Federal Register / Vol. 63, No. 138 / Monday, July 20, 1998 /Rules and Regulations 38747

that residues of these compounds would

be removed from the treated produce if

the treatment with chlorine dioxide is

followed by a potable water rinse or by

blanching, cooking or canning.

Therefore, the agency is including in the

regulation the requirement that

treatment of fruits and vegetables with

chlorine dioxide shall be followed by a

potable water rinse or by blanching,

cooking or canning. Based on the

agency’s conclusions concerning this

proposed use, the regulations in 21 CFR

173.300 should be amended as set forth

below.

In accordance with § 171.1(h) (21 CFR

171.1(h)), the petition and the

documents that FDA considered and

relied upon in reaching its decision to

approve the petition are available for

inspection at the Center for Food Safety

and Applied Nutrition by appointment

with the information contact person

listed above. As provided in § 171.1(h),

the agency will delete from the

documents any materials that are not

available for public disclosure before

making the documents available for

inspection.

In the notice of filing, FDA gave

interested parties an opportunity to

submit comments on the petitioner’s

environmental assessment. FDA

received no comments in response to

that notice. 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 (address above)

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

through Friday.

Any person who will be adversely

affected by this regulation may at any

time on or before August 19, 1998, file

with the Dockets Management Branch

(address above) written objections

thereto. Each objection shall be

separately numbered, and each

numbered objection shall specify with

particularity the provisions of the

regulation to which objection is made

and the grounds for the objection. Each

numbered objection on which a hearing

is requested shall specifically so state.

Failure to request a hearing for any

particular objection shall constitute a

waiver of the right to a hearing on that

objection. Each numbered objection for

which a hearing is requested shall

include a detailed description and

analysis of the specific factual

information intended to be presented in

support of the objection in the event

that a hearing is held. Failure to include

such a description and analysis for any

particular objection shall constitute a

waiver of the right to a hearing on the

objection. Three copies of all documents

shall be submitted and shall be

identified with the docket number

found in brackets in the heading of this

document. Any objections received in

response to the regulation may be seen

in the Dockets Management Branch

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

through Friday.

This final rule contains no collections

of information. Therefore, clearance of

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.

List of Subjects in 21 CFR Part 173

Food additives.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 173 is

amended as follows:

PART 173—SECONDARY DIRECT

FOOD ADDITIVES PERMITTED IN

FOOD FOR HUMAN CONSUMPTION

1. The authority citation for 21 CFR

part 173 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348.

2. Section 173.300 is amended by

revising paragraph (b) to read as follows:

§ 173.300 Chlorine dioxide.

* * * * *

(b)(1) The additive may be used as an

antimicrobial agent in water used in

poultry processing in an amount not to

exceed 3 parts per million (ppm)

residual chlorine dioxide as determined

by Method 4500–ClO2 E, referenced in

paragraph (a) of this section, or an

equivalent method.

(2) The additive may be used as an

antimicrobial agent in water used to

wash fruits and vegetables that are not

raw agricultural commodities in an

amount not to exceed 3 ppm residual

chlorine dioxide as determined by

Method 4500–ClO2 E, referenced in

paragraph (a) of this section, or an

equivalent method. Treatment of the

fruits and vegetables with chlorine

dioxide shall be followed by a potable

water rinse or by blanching, cooking, or

canning.

Dated: July 9, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–19314 Filed 7–17–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 97F–0405]

Indirect Food Additives: Adjuvants,

Production Aids, and Sanitizers

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

food additive regulations to provide for

the safe use of aluminum borate as an

antistatic agent and/or antifogging agent

for olefin polymers intended for use as

packaging materials in contact with

food. This action is in response to a

petition filed by Shikoku Chemical

Corp.

DATES: The regulation is effective July

20, 1998; written objections and

requests for a hearing by August 19,

1998.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3081.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

September 25, 1997 (62 FR 50387), FDA

announced that a food additive petition

(FAP 7B4559) had been filed by

Shikoku Chemical Corp., c/o SRS

International Corp., suite 1000, 1625 K

St. NW., Washington, DC 20006–1604.

The petition proposed to amend the

food additive regulations in § 178.3130

Antistatic and/or antifogging agents in

food-packaging materials (21 CFR

178.3130) to provide for the safe use of

aluminum borate as an antistatic and/or

antifogging agent for olefin polymers

complying with 21 CFR 177.1520(c) as

packaging materials intended for use in

contact with food.

FDA has evaluated data in the

petition and other relevant material.

Based on this information, the agency

concludes that the proposed use of the

additive is safe, that the additive will

achieve its intended technical effect,

and therefore, that the regulations in

§ 178.3130 should be amended as set

forth below.

