Federal Register / Vol. 63, No. 102 /Thursday, May 28, 1998 /Rules and Regulations 29133

paragraph (b)(4) of this section. It is

within the discretion of the concerned

Fines, Penalties and Forfeitures Officer

to grant or deny such requests.

(g) Commencement of a formal

investigation. A formal investigation of

a violation is considered to be

commenced with regard to the

disclosing party on the date recorded in

writing by the Customs Service as the

date on which facts and circumstances

were discovered or information was

received that caused the Customs

Service to believe that a possibility of a

violation existed. In the event that a

party affirmatively asserts a prior

disclosure (i.e., identified or labeled as

a prior disclosure) and is denied prior

disclosure treatment on the basis that

Customs had commenced a formal

investigation of the disclosed violation,

and Customs initiates a penalty action

against the disclosing party involving

the disclosed violation, a copy of a

‘‘writing’’ evidencing the

commencement of a formal

investigation of the disclosed violation

shall be attached to any required

prepenalty notice issued to the

disclosing party pursuant to 19 U.S.C.

1592 or 19 U.S.C. 1593a.

(h) Scope of the disclosure and

expansion of a formal investigation. A

formal investigation is deemed to have

commenced as to additional violations

not included or specified by the

disclosing party in the party’s original

prior disclosure on the date recorded in

writing by the Customs Service as the

date on which facts and circumstances

were discovered or information was

received that caused the Customs

Service to believe that a possibility of

such additional violations existed.

Additional violations not disclosed or

covered within the scope of the party’s

prior disclosure that are discovered by

Customs as a result of an investigation

and/or verification of the prior

disclosure shall not be entitled to

treatment under the prior disclosure

provisions.

(i) Knowledge of the commencement

of a formal investigation.—(1) A

disclosing party who claims lack of

knowledge of the commencement of a

formal investigation has the burden to

prove that lack of knowledge. A person

shall be presumed to have had

knowledge of the commencement of a

formal investigation of a violation if

before the claimed prior disclosure of

the violation a formal investigation has

been commenced and:

(i) Customs, having reasonable cause

to believe that there has been a violation

of 19 U.S.C. 1592 or 19 U.S.C. 1593a, so

informed the person of the type of or

circumstances of the disclosed

violation; or

(ii) A Customs Special Agent, having

properly identified himself or herself

and the nature of his or her inquiry,

had, either orally or in writing, made an

inquiry of the person concerning the

type of or circumstances of the

disclosed violation; or

(iii) A Customs Special Agent, having

properly identified himself or herself

and the nature of his or her inquiry,

requested specific books and/or records

of the person relating to the disclosed

violation; or

(iv) Customs issues a prepenalty or

penalty notice to the disclosing party

pursuant to 19 U.S.C. 1592 or 19 U.S.C.

1593a relating to the type of or

circumstances of the disclosed

violation; or

(v) The merchandise that is the

subject of the disclosure was seized; or

(vi) In the case of violations involving

merchandise accompanying persons

entering the United States or

commercial merchandise inspected in

connection with entry, the person has

received oral or written notification of

Customs finding of a violation.

(2) The presumption of knowledge

may be rebutted by evidence that,

notwithstanding the foregoing notice,

inquiry or request, the person did not

have knowledge that an investigation

had commenced with respect to the

disclosed information.

PART 178—APPROVAL OF

INFORMATION COLLECTION

REQUIREMENTS

1. The authority citation for part 178

continues to read as follows:

Authority: 5 U.S.C. 301; 19 U.S.C. 1624; 44

U.S.C. 3501 et seq.

2. Section 178.2 is amended by

adding a new listing to the table in

numerical order to read as follows:

§ 178.2 Listing of OMB control numbers.

19 CFR section Description OMB control

No.

* * * * *

§ 162.74 ........................................................................................................................................................ Prior disclosure ......... 1515–0212

* * * * *

Samuel H. Banks,

Acting Commissioner of Customs.

Approved: May 12, 1998.

John P. Simpson,

Deputy Assistant Secretary of the Treasury.

[FR Doc. 98–14154 Filed 5–27–98; 8:45 am]

BILLING CODE 4820–02–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 97F–0283]

Secondary Direct Food Additives

Permitted in Food for Human

Consumption; Monester of alphaHydro-omega-HydroxyPoly(Oxyethylene) Poly(Oxypropylene)

Poly(Oxyethylene) (15 Mole Minimum)

Blocked Copolymer

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

food additive regulations for safe use of

monoester of alpha-hydro-omegahydroxy-poly(oxyethylene)

poly(oxypropylene) poly(oxyethylene)

(15 mole minimum) blocked copolymer

derived from low erucic acid rapeseed

oil as a component of defoaming agents

used in the washing of sugar beets for

processing into sugar. This action

responds to a petition filed by Akzo

Nobel Chemical, Inc.

