71764 Federal Register / Vol. 69, No. 237 / Friday, December 10, 2004 / Proposed Rules 

within the zone without prior approval 

by the Captain of the Port or his 

designated representatives. Vessels or 

persons desiring to enter or transit the 

areas encompassed by any of the 

security zones may contact the Coast 

Guard Captain of the Port or his 

designated representatives on VHF 

Channel Marine 12 to seek permission 

to enter or transit the zone. If 

permission is granted, all persons and 

vessels must comply with the 

instructions of the COTP or that officer’s 

designated representatives. 

(d) Effective period. This section is 

effective from 6 a.m. on February 2, 

2004, until 11:59 p.m. on February 7, 

2005.

Dated: November 26, 2004. 

David B. Peterman, 

Rear Admiral, U.S. Coast Guard, Commander, 

Seventh Coast Guard District.

[FR Doc. 04–27100 Filed 12–9–04; 8:45 am] 

BILLING CODE 4910–15–P

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[Region 2 Docket No. R02–OAR–2004–NJ–

0004, FRL–7847–1] 

Approval and Promulgation of 

Implementation Plans; New Jersey 

Consumer Product Rule

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve a 

revision to the New Jersey State 

Implementation Plan (SIP) for ozone 

concerning the control of volatile 

organic compounds. The SIP revision 

consists of amendments to Subchapter 

24 ‘‘Prevention of Air Pollution From 

Consumer Products’’ of 7:27 of the New 

Jersey Administrative Codes. This SIP 

revision consists of two control 

measures, consumer products and 

portable fuel containers, needed to meet 

the shortfall emissions reduction 

identified by EPA in New Jersey’s 1-

hour ozone attainment demonstration 

SIP. The intended effect of this action is 

to approve control strategies required by 

the Clean Air Act which will result in 

emission reductions that will help 

achieve attainment of the national 

ambient air quality standard for ozone.

DATES: Comments must be received on 

or before January 10, 2005.

ADDRESSES: Submit your comments, 

identified by Regional Material in 

EDocket (RME) ID Number R02–OAR–

2004–NJ–0004 by one of the following 

methods: 

Federal eRulemaking Portal: http://

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

1. Agency Web site: http://

docket.epa.gov/rmepub/ Regional 

Material in EDocket (RME), EPA’s 

electronic public docket and comment 

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. 

2. E-mail: Werner.Raymond@epa.gov.

3. Fax: (212) 637–3901. 

4. Mail: ‘‘RME ID Number R02–OAR–

2004–NJ–0004’’, Raymond Werner, 

Chief, Air Programs Branch, 

Environmental Protection Agency, 

Region 2 Office, 290 Broadway, 25th 

Floor, New York, New York 10007–

1866. 

5. Hand Delivery or Courier. Deliver 

your comments to: Raymond Werner, 

Chief, Air Programs Branch, 

Environmental Protection Agency, 

Region 2 Office, 290 Broadway, 25th 

Floor, New York, New York 10007–

1866. 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 to 4:30 

excluding Federal holidays. 

A copy of the New Jersey submittal is 

available at the following addresses for 

inspection during normal business 

hours:

Environmental Protection Agency, 

Region 2 Office, Air Programs Branch, 

290 Broadway, 25th Floor, New York, 

New York 10007–1866.

New Jersey Department of 

Environmental Protection, Office of Air 

Quality Management, Bureau of Air 

Quality Planning, 401 East State Street, 

CN418, Trenton, New Jersey 08625.

FOR FURTHER INFORMATION CONTACT: Paul 

R. Truchan, Air Programs Branch, 

Environmental Protection Agency, 290 

Broadway, 25th Floor, New York, New 

York 10007–1866, (212) 637–3711.

SUPPLEMENTARY INFORMATION: 

I. What Is Required by the Clean Air 

Act and How Does It Apply to New 

Jersey? 

Section 182 of the Clean Air Act (Act) 

specifies the required State 

Implementation Plan (SIP) submissions 

and requirements for areas classified as 

nonattainment for ozone and when 

these submissions and requirements are 

to be submitted to EPA by the states. 