In accordance with § 171.1(h) (21 CFR

171.1(h)), the petition and the
38748 Federal Register / Vol. 63, No. 138 / Monday, July 20, 1998 /Rules and Regulations

documents that FDA considered and

relied upon in reaching its decision to

approve the petition are available for

inspection at the Center for Food Safety

and Applied Nutrition by appointment

with the information contact person

listed above. As provided in § 171.1(h),

the agency will delete from the

documents any materials that are not

available for public disclosure before

making the documents available for

inspection.

The agency has previously considered

the environmental effects of this rule as

announced in the notice of filing for

FAP 7B4559 (62 FR 50387, September

25, 1997). FDA has concluded that the

action is of a type that does not

individually or cumulatively have a

significant effect on the human

environment, and therefore, neither an

environmental assessment nor an

environmental impact statement is

required.

Any person who will be adversely

affected by this regulation may at any

time on or before August 19, 1998, file

with the Dockets Management Branch

(address above) written objections

thereto. Each objection shall be

separately numbered, and each

numbered objection shall specify with

particularity the provisions of the

regulation to which objection is made

and the grounds for the objection. Each

numbered objection on which a hearing

is requested shall specifically so state.

Failure to request a hearing for any

particular objection shall constitute a

waiver of the right to a hearing on that

objection. Each numbered objection for

which a hearing is requested shall

include a detailed description and

analysis of the specific factual

information intended to be presented in

support of the objection in the event

that a hearing is held. Failure to include

such a description and analysis for any

particular objection shall constitute a

waiver of the right to a hearing on the

objection. Three copies of all documents

shall be submitted and shall be

identified with the docket number

found in brackets in the heading of this

document. Any objections received in

response to the regulation may be seen

in the Dockets Management Branch

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

through Friday.

This final rule contains no collections

of information. Therefore, clearance by

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.

List of Subjects in 21 CFR Part 178

Food additives, Food packaging.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Director, Center for Food Safety and

Applied Nutrition, 21 CFR part 178 is

amended as follows:

PART 178—INDIRECT FOOD

ADDITIVES: ADJUVANTS,

PRODUCTION AIDS, AND SANITIZERS

1. The authority citation for 21 CFR

part 178 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348, 379e.

2. Section 178.3130 is amended in the

table in paragraph (b) by alphabetically

adding an entry under the headings

‘‘List of substances’’ and ‘‘Limitations’’

to read as follows:

§ 178.3130 Antistatic and/or antifogging

agents in food-packaging materials.

* * * * *

(b) * * *

ist of substances

List of substances Limitations

* * * * * * *

Aluminum Borate ((9Al2O3)•2(B2O3), CAS Reg. No. 11121–16–7) produced by reaction between aluminum oxide and/or aluminum hydroxide with boric acid and/or metaboric acid at temperatures in excess of

1000 °C

For use only:

1. At levels not to exceed 1 percent by weight of polypropylene films

complying with § 177.1520(c) of this chapter, item 1.1, of polyethylene films complying with § 177.1520(c) of this chapter, items

2.1 and 2.2 and having a density greater than 0.94 gram per cubic

centimeter, and of polyolefin copolymer films complying with

§ 177.1520(c) of this chapter, items 3.1(a), 3.1(b), 3.2(a), and 3.2(b).

The finished polymers may be used in contact with all food types

identified in Table 1 of § 176.170(c) of this chapter, under conditions

of use A through H as described in Table 2 of § 176.170(c) of this

chapter. The thickness of the films shall not exceed 0.005 inch.

2. At levels not to exceed 2 percent by weight of polypropylene films

complying with § 177.1520(c) of this chapter, item 1.1, of polyethylene films complying with § 177.1520(c) of this chapter, items

2.1 and 2.2 and having a density greater than 0.94 gram per cubic

centimeter, and of polyolefin copolymer films complying with

§ 177.1520(c) of this chapter, items 3.1(a), 3.1(b), 3.2(a), and 3.2(b).

The finished polymers may be used in contact with all food types

identified in Table 1 of § 176.170(c) of this chapter under conditions

of use B through H as described in Table 2 of § 176.170(c) of this

chapter. The thickness of the films shall not exceed 0.005 inch.

* * * * * * *
Federal Register / Vol. 63, No. 138 / Monday, July 20, 1998 /Rules and Regulations 38749

Dated: June 24, 1998.

L. Robert Lake,

Director, Office of Policy, Planning and

Strategic Initiatives, Center for Food Safety

and Applied Nutrition.

[FR Doc. 98–19174 Filed 7–17–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 556

Implantation or Injectable Dosage

Form New Animal Drugs; Flunixin

Meglumine

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of a supplemental new animal

drug application (NADA) filed by

Schering-Plough Animal Health Corp.

