55062 Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Proposed Rules 

Subpart J—Distribution 

§ 212.90 What actions must I take to 

control the distribution of PET drug 

products? 

(a) Written distribution procedures. 

You must establish, maintain, and 

follow written procedures for the 

control of distribution of PET drug 

products shipped from the PET 

production facility to ensure that the 

method of shipping chosen will not 

adversely affect the identity, purity, or 

quality of the PET drug product. 

(b) Distribution records. You must 

maintain distribution records for each 

PET drug product that include or refer 

to the following: 

(1) The name, address, and telephone 

number of the receiving facility that 

received each batch of a PET drug 

product; 

(2) The name and quantity of the PET 

drug product shipped; 

(3) The lot number, control number, 

or batch number for the PET drug 

product shipped; and 

(4) The date and time you shipped the 

PET drug product. 

Subpart K—Complaint Handling 

§ 212.100 What do I do if I receive a 

complaint about a PET drug product 

produced at my facility? 

(a) Written complaint procedures. You 

must develop and follow written 

procedures for the receipt and handling 

of all complaints concerning a PET drug 

product. 

(b) Complaint review. The procedures 

must include review by a designated 

person of any complaint involving the 

possible failure of a PET drug product 

to meet any of its specifications and an 

investigation to determine the cause of 

the failure. 

(c) Complaint records. A written 

record of each complaint must be 

maintained in a file designated for PET 

drug product complaints. The record 

must include the name and strength of 

the PET drug product, the batch 

number, the name of the complainant, 

the date the complaint was received, the 

nature of the complaint, and the 

response to the complaint. It must also 

include the findings of any investigation 

and followup. 

(d) Returned products. A PET drug 

product that is returned because of a 

complaint may not be reprocessed and 

must be destroyed in accordance with 

applicable Federal and State law. 

Subpart L—Records 

§ 212.110 How must I maintain records of 

my production of PET drug products? 

(a) Record availability. Records must 

be maintained at the PET production 

facility or another location that is 

reasonably accessible to responsible 

officials of the production facility and to 

employees of FDA designated to 

perform inspections. 

(b) Record quality. All records, 

including those not stored at the 

inspected establishment, must be 

legible, stored to prevent deterioration 

or loss, and readily available for review 

and copying by FDA employees. 

(c) Record retention period. You must 

maintain all records and documentation 

referenced in other parts of this 

regulation for a period of at least 1 year 

from the date of final release, including 

conditional final release, of a PET drug 

product. 

Dated: September 1, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–18510 Filed 9–15–05; 8:45 am] 

BILLING CODE 4160–01–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[R05–OAR–2005–WI–0003; FRL–7970–7] 

Approval and Promulgation of 

Implementation Plans; Wisconsin; 

General and Registration Permit 

Programs 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing to approve 

revisions to the Wisconsin State 

Implementation Plan (SIP) submitted by 

the State of Wisconsin on July 28, 2005. 

These revisions include General and 

Registration permit programs that 

provide for the issuance of general and 

registration permits as part of the State’s 

construction permit and operation 

permit programs. In addition, these 

permit programs may include the 

regulation of hazardous air pollutants 

(HAPs) which may be regulated under 

section 112 of the Clean Air Act (the 

Act). Thus, EPA is also proposing 

approval of Wisconsin’s general and 

registration permit program under 

section 112(l) of the Act. 

These SIP revisions also contain 

changes to definitions related to 

Wisconsin’s air permit program, as well 

as a minor technical change to provide 

correct references to the recently 

updated chapter NR 445, which was 

inadvertently omitted in the processing 

of that rule package. Additionally, these 

revisions clarify an existing 

construction permit exemption and 

operation permit exemption for certain 

grain storage and drying operations. 

This clarification is necessary to ensure 

that column dryers and rack dryers are 

included in the exemption criteria. 

DATES: Written comments must be 

received on or before October 20, 2005. 

ADDRESSES: Submit comments, 

identified by Regional Material in 

EDocket (RME) ID No. R05–OAR–2005–

WI–0003, by one of the following 

methods: 

Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

Agency Web site: http:// 

docket.epa.gov/rmepub/. RME, EPA’s 

electronic public docket and comments 

system, is EPA’s preferred method for 

receiving comments. Once in the 

system, select ‘‘quick search,’’ then key 

in the appropriate RME Docket 

identification number. Follow the online instructions for submitting 

comments. 

E-mail: blakley.pamela@epa.gov. 

Fax: (312) 886–5824. 

Mail: You may send written 

comments to: Pamela Blakley, Chief, Air 

Permit Section, (AR–18J), U.S. 

Environmental Protection Agency, 

Region 5, 77 West Jackson Boulevard, 

Chicago, Illinois 60604. 

Hand Delivery or Courier: Deliver 

your comments to: Pamela Blakley, 

Chief, Air Permit Section, (AR–18J), 

U.S. Environmental Protection Agency, 

Region 5, 77 West Jackson Boulevard, 

18th floor, Chicago, Illinois 60604. Such 

deliveries are only accepted during the 

Regional Office’s normal hours of 

operation. The Regional Office’s official 

hours of business are Monday through 

Friday, 8:30 a.m. to 4:30 p.m. excluding 

Federal holidays. 

Instructions: Direct your comments to 

RME ID No. R05–OAR–2005–WI–0003. 

EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at http:// 

docket.epa.gov/rmepub/, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through RME, regulations.gov, 

or e-mail. The EPA RME website and 

the federal regulations.gov Web site are 

‘‘anonymous access’’ systems, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through RME or 

Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Proposed Rules 55063 

regulations.gov, your e-mail address 

will be automatically captured and 

included as part of the comment that is 

placed in the public docket and made 

available on the Internet. If you submit 

an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD–ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. 

Docket: All documents in the 

electronic docket are listed in the RME 

index at http://docket.epa.gov/rmepub/. 

Although listed in the index, some 

information is not publicly available, 

i.e., 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 either electronically in RME or 

in hard copy at Environmental 

Protection Agency, Region 5, Air and 

Radiation Division, 77 West Jackson 

Boulevard, Chicago, Illinois 60604. We 

recommend that you telephone Susan 

Siepkowski, Environmental Engineer, at 

(312) 353–2654 before visiting the 

Region 5 office. This Facility is open 

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

through Friday, excluding legal 

holidays. 

FOR FURTHER INFORMATION CONTACT: 

Susan Siepkowski, Environmental 

Engineer, Air Permit Section, Air 

Programs Branch (AR–18J), U.S. 

Environmental Protection Agency, 

Region 5, 77 West Jackson Boulevard, 

Chicago, Illinois 60604, (312) 353–2654, 

siepkowski.susan@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document whenever 

‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean 

EPA. This supplementary information 

section is arranged as follows: 

I. Does This Action Apply to Me? 

II. What Has Wisconsin Submitted? 

A. General Permit Rule 

B. Registration Permit Rule 

C. Clarification to Grain Elevator 

Exemption 

D. Changes to Definitions, References, and 

Numbering 

III. Do These Rules Comply With Federal 

Requirements? 

A. Evaluation of the General Permit Rule 

B. Evaluation of the Registration Permit 

Rule 

C. Evaluation of the Clarification to Grain 

Elevator Exemption 

D. Evaluation of the Changes to 

Definitions, References, and Numbering 

IV. What Action Is EPA Taking Today? 

V. Statutory and Executive Order Reviews 

I. Does This Action Apply to Me? 

This rule provides certain owners and 

operators in Wisconsin with alternatives 

to traditional construction and 

operation air permits. Wisconsin has 

created new permitting programs to 

provide registration and general air 

permits as an alternative to individual 

source permits. The rule sets certain 

standards for developing the permits 

and criteria under which sources would 

qualify for coverage under the permits. 

Specific terms and conditions will be 

established during the development of 

each permit, which will then be 

standard for all sources that are covered 

under the permit. Sources may apply for 

coverage under these permits by 

submitting an application to the 

Wisconsin Department of Natural 

Resources (WDNR), who will determine 

whether the source is eligible for the 

permit. 

