[Federal Register Volume 63, Number 130 (Wednesday, July 8, 1998)]
[Proposed Rules]
[Page 37057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18286]



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

[[Page 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.

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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