The supplemental NADA provides for

veterinary prescription use of flunixin

meglumine solution, intravenously, for

control of pyrexia associated with

bovine respiratory disease and

endotoxemia, and control of

inflammation in endotoxemia, in beef

and nonlactating dairy cattle.

EFFECTIVE DATE: July 20, 1998.

FOR FURTHER INFORMATION CONTACT:

Estella Z. Jones, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1643.

SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health Corp., 1095

Morris Ave., P.O. Box 3182, Union, NJ

07083–1982, is sponsor of NADA 101–

479 Banamine (flunixin meglumine)

Injectable Solution that provides for

veterinary prescription use of flunixin

meglumine, intravenously or

intramuscularly, for alleviation of

inflammation and pain associated with

musculoskeletal disorders, and

alleviation of visceral pain associated

with colic in the horse. The sponsor

filed a supplemental NADA that

provides for veterinary prescription use

of flunixin meglumine solution,

intravenously, for control of pyrexia

associated with bovine respiratory

disease and endotoxemia, and control of

inflammation in endotoxemia, in beef

cattle and nonlactating dairy cattle. The

supplemental NADA is approved as of

May 6, 1998, and the regulations are

amended in 21 CFR 522.970 by revising

paragraph (b), by redesignating existing

paragraph (c) as (d), by revising newly

redesignated paragraph (d), and by

adding paragraph (c) to reflect the

approval. The basis for approval is

discussed in the freedom of information

summary.

In addition, a tolerance for residues of

flunixin meglumine in edible tissues of

cattle has not been previously

established. Section 556.286 is added to

provide tolerances for flunixin

meglumine residues in cattle liver

(target tissue) and in cattle muscle.

Also, in addition to codifying a

tolerance for flunixin residues in cattle

tissues, FDA is amending the regulation

to codify the acceptable daily intake

(ADI) for total residues of flunixin. The

ADI is the amount of total drug residue

that can be consumed by humans every

day. Previously, FDA had codified safe

concentrations which represent the ADI

corrected for consumption. The safe

concentrations were confusing because

few individuals understood the

relationship between safe

concentrations, a value representing

total residues, and tolerance, the part of

the drug residue in a given tissue that

is detected by an analytical method. To

eliminate this confusion, FDA is

codifying the ADI.

Under section 512(c)(2)(F)(iii) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b(c)(2)(F)(iii)), this

supplemental approval for beef cattle

and nonlactating dairy cattle qualifies

for 3 years of marketing exclusivity

beginning May 6, 1998, because the

supplemental application contains

substantial evidence of the effectiveness

of the drug involved, any studies of

animal safety or, in the case of foodproducing animals, human food safety

studies (other than bioequivalence or

residue studies) required for approval

and conducted or sponsored by the

applicant. Three years marketing

exclusivity is limited to use of the drug

for the control of pyrexia associated

with bovine respiratory disease and

endotoxemia, and control of

inflammation in endotoxemia, in beef

cattle and nonlactating dairy cattle.

In accordance with the freedom of

information provisions of 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

safety and effectiveness data and

information submitted to support

approval of this application may be seen

in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, between 9

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

Friday.

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

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

List of Subjects

21 CFR Part 522

Animal drugs.

21 CFR Part 556

Animal drugs, Foods.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR parts 522 and 556 are amended as

follows:

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 522 continues to read as follows:

Authority: 21 U.S.C. 360b.

2. Section 522.970 is amended by

revising paragraph (b), by redesignating

paragraph (c) as (d), by revising newly

redesignated paragraph (d), and by

adding paragraph (c) to read as follows:

§ 522.970 Flunixin meglumine solution.

* * * * *

(b) Sponsors. See 000061 in

§ 510.600(c) of this chapter for use as in

paragraph (d) of this section. See 000856

and 059130 for use as in paragraph

(d)(1) of this section only.

(c) Related tolerances. See § 556.286

of this chapter.

(d) Conditions of use—(1) Horses—(i)

Amount. 0.5 milligram of flunixin per

pound of body weight (1 milliliter per

100 pounds) per day.

(ii) Indications for use. For alleviation

of inflammation and pain associated

with musculoskeletal disorders, and

alleviation of visceral pain associated

with colic.

(iii) Limitations. For musculoskeletal

disorders, administer intravenously or

intramuscularly for up to 5 days. For

colic, administer a single dose

intravenously—treatment may be

repeated when signs of colic recur.

Caution: The effect of this drug on

pregnancy has not been determined. Not

for use in horses intended for food.

Federal law restricts this drug to use by

or on the order of a licensed

veterinarian.