Under the registration permit rule, 

registration construction and 

registration operation permits will be 

developed for sources with low actual 

or potential emissions of air pollutants. 

The rule provides that a registration 

construction permit will be issued to a 

facility for the construction, 

reconstruction, replacement, relocation 

or modification of stationary sources 

whose actual emissions do not exceed 

25% of any major source threshold. The 

rule also provides that a registration 

operation permit must be issued to 

facilities whose actual emissions do not 

exceed 25% of major source thresholds. 

The second revision to the Wisconsin 

SIP permitting program is the general 

permit rule. This rule establishes that 

general construction and general 

operation permits will be developed for 

categories of sources with the same or 

similar emissions, operations, control 

systems, and regulatory requirements. 

Categories of sources that are or could 

be eligible for general permits include 

nonmetallic mineral processing plants, 

asphalt plants, small natural gas fired 

generators, small heating units, printing 

presses and hospital sterilization 

equipment. If an eligible owner or 

operator elects to comply with the rule, 

a generic permit that requires operation 

in compliance with the applicable 

sections of the Wisconsin rules will be 

issued to the source. 

II. What Has Wisconsin Submitted? 

On July 28, 2005, Wisconsin 

submitted the following revisions to its 

SIP: To repeal NR 406.04(1)(c) and 

407.03(1)(c); to renumber NR 406.02(1) 

to (4); to amend NR 406.04(1)(ce), (cm) 

and (m)(intro.), 406.11(1)(intro.) and (c), 

407.03(1)(ce) and (cm), 407.05(7), 

407.15(intro.) and (3), 410.03(1)(a)(5), 

and 484.05(1); to repeal and recreate NR 

407.02(3) and 407.10; and to create NR 

400.02(73m) and (131m), 406.02(1) and 

(2), 406.04(2m), 406.11(3), 406.16, 

406.17, 406.18, 407.02(3m), 407.105, 

407.107, 407.14 Note, 407.14(4)(c) and 

410.03(1)(a)(6) and (7). These rules, as 

discussed in more detail below, 

establish general and registration permit 

programs, clarify an exemption for grain 

elevators under the State’s construction 

and operation permit programs, define 

terms related to the State’s permitting 

programs, and correct a reference in 

Wisconsin’s regulations. 

The WDNR held a second public 

comment period on this rule because it 

made significant changes to the 

proposed rule to address comments 

received during the first comment 

period. The first comment period ran 

during October and November 2004, 

and the second through February and 

March 2005. WDNR held public 

hearings during both comment periods. 

As a result of the public comments, 

WDNR made more specific the criteria 

for developing the permits and the 

criteria under which sources would be 

eligible for coverage. 

In April 2005, WDNR proposed this 

rule revision to the Wisconsin Natural 

Resources Board for adoption, and the 

Board approved the rule on April 27, 

2005. WDNR submitted its request that 

EPA approve the rules as a SIP revision 

to EPA on July 28, 2005, and EPA 

determined on August 11, 2005 that the 

submittal was complete. 

A. General Permit Rule 

On February 5, 2004, Wisconsin 

enacted Act 118, which gave WDNR the 

authority to develop a general 

construction permit program. The State 

has existing authority to issue general 

operation permits under its operation 

permit program. Act 118 required 

WDNR to establish the general permit 

program to provide industry and the 

WDNR with a streamlined approach for 

permitting sources that have similar 

operations and air emissions levels. The 

general construction and operation 

permit provisions are codified at NR 

406.16 and NR 407.10 of the Wisconsin 

Administrative Code, respectively. A 

definition for ‘‘general permit’’ is 

codified at NR 400.02(73m) of the 

Wisconsin Administrative Code. 

Under the general permit program, 

WDNR must develop construction and 

operation permits for categories of 

55064 Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Proposed Rules 

sources with the same or similar 

emissions, operations, control systems 

and regulatory requirements, as 

described at NR 407.16(1) and NR 

407.10(1) of the Wisconsin 

Administrative Code. Categories of 

sources that are, or could be, eligible for 

general permits include: Nonmetallic 

mineral processing plants, asphalt 

plants, small natural gas fired 

generators, small heating units, printing 

presses, and hospital sterilization 

equipment. The procedure for 

establishing general construction or 

operation permits includes the 

preparation of an air quality analysis 

and preliminary determination, and the 

distribution of a notice of the 

opportunity for public and EPA 

comment and of the opportunity to 

request a public hearing. Once WDNR 

has established a general permit, 

individual sources may apply for 

coverage. 

Pursuant to NR 406.16(2) and NR 

407.10(2), sources that are not eligible 

for coverage under general permits 

include: Municipal solid waste 

combustion sources; projects that 

require a Prevention of Significant 

Deterioration (PSD) or New Source 

Review (NSR) permit or emission units 

that may cause or exacerbate, a violation 

of an ambient air quality standard or air 

increment. Further, NR 406.11(1)(g) and 

NR 407.15(8) provide the methodologies 

that WDNR will use to determine for 

general construction and general 

operation permits, respectively, whether 

a source covered under a general permit 

has emissions that may cause or 

exacerbate a violation of an ambient air 

quality standard or air increment. 

The process for determining coverage 

under a general construction or 

operation permit is described under NR 

406.16(3) and NR 407.10(3), 

respectively. This process requires the 

source to submit an application to the 

WDNR, who will then determine 

whether the source is eligible for 

coverage. 

NR 406.16(4) of the Wisconsin 

Administrative Code requires that the 

general construction permit be 

incorporated into the facility operation 

permit. NR 407.10(4) of the Wisconsin 

Administrative Code creates an 

exemption from the requirement to 

obtain a construction permit for sources 

covered under a general operation 

permit as long as, among other things, 

the modification does not result in a 

violation of the terms and conditions of 

the general operation permit. NR 

406.04(2m) creates a similar exemption 

for sources that are covered under either 

a registration or general operation 

permit. 

NR 406.16(5) and NR 407.10(5) 

describe the process by which sources 

covered under a general construction or 

operation permit may apply for and 

request a different type of permit. In 

addition, NR 407.10(6) provides that 

sources covered under a general 

operation permit which are later 

determined not to qualify would be 

subject to legal action. 

The rule also creates NR 406.18 and 

NR 407.107, both of which describe the 

procedures for a party to petition WDNR 

to develop a general permit for other 

categories of stationary sources, and 

describe the factors that WDNR will use 

in setting its priorities for general permit 

development. 

In addition to criteria pollutants, 

Wisconsin’s general permit program 

applies to HAPs. Certain HAPs are, or 

will be, regulated under sections 111 

and 112 of the Act. Thus, EPA is also 

approving Wisconsin’s general permit 

program under section 112(l) of the Act 

for the purpose of creating federally 

enforceable limitations on the potential 

to emit HAPs regulated under section 

112. 

B. Registration Permit Rule 

Wisconsin Act 118 also provided 

WDNR with the authority to develop a 

registration permit program for 

construction and operation permits. The 

registration permit program is designed 

to provide industry and the WDNR with 

a streamlined approach for permitting 

sources with low actual or potential 

emissions. The registration permit 

program is also a mechanism to permit 

small sources that may otherwise be 

subject to the Federally Enforceable 

State Operating Permit (FESOP) 

program and require an individual 

source permit. This program thereby 

reduces the permitting burden on both 

sources and the WDNR. Registration 

construction permit provisions are 

codified at NR 406.17, and the 

registration operation permit provisions 

are codified at NR 407.105. A definition 

was created for ‘‘registration permit’’ at 

NR 400.02(131m). 

NR 406.17(1) and NR 407.105(1) allow 

the WDNR to issue registration permits 

to sources which meet specific criteria. 

The process for issuing these permits 

includes the preparation of an air 

quality analysis and preliminary 

determination, and the distribution of a 

notice of the opportunity for public and 

EPA comment and of the opportunity to 

request a public hearing. Once WDNR 

has issued the registration permit, 

individual sources may apply for 

coverage. The registration permit will 

essentially cap, or limit, the facility, or 

unit emissions to a specified level. 

