 

Implementation Plan (SIP); a limited 

approval and limited disapproval of 

revisions to the Kern County Air 

Pollution Control District (KCAPCD) 

SIP; and, a limited approval and limited 

disapproval of revisions to the Mohave 

Desert Air Quality Management District 

(MDAQMD) SIP. These revisions 

concern particulate matter (PM) 

emissions from fugitive dust sources. 

This action was proposed in the Federal 

Register on November 18, 2008. Under 

authority of the Clean Air Act as 

amended in 1990 (CAA or the Act), this 

action directs California to correct rule 

deficiencies in GBUAPCD Rule 401; 

and, this action simultaneously 

approves KCAPCD Rule 402 and 

MDAQMD Rule 403.1 and directs 

California to correct the deficiencies 

within these rules. 

DATES: Effective Date: This rule is 

effective on September 14, 2009. 

ADDRESSES: EPA has established docket 

number EPA–R09–OAR–2008–0566 for 

this action. The index to the docket is 

available electronically at http:// 

www.regulations.gov and in hard copy 

at EPA Region IX, 75 Hawthorne Street, 

San Francisco, California. While all 

documents in the docket are listed in 

the index, some information may be 

publicly available only at the hard copy 

location (e.g., copyrighted material), and 

some may not be publicly available in 

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

hard copy materials, please schedule an 

appointment during normal business 

hours with the contact listed in the FOR

FURTHER INFORMATION CONTACT section. 

FOR FURTHER INFORMATION CONTACT: Jerry 

Wamsley, EPA Region IX, (415) 947– 

4111, wamsley.jerry@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document, ‘‘we,’’ ‘‘us’’ 

and ‘‘our’’ refer to EPA. 

Table of Contents 

I. Proposed Action 

II. Public Comments and EPA Responses 

III. EPA Action 

IV. Statutory and Executive Order Reviews 

I. Proposed Action 

On November 18, 2008 (73 FR 68369), 

EPA proposed to disapprove GBUAPCD 

Rule 401. In this same action, EPA 

proposed a limited approval and limited 

disapproval of KCAPCD Rule 402 and 

MDAQMD Rule 403.1. Table 1 lists the 

rules that California submitted for 

incorporation within the SIP. 

TABLE 1—SUBMITTED RULES

Local agency Rule # Rule title Adopted Submitted 

GBUAPCD ..................................................... 401 Fugitive Dust ................................................. 12/04/06 05/08/07 

KCAPCD ........................................................ 402 Fugitive Dust ................................................. 11/03/04 01/13/05 

MDAQMD ....................................................... 403 .1 Fugitive Dust Control .................................... 11/25/96 03/03/97 

We proposed to disapprove 

GBUAPCD Rule 401 because some 

provisions do not satisfy the 

requirements of section 110 and part D 

of the Act. These provisions are 

discussed below. 

1. The rule lacks a 20% opacity limit. 

GBUAPCD should either incorporate or 

reference such a 20% opacity limit. 

2. The rule lacks a clear description 

of required control measures for meeting 

the rule’s opacity and property line PM 

emission limits. GBUAPCD should also 

remove the ‘‘reasonable precautions’’ 

language. 

3. GBUAPCD should either provide a 

precise wind speed exemption from the 

rule’s emission standards, or delete the 

language concerning ‘‘normal wind 

conditions’’. 

4. GBUAPCD should remove 

director’s discretionary language in 

Section D.1. 

5. As specified by the PM–10 plan, 

GBUAPCD should define required 

BACM provisions beyond those already 

adopted to reduce Owens dry lakebed 

dust emissions, and specify an 

enforceable implementation schedule. 

We proposed a limited approval of 

KCAPCD Rule 402 and MDAPCD Rule 

403.1 because we determined that these 

rules improve the SIP and are largely 

consistent with the relevant CAA 

requirements. We simultaneously 

proposed a limited disapproval because 

some rule provisions conflict with 

section 110 and part D of the Act. 


pwalker on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 74, No. 155 / Thursday, August 13, 2009 / Rules and Regulations 40751 

Regarding KCAPCD Rule 402, the 

provisions listed below conflict with 

section 110 and part D of the Act and 

prevent full approval of the SIP 

revision. 

1. The definitions for ‘‘open storage 

piles’’ and ‘‘prevailing wind direction’’ 

contain instances of APCO discretion 

that should be delimited by specific 

criteria for adjudicating the issues 

within these definitions. 

2. The rule provides an overly broad 

exemption for agricultural operations. 

3. The rule provides an overly broad 

exemption for actions required by 

Federal or State endangered species 

legislation, or the Surface Mining and 

Reclamation Act. 

4. The rule provides an overly broad 

exemption for public parks and 

recreation areas such as county, State, 

and national parks, recreation areas, 

forests, and monuments. 

