3384 Federal Register / Vol. 65, No. 14 / Friday, January 21, 2000 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 98F–0569]

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 ethylene-norbornene

copolymers as articles or components of

articles in contact with dry food. This

action responds to a petition filed by

Ticona.

DATES: This regulation is effective

January 21, 2000. Submit written

objections and requests for a hearing by

February 22, 2000.

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:

Julius Smith, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3091.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

July 23, 1998 (63 FR 39583), FDA

announced that a food additive petition

(FAP 8B4597) had been filed by Ticona,

c/o Keller and Heckman, 1001 G St.

NW., suite 500 West, Washington, DC

20001. The petition proposed to amend

the food additive regulations in

§ 177.1520 Olefin polymers (21 CFR

177.1520) to provide for the safe use of

ethylene-norbornene copolymers as

articles or components of articles in

contact with dry foods.

In its evaluation of the safety of this

additive, FDA has reviewed the safety of

the additive itself and the chemical

impurities that may be present in the

additive resulting from its

manufacturing process. Although the

additive itself has not been shown to

cause cancer, it has been found to

contain residual amounts of benzene, a

carcinogenic impurity resulting from the

manufacture of the additive. Residual

amounts of reactants and manufacturing

aids, such as benzene, are commonly

found as contaminants in chemical

products, including food additives.

I. Determination of Safety

Under the general safety standard of

the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 348(c)(3)(A)), a

food additive cannot be approved for a

particular use unless a fair evaluation of

the data available to FDA establishes

that the additive is safe for that use.

FDA’s food additive regulations (21 CFR

170.3(i)) define safe as ‘‘a reasonable

certainty in the minds of competent

scientists that the substance is not

harmful under the intended conditions

of use.’’

The food additives anticancer, or

Delaney, clause of the act (21 U.S.C. 348

(c)(3)(A)) provides that no food additive

shall be deemed safe if it is found to

induce cancer when ingested by man or

animal. Importantly, however, the

Delaney clause applies to the additive

itself and not to impurities in the

additive. That is, where an additive

itself has not been shown to cause

cancer, but contains a carcinogenic

impurity, the additive is properly

evaluated under the general safety

standard using risk assessment

procedures to determine whether there

is a reasonable certainty that no harm

will result from the intended use of the

additive (Scott v. FDA, 728 F.2d 322

(6th Cir. 1984)).

II. Safety of the Petitioned Use of the

Additive

FDA estimates that the petitioned use

of the additive, ethylene-norbornene

copolymers, will result in exposure to

no greater than 2.5 parts per billion of

the additive in the daily diet (3

kilograms (kg)) or an estimated daily

intake of 7.5 micrograms per person per

day (Refs. 1 and 2).

FDA does not ordinarily consider

chronic toxicological studies to be

necessary to determine the safety of an

additive whose use will result in such

low exposure levels (Ref. 3), and the

agency has not required such testing

here. However, the agency has reviewed

the available toxicological data on the

additive and concludes that the

estimated small dietary exposure

resulting from the petitioned use of this

additive is safe.

FDA has evaluated the safety of this

additive under the general safety

standard, considering all available data

and using risk assessment procedures to

estimate the upper-bound limit of

lifetime human risk presented by

benzene, the carcinogenic chemical that

may be present as an impurity in the

additive. The risk evaluation of benzene

has two aspects: (1) Assessment of

exposure to the impurity from the

petitioned use of the additive, and (2)

extrapolation of the risk observed in the

animal bioassay to the conditions of

probable exposure to humans.

A. Benzene

FDA has estimated the exposure to

benzene from the petitioned use of the

additive to be no more than 15 parts per

trillion in the daily diet (3 kg) or 50

nanograms/person/day (ng/p/d) (Ref. 1).

The agency used data from a

carcinogenesis bioassay of benzene

using B6C3F1 hybrid mice (Ref. 4),

sponsored by the National Toxicology

Program, to estimate the upper-bound

limit of lifetime human risk from

exposure to this chemical resulting from

the petitioned use of the additive. The

authors reported that there were

significantly increased incidences of

mice with neoplasms at several organ

sites associated with the administration

of benzene by the oral route.

Based on the agency’s estimate that

exposure to benzene will not exceed 50

ng/p/d, FDA estimates that the upperbound limit of lifetime human risk from

the petitioned use of the subject

additive is 3.6 × 10¥8, or 3.6 in 100

million (Refs. 1 and 5). Because of the

numerous conservative assumptions

used in calculating the exposure

estimate, the actual lifetime-averaged

individual exposure to benzene is likely

to be substantially less than the

estimated exposure, and therefore, the

probable lifetime human risk would be

less than the upper-bound limit of

lifetime human risk. Thus, the agency

concludes that there is reasonable

certainty that no harm from exposure to

benzene would result from the

petitioned use of the additive.

B. Need for Specifications

The agency also has considered

whether specifications are necessary to

control the amount of benzene present

as an impurity in the additive. The

agency finds that specifications are not

necessary for the following reasons: (1)

Because of the low level at which

benzene may be expected to remain as

an impurity following production of the

additive, the agency would not expect

this impurity to become a component of

food at other than extremely low levels;

and (2) the upper-bound limit of

lifetime risk from exposure to benzene

from the petitioned use is very low, 3.6

in 100 million.