NR 406.17(2) establishes the criteria 

for issuance of a registration 

construction permit. It provides that a 

registration construction permit shall be 

issued to a facility for the construction, 

reconstruction, replacement, relocation 

or modification of stationary sources 

whose actual emissions do not exceed 

25% of any major source threshold. NR 

407.105(2) establishes the criteria for 

issuance of a registration operation 

permit. A source is eligible for coverage 

under a registration operation permit if 

its actual emissions do not exceed 25% 

of any major source threshold. This 

section also establishes physical design 

and air dispersion modeling criteria. 

Sources that are not eligible for 

coverage under a registration permit are 

described at NR 406.17(3) and NR 

407.105(3), and include: Municipal 

solid waste combustion sources; 

projects that require a PSD or NSR major 

source permit (NR 406.16); emission 

units subject to section 111 or 112 of the 

Act other than those deemed by WDNR 

not to preclude eligibility for the 

registration operation permit; or 

emission units that may cause or 

exacerbate, a violation of an ambient air 

quality standard or air increment. NR 

406.11(1) and NR 407.15(8) authorize 

WDNR, among other things, to 

withdraw a source from coverage of the 

general or registration permits, and 

provide the methodologies that WDNR 

must use to determine if a source 

covered under a registration permit has 

emissions that may cause or exacerbate 

a violation of an ambient air quality 

standard or air increment. 

NR 406.17(4) and NR 407.105(4) 

describe the process for determining 

coverage under a registration 

construction or operation permit, 

respectively. This process requires the 

source to submit an application to the 

WDNR, who will then determine 

whether the source is eligible for 

coverage. 

NR 406.17(5) requires that the terms 

of a registration construction permit be 

incorporated into the facility’s 

registration operation permit. NR 

407.105(5) exempts sources with a 

registration operation permit from 

obtaining a construction permit for 

construction activities that will not 

violate the terms or conditions of the 

registration operation permit. NR 

406.04(2m) also creates this exemption 

for sources that are covered under a 

registration or general operation permit. 

NR 406.17(6) and NR 407.105(6) 

describe the process by which a source 

with a registration construction or 

operation permit can apply for a 

different type of permit. NR 407.105(7) 

describes the criteria WDNR will use for 

Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Proposed Rules 55065 

determining whether a facility under the 

registration operation permit is in 

compliance with all applicable 

requirements. 

The rule also creates provisions NR 

406.18 and NR 407.107, which describe 

the procedures for a person to petition 

WDNR to develop a general or 

registration construction or operation 

permit for a category of stationary 

sources, and describes the factors that 

WDNR will consider in determining 

whether to grant or deny the petition. 

Wisconsin’s registration permit 

program not only applies to criteria 

pollutants, but also to hazardous air 

pollutants (HAPs). Certain HAPs are, or 

will be, regulated under sections 111 

and 112 of the Act. Thus, EPA is also 

approving under section 112(l) of the 

Act Wisconsin’s registration permit 

program for the purposes of creating 

federally enforceable limitations on the 

potential to emit HAPs regulated under 

section 112 of the Act. 

C. Clarification to Grain Elevator 

Exemption 

This rule amends provisions of 

Wisconsin’s construction and operation 

permit programs, NR 406.04(1) and NR 

407.03(1), respectively, relating to an 

existing exemption for certain grain 

storage and processing facilities from 

needing to obtain a construction or 

operation permit. This clarification is 

necessary to ensure that facilities with 

column dryers and rack dryers that 

remain below the major source 

threshold for air permit programs are 

included in the exemption. This 

exemption does not apply to sources 

subject to New Source Performance 

Standards (NSPS), Standards of 

Performance for Grain Elevators, (40 

CFR part 60, subpart DD) or subject to 

part 70 (40 CFR part 70). 

D. Changes to Definitions, References, 

and Numbering 

Several other changes are being made 

to Wisconsin’s construction and 

operation permit program rules, NR 406 

and NR 407. Several sections are 

renumbered because of the addition of 

new provisions and definitions. 

Additional changes are being made to 

NR 410, Wisconsin’s air permit fee 

rules. NR 410.03(1)(a)(5), related to the 

fees for a construction permit revision, 

is amended to exempt the fee if the 

requested revision is to make the source 

eligible for a registration operation 

permit. NR 410.03(1)(a)(6) and (7) 

provide that sources subject to Part 70 

pay fees for coverage under a general or 

registration construction permit. 

III. Do These Rules Comply With 

Federal Requirements? 

EPA reviewed Wisconsin’s July 28, 

2005, SIP revision submittal to 

determine completeness, in accordance 

with the completeness criteria set out at 

40 CFR part 51, appendix V (1991), as 

amended by 57 FR 42216 (August 26, 

1991). We found the submittal to be 

complete, and sent a letter dated August 

11, 2005, to the WDNR Bureau of Air 

Management Director indicating the 

completeness of the submittal. 

The next step in the review process 

was EPA’s analysis of the State’s 

submittal. EPA evaluated Wisconsin’s 

general and registration permit 

programs with respect to the SIP 

approval criteria established in EPA’s 

June 28, 1989, rulemaking 

‘‘Requirements for the Preparation, 

Adoption, and Submittal of 

Implementation Plans,’’ (EPA’s 1989 

rulemaking); Approval and 

Promulgation of Implementation Plans, 

54 FR 27274. In addition, EPA has 

evaluated portions of Wisconsin’s rule 

with respect to relevant EPA guidance 

documents, as discussed in more detail 

below. 

The EPA’s 1989 rulemaking criteria 

are as follows: 

1. The state operating permit program 

(i.e., the regulations or other 

administrative framework describing 

how such permits are issued) is 

submitted and approved by EPA into 

the SIP. 

2. The SIP imposes a legal obligation 

that operating permit holders adhere to 

the terms and limitations of such 

permits (or subsequent revisions of the 

permit made in accordance with the 

approved operating permit program.) 

3. The State operating permit program 

requires that all emissions, limitations, 

controls and other requirements 

imposed by such permits will be at least 

as stringent as any other applicable 

limitation or requirement contained in 

the SIP or enforceable under the SIP, 

and that the program may not issue 

permits that waive, or make less 

stringent, any limitation or requirement 

contained in or issued pursuant to the 

SIP, or that are otherwise ‘federally 

enforceable’ (e.g., standards established 

under sections 111 and 112 of the Act). 

4. The limitations, controls, and 

requirements in the operating permits 

are permanent, quantifiable and 

otherwise enforceable as a practical 

matter. 

5. The permits are issued subject to 

public participation. 

A. Evaluation of the General Permit 

Rule 

The general permit rule establishes 

the fundamental framework for the 

general permits to be issued by setting 

certain criteria for developing the 

permits, and criteria under which 

sources would qualify for coverage 

under the permits. WDNR will establish 

specific terms and conditions during the 

development of each general permit, 

which then will be standard for all 

sources that are covered under the 

permit. 

In the past, Wisconsin has issued 

general operation permits for certain 

source categories, such as rock crushers. 

WDNR now is establishing standard 

general construction permits with this 

rule, and revising its general operation 

permit program. EPA has the authority 

to enforce these types of permits if the 

permit program establishing them is 

approved into the SIP. EPA 

acknowledged in our July 10, 1995 

memorandum, ‘‘White Paper for 

Streamlined Development of Part 70 

Permit Applications,’’ as well as in 

various other policy and guidance 

documents related to permitting, the 

development of general permits as a 

mechanism for streamlining. 

For example, EPA’s April 14, 1998, 

memorandum ‘‘Potential to Emit (PTE) 

Guidance for Specific Source 

Categories’’ discusses approaches that 

permitting authorities can use to 

establish enforceable emission limits, 

such as general permits. Generally 

appropriate for less complex sources, 

states create a standard set of terms and 

conditions for many similar sources at 

the same time. Sources wishing to be 

subject to the general permit must 

provide a notification to the permitting 

agency, and must comply with the 

standard terms and conditions. This 

EPA memorandum also states that ‘‘[i]n 

making any change to a minor NSR 

program, the State or local agency needs 

to address air quality impact 

considerations in addition to those 

discussed here.’’ Additionally, Section 

110 of the Act specifies that permit 

programs must ensure that the National 

Ambient Air Quality Standards 

(NAAQS) are protected. 