The specific requirements vary 

depending upon the severity of the 

ozone problem. The New York-Northern 

New Jersey-Long Island and 

Philadelphia-Trenton nonattainment 

areas are nonattainment areas classified 

as a severe. Under section 182, severe 

ozone nonattainment areas were 

required to submit demonstrations of 

how they would attain the 1-hour ozone 

standard. On December 16, 1999 (64 FR 

70380), EPA proposed approval of New 

Jersey’s 1-hour ozone attainment 

demonstration SIP for the New Jersey 

portion of the New York-Northern New 

Jersey-Long Island nonattainment area 

and the New Jersey portion of the 

Philadelphia-Trenton nonattainment 

area. In that rulemaking, EPA identified 

an emission reduction shortfall 

associated with New Jersey’s 1-hour 

ozone attainment demonstration SIPs, 

and required New Jersey to address the 

shortfalls. In a related matter, the Ozone 

Transport Commission (OTC) developed 

control measures into model rules for a 

number of source categories and 

estimated emission reduction benefits 

from implementing these model rules. 

These model rules were designed for 

use by states in developing their own 

regulations to achieve additional 

emission reductions to close emission 

shortfalls. 

On February 4, 2002 (67 FR 5152), 

EPA approved New Jersey’s 1-hour 

ozone attainment demonstration SIPs. 

This approval included an enforceable 

commitment submitted by New Jersey to 

adopt additional control measures to 

close the shortfalls identified by EPA for 

attainment of the 1-hour ozone 

standard. 

II. What Was Included in New Jersey’s 

Submittal? 

On June 22, 2004, Bradley M. 

Campbell, Commissioner, New Jersey 

Department of Environmental Protection 

(NJDEP), submitted to EPA a revision to 

the SIP which included an adopted 

revision to subchapter 24, ‘‘Prevention 

of Air Pollution From Consumer 

Products,’’ which contained two control 

programs. The two control programs are 

consumer products and portable fuel 

container spillage control. This SIP 

revision will provide volatile organic 

compound (VOC) emission reductions 

to address, in part, the shortfall 

identified by EPA when New Jersey’s 

one-hour ozone attainment 

demonstrations were approved. New 

Jersey used the OTC model rules as 

guidelines to develop its rules.

Federal Register / Vol. 69, No. 237 / Friday, December 10, 2004 / Proposed Rules 71765

III. Was Subchapter 24 Previously 

Aproved by EPA? 

On May 2, 1997 as part of the New 

Jersey SIP EPA previously approved 

subchapter 24 (62 FR 24036) which 

included the innovative product 

exemption as a method of compliance 

and the option of variances. The 

innovative product exemption and 

variance provision was fully discussed 

in the proposed approval (January 21, 

1997, 62 FR 2984). As part of the SIP 

revision, New Jersey commited to 

forwarding all innovative product 

exemptions and variances that the State 

accepts to EPA, Region 2, in order for 

EPA to be able to determine compliance 

with the New Jersey SIP. 

IV. What Are the Requirements for 

‘‘Consumer Products’’ ? 

The revised Subchapter 24 now 

regulates 45 separate consumer product 

categories and applies statewide. It 

requires that, on or after January 1, 

2005, no person shall sell, supply, offer 

for sale, or manufacture consumer 

products which contain VOCs in excess 

of the VOC content limits specified by 

New Jersey for those products. 

Subchapter 24 includes specific 

exemptions, as well as registration and 

product labeling requirements, 

recordkeeping and reporting 

requirements, and test methods and 

procedures. 

Consumer products that are sold in 

New Jersey for shipment and use 

outside of the State of New Jersey are 

exempt from the VOC content limits, 

and administrative and testing 

requirements of Subchapter 24. This 

exemption reflects the intent to regulate 

only the manufacture and distribution 

of consumer products that actually emit 

VOCs into New Jersey’s air and not to 

interfere in the transportation of goods 

that are destined for use outside of the 

State.

In addition, subchapter 24 contains 

provisions for accepting innovative 

products exemptions (IPEs), alternative 

compliance plans (ACPs), and variances 

that have been approved by the 

California Air Resources Board (CARB) 

or other states with adopted consumer 

product regulations based on the Ozone 

Transport Commission (OTC) ‘‘Model 

Rule for Consumer Products’’ dated 

November 29, 2001. 

The Subchapter 24 IPE and ACP 

provisions provide alternatives to 

complying with the VOC content limits 

specified in the Table 1—VOC Content 

Limits For Chemically Formulated 

Consumer Products of Subchapter 24. 

The IPE provisions require a 

manufacturer to demonstrate that due to 

some characteristics of the formulation, 

design, delivery system or other factor, 

VOC emissions resulting from the use of 

the innovative product would be less 

than the emissions resulting from the 

use of a representative product that 

meets the VOC content standard. The 

ACP provisions specify a method for 

averaging the emissions from several 

consumer products manufactured by the 

same company such that the total 

emissions from the products included in 

the plan will have emissions equal to or 

less than the sum of emissions from 

products that actually complied with 

the individual product emission 

limitations. The variance provision 

allows for a temporary exemption based 

on an extraordinary economic hardship 

that is beyond the reasonable control of 

the manufacturer of the regulated 

consumer product. 

