7712 Federal Register / Vol. 60, No. 27 / Thursday, February 9, 1995 / Rules and Regulations

ensure that it would be given effect

without undue delay. In the 1994

DSHEA, Congress, while embracing

most of what FDA has done under the

1990 amendments with respect to

dietary supplements, sought to provide

for the inclusion of additional

information on the nutrition label and to

provide additional flexibility in how

that information is presented. The

dietary supplement industry is left

facing an applicability date for FDA’s

nutrition labeling and nutrient content

claim regulations for dietary

supplements of July 1, 1995, without

complete guidance on how the nutrition

label is ultimately to be presented on

these products. As for consumers, they

are currently provided with nutrition

information on many, but by no means

all, dietary supplements, but that

information is not being presented in a

form that is consistent with the

‘‘Nutrition Facts’’ panel that appears on

conventional foods.

Having considered these factors, FDA

advises that, while the nutrition labeling

and nutrient content claim regulations

implementing the 1990 amendments for

dietary supplements will go into effect

on July 1, 1995, it does not intend to

enforce those regulations until it has

modified them to reflect the 1994

DSHEA, and until after dietary

supplement manufacturers are required

to label their products in accordance

with the 1994 DSHEA; that is, not until

after December 31, 1996.

FDA considers this course of action

appropriate for several reasons. First,

FDA recognizes the merit in the dietary

supplement industry’s argument that it

should not be required to relabel its

products until it has a full

understanding of what its alternatives

and obligations are. Enforcing the

nutrition labeling and nutrient content

claims regulations on July 1, 1995,

would require dietary supplement

manufacturers to choose between

relabeling their products twice, the first

time to come into compliance and the

second to take advantage of the

flexibility provided by the new law, or

foregoing that flexibility. To force

dietary supplement manufacturers to

make such a choice would be a result

that the agency does not believe

Congress contemplated or would have

intended in enacting the 1994 DSHEA.

The 1994 DSHEA provides for

flexibility in the dietary ingredients that

can be included in the ‘‘Nutrition Facts’’

box and in the presentation of

ingredient information. FDA, pursuant

to the 1994 DSHEA, is at work on

regulations that define this flexibility.

FDA agrees that industry should have

an opportunity to take advantage of this

flexibility without being forced to

relabel twice to do so. FDA

acknowledges that it will not be

possible for the agency to have its

regulations in place, nor for the industry

to have adequate time to design its

labeling in accordance with these

regulations, by July of this year. Thus,

the interests of industry and the policies

embodied in the 1994 DSHEA will be

advanced if FDA declines to enforce the

nutrition labeling and nutrient content

claim regulations that apply to dietary

supplements until after December 31,

1996, when they will be fully modified

to reflect the 1994 DSHEA.

While the purposes of the 1990

amendments will not be as clearly

advanced by such a course of action,

they will also not be contravened.

Implementation of the 1994 DSHEA will

move FDA forward toward its goal of

full implementation of the 1990

amendments. Moreover, while Congress

sought to rule out undue delay in

implementation of the 1990

amendments, a delay caused by

implementation of another law enacted

by Congress can hardly be considered

‘‘undue.’’

Finally, it is true that consumers face

an additional delay before dietary

supplements bear nutrition information

that is as consistent as possible, both in

content and presentation, with that on

other foods, and until there is full

compliance by dietary supplements

with the nutrient content claim

provisions of the act. These facts are

mitigated, however, by the fact that

there is information listing nutrients

and their levels on many dietary

supplements, and that many dietary

supplements do not bear nutrient

content claims.

Thus, having fully considered these

factors, the agency advises that it does

not intend to enforce the nutrition

labeling and nutrient content claims

regulations that apply to dietary

supplements until after December 31,

1996. The agency is at work developing

a proposal that implements the labeling

provisions of the 1994 DSHEA and

expects to publish it in the near future.

III. References

The following references have been

placed on display in the Dockets

Management Branch (HFA–305), Food

and Drug Administration, rm. 1–23,

12420 Parklawn Dr., Rockville, MD

20857, and may be seen by interested

persons between 9 a.m. and 4 p.m.,

Monday through Friday.

1. Cordaro, John, President, Council for

Responsible Nutrition, letter to David A.

Kessler, Commissioner, FDA, December 7,

1994.