III. Conclusion

FDA has evaluated the 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 additive will

achieve its intended technical effect,

Federal Register / Vol. 65, No. 14 / Friday, January 21, 2000 / Rules and Regulations 3385

and therefore, (3) the regulations in

§ 177.1520 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.

IV. Environmental Impact

The agency has carefully considered

the 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.

V. Paperwork Reduction Act of 1995

This final rule contains no collection

of information. Therefore, clearance by

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.

VI. Objections

Any person who will be adversely

affected by this regulation may at any

time on or before February 22, 2000, 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 office above between 9 a.m. and

4 p.m., Monday through Friday.

VII. References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

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

through Friday.

1. Memorandum from the Division of

Product Manufacture and Use, Chemistry

Review Team (HFS–246), to the Division of

Petition Control (HFS–215), entitled ‘‘FAP

8B4597 (MATS# 974, M2.0 & 2.1): Ticona

Submission, Through Their Agent Keller and

Heckman, Dated 5–8–98. EthyleneNorbornene Copolymers for Use in Contact

With Dry Food,’’ February 16, 1999.

2. Memorandum from the Division of

Product Manufacture and Use, Chemistry

Review Team (HFS–246), to the Division of

Petition Control (HFS–215), entitled ‘‘FAP

8B4597 (MATS# 974, M2.2): Ticona

Submission, Through Their Agent Keller and

Heckman, Dated 5–8–98. EthyleneNorbornene Copolymers for Use in Contact

With Dry Food,’’ June 15, 1999.

3. Kokoski, C. J., ‘‘Regulatory Food

Additive Toxicology,’’ Chemical Safety

Regulation and Compliance, edited by F.

Homburger, J. K. Marquis, published by S.

Karger, New York, NY, pp. 24–33, 1985.

4. ‘‘Toxicology And Carcinogenesis Studies

of Benzene (CAS No. 71–43–2) in F344/N

Rats And B6C3F1 Mice (Gavage Studies),’’

National Toxicology Program Technical

Report Series, No. 289, April 1986.

5. Memorandum from the Division of

Petition Control (HFS–215), to Executive

Secretary, Quantitative Risk Assessment

Committee (QRAC) (HFS–308), entitled

‘‘Estimation of the Upper-Bound Lifetime

Risk From Benzene, an Impurity in EthyleneNorbornene Copolymers, the Subject of Food

Additive Petition 8B4597 (Ticona Co.),’’

March 23, 1999.

List of Subjects in 21 CFR Part 177

Food additives, Food packaging.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 177 is

amended as follows:

PART 177—INDIRECT FOOD

ADDITIVES: POLYMERS

1. The authority citation for 21 CFR

part 177 continues to read as follows:

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

2. Section 177.1520 is amended by

adding paragraph (a)(3)(vii), and by

amending paragraph (c) in the table by

adding item 3.9 to read as follows:

§ 177.1520 Olefin polymers.

(a) * * *

(3) * * *

(vii) Ethylene and 2-norbornene (CAS

Reg. No. 26007–43–2) copolymers that

shall contain not less than 30 and not

more than 70 mole percent of polymer

units derived from 2-norbornene.

* * * * *

(c) * * *

Olefin Polymers Density

Melting Point (MP) or softening point (SP) (Degrees

Centigrade)

Maximum extractable fraction (expressed as percent

by weight of the polymer)

in N-hexane at specified

temperatures.

Maximum soluble fraction

(expressed as percent by

weight of polymer) in xylene at specified temperatures

*******

3.9 Olefin copolymers described in paragraph

(a)(3)(vii) of this section

may only be used in contact with dry foods, Type

VIII, as identified in

§ 176.170(c) of this chapter, Table 1.

Not less than 1.0

*******

3386 Federal Register / Vol. 65, No. 14 / Friday, January 21, 2000 / Rules and Regulations

* * * * *

Dated: January 11, 2000.

Margaret M. Dotzel,

Acting Associate for Commissioner for Policy.

[FR Doc. 00–1408 Filed 1–20–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

24 CFR Parts 35, 968, and 1000

[Docket No. FR–3482–C–07]

RIN 2501–AB57

Requirements for Notification,

Evaluation and Reduction of LeadBased Paint Hazards in Housing

Receiving Federal Assistance and

Federally Owned Residential Property

Being Sold; Correction

AGENCY: Office of the Secretary—Office

of Lead Hazard Control, HUD.

ACTION: Correction.

SUMMARY: This document makes several

corrections to HUD’s September 15,

1999 final rule implementing sections

1012 and 1013 of the Residential LeadBased Paint Hazard Reduction Act of

1992. Among other corrections, this

document corrects the numbering of the

sections containing the regulatory

requirements governing lead-based

paint disclosure; corrects the September

15, 1999 final rule to reflect the effective

date of a related rule issued by the

Environmental Protection Agency; and

corrects several typographical errors

contained in the final rule.

DATES: Effective date: September 15,

2000.

