12 November 2002

U.S. Food and Drug Administration

Dockets Management Branch (HFA-305)

5360 Fishers Lane, Room 1061

Rockville, MD 20852

RE: Docket Number 02D-0333; Juice HACCP Hazards and Controls Guide,
First Edition

Safe Tables Our Priority is a nonprofit, grassroots organization
consisting of victims of foodborne illness, family, friends and
concerned individuals who recognize the threat pathogens pose in the
U.S. food supply. We count among our members victims of outbreaks from
*E. coli* O157:H7 contaminated apple juice and *Salmonella* contaminated
orange juice. S.T.O.P.\'s mission is to prevent unnecessary illness and
loss of life from pathogenic foodborne illness. We have previously
submitted comments on this topic for:

o the February 3, 1997 docket on the topic of juice safety;

o the September 12, 1997 docket for FDA's Notice of Intent on Juice
Safety;

o the May 26, 1998 docket on FDA's Proposed Rule on Juice Labeling;

o the August 7, 1998 docket on FDA's Proposed Rule for Juice HACCP;

o the January 19, 1999 docket on Citrus Juice Scientific Technical
Meetings.

o the January 24, 2000 docket on the NACMCF Meeting on relative safety
or

unpasteurized citrus juices

We appreciate the opportunity to comment on CFSAN's Guidance on Juice
HACCP Hazards and Controls. We consider this a very important step in
clarifying aspects of the juice HACCP law for producers.

Our comments today are organized as follows:

I. Overview

A. The Need for Controlling Microbial Contamination

B. The Potential for Overwhelming the Pasteurization Killstep

C. Additional Opportunities for Controlling Contamination

D. Specific Examples of the Types of Processors Addressed by the Rule

II\. Comments Pertinent to Specific Sections

A. Executive Summary

B. Terms and Definitions

C. Overview of Juice HACCP

D. Some Key Requirements of the Juice HACCP Regulation

E. Juice Hazard Analysis

F. Control Measures

G. Example Documents

H. Recalls and Traceback

III\. In Conclusion

[Appendix A: Juice Chart](../02D-0333_emc-000002-02.xls)

**I. Overview**

The recently released First Edition of Draft Guidance for Juice HACCP
achieves FDA's basic purpose of clarifying the juice HACCP regulation,
with exceptions that S.T.O.P. will enumerate below. However, in
attempting to cover the wide range of topics and control points that the
regulation addresses, it may lose track of the original purpose of the
regulation, and unintentionally may demotivate the intended audience
from addressing that purpose.

The final juice HACCP regulation was the product of tireless efforts on
the parts of government, industry and consumer groups addressing the
very specific issue of microbial contamination, and specifically enteric
microbial pathogens. During this deliberation process, literally
hundreds of Americans continued to be poisoned by pathogenic
contamination in undertreated juice. S.T.O.P. is not arguing that CFSAN
should downplay the significance of chemical and physical hazards or of
toxins that are the byproduct of microbial contamination upon which
CFSAN has elaborated extensively; however, we strongly recommend that
this document clarify:

1\) the need for controlling microbial contamination,

2\) the potential for overwhelming the pasteurization process,

3\) the opportunities for processors to improve their chances of
controlling

contamination outside of the HACCP process, and

4\) specific examples of the types of processors addressed by the rule.

***1) The Need for Controlling Microbial Contamination***

In many of its public comments, S.T.O.P. has urged CFSAN to create a
chart that expresses the sheer number of juice outbreaks that the U.S.
has faced in the last seven years, along with the number of consumers
affected and how they were affected, accompanied by the data of
hypothesized sources of contamination. We have attached an example of
such a chart in Appendix A. Such a chart would serve two critical
purposes in the Guidance document.

First, it would give producers a "fighting chance" at identifying the
types of on-farm controls processors might like to include in their
contracts with suppliers. Because many of the incidents of contamination
in untreated juices have occurred before the fruit arrived at a plant,
and many have "yet to be determined," this would be appropriate. Indeed,
with this in mind, it might also be desirable to have a second chart
that describes outbreaks in Canada and Australia, which highlight
additional ways of contamination entering the juice production process.

Second, it conveys the very real data behind the purpose of the HACCP
law. It is unfortunately true that some members of industry are unaware
of how many people, particularly children, as well as different
suppliers and companies, have been embroiled in ongoing U.S. juice
outbreaks. CFSAN unintentionally demotivates producers when it fails to
provide the data about the breadth and depth of juice outbreaks prior to
introduction of the regulation. When CFSAN couples this with Guidance
that emphasizes physical, chemical and toxin related hazards at the same
level with microbial contamination, the effect is to focus the producers
first on those hazards and to present an argument that all microbial
contamination is handled by pasteurization.