5. The rule provides exemptions for 

contractors provided reasonably 

available control measures were 

implemented prior to a contract 

termination date and a final grading 

inspection. However, no records are 

required to demonstrate implementation 

of reasonably available control 

measures. 

6. Monitoring provisions are set aside 

for large operations for a calendar 

quarter. This exemption from 

monitoring is not justified or explained. 

7. The rule states that no visible 

emissions are allowed beyond the 

property line of an active operation; 

however, the rule does not specify an 

opacity limit and the test methods for 

determining compliance for unpaved 

roads which are exempted from the 

property line limit. 

8. The suggested reasonably available 

control measures for fugitive dust listed 

in Table 1 are not specific and lack 

standards for determining compliance 

and allied test methods. 

9. Large operations may set aside 

applying control measures if the APCO 

concurs that ‘‘special technical, e.g. 

non-economic circumstances’’ prevent 

control measure implementation. This 

exemption is vague and allows for 

inappropriate Director’s Discretion. 

KCAPCD should define the 

circumstances that may prevent control 

measure implementation and the 

criteria the APCO will use to decide 

these issues. 

10. The rule should specify that all 

records demonstrating compliance 

should be maintained for two years and 

made available to the Control Officer 

upon request. 

Regarding Rule MDAQMD Rule 403.1, 

the provisions listed below conflict with 

section 110 and part D of the Act and 

prevent full approval of the SIP 

revision. 

1. The following terms should be 

defined: Brackish water, paved roads 

used for industrial activity, Dust Control 

Plan, industrial fugitive dust sources, 

industrial fugitive dust sources, and 

exterior transfer lines. 

2. Sections C.2.(a)(i), C.2.(b)(i), 

C.2(d)(i), C.4(d)(i) state that weekly 

brackish water treatments or biweekly 

sweeping and collection are presumed 

to be sufficient for meeting the required 

Road Surface Silt Loading standard. 

However, compliance with the rule’s silt 

loading standard needs to be confirmed 

by observations using the appropriate 

test method. 

3. At Section C.4.(b), there is a 

requirement to permanently eliminate 

2,750 square feet of bulk material 

storage piles that were exposed during 

1990; however, it is unclear how this 

provision can be enforced effectively 

given the lack of specificity within the 

rule concerning these storage piles. 

4. Section C.5 does not provide a date 

certain by which the BLM and the 

District jointly prepare a dust control 

plan that reduces BLM PM–10 

emissions by at least 20 percent relative 

to 1990 levels. 

5. The exemption for agricultural 

operations at Section D(1)(a) should be 

removed. 

6. In Section F.1(c), the rule should 

state explicitly what the freeboard 

requirements are instead of 

incorporating the California Vehicle 

Code by reference. Also, these 

requirements should be incorporated 

within the appropriate paragraph in 

Section C. 

Our proposed action contains more 

information on the basis for this 

rulemaking and on our evaluation of 

these rules. 

II. Public Comments and EPA 

Responses 

EPA’s proposed action provided a 30- 

day public comment period. During this 

period, we received no comments on 

our proposed actions on these rules. 

This comment period closed December 

18, 2008. 

III. EPA Action 

No comments were submitted 

sufficient to change our assessment of 

these rules as described in our proposed 

action. Therefore, as authorized in 

sections 110(k)(3) and 301(a) of the Act, 

EPA is finalizing a disapproval of 

GBUAPCD Rule 401; this action will not 

incorporate GBUAPCD Rule 401 into the 

SIP. Also, as authorized in sections 

110(k)(3) and 301(a) of the Act, we are 

finalizing a limited approval and a 

limited disapproval of KCAPCD Rule 

402 and MDAQMD Rule 403.1; these 

rules will be incorporated within the 

SIP, including those provisions 

identified as deficient. 

In finalizing a disapproval of 

GBUAPCD Rule 401, our action will not 

incorporate submitted GBUAPCD Rule 

401 into the SIP, instead, it will retain 

1977 adopted rule within the SIP. We 

will not impose sanctions, pursuant to 

section 179 of the Act, because Rule 401 

is not a required CAA submittal. Note 

that the submitted rule has been 

adopted by the GBUAPCD, and EPA’s 

final disapproval does not prevent the 

local agency from enforcing it. 

With KCAPCD Rule 402, we will not 

impose sanctions under section 179 of 

the Act, because Rule 402 is not a 

required submittal under the CAA and 

is not an essential Reasonably Available 

Control Measure (RACM) under the 

Indian Wells Maintenance Plan. The 

submitted rule has been adopted by the 

KCAPCD, and EPA’s final limited 

disapproval does not prevent the local 

agency from enforcing it. 