Wisconsin’s submittal satisfies this 

requirement. Rules NR 406.16(2)(c) and 

NR 407.10(2)(b), for general 

construction and general operation 

permits, respectively, state that a source 

is ineligible for coverage under a general 

permit if the emissions unit or units 

cause or exacerbate, or may cause or 

exacerbate, a violation of any ambient 

air quality standard or ambient air 

55066 Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Proposed Rules 

increment, as determined by the WDNR 

through an air quality assessment. 

Another guidance document, EPA’s 

January 25, 1995 memorandum 

‘‘Guidance an Enforceability 

Requirements for Limiting Potential to 

Emit through SIP and section 112 Rules 

and General Permits’’ (sic) (EPA’s 1995 

guidance) discusses general permit rule 

requirements. This guidance states that 

‘‘[a]lthough this concept [of general 

permits] is generally thought of as an 

element of Title V permit programs 

there in no reason that a state or local 

agency could not submit a general 

permit program as a SIP submittal 

aimed at creating synthetic minor 

sources.’’ This guidance document 

further states that, although general 

permit programs can be separate from 

Title V permit programs, the issuance of 

general permits under the general 

permit program should comply with 

Title V procedures. Therefore, EPA will 

evaluate Wisconsin’s general permit 

program with these procedures. That is, 

all general permits must meet certain 

legal and practical federal requirements. 

The guidance states ‘‘[w]ith respect to 

legal sufficiency, the operating permit 

regulations provide that once the 

general permit has been issued, after 

opportunity for public participation 

and, EPA and affected State review, the 

permitting authority may grant or deny 

a sources request to be covered by a 

general permit without further public 

participation or EPA or affected State 

review.’’ Id. at 4. Wisconsin’s general 

construction permit rule provides for 

public participation at NR 406.16(1)(c), 

which states that WDNR shall use the 

applicable procedures in Wisconsin 

Statutes s. 285.61 and s. 285.63 to issue 

a general construction permit. The 

general operation permit rule at NR 

407.10(1)(c) states that WDNR shall use 

the applicable procedures in Statutes s. 

285.62 to issue the general operation 

permit. Both of these statutes require 

that the WDNR distribute a notice of the 

availability of the proposed general 

permit and of the WDNR’s analysis and 

preliminary determination, a notice of 

the opportunity for public comment and 

a notice of the opportunity to request a 

public hearing. 

The general permit rule also provides 

that the WDNR may grant or deny a 

source’s request to be covered by a 

general permit. NR 406.16(1)(c) and NR 

407.10(1)(c), for general construction 

and operation permits, respectively, 

require the WDNR to prepare an air 

quality analysis and a preliminary 

determination on the approvability of 

the proposed general permit. Both NR 

406.16(3)(c) and NR 407.10(3)(c) state 

that WNDR must provide the applicant 

notice of WDNR’s determination that 

the source is covered under the general 

permit; a description of any information 

that is missing from the application for 

the general permit; or notice of WDNR’s 

determination that the source does not 

qualify for coverage and the reasons for 

that determination. 

EPA’s 1995 guidance also specifies 

that the rule establishing the general 

permit program must require that: ‘‘(1) 

General permits apply to a specific and 

narrow category of sources; (2) sources 

electing coverage under general permits 

where coverage is not mandatory, 

provide notice or reporting to the 

permitting authority; (3) general permits 

provide specific and technically 

accurate (verifiable) limits that restrict 

the potential to emit; (4) general permits 

contain specific compliance 

requirements; (5) limits in general 

permits are established based on 

practicably enforceable averaging times; 

and, (6) violations of the permit are 

considered violations of the state and 

federal requirements and result in the 

source being subject to major source 

requirements.’’ Id. at 6. 

With respect to the first requirement 

above, NR 406.16(1)(b) and NR 

407.10(1)(b) contain criteria to define 

the types of sources for which WDNR 

can issue general construction and 

operation permits. These criteria serve 

to describe and narrow the sources for 

which WDNR may establish general 

permits. 

Regarding compliance with the 

second requirement of the 1995 

guidance, sources electing to be covered 

by Wisconsin’s non-mandatory general 

construction or operation permits must 

submit applications to the WDNR, upon 

which the agency must act. 

Wisconsin’s general permit program 

satisfies requirements 3 to 5 of the 1995 

guidance regarding emission limits, 

compliance requirements, and averaging 

times. NR 406.16(1)(d) and NR 

407.10(1)(d) require that the general 

construction and operation permits 

contain applicability criteria, emission 

limits, monitoring and record keeping 

requirements, reporting requirements, 

compliance demonstration methods and 

general conditions appropriate for the 

stationary source category. 

Regarding the sixth requirement, that 

violations of the permit should be 

considered violations of the applicable 

requirement that result in the source 

becoming subject to major source 

requirements, both NR 406.16(1)(d) and 

NR 407.10(1)(d) state that the general 

construction and operation permit 

include terms and conditions required 

to comply with the Act and required to 

assure compliance with applicable 

provisions in Wisconsin’s statutes and 

regulations. In addition, NR 406.10, 

which is an existing provision of the 

Wisconsin SIP that addresses violations 

of a construction permit, states that a 

source that fails to construct and operate 

a stationary source in accordance with 

conditions imposed by the WDNR under 

Wisconsin statute s. 285.65 (which 

requires the establishment of permit 

conditions to ensure compliance with 

Wisconsin regulations and the Act) shall 

be considered in violation of Wisconsin 

statute 285.60. Wisconsin statute s. 

285.60 requires air pollution control 

permits for new or modified sources, 

specifically a construction permit for 

commencing construction, 

reconstruction, replacement or 

modification of a stationary source, and 

an operation permit before any person 

can operate a new source or a modified 

source. Further, NR 407.09(1)(f), 

operation permit content, requires that 

permits include the following provision: 

The permittee must comply with all 

conditions of the permit and any 

noncompliance with the operation 

permit constitutes a violation of the 

statutes and is grounds for enforcement 

action; for permit suspension, 

revocation or revision; or for denial of 

a permit renewal application. The 

WDNR also retains the discretion to 

determine whether violations of a 

registration or general permit result in 

the source becoming subject to major 

source permitting requirements. 

With respect to EPA’s 1989 

rulemaking criteria discussed above, 

EPA has determined that Wisconsin’s 

general permit program meets these 

criteria, as outlined below. 

1. Wisconsin submitted the 

regulations and administrative 

framework for the general permit rule, 

under NR 400, NR 406, NR 407, and NR 

410, as a revision to its SIP on July 28, 

2005. EPA’s approval of this section 

would provide legal support for these 

permit programs and, would satisfy the 

first criterion. 

2. Wisconsin’s rule imposes a legal 

obligation that permit holders adhere to 

the terms and limitations of the permits. 

NR 406.10, violations of a construction 

permit, states that a source that fails to 

construct and operate a stationary 

source in accordance with conditions 

imposed by the WDNR under Wisconsin 

statute s. 285.65, (which requires the 

establishment of permit conditions to 

ensure compliance with Wisconsin 

regulations and the Act,) shall be 

considered in violation of Wisconsin 

statute s. 285.60, (which requires the air 

pollution control permit.) Also, NR 

407.09(1)(f), an existing SIP provision 

that addresses operation permit content, 

Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Proposed Rules 55067 

requires that permits include the 

following provision: The permittee must 

comply with all conditions of the permit 

and any noncompliance with the 

operation permit constitutes a violation 

of the statutes and is grounds for 

enforcement action; for permit 

suspension, revocation or revision; or 

for denial of a permit renewal 

application. This satisfies the second 

approval criterion that the permittee 

must comply with the permit 

conditions. 

