Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Notices 5515

No comments were received and EPA

hereby approves the amended Delaware

Plan.

ADDRESSES: The amended Delaware

Certification Plan can be reviewed at the

locations listed under Unit I.B. of the

SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT:

Magda Rodriguez-Hunt, Pesticides/

Asbestos Programs and Enforcement

Branch (3WC32), Environmental

Protection Agency, Region III, 1650

Arch St., Philadelphia, PA 19103;

telephone number: 215–814–2128; fax

number: 215–814–3113; e-mail address:

rodriguez-hunt.magda.@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public

in general. This action may, however, be

of interest to those involved in

agriculture and anyone involved with

the distribution and application of

pesticides for agricultural purposes.

Others involved with pesticides in a

non-agricultural setting may also be

affected. In addition, it may be of

interest to others, such as, those persons

who are or may be required to conduct

testing of chemical substances under the

Federal Food, Drug, and Cosmetic Act

(FFDCA), or the Federal Insecticide,

Fungicide, and Rodenticide Act

(FIFRA). Since other entities may also

be interested, the Agency has not

attempted to describe all the specific

entities that may be affected by this

action. If you have any questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Copies of the

Amended State Plan, Other Related

Documents, and Additional

Information?

To obtain copies of the amended

Delaware Certification Plan, other

related documents, or additional

information contact:

1. Magda Rodriguez-Hunt at the

address listed under FOR FURTHER

INFORMATION CONTACT.

2. Larry Towle, Delaware Department

of Agriculture, Pesticides Compliance,

2320 Dupont Highway, Dover, DE

19901; telephone number: 302–739–

4811; e-mail address:

larry@smtp.dda.state.de.us.

3. John MacDonald, Field and

External Affairs Division (7506C), Office

of Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW.; telephone number: 703–305–

7370; e-mail address:

macdonald.john@epa.gov.

II. What Action is the Agency Taking?

EPA is approving the amended

Delaware Certification Plan. This

approval is based upon the EPA review

of the Delaware Plan and finding it in

compliance with FIFRA and 40 CFR

part 171. Further, there were no public

comments submitted to the earlier

Federal Register Notice soliciting

comments. The amended Delaware

Certification Plan is therefore approved.

List of Subjects

Environmental protection.

Dated: January 2, 2001,

Bradley Campbell,

Regional Administrator, Region III.

[FR Doc. 01–1350 Filed 1–18–01 8:45 am]

BILLING CODE 6560–50–S

FEDERAL RESERVE SYSTEM

Sunshine Act Meeting

AGENCY HOLDING THE MEETING: Board of

Governors of the Federal Reserve

System

TIME AND DATE: 11 a.m., Wednesday,

January 24, 2001.

PLACE: Marriner S. Eccles Federal

Reserve Board Building, 20th and C

Streets, NW., Washington, DC 20551.

STATUS: Closed.

MATTERS TO BE CONSIDERED: 

1. Personnel actions (appointments,

promotions, assignments,

reassignments, and salary actions)

involving individual Federal Reserve

System employees.

2. Any items carried forward from a

previously announced meeting.

CONTACT PERSON FOR MORE INFORMATION:

Lynn S. Fox, Assistant to the Board;

202–452–3204.

SUPPLEMENTARY INFORMATION: You may

call 202–452–3206 beginning at

approximately 5 p.m. two business days

before the meeting for a recorded

announcement of bank and bank

holding company applications

scheduled for the meeting; or you may

contact the Board’s Web site at http://

www.federalreserve.gov for an

electronic announcement that not only

lists applications, but also indicates

procedural and other information about

the meeting.

Dated: January 17, 2001.

Robert deV. Frierson,

Associate Secretary of the Board.

[FR Doc. 01–1780 Filed 1–17–01; 11:13 am]

BILLING CODE 6210–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N–1168]

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. 00–048N]

Relative Risk to Public Health from

Foodborne Listeria Monocytogenes

Among Selected Categories of Readyto-Eat Foods; Draft Risk Assessment

Document and Risk Management

Action Plan; Availability

AGENCY: Food and Drug Administration,

HHS, and Food Safety and Inspection

Service, USDA.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA), and the Food

Safety and Inspection Service (FSIS) of

the U.S. Department of Agriculture

(USDA) are announcing the availability

of two documents: A draft risk

assessment on the relationship between

foodborne Listeria monocytogenes and

human health that considers 20 readyto-eat food categories, and a risk

management action plan based on the L.

monocytogenes risk assessment. We are

making these documents available, and

we are seeking public comment of a

technical nature on the draft risk

assessment. The risk management action

plan identifies immediate actions as

well as short-term and long-term

activities targeted to reduce L.

monocytogenes associated illnesses.

This plan is intended to respond to the

President’s directive to reduce L.

monocytogenes associated illnesses by

50 percent by the year 2005. HHS and

USDA invite comments on the risk

management strategies reflected in the

action plan. A public meeting to discuss

the draft risk assessment and the risk

management plan will be announced in

a future issue of the Federal Register.

