[Federal Register Volume 64, Number 122 (Friday, June 25, 1999)]
[Rules and Regulations]
[Pages 34125-34126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16188]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 99N-1979]


Apple Cider Food Safety Control; Workshop

Agency: Food and Drug Administration, HHS.
Action: Notice of workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a 
workshop on food safety controls for the apple cider industry. The 
workshop will clarify issues related to the implementation of the 
agency's regulations requiring a warning statement for certain juice 
products. Specifically, the workshop will address pathogen reduction 
interventions that may be effective for apple cider production and the 
methods used to measure and validate such interventions. Results of 
research conducted by Federal, State, private, and academic 
institutions will be presented.

DATES: The workshop will be held on Thursday, July 15, 1999, from 9 
a.m. to 4 p.m., and Friday, July 16, 1999, from 9 a.m. to noon. Written 
comments and requests to distribute materials and scientific studies at 
the meeting will be accepted until Friday, July 2, 1999. Submit written 
notices of registration by July 8, 1999.

ADDRESSES: The workshop will be held at the Department of Health and 
Human Services, Hubert Humphrey Bldg., conference room 705-A, 200 
Independence Ave. SW., Washington, DC 20201. Submit registration and 
written notices of participation to Darrell J. Schwalm (address below). 
Submit written comments, written requests to distribute materials, and 
materials regarding relevant scientific studies to be distributed at 
the workshop to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Two 
copies of any comments and materials to be distributed are to be 
submitted, except that individuals may submit one copy. Comments and 
materials to be distributed are to be identified with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Darrell J. Schwalm, Center for Food 
Safety and Applied Nutrition (HFS-625), Food and Drug Administration, 
200 C. St. SW., Washington, DC 20204, 202-205-4040, FAX 202-205-4121 or 
e-mail ``[email protected]''.
    Registration for the workshop will be provided on a first come 
first served basis. Persons interested in attending this workshop 
should, by Friday, July 8, 1999, fax their name, title, firm name,

[[Page 34126]]

address, telephone and fax number, and e-mail address to Darrell J. 
Schwalm (fax number above). If you need special accommodations due to a 
disability, please contact Darrell J. Schwalm (address above) at least 
7 days in advance.
    Interested persons should note that additional information 
regarding the workshop will be posted on FDA's web site 
``www.cfsan.fda.gov'', as it becomes available. Accordingly, such 
persons are encouraged to visit that web site on a regular basis until 
the workshop convenes.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 8, 1998 (63 
FR 37030), FDA published a final regulation that required a warning 
statement on fruit and vegetable juice products that have not been 
processed to prevent, reduce, or eliminate pathogenic microorganisms 
that may be present in such juices. The regulation provides that the 
warning statement requirement does not apply to a juice that has been 
processed in a manner that will result in, at a minimum, a reduction in 
the pertinent microorganism of at least a 5-log magnitude (i.e., 
100,000 fold). In the preamble to the proposed rule (63 FR 20486, April 
24, 1998), FDA recognized that pasteurization is a process that can 
produce the 5-log reduction. The agency also noted that manufacturers 
may be able to use other technologies and practices, individually or in 
combination, to achieve the 5-log reduction, provided that the 
manufacturer's process is validated to achieve the 5-log reduction in 
the target microorganism.
    In the preamble to the final regulation, FDA indicated it would be 
willing to meet with manufacturers or groups of manufacturers to 
discuss and evaluate their proposed processes. FDA also stated that in 
order to help processors meet the pathogen reduction standard, the 
agency would make available, in accordance with part 20 (21 CFR part 
20) of its regulations, information received by the agency regarding 
processes that have been validated to achieve a 5-log reduction.
    The July 15 and 16, 1999, workshop will include a discussion of the 
control measures, that FDA is aware of, that can be used for apple 
cider production and of the methods for measuring and validating the 
effectiveness of measures in reducing pathogens. At the beginning of 
the workshop, a proceedings document will be provided to registered 
participants.
    FDA believes that this workshop will also provide an opportunity 
for industry representatives and other members of the public to discuss 
information regarding control measures that are believed to achieve the 
5-log reduction. Participants are requested to bring to the workshop at 
least 50 copies of any written or published materials they wish to 
distribute. Agency experts will be available to answer technical food 
safety questions.
    A video recording of the proceedings will be prepared; copies of 
the video may be requested in writing from the Freedom of Information 
Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 
12A-16, Rockville, MD 20857, approximately 15-working days after the 
meeting. The video recording of the meeting, submitted comments, and 
materials for distribution will be available for public examination at 
the Dockets Management Branch (address above) between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: June 21, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy Coordination.
[FR Doc. 99-16188 Filed 6-22-99; 12:38 pm]
BILLING CODE 4160-01-F