11898 Federal Register / Vol. 60, No. 42 / Friday, March 3, 1995 / Rules and Regulations

PART 354—OVERTIME SERVICES

RELATING TO IMPORTS AND

EXPORTS; AND USER FEES

1. The authority citation for part 354

continues to read as follows:

Authority: 7 U.S.C. 2260; 21 U.S.C. 136

and 136a; 49 U.S.C. 1741; 7 CFR 2.17, 2.51,

and 371.2(c).

2. Section 354.2 is amended by

removing and adding in the table, in

alphabetical order, the information as

shown below:

§ 354.2 Administrative instructions

prescribing commuted traveltime.

* * * * *

COMMUTED TRAVELTIME ALLOWANCES

[In hours]

Location coveredServed

from

Metropolitan

area

Within Outside

[Remove]

* * * * *

Delaware:

Claymont ...... Dover ........ .......... 4

Claymont ...... Wilmington .......... 2

Delaware City Wilmington .......... 2

Delaware City Dover ........ .......... 3

Dover ............ ................... 2 ........

Slaughter

Beach.

Dover ........ .......... 2

Wilmington

(including

marine terminal and

airport).

................... 2 ........

Wilmington

(including

marine terminal and

airport).

Carlisle, PA .......... 6

Wilmington

(including

marine terminal and

airport).

Chestertown, MD........... 4

Wilmington

(including

marine terminal and

airport).

Dallas, PA .......... 6

Wilmington

(including

marine terminal and

airport).

Dover ........ .......... 4

Wilmington

(including

marine terminal and

airport).

Gap, PA .... .......... 4

* * * * *

[Add]

COMMUTED TRAVELTIME ALLOWANCES

[In hours]

Location coveredServed

from

Metropolitan

area

Within Outside

* * * * *

Delaware:

* * * * *

Dover ............ ................... 1 ........

Dover ............ Wilmington .......... 31⁄2

* * * * *

Wilmington

(including

NCCA,

Delaware

City, and

Claymont).

................... 2 ........

Wilmington

(including

NCCA,

Delaware

City, and

Claymont).

Dover ........ .......... 3

* * * * *

Done in Washington, DC, this 27th day of

February 1995.

Terry L. Medley,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 95–5284 Filed 3–2–95; 8:45 am]

BILLING CODE 3410–34–P

9 CFR Part 77

[Docket No. 94–053–3]

Tuberculosis in Cattle and Bison; State

Designation

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Affirmation of interim rule as

final rule.

SUMMARY: We are adopting as a final

rule, without change, an interim rule

that amended the tuberculosis

regulations concerning the interstate

movement of cattle and bison by

reducing the designation of Virginia

from an accredited-free (suspended)

State to a modified accredited State. We

have determined that Virginia no longer

meets the criteria for designation as an

accredited-free (suspended) State but

meets the criteria for designation as a

modified accredited State. This change

was necessary to prevent the spread of

tuberculosis in cattle and bison.

EFFECTIVE DATE: April 3, 1995.

FOR FURTHER INFORMATION CONTACT: Dr.

Mitchell A. Essey, Senior Staff

Veterinarian, Animal and Plant Health

Inspection Service, Veterinary Services,

Cattle Diseases and Surveillance, 4700

River Road Unit 36, Riverdale, MD

20737–1231; (301) 734–8715.

SUPPLEMENTARY INFORMATION:

Background

In an interim rule effective and

published in the Federal Register on

November 29, 1994 (59 FR 60885–

60886, Docket No. 94–053–2), we

amended the tuberculosis regulations in

9 CFR part 77 by removing Virginia

from the list of accredited-free

(suspended) States in § 77.1 and adding

it to the list of modified accredited

States in that section.

Comments on the interim rule were

required to be received on or before

January 30, 1995. We did not receive

any comments. The facts presented in

the interim rule still provide a basis for

the rule.

The action also affirms the

information contained in the interim

rule concerning Executive Order 12866

and the Regulatory Flexibility Act,

Executive Orders 12372 and 12778, and

the Paperwork Reduction Act.

Further, for this action, the Office of

Management and Budget has waived the

review process required by Executive

Order 12866.

List of Subjects in 9 CFR Part 77

Animal diseases, Bison, Cattle,

Reporting and recordkeeping

requirements, Transportation,

Tuberculosis.