DATES: Comments on the draft risk

assessment and the HHS/USDA risk

management action plan must be

submitted by March 20, 2001.

ADDRESSES: Printed copies of the draft

risk assessment and the risk

management action plan may be

requested by faxing your name and

mailing address with the names of the

documents you are requesting by faxing

your name and mailing address with the

names of the documents you are

requesting to the CFSAN Outreach and

Information Center at 1–877–366–3322.

The documents may be reviewed at the

5516 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Notices

FDA Dockets Management Branch

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

p.m., Monday through Friday, and at the

FSIS Docket Clerk’s Office between 8:30

a.m. and 4:30 p.m., Monday through

Friday.

Submit written comments to the

Dockets Management Branch (HFA–

305), Docket No. 99N–1168, Food and

Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

Two copies of comments are to be

submitted, except that individuals may

submit one copy.

or

Submit one original and two copies of

written comments to FSIS Docket Clerk,

Docket No. 00–048N, U.S. Department

of Agriculture, Food Safety and

Inspection Service, Room 102, Cotton

Annex, 300 12th St. SW., Washington,

DC 20250–3700. All comments

submitted in response to this notice will

be available for public inspection in the

Docket Clerk’s Office between 8:30 a.m.

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

For electronic access to these

documents see section III of the

SUPPLEMENTARY INFORMATION section of

this document.

FOR FURTHER INFORMATION CONTACT:

For information concerning the draft

risk assessment document: Sherri B.

Dennis, Risk Assessment

Coordinator, Center for Food Safety

and Applied Nutrition (HFS–032),

Food and Drug Administration, 200

C St. SW., Washington, DC 20204,

202–260–3984, FAX 202–260–9653,

or e-mail: sdennis@cfsan.fda.gov.

For information concerning the risk

management action plan: Kathy

Gombas, Center for Food Safety and

Applied Nutrition (HFS–615), Food

and Drug Administration, 200 C St.

SW., Washington, DC 20204; 202–

205–4231; FAX 202–260–0136, email: Kathy.Gombas@cfsan.fda.gov

or Charles Edwards, Food Safety

and Inspection Service, U.S.

Department of Agriculture, rm. 405,

Cotton Annex, 300 12th St. SW.,

Washington, DC 20250–3700; 202–

205–0675; FAX 202–205–0080.

SUPPLEMENTARY INFORMATION:

I. Draft Risk Assessment

A. Background

The draft risk assessment was written

by FDA’s Center for Food Safety and

Applied Nutrition (CFSAN) and USDA/

FSIS, in consultation with the Centers

for Disease Control and Prevention

(CDC). These agencies began this

comprehensive quantitative microbial

risk assessment (QMRA) in 1999, and

have held two public meetings to

present the framework of the

assessment, the assumptions, and the

modeling procedures.

In the Federal Register of May 7, 1999

(64 FR 24661), FDA, in collaboration

with USDA/FSIS, announced plans to

conduct a risk assessment to determine

the extent of consumer exposure to

foodborne L. monocytogenes. In the

Federal Registers of May 7, 1999 (64 FR

24663), and August 13, 1999 (64 FR

44225), the agencies announced public

meetings to discuss issues related to the

risk models under development. You

may refer to these notices for further

background information.

B. The Listeria monocytogenes QMRA

The goal of this QMRA is to provide

FDA and USDA/FSIS with information

that will assist the agencies with the

review of current programs and the

development of new programs relating

to the regulation of L. monocytogenes

contamination in foods to ensure that

such programs protect the public health.

QMRA is a structured and systematic

process of collecting and evaluating data

and information to establish the risks to

human health from consumption of

pathogenic microorganisms. The draft

risk assessment evaluates the available

data on food consumption,

contamination of various foods within

20 ready-to-eat food product categories

by L. monocytogenes, growth of the

pathogen in such foods, and the

infectious dose. The draft risk

assessment follows the framework

recommended by both the National

Academy of Sciences and the Codex

Alimentarius Commission. This

structured framework involves the

following steps:

(1) Hazard identification. The

collection and critical review of data

and information on L. monocytogenes.

(2) Exposure assessment. The

determination of total exposure to L.

monocytogenes from consumption of

various foods using prevalence and food

consumption data.

(3) Hazard characterization/Doseresponse. The assessment of the

potential for L. monocytogenes to cause

illness in human populations using

epidemiological investigations and data

from animal studies.

(4) Risk characterization. The

integration of the exposure and doseresponse data into a complex model to

estimate both the risk to the public

health and the uncertainty associated

with this estimate.

The risk assessment process also

includes the identification of data gaps

and the development of, and the

reliance on, reasonable assumptions

when data are unavailable.

As part of a peer evaluation of the

draft risk assessment, FDA and USDA/

FSIS are seeking comments that can be

used to improve:

(1) The assumptions made,

(2) the modeling technique,

(3) the data used, and

(4) the transparency of the draft risk

assessment document.