3. The permit program requires that 

all emissions, limitations, controls and 

other requirements imposed by permits 

will be at least as stringent as any other 

applicable limitation or requirement 

contained in the SIP or enforceable 

under the SIP. NR 406.16(1)(d) and NR 

407.10(1)(d) both require that the 

general permit contain applicability 

criteria, emission caps and limitations, 

monitoring and record keeping 

requirements, reporting requirements, 

compliance demonstration methods and 

general conditions appropriate for the 

source category; and, that the permit 

terms and conditions shall include 

those required to comply with the Act 

and those required to assure compliance 

with applicable provisions in 

Wisconsin’s rules (ch. 285, Stats., and 

chs. NR 400 to 499.) This provision 

satisfies the third criterion. 

4. The limitations, controls, and 

requirements in the permits will be 

permanent, quantifiable and otherwise 

enforceable as a practical matter. As 

discussed above, Wisconsin’s general 

permit rule requires that WDNR provide 

a 30-day public comment on the 

proposed general permit, and it 

specifies that the general permit will 

contain applicability criteria, emission 

caps and limitations, monitoring and 

record keeping requirements, reporting 

requirements, compliance 

demonstration methods and general 

conditions appropriate for the source 

category. During the comment period, 

EPA has the opportunity to review the 

permit to ensure that the limitations, 

controls, and requirements in the 

permits are permanent, quantifiable and 

otherwise enforceable as a practical 

matter. Additionally, the general 

construction permits do not expire. For 

general operation permits, NR 

407.10(1)(e) states that a general 

operation permit issued to a part 70 

source category may not exceed 5 years, 

and that general operation permits 

issued to a non-part 70 source category 

shall only expire if an expiration date is 

requested by the source owner or 

operator, or if the WDNR finds that 

expiring coverage would significantly 

improve the likelihood of continuing 

compliance with applicable 

requirements, compared to coverage that 

does not expire. Although the general 

operation permits can expire, the 

expiration ends the source’s right to 

operate unless the permittee has 

submitted a timely and complete 

renewal application or WDNR has 

issued a renewed operation permit. 

Based on the reasons above, the fourth 

criterion is met. 

5. As discussed previously, 

Wisconsin’s rule requires that the 

general permits are issued subject to 

public participation under NR 

406.16(1)(c) and NR 407.10(1)(c), for 

construction and operation permits, 

respectively. EPA has determined that, 

in cases where standardized permits 

have been adopted, EPA and the public 

need not be involved in their 

application to individual sources as 

long as the standard permits themselves 

have been subject to notice and 

opportunity to comment. EPA’s 1995 

guidance, on page 10. Specifically, 

EPA’s 1995 guidance states that ‘‘since 

the rule establishing the program does 

not provide the specific standards to be 

met by the source, each general permit, 

but not each application under each 

general permit, must be issued pursuant 

to public and EPA notice and 

comment.’’ Id. Wisconsin’s general 

permit rule satisfies this criterion. 

Sources of HAPs may also be eligible 

for coverage under Wisconsin’s general 

permit rule. NR 406.16(2) and NR 

407.10(2), which describe the sources 

which are ineligible for coverage under 

a general construction or general 

operation permit, do not include 

sources of HAPS. Therefore, EPA is 

evaluating Wisconsin’s general permit 

program under section 112(l) of the Act 

for the purposes of creating federally 

enforceable limitations on the potential 

to emit HAPs. 

Several EPA guidance documents 

address this issue, including EPA’s 

November 3, 1993, guidance document, 

‘‘Approaches to Creating Federally 

Enforceable Emissions Limits,’’ which 

states on page 2 that a state permit 

program could be extended to create 

federally enforceable limits for 

emissions of HAPs if the program were 

approved pursuant to section 112(l) of 

the Act. Also, EPA’s 1995 guidance 

states on page 4 that a mechanism 

available to limit potential to emit is a 

general permit program approved into 

the SIP or under Section 112(1). 

Wisconsin’s general permit program 

may limit HAP emissions in permits 

and therefore must also be evaluated 

with the approval criteria for programs 

limiting potential to emit of HAPs under 

40 CFR part 63, subpart E, the 

regulations promulgated to implement 

section 112(l) of the Act. 40 CFR 

63.91(a)(5) states, ‘‘[t]he Administrator 

may, under the authority of section 

112(l) and this subpart, also approve a 

State program designed to establish 

limits on the potential to emit 

hazardous air pollutants listed pursuant 

to section 112 of the Act.’’

Section 112(l) allows EPA to approve 

a state’s permit program only if it meets 

the following statutory criteria for 

approval under section 112(l)(5): (1) It 

contains adequate authority to assure 

compliance with any section 112 

standards, regulations, or requirements 

established under section 112, (2) it 

provides for adequate authority and 

resources to implement the program, (3) 

it provides for an expeditious schedule 

for assuring compliance with section 

112 requirements, and, (4) it is 

otherwise in compliance with Agency 

guidance and is likely to satisfy the 

objectives of the Act. 

EPA has determined that Wisconsin’s 

general permit program meets these 

112(l) criteria as outlined below: 

First, Wisconsin’s general permit 

program contains adequate authority to 

assure compliance with section 112 

standards or requirements. Both NR 

406.16(1)(d) and NR 407.10(1)(d) state 

that the general construction or 

operation permit shall contain 

applicability criteria, emission limits, 

monitoring and record keeping 

requirements, reporting requirements, 

compliance demonstration methods and 

general conditions; and that the permit 

terms and conditions shall include 

those required to comply with the Act 

and those required to assure compliance 

with applicable provisions in 

Wisconsin’s regulations. 

Furthermore, Wisconsin Statutes s. 

285 provides the authority for 

Wisconsin to administer and enforce all 

of its permit programs. Section 285.11 

specifies that the WDNR shall: ‘‘(1) 

Promulgate rules implementing and 

consistent with this chapter and statute 

299.15; * * * (18) Adopt and apply 

objective performance measurements, 

for the subunit of the department that 

administers this chapter, relating to the 

issuance of permits under subchapter 

VII and to overall performance of the 

subunit.’’ In addition, section 285.13 

specifies WDNR’s powers, including 

‘‘* * * (2) Issue orders to effectuate the 

purposes of this chapter and statute 

299.15 and enforce the same by all 

appropriate administrative and judicial 

proceedings.’’

For criterion 2, regarding adequate 

resources, NR 410.03(1)(a)(6) requires 

WDNR to collect fees from sources 

subject to 40 CFR Part 70 that are 

55068 Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Proposed Rules 

covered under the general construction 

permit. The general operation permit 

program also requires fees to be 

collected, as described in the July 26, 

2005, State budget. The State anticipates 

that its new fee structure, adopted in 

this budget, will provide sufficient 

resources to administer the general 

permit program. WDNR has submitted 

this revised fee structure along with a 

fee sufficiency demonstration to EPA for 

review. EPA will monitor the State’s 

implementation of the permit program 

to assure that adequate resources 

continue to be available. 

Wisconsin’s general permit program 

also meets the third requirement for an 

expeditious schedule to assure 

compliance. Nothing in this program 

would allow a source to avoid or delay 

compliance with federal HAPs 

requirements if it fails to obtain the 

appropriate federally enforceable limit 

by the relevant deadline. 

Fourth, Wisconsin’s general permit 

program is consistent with the 

objectives of the section 112 program, 

since its purpose is to enable sources to 

obtain federally enforceable limits on 

potential to emit. This is also consistent 

with the intent of the guidance 

documents discussed above. 

Based on the discussion above, EPA 

has determined that Wisconsin’s general 

permit program is approvable under 

section 112(l). By approving 

Wisconsin’s general permit program, 

EPA recognizes it as a federally 

enforceable method of limiting a 

source’s potential to emit HAPs. 

B. Evaluation of the Registration Permit 

Rule 

The registration permit rule 

establishes the general framework for 

the registration permits by setting 

certain criteria for developing the 

permits and criteria under which 

sources would qualify for coverage 

under the permits. Specific terms and 

conditions will be established during 

the development of each registration 

permit, which will then be standard for 

all sources that are covered under the 

permit. 

