Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations 26077

18. Part 804 is amended by revising

the heading to read as set forth above.

19. Section 804.1 is amended by

revising paragraph (a) to read as follows:

§ 804.1 Scope.

(a) FDA is requiring distributors of

cigarettes or smokeless tobacco to report

deaths, serious illnesses, and serious

injuries that are attributed to

contamination of a cigarette or

smokeless tobacco product. Distributors

of cigarettes or smokeless tobacco are

also required to submit a report to FDA

annually certifying the number of

medical device reports filed during the

preceding year, or that no reports were

filed. These reports enable FDA to

protect the public health by helping to

ensure that these products are not

adulterated or misbranded and are

otherwise safe and effective for their

intended use. In addition, distributors of

cigarettes or smokeless tobacco are

required to establish and maintain

complaint files or incident files as

described in § 804.35, and to permit any

authorized FDA employee at all

reasonable times to have access to, and

to copy and verify, the records

contained in this file. This part

supplements, and does not supersede,

other provisions of this subchapter,

including the provisions of part 820 of

this chapter.

* * * * *

20. Section 804.3 is amended by

revising paragraph (d), and in

paragraphs (m)(1) and (m)(2) by adding

the phrase ‘‘related to the contamination

of cigarettes or smokeless tobacco’’ after

the word ‘‘event’’ to read as follows:

§ 804.3 Definitions.

* * * * *

(d) Distributor means, for the purpose

of this part, any person who furthers the

distribution of cigarettes or smokeless

tobacco, whether domestic or imported,

at any point from the original place of

manufacture to the person who sells or

distributes the product to individuals

for personal consumption, but who does

not repackage or otherwise change the

container, wrapper, or labeling of the

product package. Common carriers are

not considered distributors for the

purposes of this part.

* * * * *

§ 804.25 [Amended]

21. Section 804.25 Reports by

distributors is amended in paragraph

(a)(1) by removing the words ‘‘a device’’

and adding in their place the phrase

‘‘contamination of a cigarette or

smokeless tobacco product’’; in

paragraph (a)(2) by removing the phrase

‘‘one of its marketed devices’’ and

adding in its place the phrase

‘‘contamination of one of its cigarette or

smokeless tobacco products’’; and by

removing paragraph (c).

Dated: May 1, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–12614 Filed 5–11–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1240

[Docket No. 97P–0418]

Revocation of Lather Brushes

Regulation

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is revoking its

regulation pertaining to the treatment,

sterilization, handling, storage, marking,

and inspection of lather brushes. FDA is

revoking this regulation because the

regulation is no longer necessary to

protect the public health.

FOR FURTHER INFORMATION CONTACT:

Philip L. Chao, Policy Development and

Coordination Staff (HF–23), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

3380.

DATES: This final rule is effective June

11, 1998.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of October 20,

1997 (62 FR 54398), FDA proposed to

revoke a regulation pertaining to the

treatment, sterilization, handling,

storage, marking, and inspection of

lather brushes. The preamble to the

proposal explained that the lather brush

regulation was originally published in

1949 by the Federal Security Agency

and was intended to prevent cases of

cutaneous anthrax through lather

brushes made from animal hair or

bristles. A Government reorganization

transferred the Federal Security

Agency’s functions to the thenDepartment of Health, Education, and

Welfare (now known as the Department

of Health and Human Services), and

responsibility for the rule was later

assigned, in 1975, to FDA. The rule was

codified at § 1240.70 (21 CFR 1240.70).

FDA proposed to revoke the

regulation because it was unaware of

any reliance on the lather brush

requirements or of any current concerns

associated with lather brushes and

because the regulation was no longer

necessary to protect the public health.

The proposal also noted that the thenCenter for Disease Control (now the

Centers for Disease Control and

Prevention) revoked a similar lather

brush regulation in 1985 on the grounds

that no case of cutaneous anthrax in the

United States had been associated with

lather brushes since 1930.

FDA received no comments on the

proposal. Consequently, this final rule

revokes § 1240.70.

II. Analysis of Impacts

FDA has examined the impacts of the

final rule under Executive Order 12866

and the Regulatory Flexibility Act (5

U.S.C. 601–612). 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, the 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.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. Because the final rule

eliminates certain manufacturing

requirements for lather brushes, the

agency certifies that the final 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.

III. Environmental Impact

The agency has determined under 21

CFR 25.30(h) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

IV. Paperwork Reduction Act of 1995

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.
26078 Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations

List of Subjects in 21 CFR Part 1240

Communicable diseases, Public

health, Travel restrictions, Water

supply.

Therefore, under the Public Health

Service Act and under the authority

delegated to the Commissioner of Food

and Drugs, 21 CFR part 1240 is

amended as follows:

PART 1240—CONTROL OF

COMMUNICABLE DISEASES

1. The authority citation for part 1240

continues to read as follows:

Authority: 42 U.S.C. 216, 243, 264, 271.

§ 1240.70 [Removed]

2. Section 1240.70 Lather brushes is

removed.