Regarding Rule 403.1, we will not 

impose sanctions under section 179 of 

the Act, because Rule 403.1 is not an 

essential RACM given the ongoing clean 

data observed in the Trona subregion 

since 1992. The submitted rule has been 

adopted by the MDAQMD, and EPA’s 

final limited disapproval does not 

prevent the local agency from enforcing 

it. 

IV. Statutory and Executive Order 

Reviews 

A. Executive Order 12866, Regulatory 

Planning and Review 

The Office of Management and Budget 

(OMB) has exempted this regulatory 

action from Executive Order 12866, 

entitled ‘‘Regulatory Planning and 

Review.’’ 

B. Paperwork Reduction Act 

This action does not impose an 

information collection burden under the 

provisions of the Paperwork Reduction 

Act, 44 U.S.C. 3501 et seq. Burden is 

defined at 5 CFR 1320.3(b). 

C. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA) 

generally requires an agency to conduct 

a regulatory flexibility analysis of any 

rule subject to notice and comment 

rulemaking requirements unless the 

agency certifies that the rule will not 

have a significant economic impact on 

a substantial number of small entities. 

Small entities include small businesses, 

small not-for-profit enterprises, and 

small governmental jurisdictions. 


pwalker on DSK8KYBLC1PROD with RULES
40752 Federal Register / Vol. 74, No. 155 / Thursday, August 13, 2009 / Rules and Regulations 

This rule will not have a significant 

impact on a substantial number of small 

entities because SIP approvals under 

section 110 and subchapter I, part D of 

the Clean Air Act do not create any new 

requirements but simply approve 

requirements that the State is already 

imposing. Therefore, because the 

Federal SIP approval does not create 

any new requirements, I certify that this 

action will not have a significant 

economic impact on a substantial 

number of small entities. 

Moreover, due to the nature of the 

Federal-State relationship under the 

Clean Air Act, preparation of flexibility 

analysis would constitute Federal 

inquiry into the economic 

reasonableness of State action. The 

Clean Air Act forbids EPA to base its 

actions concerning SIPs on such 

grounds. Union Electric Co., v. U.S. 

EPA, 427 U.S. 246, 255–66 (1976); 42 

U.S.C. 7410(a)(2). 

D. Unfunded Mandates Reform Act 

Under sections 202 of the Unfunded 

Mandates Reform Act of 1995 

(‘‘Unfunded Mandates Act’’), signed 

into law on March 22, 1995, EPA must 

prepare a budgetary impact statement to 

accompany any proposed or final rule 

that includes a Federal mandate that 

may result in estimated costs to State, 

local, or tribal governments in the 

aggregate; or to the private sector, of 

$100 million or more. Under section 

205, EPA must select the most costeffective and least burdensome 

alternative that achieves the objectives 

of the rule and is consistent with 

statutory requirements. Section 203 

requires EPA to establish a plan for 

informing and advising any small 

governments that may be significantly 

or uniquely impacted by the rule. 

EPA has determined that the approval 

action promulgated does not include a 

Federal mandate that may result in 

estimated costs of $100 million or more 

to either State, local, or tribal 

governments in the aggregate, or to the 

private sector. This Federal action 

approves pre-existing requirements 

under State or local law, and imposes 

no new requirements. Accordingly, no 

additional costs to State, local, or tribal 

governments, or to the private sector, 

result from this action. 

E. Executive Order 13132, Federalism 

Federalism (64 FR 43255, August 10, 

1999) revokes and replaces Executive 

Orders 12612 (Federalism) and 12875 

(Enhancing the Intergovernmental 

Partnership). Executive Order 13132 

requires EPA to develop an accountable 

process to ensure ‘‘meaningful and 

timely input by State and local officials 

in the development of regulatory 

policies that have federalism 

implications.’’ ‘‘Policies that have 

federalism implications’’ is defined in 

the Executive Order to include 

regulations that have ‘‘substantial direct 

effects on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government.’’ Under 

Executive Order 13132, EPA may not 

issue a regulation that has federalism 

implications, that imposes substantial 

direct compliance costs, and that is not 

required by statute, unless the Federal 

government provides the funds 

necessary to pay the direct compliance 

costs incurred by State and local 

governments, or EPA consults with 

State and local officials early in the 

process of developing the proposed 

regulation. EPA also may not issue a 

regulation that has federalism 

implications and that preempts State 

law unless the Agency consults with 

State and local officials early in the 

process of developing the proposed 

regulation. 

This rule will not have substantial 

direct effects on the States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, because it 

merely approves a state rule 

implementing a federal standard, and 

does not alter the relationship or the 

distribution of power and 

responsibilities established in the Clean 

Air Act. Thus, the requirements of 

section 6 of the Executive Order do not 

apply to this rule. 

