[Federal Register Volume 67, Number 194 (Monday, October 7, 2002)]
[Notices]
[Pages 62488-62489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-25342]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02P-0009]


Draft Guidance for Industry: Guidance on Bulk Transport of Juice 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availability of a draft guidance document entitled ``Guidance on Bulk 
Transport of Juice Concentrates and Certain Shelf Stable Juices.'' This 
draft guidance document is intended to provide processors of juice 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 juices do not become 
contaminated or recontaminated with microbial pathogens during bulk 
transport.

DATES: Submit written or electronic comments concerning the draft 
guidance by December 6, 2002, to ensure adequate consideration in the 
preparation of the final guidance document. Comments on this guidance 
may be submitted at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to Amy Green (see FOR FURTHER INFORMATION CONTACT). See 
SUPPLEMENTARY INFORMATION section for electronic access to this draft 
guidance.
    Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with 
the docket number found in brackets in the heading of this document. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments.

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

    FDA has developed the draft guidance document to provide processors 
of juice concentrates and certain shelf stable juice products with 
recommendations for the use of appropriate control measures to help 
ensure that juice concentrates and certain shelf stable juice products 
do not become contaminated or recontaminated with microbial pathogens 
during bulk transport. The draft guidance recommends control measures 
for several transport modalities, including: (1) Multiuse or reusable 
containers (e.g., tankers, reusable drums without liners, and reusable 
totes without liners) and (2) single-use sanitary containers or liners 
(e.g., single-use sanitary totes, single-use sanitary drums, bag-in-box 
containers, totes with single-use sanitary liners, and drums with 
single-use sanitary liners). The draft document describes five major 
areas of concern with bulk transport systems, special considerations 
for tankers, and provides examples of a cleaning and sanitizing 
protocol for a tanker, control measures that might be used in loading 
and unloading a tanker, and critical control points a producer might 
use to include bulk transport in its hazard analysis critical control 
point (HACCP) plan.
    This draft guidance is partly in response to a citizen petition 
submitted by certain representatives of the juice industry asking that 
FDA: (1) Amend 21 CFR 120.24(c) to exempt processors of juice 
concentrate and certain shelf stable juice products from the ``single 
facility requirement'' and (2) delay the effective date of the ``single 
facility requirement'' until the agency has disposed of the citizen 
petition. The petitioners contend that transportation hazards, which 
the ``single facility requirement'' was designed to address, could be 
adequately addressed as part of a processor's HACCP plan. This draft 
guidance provides recommendations that producers and users of juice 
concentrates and certain shelf stable juice products can use to 
prevent, reduce to acceptable levels, or eliminate the risk of 
contamination or recontamination of these products with microbial 
pathogens during bulk transport and thus satisfy the conditions under 
which FDA will consider the exercise of enforcement discretion.
    The draft guidance entitled ``Guidance on Bulk Transport of Juice 
Concentrates and Certain Shelf Stable

[[Page 62489]]

Juices'' is being issued as a level 1 draft guidance consistent with 
FDA's good guidance practices regulation (21 CFR 10.115). This draft 
guidance represents the agency's current thinking on this subject. 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 such approach satisfies the requirements of the applicable statutes 
and regulations.

II. Comments

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

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
http://www.cfsan.fda.gov/[tilde]dms/guidance.html.

    Dated: September 27, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-25342 Filed 10-4-02; 8:45 am]
BILLING CODE 4160-01-S