[Federal Register Volume 68, Number 79 (Thursday, April 24, 2003)]
[Notices]
[Page 20159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-10074]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02P-0009]


Guidance for Industry: Guidance on Bulk Transport of Juice 
Concentrates and Certain Shelf Stable Juices; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance document entitled ``Guidance on Bulk 
Transport of Juice Concentrates and Certain Shelf Stable Juices.'' The 
purpose of the guidance is to provide industry with FDA's 
recommendations for appropriate control measures to use in the bulk 
transport of juice concentrates and certain shelf stable juices.

DATES: Submit written or electronic comments on the guidance at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance 
document to Amy Green, Center for Food Safety and Applied Nutrition 
(see FOR FURTHER INFORMATION CONTACT). Send one self-addressed adhesive 
label to assist that office in processing your requests or include a 
fax number to which the guidance document may be sent. Submit written 
comments on the guidance document to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Amy Green, Center for Food Safety and 
Applied Nutrition (HFS-306), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, 301-436-2025, FAX: 301-436-2651.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 7, 2002 (67 FR 62488), FDA 
announced the availability of a draft guidance document entitled 
``Draft Guidance for Industry: Guidance on Bulk Transport of Juice 
Concentrates and Certain Shelf Stable Juices.'' The purpose of the 
draft guidance was to provide processors of juice concentrates and 
certain shelf stable juice products with recommendations for the use of 
appropriate control measures to ensure that juice concentrates and 
certain shelf stable juice products do not become contaminated or 
recontaminated with a microbial pathogen during bulk transport. 
Interested persons were given until December 6, 2002, to comment on the 
draft guidance.
    In response to the draft guidance document, FDA received one letter 
from a State agency requesting that FDA require many of the draft 
guidance's recommended control measures in the guidance document. FDA 
disagrees with these requests. Under the agency's good guidance 
practices regulation (GGPs) (21 CFR 10.115), a guidance document is not 
legally binding on the agency or the public and mandatory words, such 
as ``shall,'' ``must,'' ``require,'' and ``requirement,'' are not to be 
used unless they describe or discuss a statutory or regulatory 
requirement. The purpose of the guidance document is to provide juice 
processors with recommendations, rather than requirements, pertaining 
to control measures that may be adequate for ensuring the safety of 
juice concentrates and certain shelf stable juices during bulk 
transport. While some juice processors may choose to adopt the State 
agency's suggested control measures (if such measures are effective), 
an alternate approach may be used if that approach offers an adequate 
level of protection from contamination or recontamination with a 
microbial pathogen during bulk transport. Therefore, FDA is not 
adopting in the guidance document any of the State agency's comments.

II. Conclusion

    The agency is adopting as guidance the recommended control measures 
as presented in the draft guidance document. After carefully 
considering the comment from a State agency suggesting that FDA require 
in this guidance more stringent and prescriptive control measures for 
bulk transport, the agency has determined that no changes are 
warranted.
    The guidance document is being issued as a level 1 guidance, 
consistent with FDA's GGPs (21 CFR 10.115). The guidance represents the 
agency's current thinking on appropriate control measures for bulk 
transport of juice concentrates and certain shelf stable juices to 
ensure that contamination or recontamination with a microbial pathogen 
during bulk transport does not occur. It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if it satisfies the 
requirements of the applicable statutes and regulations.

III. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES), written or electronic comments regarding this guidance 
document at any time. Two copies of any mailed 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. The guidance and received comments may be seen in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

IV. Electronic Access

    Interested persons also may access the guidance document at http://www.cfsan.fda.gov/guidance.html.

    Dated: April 15, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-10074 Filed 4-23-03; 8:45 am]
BILLING CODE 4160-01-S