Dated: May 4, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–12450 Filed 5–11–98; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 63

[AD–FRL–6011–6]

RIN 2060–AC19

National Emission Standards for

Hazardous Air Pollutants for Source

Categories; Organic Hazardous Air

Pollutants From the Synthetic Organic

Chemical Manufacturing Industry

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule: Amendments.

SUMMARY: This action promulgates final

amendments to the National Emission

Standards for Hazardous Air Pollutants

for Source Categories; Organic

Hazardous Air Pollutants from the

Synthetic Organic Chemical

Manufacturing Industry (SOCMI) by

adding tetrahydrobenzaldehyde (THBA)

and crotonaldehyde to, and removing

acetaldol from, the list of chemical

production processes. The amendment

also establishes a separate compliance

date of 3 years from final action for

subparts F and G of part 63 and 1 year

from final action for subpart H of part

63 for the THBA and crotonaldehyde

production processes. The EPA is also

making a change to clarify compliance

demonstration requirements for flexible

operation units.

This action implements section 112(d)

of the Clean Air Act as amended in 1990

(the Act), which requires the

Administrator to regulate emissions of

hazardous air pollutants (HAP) listed in

section 112(b) of the Act. The intended

effect of this rule is to protect the public

by requiring new and existing major

sources to control emissions of HAP to

the level reflecting application of the

maximum achievable control

technology. This action also amends the

initial list of source categories of HAP

required by section 112(c) of the Act by

removing THBA production from the

list of categories of major sources.

EFFECTIVE DATE: May 12, 1998.

FOR FURTHER INFORMATION CONTACT: For

information concerning this action

contact Mr. John Schaefer at (919) 541–

0296, Organic Chemicals Group,

Emission Standards Division (MD–13),

U.S. Environmental Protection Agency,

Research Triangle Park, North Carolina

27711.

SUPPLEMENTARY INFORMATION:

I. Regulated Entities and Background

Information

A. Regulated Entities

The regulated category and entities

affected by this action include:

Category Regulated entities

Industry .. Facilities that produce

tetrahydrobenzaldehyde; facilities that produce

crotonaldehyde.

Synthetic organic chemical manufacturing industry (SOCMI)

units, e.g., producers of benzene, toluene, or any other

chemical listed in Table 1 of 40

CFR part 63, subpart F.

This table is not intended to be

exhaustive but, rather, provides a guide

for readers regarding entities likely to be

interested in the revisions to the

regulation affected by this action.

Entities potentially regulated by the

HON are those which produce as

primary intended products any of the

chemicals listed in table 1 of 40 CFR

part 63, subpart F or facilities producing

THBA or crotonaldehyde and that are

located at facilities that are major

sources as defined in section 112 of the

Clean Air Act (CAA). To determine

whether your facility is regulated by this

action, you should carefully examine all

of the applicability criteria in 40 CFR

63.100. If you have questions regarding

the applicability of this action to a

particular entity, consult the person

listed in the preceding FOR FURTHER

INFORMATION CONTACT section.

With today’s action, EPA is making

production of THBA and

crotonaldehyde subject to subparts F, G,

and H of 40 CFR Part 63. Subparts F, G,

and H of 40 CFR Part 63 establish

National Emission Standards for

Hazardous Air Pollutants (NESHAP) for

the Synthetic Organic Chemical

Manufacturing Industry (SOCMI) (57 FR

62607). This rule is commonly referred

to as the hazardous organic NESHAP or

the HON. The HON rule applies to

SOCMI facilities located at major

sources and affects approximately 310

facilities nationwide. These SOCMI

facilities include those that produce one

or more of the synthetic organic

chemicals listed in Table 1 of Subpart

F and that either (1) use an organic HAP

as a reactant or (2) produce an organic

HAP in the process. Emission points

within these facilities affected by the

rule are process vents, storage vessels,

transfer operations, equipment leaks,

and wastewater collection systems.

Processes producing THBA were not

included on the list of SOCMI processes

to be regulated under the HON.

Crotonaldehyde production was

removed from the list of SOCMI

processes to be regulated by the HON

when the rule was issued in April 1994.

Crotonaldehyde production was deleted

because available information indicated

that this chemical was no longer

produced in the United States. Because

EPA has since learned that

crotonaldehyde is still produced in the

United States, in today’s action EPA is

adding crotonaldehyde production to

the HON.

II. Summary of Changes to Rule

A. Addition of THBA Production

Tetrahydrobenzaldehyde production

was included as a source of HAP

emissions under the source category of

butadiene dimers production on the

initial list of source categories selected

for regulation under Section 112(c) of

the Act published on July 16, 1992 (57

FR 31576) and was scheduled for

control by November 1997 on the

section 112(e) source category schedule

(58 FR 63941). Although the initial

source category list clearly identified

THBA production as being included in

the butadiene dimers production source

category, the butadiene dimers name

was a misnomer. Consequently, the

butadiene dimers production source

category was changed to

tetrahydrobenzaldehyde production by

a source category list maintenance

action finalized on June 4, 1996 (61 FR

28197). Today’s action will add THBA

production to the list of HON-affected

chemicals.

THBA is produced by reacting 1,3-

butadiene and acrolein together. Both

1,3-butadiene and acrolein are HAPs