Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 / Proposed Rules 37057

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 120

[Docket Nos. 97N–0511, 93N–0325, and

97N–0296]

RIN 0910–AA43

Hazard Analysis and Critical Control

Point (HACCP); Procedures for the

Safe and Sanitary Processing and

Importing of Juice; Extension of

Comment Period

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule; preliminary

regulatory impact analysis; extension of

comment period.

SUMMARY: The Food and Drug

Administration (FDA) published in the

Federal Register of April 24, 1998 (63

FR 20450), a proposed rule to ensure the

safe and sanitary processing of fruit and

vegetable juices and juice products. In

addition, FDA published in the Federal

Register of May 1, 1998 (63 FR 24254),

the preliminary regulatory impact

analysis (PRIA) and initial regulatory

flexibility analysis (IRFA) on the costs

and benefits of two FDA juice proposals,

including one proposal to require the

application of hazard analysis and

critical control point (HACCP)

principles to the processing of fruit and

vegetable juice and juice products (the

juice HACCP proposal). Interested

persons were given until July 8, 1998, to

comment on the juice HACCP proposal

and the corresponding economic impact

analyses. FDA has received a number of

requests for an extension of the

comment period. In response to these

requests, the agency is extending the

comment period until August 7, 1998,

on the juice HACCP proposal and on

those aspects of the PRIA and IRFA

relevant to HACCP for juice and juice

products.

DATES: Written comments must be

received by August 7, 1998.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Geraldine A. June, Center for Food

Safety and Applied Nutrition (HFS–

158), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–205–5099.

SUPPLEMENTARY INFORMATION: In the

Federal Register of April 24, 1998 (63

FR 20450), FDA issued a proposed rule

(the juice HACCP proposal) to ensure

the safe and sanitary processing of fruit

and vegetable juice and juice products.

In addition, FDA published in the

Federal Register of May 1, 1998 (63 FR

24254), the PRIA that it prepared under

Executive Order 12866 and IRFA that it

prepared under the Regulatory

Flexibility Act, as amended by the

Small Business Regulatory Enforcement

and Fairness Act, on the costs and

benefits of the juice HACCP proposal

and a related juice labeling proposal (63

FR 20486). FDA issued the juice HACCP

proposal and the juice labeling proposal

because of the recent outbreaks of

foodborne illness and deaths associated

with the consumption of juice products

that had not been pasteurized or

otherwise processed to control

pathogenic microorganisms.

Interested persons were given until

July 8, 1998, to comment on the juice

HACCP proposal and on those aspects

of the PRIA and IRFA relevant to

HACCP for juice and juice products.

FDA has received a number of requests

for an extension of the comment period.

After evaluating these requests, the

agency has decided to extend the

comment period on the juice HACCP

proposal and the corresponding

economic analyses until August 7, 1998.

To be considered, written comments

regarding the juice HACCP proposal and

those aspects of the PRIA and IRFA

relevant to the juice HACCP proposal

must be received by August 7, 1998, by

the Dockets Management Branch

(address above). Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with

Docket No. 97N–0511 (juice HACCP

proposal) and/or Docket Nos. 93N–0325

and 97N–0296 (juice HACCP aspects of

the PRIA and IRFA), as appropriate.

Received comments may be seen in the

Dockets Management Branch between 9

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

Friday.

Dated: July 6, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–18286 Filed 7–6–98; 3:34 pm]

BILLING CODE 4160–01–F