The State provisions specify the 

required documentation that must be 

submitted and the conditions under 

which New Jersey will recognize a IPE, 

ACP or variance that was granted by 

CARB or another state with equivalent 

provisions. The IPE, ACP or variance 

can become effective in New Jersey for 

the period of time that the approved 

IPE, ACP or variance remains in effect, 

provided that all the consumer products 

within the IPE, ACP or variance are 

regulated by Subchapter 24. 

Paragraph 24.7(b)(2) of subchapter 24 

provides for alternate test methods for 

consumer products provided that the 

alternate method is at least as accurate, 

precise, and appropriate as the test 

methods included in Subchapter 24 and 

that the alternate test method is first 

approved by both the NJDEP and the 

EPA. 

V. What Are the Requirements for 

‘‘Portable Fuel Containers and Spill 

Proof Spouts’’? 

Subchapter 24 (sections 24.8–24.12) 

also reduces refueling emissions from 

those equipment and engines in the offroad categories that are predominantly 

refueled with portable fuel containers. 

Subchapter 24 applies to any person 

who sells, supplies, offers for sale, or 

manufactures for sale in New Jersey 

portable fuel container(s) or spout(s) or 

both for use in New Jersey. Subchapter 

24 includes exemptions; administrative 

requirements which include date coding 

and labeling; recordkeeping and 

reporting requirements; a manufacturer 

warranty requirement; and test methods 

and procedures. 

Subchapter 24 establishes 

performance standards applicable on or 

after January 1, 2005, which are divided 

into two sections. One standard 

specifically addresses spill-proof 

systems and the other addresses spillproof spouts for use in portable fuel 

containers. Included are performance 

standards for automatic shut off, 

automatic closure, container openings, 

fuel flow rates and fill levels. 

Subchapter 24 also includes a 

permeation rate for spill-proof systems 

only.

Portable fuel containers or spouts or 

both portable fuel containers and spouts 

manufactured before January 1, 2005 

may continue to be sold until January 1, 

2006 provided the date of manufacture 

or a date-code representing the date of 

manufacture is clearly displayed on the 

product. 

Subchapter 24 also establishes IPE 

provisions which allow for alternatives 

to complying with the performance 

standards specified in subchapter 24 

and a variance provision for situations 

where there is extraordinary economic 

hardships. Also as in the case for 

consumer products, the portable fuel 

container provisions provide for 

accepting IPE or variances that have 

been granted by CARB or another state 

with equivalent provisions. The IPE or 

variance can become effective in New 

Jersey for the period of time that the 

approved IPE or variance remains in 

effect in the state which originally 

granted the IPE or variance. 

Paragraph 24.11(c) of subchapter 24 

provides for alternate test methods for 

portable fuel containers provided that 

the alternate method is at least as 

accurate, precise, and appropriate as the 

test methods included in subchapter 24 

and that the alternate test method is first 

approved by both the NJDEP and the 

EPA. 

VI. What Is EPA’s Conclusion? 

EPA has evaluated New Jersey’s 

submittal for consistency with the Act, 

EPA regulations, and EPA policy. EPA 

has determined that the revisions made 

to subchapter 24 ‘‘Prevention of Air 

Pollution From Consumer Products’’ of 

title 7, Chapter 27 of the New Jersey 

Administrative Codes, meet the SIP 

revision requirements of the Act with 

the following exception. While the 

provisions related to variances, IPE and 

ACP pursuant to subchapter 24, 

‘‘Consumer Products’’ are acceptable, 

each specific application of those 

provisions will not be recognized as 

meeting Federal requirements until it is 

approved by EPA as a SIP revision. 

Therefore, EPA is proposing to approve 

the regulation as part of the New Jersey 

SIP with the exception that any specific 

application of provisions associated 

with variances, IPE and ACP, must be 

submitted as SIP revisions. 

71766 Federal Register / Vol. 69, No. 237 / Friday, December 10, 2004 / Proposed Rules 

VII. Statutory and Executive Order 

Reviews 

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. For this reason, this action is 

also not subject to Executive Order 

13211, ‘‘Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

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

22, 2001). This proposed 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.). Because this rule 

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).

This proposed rule also 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). This 

action also does not have Federalism 

implications because it does not have 

substantial direct effects on the states, 

on the relationship between the national 

government and the states, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132 (64 FR 43255, 

August 10, 1999). This action merely 

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. 

