[Federal Register Volume 63, Number 208 (Wednesday, October 28, 1998)]
[Rules and Regulations]
[Pages 57594-57596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-28901]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 97N-0524]


Food Labeling: Warning and Notice Statement; Labeling of Juice 
Products; Technical Scientific Workshops; Requests for Additional Time 
to Achieve the Pathogen Reduction Standard

AGENCY: Food and Drug Administration, HHS.

ACTION: Technical scientific workshops; requests for additional time to 
achieve the pathogen reduction standard; rule related.

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SUMMARY: The Food and Drug Administration (FDA) is announcing two 
technical scientific workshops to discuss and clarify issues related to 
the implementation of the agency's rule requiring a warning statement 
for certain juice products. In particular, the workshops will address 
the pathogen reduction interventions that have been developed for 
citrus juice production and the methods for measuring and validating 
such systems. FDA is also announcing a process by which individual 
manufacturers of citrus juices may request additional time, beyond the 
current compliance date of November 5, 1998, to implement a validated 
system of control measures that achieves the required reduction in 
pathogenic microorganisms. Manufacturers who implement such control 
measures will not be required to use the warning statement on their 
juice products. These actions are being taken in response to requests 
from several fresh citrus juice manufacturers that have indicated they 
want to implement improved controls but need additional time to do so.

DATES: The technical scientific workshops will be held on November 12, 
1998, and on November 19, 1998. Both workshops will be from 8:30 a.m. 
to 5:30 p.m. Registration for the workshops will be provided on a first 
come, first served basis and must be received by November 6, 1998.
    Individual fresh citrus juice producers may request additional time 
to comply with the pathogen reduction standard in Sec. 101.17(g)(7)(i) 
(21 CFR 101.17(g)(7)(i)) until December 19, 1998. For requests for 
additional time, see the FDA District Directors listed under the 
SUPPLEMENTARY INFORMATION section of this document.
ADDRESSES: The technical scientific workshops will be held at the 
following locations:
    The November 12, 1998, workshop will be held at the Citrus Research 
and Education Center, University of Florida, Lake Alfred, FL 33850, 
941-956-1151 and
     the November 19, 1998, workshop will be held at the FDA District 
Office, 19900 MacArthur Blvd., suite 300, Irvine, CA 90015-2486, 949-
252-7592.
    For requests for additional time, see the FDA District Directors 
listed under the SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT:
    To register for a technical workshop, please contact Catherine M. 
DeRoever, Center for Food Safety and Applied Nutrition (CFSAN) (HFS-
22), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 
202-205-4251, FAX 202-205-4970 or e-mail ``[email protected]''. 
Registration information (including name, title, firm name, address, 
telephone and fax numbers) must be received no later than November 6, 
1998.
    For information on requests for additional time to achieve the 
pathogen reduction standard, please contact, as listed in the 
SUPPLEMENTARY INFORMATION section of this document, the Director of the 
FDA District Office in which the firm is located.
    If you need special accommodations due to a disability, please 
contact Catherine M. DeRoever at the previous address at least 7 days 
in advance.
    Interested persons should note that additional information 
regarding the technical scientific workshops, making requests for 
additional time and other relevant information will be posted on 
CFSAN's web site, ``www.cfsan.fda.gov,'' as it becomes available. 
Accordingly, such persons may wish to visit that web site on a regular 
basis until the workshop convenes.
SUPPLEMENTARY INFORMATION: Requests by individual citrus firms for 
additional time to implement control measures and validate that the 
process achieves the pathogen reduction in Sec. 101.17(g)(7)(i) should 
be addressed to the Director of the FDA District in which the firm is 
located. For firms in Florida, Texas, Arizona, and California the 
addresses are:
    Douglas Tolen, District Director, FDA Florida District Office, 7200 
Lake Ellenor Dr., suite 120, Orlando, FL 32809, 407-475-4700;

[[Page 57595]]

