19542 Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Rules and Regulations

a ‘‘significant rule’’ under DOT

Regulatory Policies and Procedures (44

FR 11034; February 26, 1979); and (3)

does not warrant preparation of a

Regulatory Evaluation as the anticipated

impact is so minimal. Since this is a

routine matter that will only affect air

traffic procedures and air navigation, it

is certified that this rule will not have

a significant economic impact on a

substantial number of small entities

under the criteria of the Regulatory

Flexibility Act.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference,

Navigation (air).

Adoption of the Amendment

In consideration of the foregoing, the

Federal Aviation Administration

amends 14 CFR part 71 as follows:

PART 71—[AMENDED]

1. The authority citation for part 71

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113,

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389; 14 CFR 11.69.

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of the Federal Aviation

Administration Order 7400.9C, Airspace

Designations and Reporting Points,

dated August 17, 1995, and effective

September 16, 1995, is amended as

follows:

Paragraph 6005 Class E airspace areas

extending upward from 700 feet or more

above the surface of the earth.

* * * * *

AGL MN E5 Bigforks, MN [New]

(Lat. 47°46′45′′ N, long. 93°39′01′′ W)

That airspace extending upward from 700

feet above the surface within a 7-mile radius

of the Bigfork Municipal Airport.

* * * * *

Issued in Des Plains, Illinois on April 17,

1996.

Maureen Woods,

Acting Manager, Air Traffic Division.

[FR Doc. 96–10972 Filed 5–1–96; 8:45 am]

BILLING CODE 4910–13–M

14 CFR Part 71

[Airspace Docket No. 96–AWP–7]

Amendment of Class E Airspace;

Jackson, CA

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Final rule.

SUMMARY: This action amends the Class

E airspace area at Jackson, CA. The

development of a Global Positioning

System (GPS) Standard Instrument

Approach Procedure (SIAP) to Runway

(RWY) 1 has made this action necessary.

The intended effect of this action is to

provide adequate controlled airspace for

Instrument Flight Rules (IFR) operations

at Westover Field Amador County,

Jackson, CA.

EFFECTIVE DATE: 0901 UTC August 15,

1996.

FOR FURTHER INFORMATION CONTACT:

William Buck, Airspace Specialist,

System Management Branch, AWP–530,

Air Traffic Division, Western-Pacific

Region, Federal Aviation

Administration, 15000 Aviation

Boulevard, Lawndale, California 90261,

telephone (310) 725–6556.

SUPPLEMENTARY INFORMATION:

History

On March 11, 1996, the FAA

proposed to amend part 71 of the

Federal Aviation Regulations (14 CFR

part 71) by amending the Class E

airspace area at Jackson, CA (61 FR

9657). This action will provide adequate

controlled airspace for Instrument Flight

Rules (IFR) operations at Westover Field

Amador County, Jackson, CA.

Interested parties were invited to

participate in this rulemaking

proceedings by submitting written

comments on the proposal to the FAA.

No comments to the proposal were

received. Class E airspace designations

are published in paragraph 6005 of FAA

Order 7400.9C dated August 17, 1995,

and effective September 16, 1995, which

is incorporated by reference in 14 CFR

71.1. The Class E airspace designations

listed in this document will be

published subsequently in this Order.

The Rule

This amendment to part 71 of the

Federal Aviation Regulations (14 CFR

part 71) amends the Class E airspace

area at Jackson, CA. The development of

a GPS SIAP at Westover Field Amador

County has made this action necessary.

The intended effect of this action is to

provide adequate Class E airspace for

aircraft executing the GPS RWY 1 SIAP

at Westover Field Amador County,

Jackson, CA.

The FAA has determined that this

regulation only involves an established

body of technical regulations for which

frequent and routine amendments are

necessary to keep them operationally

current. Therefore, this regulation—(1)

is not a ‘‘significant regulatory action’’

under Executive Order 12866; (2) is not

a ‘‘significant rule’’ under DOT

Regulatory Policies and Procedures (44

FR 10034; February 26, 1979); and (3)

does not warrant preparation of a

Regulatory Evaluation as the anticipated

impact is so minimal. Since this is a

routine matter that will only affect air

traffic procedures and air navigation, it

is certified that this rule would not have

a significant economic impact on a

substantial number of small entities

under the criteria of the Regulatory

Flexibility Act.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference,

Navigation (air).