PART 77—TUBERCULOSIS

Accordingly, we are adopting as a

final rule, without change, the interim

rule that amended 9 CFR 77.1 and that

was published at 59 FR 60885–60886 on

November 29, 1994.

Authority: 21 U.S.C. 111, 114, 114a, 115–

117, 120, 121, 134b, and 134f; 7 CFR 2.17,

2.51, and 371.2(d).

Done in Washington, DC, this 27th day of

February 1995.

Terry L. Medley,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 95–5287 Filed 3–2–95; 8:45 am]

BILLING CODE 3410–34–P
Federal Register / Vol. 60, No. 42 / Friday, March 3, 1995 / Rules and Regulations 11899

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 93F–0483]

Secondary Direct Food Additives

Permitted in Food for Human

Consumption

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 chlorine dioxide to

control the microbial population in

poultry process water. This action is in

response to a petition filed by Rio Linda

Chemical Co., Inc.

DATES: The regulation is effective March

3, 1995; written objections and requests

for a hearing by April 3, 1995. The

Director of the Office of the Federal

Register approves the incorporation by

reference in accordance with 5 U.S.C.

552(a) and 1 CFR part 51 of certain

publications in new § 173.69, effective

March 3, 1995.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Robert L. Martin, Center for Food Safety

and Applied Nutrition (HFS–217), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204–0001, 202–418–

3074.

SUPPLEMENTARY INFORMATION:

I. Background

In a notice published in the Federal

Register of February 2, 1994 (59 FR

4924), FDA announced that a food

additive petition (FAP 4A4408) had

been filed by Rio Linda Chemical Co.,

Inc., 410 North 10th St., Sacramento, CA

95814, proposing that the food additive

regulations be amended to provide for

the safe use of chlorine dioxide to

disinfect waters contacting fresh meat,

fresh poultry, processed meat, and

processed poultry. Since filing the

petition, the agency has concluded that

it is more appropriate to replace the

term ‘‘disinfect’’ with ‘‘control the

microbial population’’ because

‘‘disinfect’’ implies total eradication of

microbial contamination.

FDA has completed its review of the

use of up to 3 parts per million (ppm)

residual chlorine dioxide in process

water contacting whole fresh poultry

carcasses. The agency is issuing this

regulation to permit this use while its

review of the other proposed uses of

chlorine dioxide continues.

II. Chlorine Dioxide

Chlorine dioxide (CAS Reg. No.

10049–04–4) is a yellow to reddishyellow gas with a pungent odor similar

to that of chlorine. Because chlorine

dioxide is explosive when concentrated,

it is usually generated at the site where

it is used. Chlorine dioxide can be

prepared by reaction of chlorine with

sodium chlorite, reduction of sodium

chlorate, or acidification of sodium

chlorite. High yield production of

chlorine dioxide (greater than 90

percent) is accomplished by reaction of

sodium chlorite with chlorine or by

reaction of an acid, sodium

hypochlorite, and sodium chlorite (Ref.

1).

Chlorine dioxide is a strong oxidant

which is expected to react with

microbial contaminants and other

organic material present in poultry

process water. Oxidation of chlorine

dioxide results in the formation of

chlorite ion, which is an oxidant that is

capable of reacting with organic

material in poultry process water.

Residual chlorate present as an impurity

in chlorine dioxide solutions can also

act as an oxidant.

Chlorine dioxide is currently listed in

21 CFR 178.1010(b)(34) as a component

of a sanitizer solution. Chlorine dioxide

is also listed in 21 CFR 137.105 for use

as a bleaching agent for flour and is also

approved by the Environmental

Protection Agency (EPA) for use in

potable water treatment plants (40 CFR

part 141, subpart H). The Health

Protection Branch of Health and Welfare

Canada has stated in a letter to the

petitioner that chlorine dioxide is

permitted for use in poultry chiller

water in Canada (Ref. 2).

Chlorine dioxide is a potential

substitute for chlorine, which is

currently commonly used in poultry

processing. Published studies that were

included in the petition show that

chlorine dioxide is four to seven times

more effective than an equal

concentration of chlorine as a

bactericide in poultry chiller water

(Refs. 3, 4, and 5). Thus, chlorine

dioxide can be used at considerably

lower levels than chlorine without

compromising bactericidal effects. Most

of the studies conducted by the

petitioner were with residual chlorine

dioxide levels in the process water of 3

ppm.