In the past, Wisconsin has placed 

federally enforceable synthetic minor 

limitations on sources through 

individual permits issued pursuant to a 

federally approved program. WDNR is 

now establishing standardized federally 

enforceable synthetic minor permits. 

EPA has the authority to enforce the 

terms of these permits if the permit 

program under which they are issued is 

approved into the SIP. EPA has 

acknowledged this approach for creating 

emission limitations and discussed 

various criteria that must be considered 

for approval in several policy and 

guidance documents related to creating 

federally enforceable emissions limits 

and approval of SIPs. 

As discussed above, various 

regulatory options exist for the creation 

of federally enforceable limits on 

potential to emit. Several guidance 

documents, including EPA’s November 

3, 1993, memorandum, ‘‘Approaches to 

Creating Federally Enforceable Emission 

Limits,’’ summarize these options. 

Major NSR permits, minor NSR permits 

(if EPA has approved the NSR program 

into the SIP and the program meets 

certain procedural requirements), and 

operating permits based on programs 

approved into the SIP pursuant to the 

criteria in the June 28, 1989 Federal 

Register (54 FR 27274), are available 

regulatory mechanisms. 

EPA’s April 14, 1998, memorandum 

‘‘Potential to Emit (PTE) Guidance for 

Specific Source Categories’’ also 

discusses on page 2 approaches that 

permitting authorities can use to 

establish enforceable emission limits 

which ensure that a source’s potential 

emissions are below the major source 

threshold, such as using a general 

permit. Under its registration permit 

program, Wisconsin establishes permits 

which, like general permits, contain 

standardized conditions that will cap or 

limit source or unit emissions below a 

certain threshold. The guidance states 

that sources wishing to be subject to the 

standard permit must provide a 

notification to the permitting agency, 

and must comply with the standard 

terms and conditions. Wisconsin’s 

registration permit program specifically 

requires sources to apply for coverage 

under NR 406.17(4) and NR 407.105(4), 

for registration construction and 

operation permits, respectively. 

EPA’s April 14, 1998 memorandum 

states that, ‘‘[i]n making any change to 

a minor NSR program, the State or local 

agency needs to address air quality 

impact considerations in addition to 

those discussed here.’’ Id. at 6. 

Additionally, Section 110 of the Act 

specifies that permit programs must 

ensure that the NAAQS are protected. 

NR 406.17(3)(c) and NR 407.105(3)(c) 

for registration construction and 

operation permits, respectively, state 

that a source is ineligible for coverage 

under a registration permit if the 

emissions unit or units cause or 

exacerbate, or may cause or exacerbate, 

a violation of any ambient air quality 

standard or ambient air increment, as 

determined by the WDNR through an air 

quality assessment. 

EPA’s 1995 guidance, as discussed in 

Section A, above, outlines general 

permit rule requirements. Again, this 

guidance states on page 3 that 

‘‘[a]lthough this concept [of general 

permits] is generally thought of as an 

element of Title V permit programs 

there is no reason that a state or local 

agency could not submit a general 

permit program as a SIP submittal 

aimed at creating synthetic minor 

sources.’’ The guidance further states on 

page 4 that ‘‘[a]nother mechanism 

available to limit potential to emit is a 

general permit program approved into 

the SIP or under section 112(1).’’

This guidance document further states 

that, although general permit programs 

can be separate from Title V permit 

programs, the issuance of general 

permits should comply with Title V 

procedures. That is, all general permits 

must meet certain legal and practical 

requirements for federal enforceability. 

The guidance states on page 4 ‘‘[w]ith 

respect to legal sufficiency, the 

operating permit regulations provide 

that once the general permit has been 

issued, after opportunity for public 

participation and, EPA and affected 

State review, the permitting authority 

may grant or deny a sources request to 

be covered by a general permit without 

further public participation or EPA or 

affected State review.’’ Because 

Wisconsin’s registration permit program 

is essentially a general permit that will 

contain standardized emissions 

limitations, we have evaluated it using 

the criteria from EPA’s 1995 guidance 

discussed above. Wisconsin’s 

registration construction permit rule 

provides for public participation at NR 

406.17(1)(b), which states that WDNR 

shall use the applicable procedures in 

Wisconsin Statutes s. 285.61 to issue 

registration construction permits. NR 

407.105(1)(b) states that WDNR shall 

use the applicable procedures in 

Statutes s. 285.62 to issue registration 

operation permits. Both of these statutes 

require that the WDNR distribute a 

notice of the availability of the proposed 

registration permit and of the WDNR’s 

analysis and preliminary determination, 

a notice of the opportunity for public 

comment and a notice of the 

opportunity to request a public hearing. 

Wisconsin’s registration permit rules 

also provides that the WDNR may grant 

or deny a source’s request to be covered 

by a registration permit. Both the 

registration construction and operation 

permit rules, at NR 406.17(1)(b) and NR 

407.105(1)(b), respectively, state that the 

WDNR shall prepare an air quality 

analysis and a preliminary 

determination on the approvability of 

the proposed registration permit. NR 

406.17(2) and NR 407.105(2) establish 

the criteria that the WDNR will use to 

determine if a facility is eligible for 

Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Proposed Rules 55069 

coverage under a registration permit. 

Additionally, NR 406.17(4)(c) and NR 

407.105(4)(c) require that WDNR 

provide notice of its determination that 

the source is covered under the 

registration permit; a description of any 

information that is missing from the 

application for coverage under the 

registration permit; or a notice of its 

determination that the source does not 

qualify for coverage, and the reasons for 

that determination. 

EPA’s 1995 guidance specifies that 

the rule establishing the general permit 

program must require that: ‘‘(1) General 

permits apply to a specific and narrow 

category of sources; (2) sources electing 

coverage under general permits where 

coverage is not mandatory, provide 

notice or reporting to the permitting 

authority; (3) general permits provide 

specific and technically accurate 

(verifiable) limits that restrict the 

potential to emit; (4) general permits 

contain specific compliance 

requirements; (5) limits in general 

permits are established based on 

practicably enforceable averaging times; 

and (6) violations of the permit are 

considered violations of the state and 

federal requirements and result in the 

source being subject to major source 

requirements.’’ For the reasons 

explained previously, EPA will evaluate 

Wisconsin’s registration permit program 

based upon these general permit 

program criteria with respect to 

establishing emissions limits. 

For the first criterion, registration 

permits will be available to types of 

sources that have low actual emissions 

and that meet other criteria. These types 

of sources may elect to limit their 

emissions to specified levels. 

Because coverage under Wisconsin’s 

registration permit program is not 

mandatory, and sources electing to be 

covered by a general permit must 

submit an application to the WDNR 

which the agency must act on, the 

registration permit program complies 

with the second requirement. 

For requirements 3 to 5, regarding 

emission limits, compliance 

requirements, and averaging times, both 

NR 406.17(1)(c) and NR 407.105(1)(c) 

require the registration construction or 

operation permit to contain 

applicability criteria, emission limits, 

monitoring and record keeping 

requirements, reporting requirements, 

compliance demonstration methods and 

general conditions. 

Regarding criterion 6, that violations 

of the permit should be considered 

violations of the applicable requirement, 

both NR 406.17(1)(c) and NR 

407.105(1)(c) state that the permit must 

include terms and conditions required 

to comply with the Act and required to 

assure compliance with applicable 

provisions in Wisconsin’s statutes and 

regulations. In addition, NR 406.10, 

which governs violations of a 

construction permit, states that a source 

that fails to construct and operate a 

stationary source in accordance with 

conditions imposed by the WDNR under 

Wisconsin statutes. 285.65 (which 

requires the establishment of permit 

conditions to ensure compliance with 

Wisconsin regulations and the Act) will 

be considered in violation of Wisconsin 

statutes. 285.60, (which requires the air 

pollution control permit.) Also, NR 

407.09(1)(f), operation permit content, 

requires permits to provide that the 

permittee must comply with all 

conditions of the permit and that any 

noncompliance with the operation 

permit constitutes a violation of the 

statutes and is grounds for enforcement 

action; for permit suspension, 

revocation or revision; or for denial of 

a permit renewal application. Therefore, 

EPA concludes that the portion of the 

Wisconsin’s SIP which deals with 

registration permits complies with the 

1995 guidance. 