Adoption of the Amendment

In consideration of the foregoing, the

Federal Aviation Administration

amends 14 CFR part 71 a follows:

PART 71—[AMENDED]

1. The authority citation for 14 CFR

part 71 continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113,

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389; 14 CFR 11.69.

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of the Federal Aviation

Administration Order 7400.9C, Airspace

Designations and Reporting Points,

dated August 17, 1995, and effective

September 16, 1995, is amended as

follows:

Paragraph 6005 Class E airspace areas

extending upward from 700 feet or more

above the surface of the earth.

* * * * *

AWP CA E5 Jackson, CA [Revised]

Jackson, Westover Field Amador County, CA

(Lat. 38°22′36′′ N, long. 120°47′38′′ W)

That airspace extending upward from 700

feet above the surface within a 6.3-mile

radius of Westover Field Amador County.

* * * * *

Issued in Los Angeles, California, on April

18, 1996.

Harvey R. Riebel,

Acting Manager, Air Traffic Division,

Western-Pacific Region.

[FR Doc. 96–10971 Filed 5–1–96; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 500, 582, and 589

[Docket No. 94G–0239]

GRAS Status of Propylene Glycol;

Exclusion of Use in Cat Food

AGENCY: Food and Drug Administration,

HHS.
Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Rules and Regulations 19543

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to exclude from

generally recognized as safe (GRAS)

status the use of propylene glycol (PG)

in or on cat food. This final action is

based on FDA’s review of currently

available information which has raised

significant questions about the safety of

this use. Semimoist pet foods containing

PG were not in existence when the

GRAS status of PG for use in animal

feeds was established, thus the agency’s

prior GRAS determination does not

apply to the newly intended uses of PG.

EFFECTIVE DATE: June 3, 1996.

FOR FURTHER INFORMATION CONTACT:

David A. Dzanis, Center for Veterinary

Medicine (HFV–222), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0169.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of May 10,

1995 (60 FR 24808), FDA issued a

proposed rule to amend the animal drug

regulations to exclude from GRAS status

the use of PG in or on cat food. In the

proposed rule of May 10, 1995, the

regulatory history of PG was reviewed

as well as the last 13 years of scientific

literature on the safety of PG in cat food.

FDA concluded that there are significant

questions about the safety of PG in cat

food. FDA also concluded that PG is not

GRAS as an ingredient of cat food, and

the use is not subject to a prior sanction.

When used in or on cat food, PG is

deemed to be a food additive, subject to

section 409 of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

348), and its use in cat food must be in

accordance with a published food

additive regulation. Comments by the

public on the proposed rule were

requested to be submitted by July 24,

1995.

II. Comments on the Proposed Rule

In response to publication of the

proposed rule to amend the GRAS status

of PG to exclude its use in cat foods,

three parties submitted comments: Two

manufacturers of PG, and one pet food

industry association. One party offered

unconditional support of the proposed

rule. The other two parties offered

comments to amend the proposed rule

to allow for limited use of PG.

1. One comment argued for the need

for PG as a carrier for antioxidants

added to cat food. Antioxidants are

needed to prevent oxidation of

unsaturated fats and other components

of cat foods, which could adversely

affect nutritional and organoleptic

properties of the products. The amount

of PG in the finished food stemming

from such use was estimated to be

0.0009 to 0.007 percent (9 to 70

milligrams per kilogram (mg/kg).

FDA agrees that the judicious use of

antioxidants serves a vital role in

preserving the freshness and quality of

cat foods. FDA has previously reviewed

data relative to the use of PG as an

antioxidant carrier and estimates the

‘‘worst case’’ inclusion level in the

finished food to be less than 0.02

percent (200 mg/kg) on a dry matter

basis. In such cases, PG would no longer

serve any technical or functional effect

in the finished food and would be

present at insignificant levels.