2. Shank, Fred, R., Director, Center for

Food Safety and Applied Nutrition, FDA,

letter to John B. Cordaro, President, Council

for Responsible Nutrition, January 30, 1995.

Dated: February 6, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–3294 Filed 2–8–95; 8:45 am]

BILLING CODE 4160–01–F

AGENCY FOR INTERNATIONAL

DEVELOPMENT

22 CFR Part 226

Administration of Assistance Awards

to U.S. Non-Governmental

Organizations

AGENCY: Agency for International

Development (USAID).

ACTION: Correction to interim final rule.

SUMMARY: This document contains a

correction to the interim final rule

which was published Thursday, January

19, 1995 (60 FR 3743). The rule relates

to the administration of assistance

awards to U.S. Non-Governmental

Organizations.

EFFECTIVE DATE: February 9, 1995.

FOR FURTHER INFORMATION CONTACT:

Diana Joan Esposito, Office of

Procurement, Procurement Policy and

Evaluation (M/OP/P), USAID, SA–14

Rm. 1600I, 320 21st Street, Washington,

DC 20523. Telephone 703 875–1529,

Fax 703–875–1243.

SUPPLEMENTARY INFORMATION:

Background

On January 19, 1995, USAID issued

an interim final rule at 22 CFR part 226

which implemented Office of

Management and Budget (OMB)

Circular A–110.

Need for Correction

As published, the preamble refers to

a change that was not implemented in

the interim final rule.

Correction of Publication

Accordingly, the publication on

January 19, 1995 of the interim final

rule, is corrected as follows:

Preamble [Corrected]

On page 3744, in the first column, at

the paragraph beginning ‘‘Section

226.22(l) is revised to provide * * *’’ is

corrected to read: ‘‘Section 226.22(l) is

revised to provide that USAID may

authorize recipients to retain all interest

earned in accordance with USAID’s

statutory authority.’’ The statement in

the preamble that interest earned will be

remitted to USAID has been deleted.
Federal Register / Vol. 60, No. 27 / Thursday, February 9, 1995 / Rules and Regulations 7713

With this correction, the preamble and

the rule at 226.22(l) are in agreement.

Dated: January 27, 1995.

Michael D. Sherwin,

Deputy Assistant Administrator for

Management.

[FR Doc. 95–3271 Filed 2–8–95; 8:45 am]

BILLING CODE 6116–01–M

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[TN–118–1–6083a; TN–101–1–5718a; TN–

110–2–6569a; FRL–5146–1]

Approval and Promulgation of

Implementation Plans; Tennessee:

Approval of Revisions to Tennessee

Regulations

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Direct final rule.

SUMMARY: EPA is approving revisions to

the Tennessee State Implementation

Plan (SIP) for ozone. These revisions

were submitted to EPA through the

Tennessee Department of Environment

and Conservation (TDEC) on November

5, 1992, May 18, 1993, and July 6, 1993,

for the Nashville nonattainment area

and revise regulations for Stage I vapor

recovery (Stage I) in the Tennessee SIP

and add regulations pertaining to Stage

II vapor recovery (Stage II). These

revisions regulate gasoline dispensing

stations in Davidson, Rutherford,

Sumner, Williamson, and Wilson

counties. These regulations have been

submitted by the TDEC to satisfy the

requirement of section 182(b)(3) of the

1990 Clean Air Act, which requires all

ozone nonattainment areas classified as

moderate or above to require owners

and operators of gasoline dispensing

facilities to install and operate Stage II

vapor recovery systems. The revisions

also make minor changes to the

Nashville-Davidson County Rules

regulating definitions and

recordkeeping. The TDEC has also

submitted this plan as an integral part

of the program to achieve and maintain

the National Ambient Air Quality

Standards (NAAQS) for ozone. These

regulations meet all of EPA’s

requirements and therefore EPA is

approving this SIP revision.

DATES: This final rule will be effective

April 10, 1995 unless adverse or critical

comments are received by March 13,

1995. If the effective date is delayed,

timely notice will be published in the

Federal Register.

ADDRESSES: Written comments on this

action should be addressed to Alan W.

Powell, at the EPA Regional Office

listed.

Copies of the documents relative to

this action are available for public

inspection during normal business

hours at the following locations. The

interested persons wanting to examine

these documents should make an

appointment with the appropriate office

at least 24 hours before the visiting day.

