[Federal Register Volume 64, Number 225 (Tuesday, November 23, 1999)]
[Proposed Rules]
[Pages 65669-65671]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30525]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 120

[Docket No. 97N-0511]

RIN 0910-AA43


Hazard Analysis and Critical Control Point (HACCP); Procedures 
for the Safe and Sanitary Processing and Importing of Juice; 
Availability of New Data and Information and Reopening of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening to January 
24, 2000, the comment period for the proposal to require the 
application of hazard analysis and critical control point (HACCP) 
principles to the processing of fruit and vegetable juices and juice 
products (the juice HACCP proposal) that published in the Federal 
Register of April 24, 1998 (63 FR 20450). The agency is reopening the 
comment period for the juice

[[Page 65670]]

HACCP proposal in order to receive comment and other information on 
four specific issues: internalization and survival of pathogens in 
produce used to produce juice, especially citrus fruit; application and 
measurement of the 5-log reduction standard; current methods used by 
juice processors to monitor the application of heat treatment to juice; 
and certain economic matters related to juice regulation. FDA is also 
announcing the availability of new data and other information about the 
safe processing of juice and juice products, and is requesting comment 
on the new data and other information.

DATES: Written comments must be received by January 24, 2000.
ADDRESSES: Submit written comments and requests for single copies of 
the transcripts to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Shellee Anderson, Center for Food 
Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5023.

SUPPLEMENTARY INFORMATION:

I. Background

     In the Federal Register of April 24, 1998 (63 FR 20450), FDA 
proposed regulations to ensure the safe and sanitary processing of 
fruit and vegetable juices. In addition, in the Federal Register of 
July 8, 1998 (63 FR 37030), FDA published a final rule requiring that 
juice products not specifically processed to destroy harmful bacteria 
(i.e., processed to achieve a 5-log (105) reduction in the most 
resistant pathogen of public health significance) bear a warning 
statement informing consumers of the potential risk of foodborne 
illness associated with the product (the warning statement rule). The 
compliance date for the warning statement rule was September 8, 1998, 
for apple juice and apple cider; the compliance date for juices other 
than apple juice or apple cider was November 5, 1998.
     Interested persons were initially given until July 8, 1998, to 
comment on the HACCP proposal. On July 8, 1998 (63 FR 37057), in 
response to requests, the HACCP proposal comment period was extended to 
August 7, 1998. FDA subsequently reopened the comment period on 
December 17, 1998 (63 FR 69579) until January 19, 1999, to receive 
comments on data and other information that were presented at or 
developed as a result of two technical scientific workshops sponsored 
by FDA regarding implementation of the agency's warning statement 
requirement for fruit and vegetable juices and juice products and to 
receive comments and other information regarding the application of the 
5-log pathogen reduction standard.
     As noted, in the HACCP proposal, FDA proposed to require that 
juice processors include in their HACCP plans control measures that 
will produce at least a 5-log reduction in the pertinent pathogen. The 