Regardless, no argument was made that

PG was unique in its ability to serve as

an antioxidant carrier, or that a suitable

substitute for PG was unavailable or

impractical.

2. Two comments argued that an

establishment of an adequate safety

margin below the known ‘‘no-observedeffect-level’’ (NOEL) for cats and kittens

should allow for limited use of PG. The

most conservative known NOEL for

growing kittens is 0.135 percent (1,350

mg/kg), well below the expected levels

of inclusion resulting from its use as an

antioxidant carrier. Thus, establishment

of an acceptable daily intake level at

some level below the NOEL should

allow for safe use of PG in cat foods.

FDA agrees that the estimated level of

PG in cat foods resulting from its use as

an antioxidant carrier appears to offer

an adequate margin of safety relative to

the known NOEL. Thus, FDA’s primary

regulatory concern at this time is

limited to cat foods containing PG at

levels exceeding 0.02 percent. However,

FDA does not believe that a specific

level of PG for inclusion in cat food can

be based solely on the existing NOEL.

This is because the NOEL was

determined on the basis of the presence

or absence of Heinz bodies in a study

performed in 1979, and it has not been

subject to reassessment using the more

sensitive methods available today to

evaluate possible adverse effects. The

more current studies using more

specific indicators of red blood cell

damage did not look at effects near the

existing NOEL, nor did they establish an

NOEL in and of themselves. Also,

although data are known on the effects

of PG on adult cats and growing kittens,

there are no data on the potential effects

of PG on other life stages of cats. For

example, the possible congenital effects

stemming from the feeding of PG to

pregnant cats has not been adequately

assessed.

III. Conclusion

The proposed rule has not been

changed as a result of received

comments. Therefore, the final rule

provides that PG for use in cat food is

not GRAS and is a food additive subject

to section 409 of the act.

IV. Environmental Impact

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, between

9 a.m. and 4 p.m., Monday through

Friday.

V. Analysis of Impacts

FDA has examined the impacts of the

final rule under Executive Order 12866

and the Regulatory Flexibility Act (Pub.

L. 96–354). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). The agency

believes that this final rule is consistent

with the regulatory philosophy and

principles identified in the Executive

Order. In addition, this final rule is not

a significant regulatory action as defined

by the Executive Order and so is not

subject to review under the Executive

Order.

This assessment analyzes the

economic effects of this rule to exclude

from GRAS status the use of PG in or on

cat food. PG is used as a humectant,

plasticizer, and microbiological

preservative in semimoist cat food.

Semimoist cat foods containing PG did

not exist when the GRAS status for its

use in animal feeds was established, and

this GRAS determination does not apply

to the newly intended use of PG.

Currently available information on the

effects of PG demonstrates serious

concerns about its safety in cats.

FDA requested that pet food

manufacturers discontinue the use of PG

as an ingredient in semimoist cat foods

in 1992. The majority of manufacturers

in the industry have complied with this

request. Agency experts estimate that
19544 Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Rules and Regulations

PG is currently used in at most 5

percent of semimoist cat foods and at

most 10 percent of cat snacks, which are

similar in texture and content to

semimoist foods. These usage rates

continue to decline.

FDA estimates of 1993 sales of

semimoist cat foods and snacks to U.S.

households are $85 million and $53

million, respectively (Neilsen Marketing

Research data). Those sales representing

semimoist cat foods and cat snacks

which contain PG are approximately

$9,550 million (5 percent of $85 million

plus 10 percent of $53 million). The

effect of this rule would be to replace

these sales with other cat foods and cat

snacks not containing PG. Most of the

industry has already substituted

glycerin for PG in semimoist foods and

snacks. It is likely that the remaining

portion of the industry would make the

substitution of glycerin for PG rather

than surrender their share of the

semimoist cat food and cat snack

market. The cost of this substitution to

the production process is expected to be

small.

Purchases of PG by semimoist cat

food and cat snack manufacturers

represent a very small percentage of

total PG sales, estimated at less than 1

percent. Demand for semimoist cat

foods has declined considerably since

1987. Although demand for cat snacks

continues to grow, its sales are still a

small part of the total pet food industry.

