This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

3121

Vol. 65, No. 13

Thursday, January 20, 2000

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 424

[Docket No. 99–028DF]

Food Additives for Use in Meat and

Poultry Products: Sodium Diacetate,

Sodium Acetate, Sodium Lactate and

Potassium Lactate

AGENCY: Food Safety and Inspection

Service, USDA.

ACTION: Direct final rule.

SUMMARY: The Food Safety and

Inspection Service (FSIS) is amending

the Federal meat and poultry products

inspection regulations to increase

permissible levels of sodium acetate as

a flavor enhancer in meat and poultry

products and of sodium diacetate as a

flavor enhancer and as an inhibitor of

the growth of certain pathogens. FSIS is

also permitting the use of sodium lactate

and potassium lactate in meat and

poultry products, except for infant

formulas and infant food, for purposes

of inhibiting the growth of certain

pathogens. FSIS is proceeding with this

direct final rule in response to petitions

submitted by Armour Swift-Ekrich and

Purac America, Inc.

DATES: This rule will be effective March

20, 2000 unless FSIS receives written

adverse comments within the scope of

this rulemaking or written notice of

intent to submit adverse comments

within the scope of this rulemaking on

or before February 22, 2000.

ADDRESSES: Submit adverse comments

or notice of intent to submit adverse

comments within the scope of this

rulemaking to: FSIS Docket Clerk,

Docket #99–028DF, Department of

Agriculture, Food Safety and Inspection

Service, Cotton Annex, Room 102, 300

12th Street, SW, Washington, DC

20250–3700. Any written comments

submitted in response to this direct final

rule and reference materials will be

available for public inspection in the

FSIS Docket Room from 8:30 a.m. to

4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Robert Post, Director, Labeling and

Additives Policy Division, Office of

Policy, Program Development and

Evaluation, Food Safety and Inspection

Service, U.S. Department of Agriculture,

Washington, DC 20250–3700; (202) 205–

0279.

SUPPLEMENTARY INFORMATION:

Background

FSIS was petitioned by Armour SwiftEkrich to amend the Federal meat and

poultry products inspection regulations

to increase the amount of sodium

diacetate and sodium acetate that may

be added to meat and poultry products

to levels up to 0.25 percent by weight

of total formulation. The reason for the

requested increase was for the purpose

of inhibiting the growth of

microorganisms, specifically Lm. The

petitioner also requested that the

Agency expand the approval to include

potassium acetate and potassium

diacetate.

The petitioner submitted data with

the petition that it had gathered over ten

years from experiments in its

laboratories. FSIS determined that the

data demonstrate that increasing the

currently approved level of sodium

diacetate to 0.25 percent effectively

inhibits the growth of Lm in meat and

poultry products. However, there was

insufficient data submitted with the

petition to allow an increase in the

amount of sodium acetate to be used as

an anti-microbial agent in meat and

poultry products. Also, the Food and

Drug Administration (FDA) has only

approved sodium diacetate to be used as

an anti-microbial in accordance with 21

CFR 184.1754. Therefore, FSIS is only

approving sodium diacetate at a level up

to .25 percent for anti-microbial use in

meat and poultry products.

In a June 9, 1995, letter to the

petitioner, FDA stated that it had no

objection to sodium acetate and sodium

diacetate to be used at levels up to .25

percent as flavoring agents. Therefore, to

reflect FDA’s action, FSIS will permit

the use of sodium acetate and sodium

diacetate to a level of up to .25 percent

as flavoring agents in meat and poultry

products.

FDA has not established a use level

for potassium acetate or potassium

diacetate as either flavoring agents or

anti-microbials. Nor did the petitioner

supply any data supporting the request

for potassium acetate or potassium

diacetate. Consequently, the Agency

cannot permit the use of potassium

acetate or potassium diacetate in meat

and poultry products at this time.

FSIS also received a petition from

Purac America, Inc. The petition

requested that FSIS amend the Federal

meat and poultry products inspection

regulations to permit the use of sodium

lactate and potassium lactate in fully

cooked meat, meat food products,

poultry, and poultry food products,

except for infant foods and formulas, at

levels up to 4.8 percent of total product

formulation to inhibit the growth of

certain pathogens such as Lm and C.

botulinum.