DATES: The regulation is effective May

28, 1998; written objections and

requests for a hearing by June 29, 1998.
29134 Federal Register / Vol. 63, No. 102 /Thursday, May 28, 1998 /Rules and Regulations

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Vivian M. Gilliam, Center for Food

Safety and Applied Nutrition (HFS–

215), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3167.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

July 11, 1997 (62 FR 37266), FDA

announced that a food additive petition

(FAP 6A4494) had been filed by Akzo

Nobel Chemical, Inc., 5 Livingstone

Ave., Dobbs Ferry, NY 10522–3407. The

petition proposed to amend the food

additive regulations in § 173.340

Defoaming agents (21 CFR 173.340) to

provide for the safe use of monoester of

α-hydro-ω-hydroxy-poly(oxyethylene)

poly(oxypropylene)

poly(oxyethylene)(15 mole minimum)

blocked copolymer derived from low

erucic acid rapeseed (LEAR) oil as a

component of defoaming agents used in

the washing of sugar beets for

processing into sugar. (Although the

additive was named in the filing notice

using the Greek symbols for alpha and

omega, the agency has chosen to spell

out the words in the listing of the

additive to facilitate electronic

searches.)

FDA has evaluated data in the

petition and other relevant material.

Based on this information the agency

concludes that the proposed use of

monoester of alpha-hydro-omegahydroxy-poly(oxyethylene)

poly(oxypropylene) poly(oxyethylene)

(15 mole minimum) blocked copolymer

is safe, that the additive will achieve its

intended technical effect, and therefore,

that the regulations 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.

The agency has previously considered

the potential environmental effects of

this action, as announced in the notice

of filing for FAP 6A4494 (62 FR 37266).

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 a

environmental assessment, may be seen

in the Dockets Management Branch

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

p.m., Monday through Friday. No

comments were received during the 30-

day comment period specified in the

filing notice for comments on the

environmental assessment submitted

with the petition.

Any person who will be adversely

affected by this regulation may at any

time on or before June 29, 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 173

Food additives.

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 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 173.340 is amended by

revising paragraph (a)(4) and in the table

in paragraph (a)(4) by revising the first

heading and by alphabetically adding

the entry for ‘‘monoester of alpha-hydroomega-hydroxy-poly(oxyethylene)

poly(oxypropylene) poly(oxyethylene)

(15 mole minimum) blocked copolymer

derived from low erucic acid rapeseed

oil’’ under the newly revised heading

‘‘Substances’’ to read as follows:

§ 173.340 Defoaming agents.

* * * * *

(a) * * *

(4) The substances listed in this

paragraph (a) (4), provided they are

components of defoaming agents limited

to use in processing beet sugar only, and

subject to the limitations imposed:

Substances Limitations

* * * * * * *

Monoester of alpha-hydro-omega-hydroxy-poly(oxyethylene)

poly(oxypropylene) poly(oxyethylene) (15 mole minimum) blocked

copolymer derived from low erucic acid rapeseed oil.
Federal Register / Vol. 63, No. 102 /Thursday, May 28, 1998 /Rules and Regulations 29135

* * * * *

Dated: May 19, 1998.

L. Robert Lake,

Director, Office of Policy, Planning and

Strategic Initiatives, Center for Food Safety

and Applied Nutrition.

[FR Doc. 98–14105 Filed 5–27–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 96F–0489]

Indirect Food Additives: Polymers

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 5,7-bis(1,1-

dimethylethyl)-3-hydroxy-2(3H)-

benzofuranone, reaction products with

o-xylene, as an antioxidant and/or

stabilizer for olefin polymers intended

for use in contact with food. This action

responds to a petition filed by Ciba

Specialty Chemicals Corp.

DATES: The regulation is effective May

28, 1998. Submit written objections and

request for a hearing by June 29, 1998.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Hortense S. Macon, Center for Food

Safety and Applied Nutrition (HFS–

206), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3086.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

January 2, 1997 (62 FR 100), FDA

announced that a food additive petition

(FAP 7B4529) had been filed by Ciba

Specialty Chemicals Corp., 540 White

Plains Rd., Tarrytown, NY 10591–9005.

The petition proposed to amend the

food additive regulations in § 178.2010

Antioxidants and/or stabilizers for

polymers (21 CFR 178.2010) to provide

for the safe use of 5,7-bis(1,1-

dimethylethyl-3-hydroxy-2(3H)-

benzofuranone, reaction products with

o-xylene as an antioxidant and/or

stabilizer for olefin polymers 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: (1) The proposed use of

the additive is safe, (2) the food additive

will achieve its intended technical

effect, and therefore, (3) the regulations

in § 178.2010 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.

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 June 29, 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.

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 178.2010 is amended in the

table in paragraph (b) by alphabetically

adding an entry to read as follows:

§ 178.2010 Antioxidants and/or stabilizers

for polymers.

* * * * *

(b) * * *