***2) The Potential for Overwhelming the Pasteurization Killstep***

In section VC, Control Measures for Biological Hazards, CFSAN needs to
be more explicit about the potential for overwhelming a "minimum"
pasteurization process. The phrase

*"The initial number of pathogens present in your untreated juice is
likely to be far less than 10^5^ organisms per gram, i.e., only 10^1^ or
10^2^ organisms per gram."*

is inaccurate without some qualification. Perhaps, rather than say "is
likely to be," CFSAN intended to say "should be on average." That the
pathogens are "likely" to be few is only true if all procedures are
followed and relatively sanitary inputs are used. Indeed, a U.S. apple
juice outbreak was traced to a "model" facility whose only immediately
obvious issue was with the quality of incoming fruit. Thus, this
sentence might better read "Presuming a meticulous HACCP plan is in
place and followed and incoming produce is of appropriate quality, the
initial number\..."

This section would be an appropriate location for CFSAN to address that
an otherwise seemingly powerful killstep can be overwhelmed by bad
input. A simple example, such as illustrating that if heavily
contaminated fruit came into a process where one or two HACCP controls
were not adequately monitored, would at least demonstrate the need for
close to attention to these HACCP details, which is otherwise not
illustrated in the document.

***3) Additional Opportunities for Controlling Contamination***

CFSAN and S.T.O.P. now have an extensive list of potential sources of
contamination that might come in on incoming fruit or juice. Amongst
these is the use of drop fruit, the use of contaminated water for
irrigation or for mixing with pesticides, and the contamination of fruit
or juice in transport. As mentioned above, a chart describing these
potential sources of contamination would edify producers about the need
to exert some control over inputs (once again, to ensure that the HACCP
process is not overwhelmed) through GMPs or otherwise. A paragraph on
the subject would be well worth the effort.

In addition, in Table 2, Hazard Analysis Summary Table (for Pasteurized
Refrigerated Apple Juice) and Table 4. Hazard Analysis Summary Table
(for Not-from-concentrate Pasteurized Orange Juice), there are no
references under "What preventative measure(s) can be applied to
prevent/reduce/eliminate the hazard?" to the use of tree picked fruit,
rejection of incoming products, or culling to reduce the hazard. It is
possible that CFSAN intentionally excluded these items because they do
not "count" toward the 5 log reduction. Yet, they could play a role in
whether a 5 log killstep is overwhelmed. Therefore, we would encourage
CFSAN to find a way to express that these are still valuable steps to
take. To do otherwise is to unintentionally discourage processors from
these practices.

***4) Specific Examples of the Types of Processors Addressed by the
Rule***

Perhaps one of the biggest challenges in applying this regulation will
be in aiding juice processors to identify themselves as such. Ambiguity
abounds and is not dramatically clarified by the first draft of the
Guidance. We would recommend a section that describes different types of
businesses and whether the rules applies to them. Examples would
include: a grocery store selling both packaged orange juice and orange
juice by the glass through a juice bar; a grower that produces apple
juice at a facility on one side of the orchard but sells it by the cup
and bottle at a roadside stand three acres away across the same
property, and a smoothie producer that uses orange juice as 25% of a
mixture that includes strawberry and banana puree. Likewise, the
applicability of the regulation to hard apple cider and to retailed
juice sold frozen as treats-on-a-stick should be addressed.

**II. Comments Pertinent to Specific Sections**

**A. Executive Summary Section**

In the Executive Summary section, there is a paragraph that reads:

*"Retail establishments or businesses that make and sell juice directly
to consumers and do not sell or distribute juice to other businesses are
exempt from the juice HACCP regulation, but must comply with any
applicable state regulations."*

This paragraph implies that retail juice producers of packaged products,
such as grocery stores, are exempt from the juice HACCP regulation and
are no longer required to label. Therefore, this paragraph needs to be
much more explicit about how these retailers are affected by the rule,
and we strongly urge CFSAN to separately notify grocers' organizations
of the changes in the rules. Also, there should be a paragraph in the
Executive Summary addressing whether any juice producer will still be
covered by the juice labeling rule once all the producers fall under the
Juice HACCP rule.

**B. Terms and Definitions**

The Guidance presently reads*: "Cleaned means washed with water of
adequate sanitary quality."* Meriam-Webster's definition (Third New
International Dictionary) of "clean" is "free from matter that
adulterates, contaminates or pollutes." The college dictionary indicates
"free from dirt or pollution." "Wash" is "to clean by the action of
water or other liquid." Unfortunately, as CFSAN defines "cleaned," it is
not equivalent to that of the dictionary. We would discourage CFSAN from
perpetuating the unclear language of the regulation in the Guidance
because the Guidance is intended to enlighten its readers. A term more
appropriate than "cleaned" may indeed be "rinsed" or "washed." Thus, the
Guidance could define "washed" as "rinsed with water of adequate
sanitary quality until there is no visible detritus."

The Guidance also presently reads*: "Culled means separation of damaged
fruit from undamaged fruit."* S.T.O.P. respectfully requests that CFSAN
clarify whether it is referring to all forms of damage, microscopic or
otherwise. Presently, it is possible to detect "dirt" on fruit, which
otherwise appears "clean" to the naked eye, with black light. In the
future, it may be possible to identify microscopic damage.