    Joseph Baca, District Director, FDA Dallas District Office, 3310 
Live Oak St., Dallas, TX 75204, 214-655-5315; or
    Elaine C. Messa, District Director, FDA Los Angeles District 
Office, 19900 MacArthur Blvd., suite 300, Irvine, CA 92612-2445, 949-
798-7714.
     In the Federal Register of July 8, 1998 (63 FR 37030), FDA 
published a final regulation that requires 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 produce, 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 (such 
as a combination of eliminating use of drops, brushing, washing and 
using sanitizers) 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 stated its expectation 
that citrus juice processors should be able to achieve and validate a 
5-log reduction without pasteurization (63 FR 37030 at 37042). FDA also 
indicated that it would be willing to meet with manufacturers or groups 
of manufacturers to discuss and evaluate their proposed processes. In 
addition, FDA stated that in order to help processors meet the pathogen 
reduction standard, the agency would make available, in accordance with 
21 CFR part 20 of its regulations, information received by the agency 
regarding processes that have been validated to achieve a 5-log 
reduction.
    FDA has received requests from several manufacturers of fresh 
citrus juice for 18-additional months beyond the November 5, 1998, 
compliance date for the warning statement requirement to permit such 
firms to develop and to validate procedures that will achieve the 5-log 
reduction in citrus juices. In discussions with the agency, there was 
evidence of widespread confusion among juice manufacturers as to how 
FDA expects the 5-log reduction to be achieved.
    Upon consideration of the fresh citrus juice manufacturers' request 
and in light of other information before the agency regarding progress 
made by some citrus juice manufacturers in identifying effective 
mechanisms for pathogen reduction, FDA has developed a two-part 
strategy to respond to these requests. First, FDA will sponsor two 
technical scientific workshops for the citrus juice industry, open to 
the public, on November 12 and November 19, l998. Each workshop will 
include a discussion of the control measures of which FDA is aware that 
are being used for citrus juice production and of the methods for 
measuring and validating the effectiveness of the measures in reducing 
pathogens. FDA believes that these workshops will provide an 
opportunity for industry representatives and other members of the 
public to share information regarding control measures that are 
believed to achieve the 5-log reduction. Participants are requested to 
bring to the workshop at least 150 copies of any written or published 
materials they wish to distribute at the workshop. Agency experts will 
be available to answer technical questions.
    Second, as noted, several firms have requested that FDA extend the 
final rule's compliance date for citrus juices to permit those firms 
additional time to develop and validate intervention measures that 
achieve the 5-log pathogen reduction standard. FDA believes that a 
formal extension of the rule's compliance date is not feasible in the 
current circumstances because such extension would arguably require 
notice and comment rulemaking. Nevertheless, FDA believes that under 
certain conditions (which are enumerated as follows), it would be an 
appropriate exercise of the agency's enforcement discretion to suspend 
enforcement of the final rule for a limited period of time. In 
particular, FDA will consider such an exercise of its enforcement 
discretion for those citrus juice producers who no later than December 
19, 1998, request such consideration and who make the following 
commitments in writing:
    (1) The firm agrees to use the time period between November 4, 
1998, and July 8, 1999, to develop, adapt, and validate procedures that 
are sufficient to achieve a 5-log reduction in the pertinent 
microorganism; and,
    (2) The firm agrees to establish interim protection measures in the 
form of a system that applies hazard analysis and critical control 
point (HACCP) principles. This interim system will include, at a 
minimum, good manufacturing practices and specific control measures 
such as chemical washing and brushing of the fruit, sanitizing, culling 
of damaged fruit, and utilization of only those types of fruit with 
skins that are sufficiently smooth and durable to be cleanable and to 
remain intact after cleaning; and,
    (3) The firm agrees to comply with the provisions of the warning 
label regulation (Sec. 101.17 (g)) no later than July 8, 1999. As a 
result of this commitment, the firm will use the warning label on its 
products beginning July 8, 1999, if it has been unable to implement 
validated control measures that achieve the 5-log reduction.
    FDA believes that this two-part strategy is reasonable and will 
provide appropriate public health protection. As noted in the warning 
statement rulemaking, because the warning statement provides consumers 
with important information about the risk of foodborne illness, the 
warning requirement contributes to public health protection in that it 
allows consumers to make informed purchase decisions. In FDA's view, 
this warning statement requirement is primarily an interim step 
designed to reduce the risk of fresh juice consumption pending 
completion of a final HACCP rule and its implementation. However, 
because the warning statement requirement may nevertheless allow 
contaminated juice products to reach the marketplace, FDA does not 
expect the statement to be as effective in protecting consumers as 
would a validated 5-log reduction program. FDA believes it is 
appropriate to consider exercising its enforcement discretion where, as 
a result of such exercise, the agency can provide an incentive for 
citrus juice processing firms to produce safe juice earlier than such 
firms would otherwise do.
    Because of the relationship between particular provisions in the 
warning statement regulation and the HACCP proposal, FDA is announcing 
its intention to reopen the comment period on the juice HACCP proposal 
(63 FR 20450) entitled ``Hazard Analysis and Critical Control Point 
(HACCP); Procedures for the Safe and Sanitary Processing and Importing 
of Juice.'' This reopening will allow information and data presented at 
the workshop to be included in the record of the HACCP rulemaking. A 
Federal Register document announcing the reopening of the juice HACCP 
proposal comment period will be published at a later date.
    Transcripts of the workshops will be prepared. Copies of the 
transcripts 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

[[Page 57596]]

days after the meetings at a cost of 10 cents per page.

    Dated: October 23, 1998.
 William B. Schultz,
 Deputy Commissioner for Policy.
[FR Doc. 98-28901 Filed 10-23-98; 3:47 pm]
BILLING CODE 4160-01-F