FSIS found that adequate information

exists to accept the use of sodium

lactate and potassium lactate, singly or

in combination, in all fully cooked meat

and poultry food products at a level up

to 4.8 percent by weight of total

formulation for purposes of inhibiting

the growth of certain pathogens. FDA

has listed sodium lactate and potassium

lactate for use with no limitations as

long as they are used under good

manufacturing practice as defined in 21

CFR 184.1(b). Both are currently

approved by FSIS at levels up to 2

percent of total product formulation for

use as flavors and flavor enhancers.

FSIS will permit the use of sodium

lactate and potassium lactate at a level

of 4.8 percent in meat and poultry

products to inhibit the growth of certain

pathogens.

Because the use of these substances

would change a product’s formulation,

FSIS expects that establishments

choosing to use any of these substances

will reassess their HACCP plans for the

products in which the substances will

be used. Such a reassessment is

specified in 9 CFR 417.4(a)(3).

Accordingly, FSIS expects that

establishments using sodium diacetate,

sodium lactate, or potassium lactate to

inhibit the growth of pathogens will

modify their HACCP plans to establish

the use of the substance as a critical

control point (CCP) or to incorporate the

use into an existing CCP. Also,

establishments that use sodium acetate,

sodium diacetate, sodium lactate, or

3122 Federal Register / Vol. 65, No. 13 / Thursday, January 20, 2000 / Rules and Regulations

potassium lactate in their products will

need to revise the product’s label as

specified in part 317 or 318, subpart N.

The use of these substances at the

levels that are being provided for by

FSIS is not controversial, and FSIS

expects no adverse comment to result

from the changes that it is making.

Therefore, unless the Agency receives

written adverse comments within the

scope of this rulemaking, or a written

notice of intent to submit adverse

comments within the scope of the

rulemaking, within 30 days, the action

will become final 60 days after

publication in the Federal Register. If

written adverse comments within the

scope of the rulemaking are received,

the final rulemaking notice will be

withdrawn, and the Agency will publish

a proposed rulemaking notice that

includes a comment period.

Executive Order 12988

This direct final rule has been

reviewed under Executive Order 12988,

Civil Justice Reform. This direct final

rule: (1) Preempts all state and local

laws and regulations that are

inconsistent with this rule; (2) has no

retroactive effect; and (3) does not

require administrative proceedings

before parties may file suit in court

challenging this rule.

Executive Order 12866 and Regulatory

Flexibility Act

This direct final rule has been

determined to be not significant and,

therefore, has not been reviewed by

OMB.

Effect on Small Entities

This direct final rule will permit the

use of sodium acetate as a flavor

enhancer, sodium diacetate as a flavor

enhancer and anti-microbial, and

sodium lactate and potassium lactate as

anti-microbials in meat and poultry

products.

The use of these ingredients is

voluntary. FSIS does not believe that

any costs involved with HACCP plan

reassessments or modifications, or

changes to labels, will be significant.

The decision by individual

establishments to use any of these

ingredients will be based on their

conclusions that the benefits outweigh

the implementation costs.

The Administrator, FSIS, has

determined that this direct final rule

will not have a significant economic

impact on a substantial number of small

entities, as defined by the Regulatory

Flexibility Act (5 U.S.C. 601).

Additional Public Notification

Public awareness of all segments of

rulemaking and policy development is

important. Consequently, in an effort to

better ensure that minorities, women,

and persons with disabilities are aware

of this direct final rule, FSIS will

announce it and provide copies of this

Federal Register publication in the FSIS

Constituent Update. FSIS provides a

weekly FSIS Constituent Update, which

is communicated via fax to over 300

organizations and individuals. In

addition, the update is available on line

through the FSIS web page located at

http://www.fsis.usda.gov. The update is

used to provide information regarding

FSIS policies, procedures, regulations,

Federal Register notices, FSIS public

meetings, recalls, and any other types of

information that could affect or would

be of interest to our constituents/

stakeholders. The constituent fax list

consists of industry, trade, and farm

groups, consumer interest groups, allied

health professionals, scientific

professionals, and other individuals that

have requested to be included. Through

these various channels, FSIS is able to

provide information to a much broader,

more diverse audience. For more

information and to be added to the

constituent fax list, fax your request to

the Congressional and Public Affairs

Office, at (202) 720–5704.