With respect to EPA’s 1989 

rulemaking criteria, discussed above, 

EPA has determined that Wisconsin’s 

registration permit program meets these 

criteria as outlined below: 

1. Wisconsin submitted the 

regulations and administrative 

framework for the registration permit 

rule, under NR 400, NR 406, NR 407, 

and NR 410, as a revision to its SIP on 

July 28, 2005. EPA’s approval of this 

section would provide legal support for 

these permit programs and, would 

satisfy the first criterion. 

2. Wisconsin’s rule imposes a legal 

obligation that permit holders adhere to 

the terms and limitations of the permits. 

Existing SIP provision NR 406.10, 

violations of a construction permit, 

states that a source that fails to construct 

and operate a stationary source in 

accordance with conditions imposed by 

the WDNR under Wisconsin statutes. 

285.65, (which requires the 

establishment of permit conditions to 

ensure compliance with Wisconsin 

regulations and the Act), shall be 

considered in violation of Wisconsin 

statutes. 285.60, (which requires the air 

pollution control permit.) Also, existing 

SIP provision NR 407.09(1)(f), operation 

permit content, requires that permits 

provide that the permittee must comply 

with all conditions of the permit, and 

any noncompliance with the operation 

permit constitutes a violation of the 

statutes and is grounds for enforcement 

action; for permit suspension, 

revocation or revision; or for denial of 

a permit renewal application. This 

satisfies the second approval criterion 

which requires that permit holders 

abide by the permit conditions. 

3. The registration permit program 

requires that all emissions, limitations, 

controls, and other requirements 

imposed by permits will be at least as 

stringent as any other applicable 

limitation or requirement contained in 

the SIP or enforceable under the SIP. NR 

406.17(1)(c) and NR 407.105(1)(c) 

require that the registration construction 

and operation permits contain 

applicability criteria, emission caps and 

limitations, monitoring and record 

keeping requirements, reporting 

requirements, compliance 

demonstration methods and general 

conditions; and, that the permit terms 

and conditions shall include those 

required to comply with the Act and 

those required to assure compliance 

with applicable provisions in 

Wisconsin’s rules (ch. 285, Stats., and 

chs. NR 400 to 499.) This provision 

satisfies the third criterion. 

4. This criterion provides that 

limitations, controls, and requirements 

in the permits are permanent, 

quantifiable and otherwise enforceable 

as a practical matter. As discussed 

above, Wisconsin’s registration rule 

requires that a 30-day public comment 

period be held on the proposed 

registration permit, and it specifies that 

the registration permit will contain 

applicability criteria, emission caps and 

limitations, monitoring and record 

keeping requirements, reporting 

requirements, compliance 

demonstration methods and general 

conditions. During the comment period, 

EPA has the opportunity to review the 

permits to ensure that the limitations, 

controls, and requirements in the 

permits are permanent, quantifiable and 

otherwise enforceable as a practical 

matter. Additionally, the registration 

permits do not expire. The registration 

permit program meets the fourth 

criterion for permit program approval. 

5. As discussed previously, 

Wisconsin’s rule requires that the 

registration construction and 

registration operation permits are issued 

subject to public participation under NR 

406.17(1)(b) and NR 407.105(1)(b), 

respectively. EPA has determined that, 

in cases where standardized permits 

have been adopted, EPA and the public 

need not be involved in their 

application to individual sources as 

long as the standard permits themselves 

have been subject to notice and 

opportunity to comment. Specifically, 

EPA’s 1995 guidance states on page 10, 

‘‘since the rule establishing the program 

does not provide the specific standards 

55070 Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Proposed Rules 

to be met by the source, each general 

permit, but not each application under 

each general permit, must be issued 

pursuant to public and EPA notice and 

comment.’’

Sources of HAPs also may be eligible 

for coverage under Wisconsin’s 

registration permit rule. NR 

406.17(2)(a)(1) and NR 407.105(2)(a)(1), 

the criteria for issuance of registration 

construction and operation permits, 

respectively, specify that the actual 

emissions from sources will not exceed 

25% of any major source threshold in 

NR 407.02(4). NR 407.02(4) includes 

sources that emit HAPs listed under 

section 112(b) of the Act. NR 406.17(3) 

and 407.105(3), which describe types of 

sources which are ineligible for 

coverage under registration construction 

and operation permits, does not include 

sources of HAPS. Furthermore, NR 

406.17(3)(d) states that sources 

ineligible for registration construction 

permits include an emission unit or 

units subject to a standard or regulation 

under section 111 or 112 of the Act, 

other than those contained in the 

registration construction permit or those 

determined by WDNR not to preclude 

eligibility for the registration 

construction permit. Therefore, EPA is 

evaluating Wisconsin’s registration 

permit program under section 112(l) of 

the Act for the purposes of creating 

federally enforceable limitations on the 

potential to emit HAPs. 

As discussed above, several EPA 

guidance documents address the 

creation of limitations on the potential 

to emit HAPs, including EPA’s 

November 3, 1993, guidance document, 

‘‘Approaches to Creating Federally 

Enforceable Emissions Limits.’’ This 

guidance states on page 2 that a state 

permit program could be extended to 

create federally enforceable limits for 

emissions of HAPs if the program were 

approved pursuant to section 112(l) of 

the Act. Also, EPA’s 1995 guidance on 

page 4 states that a mechanism available 

to limit potential to emit is a general 

permit program approved into the SIP or 

under Section 112(1). Wisconsin may 

establish a registration permit to cap or 

limit HAP emissions in permits and, 

therefore, is eligible under the 1995 

guidance for evaluation under 40 CFR 

part 63, subpart E, the regulations 

promulgated to implement section 

112(l) of the Act, as a program that the 

state can use to limit a source’s potential 

to emit HAPs. 40 CFR 63.91(a)(5) states 

that ‘‘[t]he Administrator may, under 

the authority of section 112(l) and this 

subpart, also approve a State program 

designed to establish limits on the 

potential to emit hazardous air 

pollutants listed pursuant to section 112 

of the Act.’’

As discussed above, section 112(l) 

allows EPA to approve a state’s permit 

program only if it meets the following 

the statutory criteria for approval under 

section 112(l)(5): (1) It contains 

adequate authority to assure compliance 

with any section 112 standards or 

requirements, (2) it provides for 

adequate resources, (3) it provides for an 

expeditious schedule for assuring 

compliance with section 112 

requirements, and, (4) it is otherwise 

likely to satisfy the objectives of the Act. 

EPA has determined that Wisconsin’s 

registration permit program meets these 

112(l) criteria as outlined below. 

First, Wisconsin’s registration permit 

program contains adequate authority to 

assure compliance with section 112 

standards or requirements. NR 

406.17(1)(c) and NR 407.105(1)(c) both 

state that a registration construction or 

operation permit must contain 

applicability criteria, emission caps and 

limitations, monitoring and record 

keeping requirements, reporting 

requirements, compliance 

demonstration methods and general 

conditions; and that the permit terms 

and conditions shall include those 

required to comply with the Act and 

those required to assure compliance 

with applicable provisions in 

Wisconsin’s regulations. 

Furthermore, Wisconsin Statutes s. 

285 provides the authority for 

Wisconsin to administer and enforce all 

of its permit programs. Section 285.11 

specifies that the WDNR shall: ‘‘(1) 

Promulgate rules implementing and 

consistent with this chapter and statute 

299.15; * * * (18) Adopt and apply 

objective performance measurements, 

for the subunit of the department that 

administers this chapter, relating to the 

issuance of permits under subchapter 

VII and to overall performance of the 

subunit.’’ In addition, section 285.13 

specifies WDNR’s powers, including 

‘‘* * * (2) Issue orders to effectuate the 

purposes of this chapter and statute 

299.15 and enforce the same by all 

appropriate administrative and judicial 

proceedings.’’