III. Safety

Data from the gas chromatographicmass spectroscopic analysis of poultry

process water containing 3 ppm of

chlorine dioxide were provided in the

petition. These data show that organic

reaction byproducts, such as the

potentially toxic trihalomethanes (e.g.,

chloroform), are not present in poultry

process water at the 0.2 parts per billion

(ppb) limit of detection when the

method for detecting chloroform is

used. (EPA proposed a drinking water

standard (59 FR 38668 at 38670, July 29,

1994) that permits a maximum

contaminant level of up to 80 ppb (400

times the amount detectable by the

analytical method) of ‘‘total

trihalomethanes’’ (chloroform,

bromoform, dibromochloromethane and

bromodichloromethane) in drinking

water.) Moreover, FDA’s review of the

results of an Ames test on poultry

process water that was treated with 20

ppm chlorine dioxide revealed no

mutagenic activity. The Ames test

results support the conclusion that

significant levels of harmful organic

reactions byproducts will not be formed

when chlorine dioxide, at a residual

level of 3 ppm, is used as the

bacteriocidal agent in poultry process

water.

In addition to evaluating the probable

formation of organic reaction

byproducts from the use of chlorine

dioxide in poultry process water, FDA

has also evaluated the possible presence

of residual chlorine dioxide, chlorite,

and chlorate on treated poultry

carcasses; the potential for the oxidation

of poultry tissue, including sensitive

fatty acids; and data from mutagenicity

tests.

Based on its evaluation of the

information in the petition, the agency

has concluded that no detectable

residues of chlorine dioxide would

remain on poultry carcasses, and that

exposure to chlorite and chlorate as a

result of this use of chlorine dioxide

would be virtually nil. (No chlorite or

chlorate could be detected on poultry

(raw or cooked) at the limit of detection

(50 ppb) for the method used.) The

agency also concluded that the very low

levels of chlorite and chlorate that may

be retained on poultry carcasses as a

result of exposure to chlorine dioxidecontaining process water would be

converted to correspondingly low levels

of chloride (a relatively innocuous

substance, e.g., chloride in table salt)

during cooking (Ref. 6).

FDA also considered potential

oxidative effects of chlorine dioxide,

chlorite, and chlorate on poultry. The

agency reviewed information in the
11900 Federal Register / Vol. 60, No. 42 / Friday, March 3, 1995 / Rules and Regulations

petition on thiobarbituric acid (TBA)

values of raw and cooked poultry

exposed to chlorine dioxide-containing

process water. A TBA test is commonly

used as an indicator of oxidative

decomposition (and of rancidity) of

meat and fat. The more oxidative

decomposition, the higher the TBA

values. The agency determined that the

TBA values for both raw and cooked

poultry exposed to chlorine dioxidecontaining process water did not

significantly differ from that for poultry

exposed to tap water. Thus, the agency

concludes that no significant oxidation

of poultry exposed to chlorine dioxidecontaining process water occurs under

the prescribed conditions of use.

FDA also evaluated information in the

petition on the levels of oxidationsensitive fatty acids (e.g., oleic, linoleic,

linolenic, and arachidonic acid) in raw

untreated poultry and in poultry

exposed to chlorine dioxide-containing

process water. Fatty acid profiles were

comparable for treated and untreated

poultry when analyzed by gas

chromatography. FDA concludes that

exposure to chlorine dioxide at levels 7

to 10 times higher than that prescribed

in the proposed regulation does not

result in appreciable loss of these fatty

acids from poultry.

Based on the above findings, the

agency concludes that 3 ppm of residual

chlorine dioxide in poultry process

water will not result in a measurable

increase in oxidation of poultry as

compared with poultry exposed to tap

water.

The agency also considered the

possibility of formation of mutagenic

compounds in poultry and poultry

process water treated with chlorine

dioxide. Ames test information

presented in the petition showed no

evidence of mutagenic activity in

poultry process water treated with

chlorine dioxide. Thus, the agency

concludes that the use of chlorine

dioxide in poultry process water under

the conditions prescribed in the

regulation should not pose a significant

health concern from the formation of

mutagenic substances.