agency did not propose a specific intervention technology (e.g., 
pasteurization), but instead proposed a flexible 5-log performance 
standard that theoretically could be met through cumulative steps and, 
at least for some fruit (e.g., oranges), through surface treatments. In 
the preamble to the proposed rule, FDA stated that pathogens are not 
reasonably likely to be present in the interior of sound whole oranges 
or other citrus fruits, and further, that the acidic nature of citrus 
fruits may further inactivate any pathogens that may be present (63 FR 
20450 at 20478). In the proposal, FDA noted that steps such as culling, 
washing, brushing, and sanitizing the surface of fruit, followed by 
extraction that minimized contact with the peel, could be used 
cumulatively to attain the 5-log reduction, as long as processors could 
validate the reduction under their HACCP systems.
     Comments to the proposed rule, as well as new information 
available to FDA, have questioned the assumption that pathogens are not 
likely to be found in the interior of citrus fruit and have further 
suggested that surface treatment of fruit alone may not be adequate to 
ensure the safety of juice. In addition, FDA has undertaken research 
that suggests that, under certain conditions, pathogens could be 
internalized into citrus fruit and could survive once inside the fruit 
(Ref. 1). Specifically, the FDA studies show that the temperature 
differential between warm citrus fruit and cool wash water containing 
dye causes uptake of the dye into the fruit (Ref. 2). FDA believes that 
this dye study suggests that pathogens could likewise be drawn into the 
fruit through the stem scar or imperceptible cracks and holes if warm 
fruit is washed in cold water during preprocessing or possibly while 
the fruit is on the tree during a heavy rain storm. These susceptible 
fruits appear to be intact and would not necessarily be culled out and 
thus, could be processed into juice.
     FDA has also reviewed the published literature and certain 
unpublished information relevant to pathogen infiltration and survival 
in produce and has summarized this information in a background document 
(Ref. 3). This information, in addition to data gathered by FDA (Ref. 
1), suggests that there is potential for internalization of pathogens 
in apparently intact fruit. Based on this information, FDA has concerns 
that citrus fruit may not be impervious to penetration by pathogens, as 
was originally assumed in the proposed HACCP rule and the final 
labeling rule.
     The Food Safety and Inspection Service (FSIS) of the U.S. 
Department of Agriculture will soon announce a 3-day meeting (December 
8 through 10, 1999) of the National Advisory Committee on 
Microbiological Criteria for Foods (NACMCF); during days one and two of 
that meeting, NACMCF will focus on juice safety. FDA intends to provide 
the members of NACMCF with a copy of the summary document, Potential 
for Infiltration, Survival, and Growth of Human Pathogens within Fruits 
and Vegetables, as well as a report of the results of the recent FDA 
studies concerning the internalization and survival of microorganisms 
in citrus, Preliminary Studies on the Potential for Infiltration, 
Growth and Survival of Salmonella enterica serovar Hartford and 
Escherichia coli O157:H7 within Oranges, for their consideration prior 
to the December meeting. At the December meeting, FDA will be asking 
NACMCF to consider performance criteria for fresh juice, and 
specifically, to make recommendations about the efficacy of surface 
treatments in ensuring the safety of citrus juices.