Paperwork Requirements

Abstract: FSIS has reviewed the

paperwork and recordkeeping

requirements in this direct final rule in

accordance with the Paperwork

Reduction Act and submitted an

information collection request to the

Office of Management and Budget for

emergency clearance. Establishments

that choose to use any of the substances

approved by this direct final rule will

have to make changes to their product

labels. Also, because establishments

using the substances will change their

products’ formulations, they will have

to reassess their HACCP plans that cover

production of the products, as specified

in 417.4(a)(3). FSIS expects that most

establishments using the substances

approved for antimicrobials will most

likely establish the use of the substance

as a critical control point (CCP) or

incorporate its use into an existing CCP.

Estimate of Burden: FSIS estimates

that it will take 1 hour for

establishments to develop any new

product labels. Establishments will only

need to make the label changes once.

The Agency estimates that it will take 1

hour for establishments to reassess their

HACCP plans. For purposes of this

paperwork analysis, FSIS assumes that

all of the establishments it has estimated

to use the substances will make changes

to one HACCP plan one time. The

Agency estimates that an establishment

will spend about 5 minutes a day (250

days) completing 1 monitoring record

and 2 minutes a day filing the record for

one HACCP plan.

Respondents: Meat and Poultry

product establishments.

Estimated Number of Respondents:

1,000.

Estimated Number of Responses per

Respondent: 1 for label changes, 1 for

HACCP reassessment; 250 for

monitoring records, and 250 for filing

the record.

Estimated Total Annual Burden on

Respondents: 31,166.

Copies of this information collection

assessment can be obtained from Lee

Puricelli, Paperwork Specialist, Food

Safety and Inspection Service, USDA,

Room 109 Cotton Annex, Washington,

DC 20250–3700.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the Agency,

including whether the information will

have practical utility; (b) the accuracy of

the Agency’s estimate of the burden of

the proposed collection of information

including the validity of the method and

the assumptions used; (c) ways to

enhance the quality, utility, and clarity

of the information to be collected; (d)

ways to minimize the burden of the

collection of information on those who

are to respond; including through use of

appropriate automated, electronic,

mechanical, or other technological

collection techniques or other forms of

information technology. Comments may

be sent to Lee Puricelli, see the address

above, and to the Desk Officer for

Agriculture, Office of Information and

Regulatory Affairs, Office of

Management and Budget (OMB)

Washington, DC 20253.

List of Subjects in 9 CFR Part 424

Food additives, Food packaging, Meat

inspection, Poultry and poultry

products.

For the reasons discussed in the

preamble, FSIS is amending 9 CFR part

424 of the Federal meat and poultry

products inspection regulations as

follows:

PART 424—PREPARATION AND

PROCESSING OPERATIONS

1. The authority citation for part 424

continues to read as follows:

Authority: 7 U.S.C. 450, 1901–1906; 21

U.S.C. 451–470; 601–695; 7 CFR 2.18, 2.53.

Federal Register / Vol. 65, No. 13 / Thursday, January 20, 2000 / Rules and Regulations 3123

1We originally adopted the Filer Manual on April

1, 1993, with an effective date of April 26, 1993.

Release No. 33–6986 (Apr. 1, 1993) [58 FR 18638].

We implemented the most recent update to the Filer

Manual on October 18, 1999. See Release No. 33–

7752 (October 20, 1999) [64 FR 56430]. 2See Rule 301 of Regulation S–T (17 CFR

232.301). 3See Release Nos. 33–6977 (Feb. 23, 1993) [58 FR

14628], IC–19284 (Feb. 23, 1993) [58 FR 14848], 35–

25746 (Feb. 23, 1993) [58 FR 14999], and 33–6980

(Feb. 23, 1993) [58 FR 15009] in which we

comprehensively discuss the rules we adopted to

govern mandated electronic filing. See also Release

No. 33–7122 (Dec. 19, 1994) [59 FR 67752], in

which we made the EDGAR rules final and

applicable to all domestic registrants; Release No.

33–7427 (July 1, 1997) [62 FR 36450], in which we

adopted minor amendments to the EDGAR rules;

Release No. 33–7472 (Oct. 24, 1997) [62 FR 58647],

in which we announced that, as of January 1, 1998,

we would not accept in paper filings that we

require filers to submit electronically; Release No.

34–40935 (Jan. 12, 1999) [64 FR 2843], in which we

made mandatory the electronic filing of Form 13F;

and Release No. 33–7684 (May 17, 1999) [64 FR

27888], in which we adopted amendments to

implement the first stage of EDGAR modernization.