IV. Conclusions

FDA has evaluated the data in the

petition and other relevant material and

has consulted with scientists in the

Food Safety and Inspection Service in

the U. S. Department of Agriculture

concerning the technological and

practical aspects of the proposed use of

chlorine dioxide. Based upon this

evaluation, the agency concludes that

the proposed use of the additive is safe

and will have the intended technical

effect. The agency also concludes that a

specification for minimum purity of

chlorine dioxide should be included in

the regulation to reflect the purity of the

chlorine dioxide that it evaluated.

Therefore, 21 CFR part 173 is amended

as set forth below.

V. Inspection of Documents

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 21 CFR

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.

VI. Environmental Imapct

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.

VII. Objections

Any person who will be adversely

affected by this regulation may at any

time on or before April 3, 1995, 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.

VIII. 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. Kirk-Othmer Encyclopedia of Chemical

Technology, Vol. 5, pp. 612–632.

2. Letter dated July 30, 1991, to Dr. Richard

Higby from J. W. Salminen, Health Protection

Branch, Health and Welfare Canada.

3. Lillard, H. S., ‘‘Levels of Chlorine and

Chlorine Dioxide of Equivalent Bactericidal

Effect in Poultry Processing Water,’’ Journal

of Food Science, 44:1594–1597, 1979.

4. Lillard, H. S., ‘‘Effect on Broiler

Carcasses and Water of Treating Chiller

Water with Chlorine or Chlorine Dioxide,’’

Poultry Science, 59:1761–1766, 1980.

5. Thiesson, G. P., W. R. Usborne, and H.

L. Orr, ‘‘The Efficacy of Chlorine Dioxide in

Controlling Salmonella Contamination and

Its Effect on Product Quality of Chicken

Broiler Carcasses,’’ Poultry Science 63:647–

653, 1984.

6. Gordon, G., R. G. Kieffer, and D. H.

Rosenblatt, ‘‘The Chemistry of Chlorine

Dioxide’’ in Progress in Inorganic Chemistry,

Vol. 15, pp. 201–286, S. J. Lippard, ed.,

Wiley-Interscience, New York, 1972.

List of Subjects in 21 CFR Part 173

Food additives, Incorporation by

reference.

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: Secs. 201, 402, 409 of the

Federal Food, Drug, and Cosmetic Act (21

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

2. New section 173.69 is added to

read as follows:

§ 173.69 Chlorine dioxide.

Chlorine dioxide (CAS Reg. No.

10049–04–4) may be safely used in food

in accordance with the following

prescribed conditions:

(a) The additive is generated by

treating an aqueous solution of sodium

chlorite with either chlorine gas or a

mixture of sodium hypochlorite and

hydrochloric acid. The generator

effluent contains at least 90 percent (by

weight) of chlorine dioxide with respect
Federal Register / Vol. 60, No. 42 / Friday, March 3, 1995 / Rules and Regulations 11901

to all chlorine species as determined by

Method 4500–ClO2 E in the ‘‘Standard

Methods for the Examination of Water

and Wastewater,’’ 18th ed., 1992, or an

equivalent method. Method 4500–ClO2

E is incorporated by reference in

accordance with 5 U.S.C. 552(a) and 1

CFR part 51. Copies are available from

the Division of Petition Control, Center

for Food Safety and Applied Nutrition

(HFS–215), Food And Drug

Administration, 200 C St., SW.,

Washington, DC 20204–0001 and The

American Public Health Association,

1015 Fifteenth St., NW., Washington,

DC 20005, or may be examined at the

Office of the Federal Register, 800 North

Capitol St., NW., suite 700, Washington,

DC.

(b) 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

above or an equivalent method.

Dated: February 23, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–5275 Filed 3–2–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

Office of the Secretary

24 CFR Part 15

[Docket R–95–1682; FR–3282–F–01]

RIN 2501–AB47

Freedom of Information Act

Procedures

AGENCY: Office of the Secretary, HUD.

ACTION: Final rule.

SUMMARY: This rule amends 24 CFR part

15, which implements the Freedom of

Information Act and sets forth the

procedures to be followed by the

Department in responding to requests

from the public for documents. The rule

fashions certain in-house administrative

and procedural changes in the

processing of requests for documents

and appeals from denials of requests for

documents, and is necessary to reflect

current organizational responsibilities of

the various offices within the

Department. The rule also implements

the Department’s FOIA Handbook

procedures for notifying business

submitters and affording them an

opportunity to object to disclosure of

their business information.