For criterion 2, regarding adequate 

resources, NR 410.03(1)(a)(7) provides 

that sources subject to 40 CFR part 70 

must pay fees for coverage under a 

registration construction permit. The 

registration operation permit also 

requires fees to be collected, as 

described in the July 26, 2005, state 

budget. The State anticipates that its 

new fee structure, adopted in this 

budget, will provide sufficient resources 

to administer the registration permit 

program. WDNR has submitted this 

revised fee structure along with a fee 

sufficiency demonstration to EPA for 

review. EPA will monitor the State’s 

implementation of the permit program 

to assure that adequate resources 

continue to be available. 

Regarding the third requirement, 

Wisconsin’s registration permit program 

provides for an expeditious schedule for 

assuring compliance. Nothing in this 

program would allow a source to avoid 

or delay compliance with the Federal 

requirement if it fails to obtain the 

appropriate federally enforceable limit 

by the relevant deadline. 

Fourth, Wisconsin’s registration 

permit program is consistent with the 

objectives of the section 112 program, 

since its purpose is to enable sources to 

obtain federally enforceable limits on 

potential to emit. This also is consistent 

with the intent of the guidance 

documents discussed above. 

Based on the discussion above, EPA 

has determined that Wisconsin’s 

registration permit program is 

approvable under section 112(l). By 

approving Wisconsin’s registration 

permit program, EPA recognizes the 

program as a federally enforceable 

method of limiting a source’s potential 

to emit HAPs. 

C. Evaluation of the Clarification to 

Grain Elevator Exemption 

EPA reviewed Wisconsin’s permit 

exemption with regard to its potential 

emissions and with respect to relevant 

EPA guidance, such as EPA’s November 

14, 1995, memorandum, ‘‘Calculating 

the Potential to Emit (PTE) for Grain 

Handling Facilities.’’ The WDNR 

provided EPA with additional 

documentation regarding its grain 

storage and grain handling facilities 

exemption in a May 31, 2005, internal 

memorandum which contains its PTE 

calculations for these permit 

exemptions. This document 

demonstrates and clarifies the 

following: Only non-part 70 sources are 

eligible for the air operation permit 

exemptions; only non-NSPS sources are 

eligible for the air construction and 

operation permit exemptions; air 

emission calculations for the ‘‘worst 

case’’ facility exempt from operation 

permit requirements demonstrate that 

the Particulate Matter (PM–10) emission 

rate is 29.6 tons per year, which is 

below the 100 tons per year part 70 

major source threshold level; air 

emission calculations for the ‘‘worst 

case’’ facility exempt from construction 

permit requirements demonstrate that 

the PM–10 emission rate is 8.8 tons per 

year; and sources subject to PSD are 

excluded from the construction permit 

exemptions in ch. NR 406, Wis. Adm. 

Federal Register / Vol. 70, No. 181 / Tuesday, September 20, 2005 / Proposed Rules 55071 

Code. Based on this information, EPA is 

proposing to approve these exemptions. 

D. Evaluation of the Changes to 

Definitions, References, and Numbering 

Several definitions were created or 

amended due to the creation of the 

general and registration permit 

programs. In addition, several regulatory 

citations were revised as well as other 

administrative changes related to the 

registration and general permit 

programs. All of the changes, as 

described in Part I, Section D, ‘‘Changes 

to Definitions, References, and 

Numbering’’, are consistent with 

Wisconsin’s statutes and the Act. 

IV. What Action Is EPA Taking Today? 

EPA is proposing to approve revisions 

to Wisconsin SIP rules NR 400, 406, 

407, and 410 submitted by the State on 

July 28, 2005. EPA also is soliciting 

comment on this proposed approval. 

V. Statutory and Executive Order 

Reviews 

Executive Order 12866; Regulatory 

Planning and Review 

Under Executive Order 12866 (58 FR 

51735, October 4, 1993), this proposed 

action is not a ‘‘significant regulatory 

action’’ and therefore is not subject to 

review by the Office of Management and 

Budget. 

Executive Order 13211: Actions That 

Significantly Affect Energy Supply, 

Distribution, or Use 

Because it is not a ‘‘significant 

regulatory action’’ under Executive 

Order 12866 or a ‘‘significant energy 

action,’’ this action also is not subject to 

Executive Order 13211, ‘‘Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355, May 

22, 2001). 

Regulatory Flexibility Act 

This action merely proposes to 

approve state law as meeting Federal 

requirements and imposes no additional 

requirements beyond those imposed by 

state law. Accordingly, the 

Administrator certifies that this 

proposed rule will not have a significant 

economic impact on a substantial 

number of small entities under the 

Regulatory Flexibility Act (5 U.S.C. 601 

et seq.). 

Unfunded Mandates Reform Act 

Because this action proposes to 

approve pre-existing requirements 

under state law and does not impose 

any additional enforceable duty beyond 

that required by state law, it does not 

contain any unfunded mandate or 

significantly or uniquely affect small 

governments, as described in the 

Unfunded Mandates Reform Act of 1995 

(Pub. L. 104–4). 

Executive Order 13175 Consultation 

and Coordination With Indian Tribal 

Governments 

This proposed action does not have 

tribal implications because it will not 

have a substantial direct effect on one or 

more Indian tribes, 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, 

as specified by Executive Order 13175 

(65 FR 67249, November 9, 2000). 

Executive Order 13132 Federalism 

This proposed action does not have 

Federalism implications because it does 

not have substantial direct effects on the 

states, on the relationship between the 

national government and the states, or 

on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132 (64 FR 43255, 

August 10, 1999). This action merely 

proposes to approve a state rule 

implementing a federal standard, and 

does not alter the relationship or the 

distribution of power and 

responsibilities established in the Act. 

Executive Order 13045 Protection of 

Children From Environmental Health 

and Safety Risks 

This proposed approval is not subject 

to Executive Order 13045 ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997), because it is not a 

significant regulatory action under 

executive order 12866. 

National Technology Transfer 

Advancement Act 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (NTTA), 15 U.S.C. 272, 

requires federal agencies to use 

technical standards that are developed 

or adopted by voluntary consensus to 

carry out policy objectives, so long as 

such standards are not inconsistent with 

applicable law or otherwise 

impracticable. In reviewing program 

submissions, EPA’s role is to approve 

state choices, provided that they meet 

the criteria of the Act. Absent a prior 

existing requirement for the state to use 

voluntary consensus standards, EPA has 

no authority to disapprove a program 

submission for failure to use such 

standards, and it would thus be 

inconsistent with applicable law for 

EPA to use voluntary consensus 

standards in place of a program 

submission that otherwise satisfies the 

provisions of the Act. Therefore, the 

requirements of section 12(d) of the 

NTTA do not apply. 

Civil Justice Reform 

As required by section 3 of Executive 

Order 12988 (61 FR 4729, February 7, 

1996), in issuing this rule, EPA has 

taken the necessary steps to eliminate 

drafting errors and ambiguity, minimize 

potential litigation, and provide a clear 

legal standard for affected conduct. 

Governmental Interference With 

Constitutionally Protected Property 

Rights 

EPA has complied with Executive 

Order 12630 (53 FR 8859, March 15, 

1988) by examining the takings 

implications of the rule in accordance 

with the ‘‘Attorney General’s 

Supplemental Guidelines for the 

Evaluation of Risk and Avoidance of 

Unanticipated Takings’’ issued under 

the executive order, and has determined 

that the rule’s requirements do not 

constitute a taking. 

Paperwork Reduction Act 

This proposed action does not impose 

an information collection burden under 

the provisions of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Carbon monoxide, 

Intergovernmental relations, Lead, 

Nitrogen dioxide, Ozone, Particulate 

matter, Reporting and recordkeeping 

requirements, Sulfur oxides, Volatile 

organic compounds. 

Dated: September 12, 2005. 

Bharat Mathur, 

Acting Regional Administrator, Region 5. 

[FR Doc. 05–18722 Filed 9–19–05; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 67 

[Docket No. FEMA–D–7638] 

Proposed Flood Elevation 

Determinations 

AGENCY: Federal Emergency 

Management Agency (FEMA), 

Emergency Preparedness and Response 

Directorate, Department of Homeland 

Security.