II. Request for Comments

     In order for FDA to make sound decisions regarding the application 
of HACCP principles to the processing of juice, the agency should have 
before it the most complete administrative record possible. To that 
end, FDA is requesting additional comment in four separate areas: (1) 
Internalization and survival of pathogens in produce used to produce 
juice, especially citrus fruit; (2) application and measurement of the 
5-log reduction standard; (3) current methods used by juice processors 
to monitor the application of heat treatment to juice; and (4) certain 
economic matters related to juice regulation. In addition, FDA is 
requesting comment on the new data and other information being added to 
the administrative record of this rulemaking.
     First, concerning internalization and survival of pathogens, FDA 
is requesting comment, and supporting data or other information, on the 
following questions:
     (1) One assumption underlying the HACCP proposal is that there is 
no

[[Page 65671]]

internalization of pathogens in citrus fruit. Is this assumption valid?
     (2) Is internalization of pathogens into citrus fruit 
theoretically possible?
     (3) If internationalization of pathogens into citrus fruit is 
theoretically possible, is such internalization likely to result in a 
public health risk?
     (4) If internalization does occur and it results in a public 
health risk, are there techniques to assure that internalization of 
pathogens does not occur? What are they?
     Second, comments to the proposed HACCP rule requested that FDA 
clarify at what point in the production process a processor should 
begin to measure attainment of the 5-log pathogen reduction. In light 
of the new data and information on pathogen internalization and 
survival, FDA's current view is that for any juice made from fruit for 
which there is a potential for pathogens to be internalized, 
measurement of the 5-log reduction must begin where preventive 
treatment has intimate contact with pathogens. This means that the 5-
log reduction must be achieved after the juice has been extracted. 
Accordingly, in terms of the application of the 5-log reduction, FDA 
requests comment on the following:
     (1) FDA's current view is that the 5-log pathogen reduction must 
begin where the preventative treatment has intimate contact with the 
pathogens. FDA is particularly interested in any data or other 
information about scientifically validated procedures for a 5-log 
reduction that address FDA's concerns about pathogen internalization 
and that begin earlier in the process than the juice expression step.
     (2) The ability of processors to achieve the desired level of 
public health protection if processors: (a) Use cumulative steps that 
are separated in time or location, or (b) do not package product 
immediately after attaining the 5-log reduction.
     (3) For firms producing fresh juice, the costs and economic 
feasibility of achieving a 5-log pathogen reduction using the approach 
reflected in FDA's current thinking.
     (4) The benefits to processors of using this enhanced 5-log 
pathogen reduction approach in terms of improved shelf-life or other 
any benefit.
     Third, FDA is aware that the majority of juice processors already 
apply some sort of heat treatment to the juice that they produce. Under 
a HACCP system, the application of heat is a critical control point 
(CCP) in terms of controlling microbiological hazards. FDA requests 
comments that describe the monitoring methods that juice processors 
currently use to assure that the heat treatment is adequately delivered 
so as to control pathogens.
     Fourth, FDA also specifically requests comment on several economic 
issues, as follows:
     (1) The agency is aware that some consumers prefer to consume raw 
(i.e., unprocessed) juice. FDA requests comment from these consumers 
concerning how much they would be willing to pay for a gallon of raw 
juice. FDA also requests information from raw juice processors on the 
percent of annual profit that firms derive from the sale of raw juice.
     (2) The agency developed a preliminary regulatory impact analysis 
and a small entity analysis that estimate benefits and costs associated 
with the HACCP proposal. These analyses were published in the Federal 
Register of May 1, 1998 (63 FR 24254). FDA requests comment on impacts, 
costs, and benefits on businesses with fewer than 500 employees.
     (3) FDA requests comment on the ways in which processors that have 
already implemented HACCP have done so in a manner that is different 
from the provisions of the proposed rule.
     Finally, as noted above, FDA has prepared a summary of certain 
data and information regarding internalization and survival of 
pathogens in produce. The agency has also prepared reports of the 
agency's recent research. FDA is announcing the availability of the 
following: (1) Two documents summarizing new data on internalization 
and survival of microorganisms in citrus (Refs. 1 and 2); and (2) a 
review of published and unpublished information on internalization and 
survival of microorganisms in fruits and vegetables (Ref. 3). FDA is 
also announcing the availability for public comment of the transcripts 
from a July 15 to 16, 1999, FDA-sponsored technical scientific workshop 
on apple cider.
     To be considered, written comments must be received by January 24, 
2000, by the Dockets Management Branch (address above). 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. Received comments may be seen 
in the office above between 9 a.m. and 4 p.m., Monday through Friday.

III. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Walderhaug, M. O., S. Edelson-Mammel, A. DeJesus, B. S. 
Eblen, A. J. Miller, and R. L. Buchanan. ``Preliminary Studies on 
the Potential for Infiltration, Growth and Survival of Salmonella 
enterica Serovar Hartford and Escherichia coli O157:H7 Within 
Oranges.'' U.S. Food and Drug Administration, November 8, 1999.
    2. Merker, R., S. Edelson-Mammel, V. Davis, R. L. Buchanan. 
''Preliminary Experiments on the Effect of Temperature Differences 
on Dye Uptake by Oranges and Grapefruit. U.S. Food and Drug 
Administration, November 4, 1999.
    3. Potential for Infiltration, Survival, and Growth of Human 
Pathogens within Fruits and Vegetables, U.S. Food and Drug 
Administration, November 3, 1999.

    Dated: November 16, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-30525 Filed 11-22-99; 8:45 am]
BILLING CODE 4160-01-F