EFFECTIVE DATE: April 3, 1995.

FOR FURTHER INFORMATION CONTACT:

Yvette Magruder, Assistant Director,

Freedom of Information Unit, Room

10139, Department of Housing and

Urban Development, 451 Seventh Street

SW., Washington DC 20410; telephone

(202) 708–3054, or 1–800–877–8339

(TDD). (Only the ‘‘800’’ TDD number is

toll-free.)

SUPPLEMENTARY INFORMATION:

Justification for Final Rulemaking

In general, the Department publishes

a rule for public comment before issuing

a rule for effect, in accordance with its

own regulations on rulemaking in 24

CFR part 10. However, part 10 does

provide for an exception for rules

governing the Department’s organization

or its own internal practices or

procedures. Because the provisions

contained in this rule relate to the

manner in which the Department will

administer its responsibilities under the

Freedom of Information Act and related

technical amendments, notice-andcomment rulemaking would not benefit

the public and is not required.

Background

The Department’s regulations

implementing the Freedom of

Information Act (5 U.S.C. 552) (FOIA)

were published at 40 FR 48123 (October

14, 1975), and were amended at 52 FR

12160 (April 15, 1987) and 53 FR 37549

(September 27, 1988). This rule is being

issued to reflect organizational changes

relating to the manner in which the

Department administers the disclosure

of public documents.

Under Exemption 4 of the FOIA (5

U.S.C. 552(b)(4)) Federal agencies have

a responsibility to protect sensitive

business information from disclosure.

Under Executive Order 12600 (3 CFR,

1987 Comp., p. 235), in meeting this

responsibility agencies must notify

business submitters that their

information has been requested under

the FOIA and must afford them an

opportunity to object to disclosure of

the requested information. By this rule,

a new § 15.54, updating the

Department’s current business submitter

notification procedures in HUD

Handbook 1327.1 REV–1, Freedom of

Information Act, is being added to title

24 of the Code of Federal Regulations

(CFR).

In addition, the rule updates language

in § 15.21 on the protections available

for law enforcement records. The new

language duplicates statutory language

in the Freedom of Information Reform

Act of 1986 (Pub. L. 99–570, subtitle N,

approved October 27, 1986; 100 Stat.

3207–48), which modified the terms of

the exemption as provided in the FOIA.

Section-by-Section Analysis

Section 15.1(f) currently defines

‘‘information center’’ as any place,

reading room, desk, or other area or

facility, established and maintained by

the Department where the public may

request and obtain information and

records concerning the Department’s

operations and business. This rule

clarifies the means by which the public

may obtain access to those resources

that are maintained in a combination of

locations within the Department. The

rule corrects any perception that all

records are maintained in a single

location within the Department.

Section 15.13(b) currently provides

that the Department will request records

that have been stored in the National

Archives or other record centers of the

General Services Administration. This

rule deletes reference to the General

Services Administration, because the

Federal Record Centers are now

administered by the National Archives

and Records Administration. The rule

establishes that records that have been

accessioned by the National Archives

and Records Administration may be

requested directly from the National

Archives and Records Administration.

Section 15.14 addresses the payment

of fees for search time and the copying

of documents. Those fees currently

established in § 15.14(a) are inadequate

to defray the Government’s own

reasonable direct costs in processing

requests and copying documents.

Accordingly, this rule increases those

fees. In addition, § 15.14(c) currently

does not include a separate schedule of

fees for computer search time. This rule

provides for charges to be assessed on

the basis of the direct cost of running

the computer, plus the programming

cost attributable to the search. Section

15.14(e) places restrictions on the

assessment of fees against

noncommercial requesters. The rule

simplifies those restrictions by

eliminating confusing language. Section

15.14(f) currently provides that fees may

be paid in cash, by check, or by money

order. This rule removes approval of

cash payments, except when a cash

payment is made in person, and

identifies to whom the fees should be

directed.

The changes to § 15.14 will help

defray the direct reasonable cost to the

Government of compliance with the

FOIA and will simplify fee projections

for certain computer searches.

Section 15.21 currently reflects the

statutory exemptions to the Freedom of

Information Act, with the exception of