Thus, the effect of this final rule on PG

manufacturers would also be small. The

effects of this final rule on small

businesses would not be substantial.

Although more small sized companies

are involved in manufacturing cat snack

foods than in semimoist foods, their

costs of compliance would not be

significant.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. For the above reasons, the

agency certifies that this rule will not

have a significant economic impact on

a substantial number of small entities.

Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.

VI. Federalism

FDA has analyzed this rule in

accordance with the principles and

criteria set forth in Executive Order

12612 and has determined that this rule

does not warrant the preparation of a

Federalism Assessment.

List of Subjects

21 CFR Part 500

Animal drugs, Animal feeds, Cancer,

Labeling, Polychlorinated biphenyls

(PCB’s).

21 CFR Parts 582 and 589

Animal feeds, Animal foods, Food

additives.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR parts 500,

582, and 589 are amended as follows:

PART 500—GENERAL

1. The authority citation for 21 CFR

part 500 continues to read as follows:

Authority: Secs. 201, 301, 402, 403, 409,

501, 502, 503, 512, 701 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 321, 331,

342, 343, 348, 351, 352, 353, 360b, 371).

2. New § 500.50 is added to subpart B

to read as follows:

§ 500.50 Propylene glycol in or on cat

food.

The Food and Drug Administration

has determined that propylene glycol in

or on cat food is not generally

recognized as safe and is a food additive

subject to section 409 of the Federal

Food, Drug, and Cosmetic Act (the act).

The Food and Drug Administration also

has determined that this use of

propylene glycol is not prior sanctioned.

PART 582—SUBSTANCES

GENERALLY RECOGNIZED AS SAFE

3. The authority citation for 21 CFR

part 582 continues to read as follows:

Authority: Secs. 201, 402, 409, 701 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 342, 348, 371).

4. Section 582.1666 is amended by

revising paragraph (b) to read as follows:

§ 582.1666 Propylene glycol.

* * * * *

(b) Conditions of use. This substance

is generally recognized as safe (except in

cat food) when used in accordance with

good manufacturing or feeding practice.

PART 589—SUBSTANCES

PROHIBITED FROM USE IN ANIMAL

FOOD OR FEED

5. The authority citation for 21 CFR

part 589 continues to read as follows:

Authority: Secs. 201, 402, 409, 701, of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 342, 348, 371).

6. New § 589.1001 is added to subpart

B to read as follows:

§ 589.1001 Propylene glycol in or on cat

food.

The Food and Drug Administration

has determined that propylene glycol in

or on cat food has not been shown by

adequate scientific data to be safe for

use. Use of propylene glycol in or on cat

food causes the feed to be adulterated

and in violation of the Federal Food,

Drug, and Cosmetic Act (the act), in the

absence of a regulation providing for its

safe use as a food additive under section

409 of the act, unless it is subject to an

effective notice of claimed

investigational exemption for a food

additive under § 570.17 of this chapter,

or unless the substance is intended for

use as a new animal drug and is subject

to an approved application under

section 512 of the act or an effective

notice of claimed investigational

exemption for a new animal drug under

part 511 of this chapter.

Dated: April 23, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–10893 Filed 5–1–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 1

[TD 8663]

RIN 1545–AT43

Transfers to Investment Companies

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Final regulations.

SUMMARY: This document contains final

regulations amending regulations under

section 351(e) of the Internal Revenue

Code relating to transfers to investment

companies. The final regulations

concern the treatment of certain

transfers to a controlled corporation.

Generally, the final regulations amend

the regulations to provide when certain

transfers will not cause a diversification

of the transferors’ interests.

EFFEFCITVE DATE: These regulations are

effective May 2, 1996.

FOR FURTHER INFORMATION CONTACT:

Andrew M. Eisenberg, (202) 622–7790

(not a toll-free number).

SUPPLEMENTARY INFORMATION:

1. Background

This document contains final

regulations under section 351. The final

regulations provide for the treatment of