[Federal Register: April 24, 2003 (Volume 68, Number 79)]
[Notices]
[Page 20159]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24ap03-59]
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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announced the availability of a draft guidance document entitled
``Draft Guidance for Industry: Guidance on Bulk Transport of Juice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draft guidance was to provide processors of juice concentrates and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