[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