Air and Radiation Docket and

Information Center (Air Docket 6102),

U.S. Environmental Protection Agency,

401 M Street, SW., Washington, DC

20460.

Region 4 Air Programs Branch,

Environmental Protection Agency345

Courtland Street, NE., Atlanta, Georgia

30365.

Tennessee Department of

Environment and Conservation, L & C

Annex, 9th floor, 401 Church Street,

Nashville, Tennessee 37243.

Nashville-Davidson County Bureau of

Environmental Health Services,

Metropolitan Health Department, 311–

23rd Avenue, North, Nashville,

Tennessee 37203.

FOR FURTHER INFORMATION CONTACT:

Alan W. Powell, Regulatory Planning

and Development Section, Air Programs

Branch, Air, Pesticides & Toxics

Management Division, Region 4

Environmental Protection Agency, 345

Courtland Street, NE., Atlanta, Georgia

30365. The phone number is (404) 347–

3555 ext.4209. Reference file TN–118–

1–6083.

SUPPLEMENTARY INFORMATION: On

November 15, 1990, the President

signed into law the Clean Air Act

Amendments of 1990. The Clean Air

Act as amended in 1990 (CAA) includes

new requirements for the improvement

of air quality in ozone nonattainment

areas. Under section 181(a) of the CAA,

nonattainment areas were categorized

by the severity of the area’s ozone

problem, and progressively more

stringent control measures were

required for each category of higher

ozone concentrations. The basis for

classifying an area in a specific category

was determined by the ambient air

quality data obtained for the three year

period 1987 through 1989. The CAA

delineates in section 182 the SIP

requirements for ozone nonattainment

areas based on their classifications.

Section 182(b)(3) requires areas

classified as moderate to implement

Stage II controls unless and until the

EPA promulgates, On Board Vapor

Recovery (OBVR) regulations pursuant

to section 202(a)(6) of the CAA. On

January 22, 1993, the United States

Court of Appeals for the District of

Columbia ruled that the EPA’s previous

decision not to require OBVR controls

be set aside and that OBVR regulations

be promulgated pursuant to section

202(a)(6) of the CAA. The EPA

Administrator signed the OBVR final

rule on January 24, 1994.

Subsequently, the EPA determined

under section 182(b)(3) that moderate

areas are not required to implement

Stage II regulations. However,

Tennessee has indicated that a Stage II

program is necessary as a volatile

organic compound (VOC) control

measure to attain the ozone NAAQS in

Nashville, which has been classified as

a moderate nonattainment area for

ozone. Stage II vapor recovery is

included in the State’s 15% Plan

required by section 182 (b)(1) of the

CAA. Under section 182 (b)(3), the EPA

was required to issue guidance as to the

effectiveness of Stage II systems. In

November 1991, the EPA issued

technical and enforcement guidance to

meet this requirement. These two

documents are entitled ‘‘Technical

Guidance-Stage II Vapor Recovery

Systems for Control of Vehicle Refueling

Emissions at Gasoline Dispensing

Facilities’’ (EPA–450/3–91–022) and

‘‘Enforcement Guidance for Stage II

Vehicle Refueling Control Programs.’’ In

addition, on April 16, 1992, the EPA

published the ‘‘General Preamble for the

Implementation of Title I of the Clean

Air Act Amendments of 1990’’ (57 FR

13498). The guidance documents and

the General Preamble discuss Stage II

statutory requirements and discuss what

the EPA believes a State submittal needs

to include to meet those requirements.

The Tennessee regulations meet those

requirements which are discussed

below.

General Vapor Recovery Requirements

The CAA specifies the time by which

certain facilities must comply with the

State regulation. For facilities that are

not owned or operated by an

Independent Small Business Marketer

(ISBM), these times, calculated from the

time of State adoption of the regulation,

are: (1) 6 months for facilities for which

construction began after November 15,

1990, (2) 1 year for facilities that

dispense greater than 100,000 gallons of

gasoline per month, and (3) two years

for all other facilities. For ISBM’s,

section 324(a) of the Act provides that

the time periods may be: (1) 33 percent

of the facilities owned by an ISBM by

the end of the first year after the

regulations take effect, (2) 66 percent of

such facilities by the end of the second

year, and (3) 100 percent of such

facilities after the third year. Both the