F. Executive Order 13175, Coordination 

With Indian Tribal Governments 

Executive Order 13175, entitled 

‘‘Consultation and Coordination with 

Indian Tribal Governments’’ (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.’’ This final rule does not 

have tribal implications, as specified in 

Executive Order 13175. It will not have 

substantial direct effects on tribal 

governments, on the relationship 

between the Federal government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

Federal government and Indian tribes. 

Thus, Executive Order 13175 does not 

apply to this rule. 

G. Executive Order 13045, Protection of 

Children From Environmental Health 

Risks and Safety Risks 

EPA interprets Executive Order 13045 

(62 FR 19885, April 23, 1997) as 

applying only to those regulatory 

actions that concern health or safety 

risks, such that the analysis required 

under section 5–501 of the Executive 

Order has the potential to influence the 

regulation. This rule is not subject to 

Executive Order 13045, because it 

approves a state rule implementing a 

Federal standard. 

H. Executive Order 13211, Actions That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This rule is not subject to Executive 

Order 13211, ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) because it is 

not a significant regulatory action under 

Executive Order 12866. 

I. National Technology Transfer and 

Advancement Act 

Section 12 of the National Technology 

Transfer and Advancement Act 

(NTTAA) of 1995 requires Federal 

agencies to evaluate existing technical 

standards when developing a new 

regulation. To comply with NTTAA, 

EPA must consider and use ‘‘voluntary 

consensus standards’’ (VCS) if available 

and applicable when developing 

programs and policies unless doing so 

would be inconsistent with applicable 

law or otherwise impractical. 

The EPA believes that VCS are 

inapplicable to this action. Today’s 

action does not require the public to 

perform activities conducive to the use 

of VCS. 

J. Congressional Review Act 

The Congressional Review Act, 5 

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

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

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

will be effective September 14, 2009. 


pwalker on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 74, No. 155 / Thursday, August 13, 2009 / Rules and Regulations 40753 

K. Petitions for Judicial Review 

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

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by October 13, 2009. 

Filing a petition for reconsideration by 

the Administrator of this final rule does 

not affect the finality of this rule for the 

purposes of judicial review nor does it 

extend the time within which a petition 

for judicial review may be filed, and 

shall not postpone the effectiveness of 

such rule or action. Parties with 

objections to this direct final rule are 

encouraged to file a comment in 

response to the parallel notice of 

proposed rulemaking for this action 

published in the proposed rules section 

of today’s Federal Register, rather than 

file an immediate petition for judicial 

review of this direct final rule, so that 

EPA can withdraw this direct final rule 

and address the comment in the 

proposed rulemaking. This action may 

not be challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Particulate matter, Reporting and 

recordkeeping requirements. 

Dated: May 12, 2009. 

Laura Yoshii, 

Acting Regional Administrator, Region IX. 

■ Part 52, Chapter I, Title 40 of the Code 

of Federal Regulations is amended as 

follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for Part 52 

continues to read as follows: 

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

Subpart F—California 

■ 2. Section 52.220 is amended by 

adding paragraphs (c) (244)(i)(C)(2), 

(335)(i)(E), and (350)(i)(A)(2) to read as 

follows: 

§ 52.220 Identification of plan. 

* * * * * 

(c) * * * 

(244) * * * 

(i) * * * 

(C) * * * 

(2) Rule 403.1, ‘‘Fugitive Dust Control 

for the Searles Valley Planning Area’’, 

adopted on June 22, 1994 and amended 

on November 25, 1996. 

* * * * * 

(335) * * * 

(i) * * * 

(E) Kern County Air Pollution Control 

District 

(1) Rule 402, ‘‘Fugitive Dust’’, adopted 

on November 29, 1993 and amended on 

November 3, 2004. 

* * * * * 

(350) * * * 

(i) * * * 

(A) * * * 

(2) Rule 401, ‘‘Fugitive Dust’’, adopted 

on September 5, 1974 and amended on 

December 04, 2006. 

* * * * * 

[FR Doc. E9–19338 Filed 8–12–09; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0805; FRL–8426–9] 

Spinetoram; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

tolerances for the combined residues of 

spinetoram in or on almond, hulls; nut, 

tree, group 14; and pistachio and 

establishes tolerances for date; 

pomegranate; pineapple; pineapple, 

processed residue; spice, subgroup 19B, 

except black pepper; and hop, dried 

cones. The Interregional Research 

Project Number 4 (IR-4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 13, 2009. Objections and 

requests for hearings must be received 

on or before October 13, 2009, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0805. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, 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: 

Samantha Hulkower, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 603–0683; e-mail address: 

hulkower.samantha@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

cite at http://www.gpoaccess.gov/ecfr. 

To access the OPPTS Harmonized 

Guidelines referenced in this document, 

go directly to the guidelines at http:// 


pwalker on DSK8KYBLC1PROD with RULES