This proposed rule also is not subject to 

Executive Order 13045 ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997), because it is not 

economically significant. 

In reviewing SIP submissions, EPA’s 

role is to approve state choices, 

provided that they meet the criteria of 

the Act. In this context, in the absence 

of a prior existing requirement for the 

state to use voluntary consensus 

standards (VCS), EPA has no authority 

to disapprove a SIP submission for 

failure to use VCS. It would thus be 

inconsistent with applicable law for 

EPA, when it reviews a SIP submission, 

to use VCS in place of a SIP submission 

that otherwise satisfies the provisions of 

the Act. Thus, the requirements of 

section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) do not 

apply. This proposed rule does not 

impose an information collection 

burden under the provisions of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.).

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Intergovernmental 

relations, Ozone, Reporting and 

recordkeeping requirements, Volatile 

organic compounds.

Authority: 42 U.S.C. 7401—7671q.

Dated: November 30, 2004. 

George Pavlou, 

Acting Regional Administrator, Region 2.

[FR Doc. 04–27170 Filed 12–9–04; 8:45 am] 

BILLING CODE 6560–50–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of Inspector General 

42 CFR Part 1001 

Solicitation of New Safe Harbors and 

Special Fraud Alerts

AGENCY: Office of Inspector General 

(OIG), HHS.

ACTION: Notice of intent to develop 

regulations. 

SUMMARY: In accordance with section 

205 of the Health Insurance Portability 

and Accountability Act (HIPAA) of 

1996, this annual notice solicits 

proposals and recommendations for 

developing new and modifying existing 

safe harbor provisions under the Federal 

and State health care programs’ antikickback statute (section 1128B(b) of the 

Social Security Act), as well as 

developing new OIG Special Fraud 

Alerts.

DATES: To assure consideration, public 

comments must be delivered to the 

address provided below by no later than 

5 p.m. on February 8, 2005.

ADDRESSES: Please mail or deliver your 

written comments to the following 

address: Office of Inspector General, 

Department of Health and Human 

Services, Attention: OIG–91–N, Room 

5246, Cohen Building, 330 

Independence Avenue, SW., 

Washington, DC 20201. 

We do not accept comments by 

facsimile (FAX) transmission. In 

commenting, please refer to file code 

OIG–91–N. Comments received timely 

will be available for public inspection as 

they are received, generally beginning 

approximately three weeks after 

publication of a document, in Room 

5541 of the Office of Inspector General 

at 330 Independence Avenue, SW., 

Washington, DC, on Monday through 

Friday of each week from 8 a.m. to 4:30 

p.m.

FOR FURTHER INFORMATION CONTACT: Joel 

Schaer, (202) 619–0089, OIG 

Regulations Officer.

SUPPLEMENTARY INFORMATION: 

I. Background 

A. The OIG Safe Harbor Provisions 

Section 1128B(b) of the Social 

Security Act (the Act) (42 U.S.C. 1320a–

7b(b)) provides criminal penalties for 

individuals or entities that knowingly 

and willfully offer, pay, solicit or 

receive remuneration in order to induce 

or reward business reimbursable under 

the Federal health care programs. The 

offense is classified as a felony and is 

punishable by fines of up to $25,000 

and imprisonment for up to 5 years. The 

OIG may also impose civil money 

penalties, in accordance with section 

1128A(a)(7) of the Act (42 U.S.C. 1320a–

7a(a)(7)), or exclusion from the Federal 

health care programs, in accordance 

with section 1128(b)(7) of the Act (42 

U.S.C. 1320a–7(b)(7)).

Since the statute on its face is so 

broad, concern has been expressed for 

many years that some relatively 

innocuous commercial arrangements 

may be subject to criminal prosecution 

or administrative sanction. In response 

to the above concern, the Medicare and 

Medicaid Patient and Program 

Protection Act of 1987, section 14 of 

Public Law 100–93, specifically 

required the development and 

promulgation of regulations, the socalled ‘‘safe harbor’’ provisions, 

specifying various payment and 

business practices which, although 

potentially capable of inducing referrals 

of business reimbursable under the 

Federal health care programs, would not 

be treated as criminal offenses under the 

anti-kickback statute and would not 

serve as a basis for administrative 

sanctions. The OIG safe harbor 

provisions have been developed ‘‘to 

limit the reach of the statute somewhat 

by permitting certain non-abusive 

arrangements, while encouraging 

beneficial and innocuous arrangements’’