It is our intent to review and evaluate

all public comments and make

modifications to the assessment, as

appropriate. As noted previously, the

draft risk assessment is available

electronically on websites listed in

section III of the Supplementary

Information section of this document

and may be reviewed at the FDA’s

Dockets Management Branch and FSIS’s

Docket Clerk’s Office (addresses above).

II. HHS/USDA Risk Management

Action Plan

A. Background

On May 5, 2000, the President

directed the Secretary of HHS and the

Secretary of Agriculture to identify

aggressive steps to reduce significantly

the risk of illness and death from L.

monocytogenes in ready-to-eat foods.

The President called for action to reduce

the number of L. monocytogenes

illnesses by 50 percent by the year

2005—5 years ahead of the previously

established Healthy People 2010 target.

The President directed the Secretary

of HHS to develop an action plan

identifying additional steps necessary to

reduce L. monocytogenes

contamination. He specifically directed

that the HHS plan include consideration

of control measures for at-risk foods,

publication of guidance for processors,

retailers, and food service facilities, and

consideration of enhanced labeling to

provide additional safeguards for

consumers. The President also directed

the Secretary of Agriculture to report

back on the actions that would reduce

significantly the risk of illness and

death from L. monocytogenes in readyto-eat foods. The President in particular

directed the Secretary of Agriculture to

‘‘complete proposed regulations that

include any appropriate microbiological

testing and other industry measures’’ to

prevent cross-contamination in the

processing environment; ensure that the

processing of ready-to-eat products

meets appropriate standards; and ensure

that such products are safe throughout

their shelf-life. Taken together, these

actions are designed to reduce L.

monocytogenes-related illnesses by 50

percent by 2005.

B. The L. Monocytogenes Action Plan

The action plan outlines the actions

HHS and USDA intend to undertake to

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Notices 5517

reduce L. monocytogenes illnesses from

ready-to-eat foods. The plan focuses on

those food categories identified in the

draft risk assessment as either

warranting additional measures to

reduce L. monocytogenes contamination

or warranting collection of additional

data. Within HHS, FDA and CDC have

the primary responsibility for

implementation of this action plan.

Within USDA, FSIS has the primary

responsibility for implementation of this

plan, working in concert with other

USDA agencies through the Office of

Food Safety.

The action plan contains the

following eight action areas:

(1) Enhance consumer and health care

provider information and education

efforts;

(2) Develop and revise guidance for

processors, retailers, and food service/

institutional establishments that

manufacture or prepare ready-to-eat

foods;

(3) Develop and deliver training/

technical assistance to the regulated

industry and food safety regulatory

employees;

(4) Review and redirect enforcement

and regulatory strategies including

microbial product sampling;

(5) Propose new regulations and

revisions to existing regulations as

needed;

(6) Enhance disease surveillance and

outbreak response;

(7) Initiate projects with retail

operations such as delicatessens and

salad bars to pilot new L.

monocytogenes control measures

including employee practices; and

(8) Coordinate research activities to

refine the risk assessment, enhance

preventive controls, and support

regulatory, enforcement, and

educational activities.

As noted, the draft risk assessment

will be available, along with other

information, to assist HHS and USDA as

they consider the specific means to

implement the elements of the action

plan.

III. Electronic Access

The draft risk assessment document

and the risk management plan are

available electronically as follows:

Draft Risk Assessment Document www.cfsan.fda.gov

www.fsis.usda.gov

www.foodsafety.gov

www.foodriskclearinghouse.umd.edu

The Risk Management Action Plan www.cfsan.fda.gov

www.foodsafety.gov

www.fsis.usda.gov

Dated: January 11, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation, Food and Drug

Administration, HHS.

Thomas J. Billy,

Administrator, Food Safety Inspection

Service, USDA.

[FR Doc. 01–1439 Filed 1–18–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N–1075]

Public Health Impact of Vibrio

Parahaemolyticus in Raw Molluscan

Shellfish; Draft Risk Assessment

Document; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft risk assessment on

the relationship between Vibrio

parahaemolyticus in raw molluscan

shellfish, specifically oysters, and

human health. FDA began this

quantitative microbial risk assessment

(QMRA) in 1999, and the agency has

held three public meetings on the

framework of the assessment, the

assumptions, and the modeling

procedures. As part of the review

process, the agency is making this draft

risk assessment available and is seeking

comments on the technical aspects of

the draft risk assessment. A public

meeting to discuss the draft risk

assessment will be announced in a

future issue of the Federal Register.

DATES: Submit written comments on the

draft risk assessment by March 20, 2001.

ADDRESSES: The draft risk assessment is

available electronically on the FDA

Internet at www.foodsafety.gov/dms/fstoc.html. Hard copies of the draft risk

assessment will be available upon

request; fax requests to 1–877–366–

3322. The draft risk assessment may

also be reviewed at the Dockets

Management Branch (address below)

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

through Friday.

Submit written comments to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. Two copies of comments are

to be submitted, except that individuals

may submit one copy. Comments must

be identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

For specific technical information

contact: Marianne Miliotis, Vibrio

parahaemolyticus Risk Assessment