[Federal Register Volume 63, Number 242 (Thursday, December 17, 1998)]
[Proposed Rules]
[Pages 69579-69580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33404]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 120

[Docket No. 97N-0511]


Hazard Analysis and Critical Control Point (HACCP); Procedures 
for the Safe and Sanitary Processing and Importing of Juice: Reopening 
of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is reopening to January 
16, 1999, the comment period for the proposal to require the 
application of hazard analysis and critical control point (HACCP) 
principles to the processing of fruit and vegetable juices and juice 
products (the juice HACCP proposal) that published in the Federal 
Register of April 24, 1998 (63 FR 20450). FDA is announcing the 
availability of the transcripts from two technical scientific workshops 
sponsored by FDA regarding implementation of the agency's warning 
statement requirement for fruit and vegetable juices and juice 
products. FDA is reopening the comment period for the juice HACCP 
proposal in order to receive comment on data and other information from 
the two technical scientific workshops. FDA is also reopening the 
comment period in order to receive comments and other information 
regarding the application of the 5-log pathogen reduction standard.

DATES: Written comments must be submitted by January 19, 1999.

ADDRESSES: Submit written comments and requests for single copies of 
the transcripts to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Shellee A. Davis, Center for Food 
Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5023.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 24, 1998 
(63 FR 20450), FDA proposed to adopt regulations to ensure the safe and 
sanitary processing of fruit and vegetable juices and juice products. 
In addition, in the Federal Register of July 8, 1998 (63 FR 37030), FDA 
published a final rule requiring that juice products not specifically 
processed to destroy harmful bacteria (i.e., processed to achieve a 5-
log reduction in the most resistant pathogen of public health concern) 
bear a warning statement informing consumers of the potential risk of 
foodborne illness associated with the product (the warning statement 
rule). The compliance date for the warning statement rule was September 
8, 1998, for apple juice and apple cider; the compliance date for 
juices other than apple juice or apple cider was November 5, 1998.
    In the Federal Register of October 28, 1998 (63 FR 57594), FDA 
announced two technical scientific workshops to discuss and clarify 
issues related to the implementation of the warning statement rule for 
citrus juice products not specifically processed to destroy harmful 
bacteria. These workshops were held November 12, 1998, and November 19, 
1998. Although the issues discussed in the workshops pertain to the 
implementation of the warning statement requirement, these issues also 
bear upon certain provisions of the HACCP proposal. FDA is announcing 
the availability of the transcripts from the two technical scientific 
workshops.
    Interested persons were initially given until July 8, 1998, to 
comment on the HACCP proposal. On July 8, 1998 (63 FR 37057), in 
response to requests, the comment period was extended to August 7, 
1998. FDA has decided to reopen the comment period to allow comment on 
data and other information that were presented at or developed as a 
result of these workshops to be included in the record of the HACCP 
rulemaking. In addition, FDA seeks comments on the application of the 
5-log pathogen reduction standard. FDA requests comments on four 
specific topics: (1) Appropriate baselines for the calculation of the 
5-log pathogen reduction; (2) feasible interventions or practices for 
the cultivation and harvest of fruits and vegetables, and acquisition 
of supplies and materials that may contribute to achieving a 5-log 
pathogen reduction; (3) feasible interventions for the production 
process that may contribute to achieving a 5-log pathogen reduction; 
and (4) acceptable methods for measuring and validating 5-log 
reductions.
    To be considered, written comments must be received by January 16, 
1999, by the Dockets Management Branch (address above). Two copies of 
any

[[Page 69580]]

comments are to be submitted, except that individuals may submit one 
copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. Received comments may be seen 
in the office above between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 23, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-33404 Filed 12-16-98; 8:45 am]
BILLING CODE 4160-01-F