4We have added the new Williams Act

submission types to accommodate the new rules

that will become effective January 24, 2000. See

Release No. 33–7760 (Oct. 22, 1999) [64 FR 61408].

5See Release Nos. 33–7514; IC–23066 (Mar. 2,

1998) [63 FR 13988], in which we proposed new

Continued

2. Section 424.21 is amended in the

chart in paragraph (c) by adding in

alphabetical order new entries for

‘‘potassium lactate,’’ ‘‘sodium

diacetate,’’ and ‘‘sodium lactate’’ under

the class ‘‘Antimicrobial agents’’ and by

revising the entries for ‘‘sodium acetate’’

and ‘‘sodium diacetate’’ under the class

‘‘Flavoring agents’’ to read as follows:

§ 424.21 Use of food ingredients and

sources of radiation.

* * * * *

(c) * * *

Class of substance Substance Purpose Products Amount

*******

Antimicrobial Agents .......... Potassium lactate ............. To inhibit microbial growth Various meat and poultry

products, except infant

formulas and infant food.

4.8% by weight of total formulation.

Sodium diacetate .............. ......do ................................ ......do ................................ 0.25% by weight of total

formulation.

Sodium lactate .................. ......do ................................ ......do ................................ 4.8% by weight of total formulation.

*******

Flavoring agents; Protectors and Developers.Sodium acetate ................. To flavor products ............. Various meat and poultry

products.

Not to exceed 0.25% of

formulate in accordance

with 21 CFR 184.1721.

Sodium diacetate .............. ......do ................................ ......do ................................ Not to exceed 0.25% of

formulate in accordance

with 21 CFR 184.1754.

*******

Done at Washington, DC, on: December 23,

1999.

Thomas J. Billy,

Administrator.

[FR Doc. 00–1220 Filed 1–19–00; 8:45 am]

BILLING CODE 3410–DM–P

SECURITIES AND EXCHANGE

COMMISSION

17 CFR Part 232

[Release Nos. 33–7789; 34–42327; 35–

27123; 39–2380; IC–24235]

RIN 3235–AG96

Adoption of Updated EDGAR Filer

Manual

AGENCY: Securities and Exchange

Commission.

ACTION: Final rule.

SUMMARY: The Commission is adopting

an updated edition of the EDGAR Filer

Manual and is providing for its

incorporation by reference into the Code

of Federal Regulations.

EFFECTIVE DATE: January 24, 2000. The

new edition of the EDGAR Filer Manual

(Release 6.75) will be effective on

January 24, 2000. The incorporation by

reference of the EDGAR Filer Manual is

approved by the Director of the Federal

Register as of January 24, 2000.

FOR FURTHER INFORMATION CONTACT: In

the Office of Information Technology,

Michael E. Bartell at (202) 942–8800; for

questions concerning investment

company filings, Ruth Armfield

Sanders, Senior Special Counsel, or

Shaswat K. Das, Attorney, Division of

Investment Management, at (202) 942–

0978; and for questions concerning

Corporation Finance company filings,

Herbert Scholl, Office Chief, EDGAR

and Information Analysis, Division of

Corporation Finance, at (202) 942–2930.

SUPPLEMENTARY INFORMATION: Today we

are adopting an updated EDGAR Filer

Manual (‘‘Filer Manual’’), which

describes the technical formatting

requirements for the preparation and

submission of electronic filings through

the Electronic Data Gathering, Analysis,

and Retrieval (EDGAR) system.1 Filers

must comply with the provisions of the

Filer Manual in order to assure the

timely acceptance and processing of

filings made in electronic format.2 Filers

should consult the Filer Manual in

conjunction with our rules governing

mandated electronic filing when

preparing documents for electronic

submission.3

The purpose of this new version of

EDGAR and the Filer Manual (Release

6.75) is to add new form types and

delete several old ones.4

We have added the following

submission types to EDGAR:

• SC TO–C—Written communication

relating to an issuer or third party

tender offer not by the subject company.

• SC 14D9–C—Written

communication by the subject company

relating to a tender offer by a third

party.

• SC TO–I and SC TO–I/A—Tender

offer schedule and amendment filed by

the issuer.

• SC TO–T and SC TO–T/A—Tender

offer schedule and amendment filed by

a third party.

• 425—A prospectus or other

communication in connection with

business combination transactions.

• N–6 and N–6/A—Submission types

for registration statements and preeffective amendments for separate

accounts (unit investment trusts) if we

adopt our proposed Form N–6.5