FOR FURTHER INFORMATION CONTACT:

Steve Weitz, Special Assistant, Office of

Lead Hazard Control, Department of

Housing and Urban Development, 451

Seventh Street, SW, Room P–3206,

Washington, DC 20410; telephone: (202)

755–1785, ext. 104 (this is not a toll-free

number); E-mail: lead—regulations

hud.gov. For legal questions, contact

John B. Shumway, Office of General

Counsel, Department of Housing and

Urban Development, Room 9262.

Persons with hearing or speech

impediments may access the above

telephone number via TTY by calling

the toll-free Federal Information Relay

Service at 1–800–877–8339.

SUPPLEMENTARY INFORMATION: On

September 15, 1999, HUD published a

final rule (64 FR 50140) that implements

sections 1012 and 1013 of the

Residential Lead-Based Paint Hazard

Reduction Act of 1992 (42 U.S.C. 4851

et seq.). The purpose of the rule is to

ensure that Federally-owned or assisted

housing does not pose lead-based paint

hazards to young children. The majority

of the provisions contained in the final

rule will become effective on September

15, 2000 (one year following the date of

publication). This document makes

several corrections to the September 15,

1999 final rule. The corrections made by

this document are as follows:

A. Correction of Section Numbers for

Lead-Based Paint Disclosure

Requirements (24 CFR part 25, subpart

A)

The September 15, 1999 final rule

redesignated subpart H of 24 CFR part

35 as subpart A. The purpose of this

action was simply to relocate the

regulatory requirements governing leadbased paint disclosure (which had been

promulgated by final rule published on

March 6, 1996 (61 FR 9082)) from

subpart H to subpart A without any

change in text. This was done to allow

the new regulatory requirements

established by the September 15, 1999

final rule to be described uninterrupted

through the remainder of part 35.

However, the September 15, 1999 final

rule also incorrectly revised the section

numbers of the relocated disclosure

provisions. These redesignations may

cause confusion because existing

section references in the lead-based

paint literature may not reflect the

revised section numbers. This document

corrects the section numbers of the

disclosure requirements contained in

part 35, subpart A. The numbering of

these sections is now identical to that

originally published in the March 6,

1996 final rule.

B. Conformance With EPA Regulations

The September 15, 1999 final rule

relies on a nationwide framework of

personnel who are or will be trained

and certified in accordance with

regulations issued by the U.S.

Environmental Protection Agency

(EPA). The EPA program is designed to

ensure the safe and effective

performance of lead-based paint

inspections, risk assessments, and

abatements. When the September 15,

1999 rule was published, the effective

date of the relevant EPA regulations at

40 CFR part 745 was August 30, 1999.

Therefore, the September 15, 1999 final

rule (at § 35.165) specifies that this is

the date after which all lead-based paint

inspections, risk assessments and

abatements must be performed by

persons certified in accordance with 24

CFR part 745.

On August 6, 1999 (64 FR 42851), the

EPA published an amendment that

extends the effective dates for

certification of individuals and firms

and use of work practices standards

from August 30, 1999 to March 1, 2000.

Therefore, HUD must correct the

September 15, 1999 final rule to

conform to the new EPA effective date.

To avoid possible further confusion, this

document provides a citation to the EPA

regulation instead of a specific date.

This reduces the likelihood that HUD

will have to again correct the September

15, 1999 final rule if EPA should have

to again change the effective date.

C. Applicability of Subpart K

This document corrects the § 35.1000,

which describes the purpose and

applicability section of subpart K. This

section erroneously provides that the

subpart K requirements apply to

‘‘residential rehabilitation activities.’’

These activities are covered under

subpart J (entitled ‘‘Rehabilitation’’), not

subpart K. Subpart K establishes the

lead-based paint requirements

acquisition, leasing, support services, or

operation of residential property.

D. NAHASDA Assisted Activities

The September 15, 1999 final rule

revised 24 CFR 1000.40, which

describes the lead-based paint

requirements for housing activities

assisted under the Native American

Housing Assistance and SelfDetermination Act (NAHASDA). In

referring to the subparts of 24 CFR part

35 that are applicable to NAHASDA

assisted activities, the September 15,

1999 revision erroneously referred to

subparts E and G, which do not apply

to NAHASDA activities. The September

15, 1999 revision did not refer to

subpart J, which pertains to

rehabilitation activities, including

NAHASDA rehabilitation assistance.

This document corrects § 1000.40 by

removing the references to subparts E

and G of part 35, and adding a reference

to 24 CFR part 35, subpart J.

E. Corrections of Typographical Errors

This document also corrects the

following typographical errors

contained in the September 15, 1999

final rule.

1. Correction to § 35.930(b)(3). This

document corrects a typographical error

contained in § 35.930(b)(3) of the

September 15, 1999 final rule. At the

end of the second sentence of this

section, an incorrect reference is made

to § 35.1350(b). This document corrects

the reference to read ‘‘§ 35.1350(d).’’

2. Correction to § 35.1200(b)(2)(i).

This document corrects a typographical

error contained in § 35.1200(b)(2)(i) of

the September 15, 1999 final rule.

Specifically, an incorrect reference to