The Guidance presently reads: *"Fallen fruit means fruit that has fallen
naturally from the tree to the ground in an orchard. It does not include
mechanically harvested fruit, which is obtained by shaking the tree and
collecting the fruit from the ground with appropriate mechanical
machinery; also called grounders, windfall fruit, drops."*

Subsequently, this term is used in phrases such as: "Fallen fruit\...
are more susceptible to the growth of patulin producing molds." Does
CFSAN have data that shows that fruit the was mechnically harvested and
touched the ground is less susceptible to the growth of patulin
producing molds? If the fruit touches the ground for five hours, but was
mechanically harvested, is it less susceptible? Microbial contamination
does not make a distinction between fruit that has fallen to the ground
by mechanical vs. "natural" means. S.T.O.P. strongly disputes that this
is the definition which CFSAN should use for describing fruit that has
touched the ground. CFSAN must distinguish between fruit that has come
into contact with dirt, and fruit that has not. In place of this
industry-favorable definition of "fallen fruit," the document should
refer to "grounders" as any fruit that has come into contact with the
ground. This definition is not only critical for patulin producing
molds, but also for microbial contamination.

The Guidance presently reads: *"Retail Establishment means an operation
that provides juice directly to consumers and does not sell or
distribute juice to other businesses. The term \"provides\" includes
storing, preparing, packaging, serving, and selling juice."* This
definition is very ambiguous, and suggests that grocery stores do not
have adhere to the HACCP regulation. Examples would help to clarify
this.

In the Definitions section, S.T.O.P. notes that "trimming," which is
used frequently throughout the Guidance is not defined. CFSAN needs to
include a definition for "trimming," which appears to be the removal of
bruises or bad spots, but could include cutting off a moldy spot when
the spores are still unseen on another part of the apple. There are
seventeen references to "trimming" in the document. CFSAN should also
clarify at what point a piece of fruit should no longer be trimmed but
instead should just be thrown out.

Lastly, the Guidance includes under the definition of "Shelf Stable
Product" the following examples:

> *• acidic shelf stable juices like canned orange juice, which are made
> using*
>
> *a single thermal processing step*
>
> *• juice concentrates like orange juice concentrate in which all
> ingredients*
>
> *of the concentrate receive a thermal concentration process*

It would be better if CFSAN used at least one example that was not
orange juice. Also, the use of the term "acidic\... orange juice"
implies that when orange juice becomes less acidic, it no longer
qualifies as shelf stable. The Guidance should also mention \"juice
box\" style packaging, which is now a significant part of shelf stable
industry, perhaps an even greater part than canned juice.

**C. Overview of Juice HACCP**

In Section IIIA, Compliance required for All Juice Processors, the
Guidance once again indicates that all retail establishments are exempt
from the regulation. As previously mentioned, grocery stores selling
that produce their own, packaged juice **do** fall under the regulation.
In addition, a retail producer such as an apple orchard that produces
both packaged and juice by the glass might misunderstand the language
currently in the Guidance. We advise CFSAN to clarify this.

In Section IIIA3.0, the Guidance indicates that a producer can import
juice from a country that has an appropriate memorandum of
understanding. It is S.T.O.P.'s understanding that at this time, no
countries presently have such a Memorandum. We believe that the Guidance
should therefore indicate as such: "As of \<\<date\>\>, the date of the
publication of this Guidance, no countries have such an MOU with the
U.S." In addition, CFSAN should develop an "easy" way for processors to
identify if such an MOU exists, which could be a webpage. Therefore, the
previously recommended sentence could be followed by: "However, CFSAN
has established a page at its website: www.cfsan.fda.gov/etc. where we
will list countries that are presently developing or have such an MOU so
that juice processors can quickly identify whether they are covered by
an MOU."

In Section IIIA4.0, CFSAN attempts to distinguish between juice sold as
an ingredient vs juice that falls under the regulation. S.T.O.P.
requests that CFSAN clarify this paragraph. For example, how much juice
and fruit puree must be in a beverage to deem it a juice under this
regulation. If it is 90% fruit juice and 10% yogurt, is it still a
juice?

**D. Some Key Requirements of the Juice HACCP Regulation**

In Section IIIB1.0, the Guidance indicates: *"You may continue to use
the label warning statement until your applicable effective date. For
example, after January 22, 2002, small businesses and very small
businesses may still use label warning statements for an additional one
and two years respectively."*

S.T.O.P. believes that the appropriate language for this is "must" and
not "may" with the additional information: "as long as a HACCP plan is
not in place." Where warning labels are required, they are still
required.

In Section IIID 1.0, the Guidance again does not address that a grocery
store that produces its own juice is a retail establishment that falls
under the HACCP regulation. In addition, it might be helpful if CFSAN
could clarify whether a processor that makes its juice and sells its at
a roadside stand, where the stand and the processing facility are
separated by a given distance, falls under the regulation. S.T.O.P.
believes that such a practice might violate the "processed and packaged
in the same facility" aspect of the regulation.

In Section IIID3.0, the Guidance indicates that *: "The juice HACCP
regulation applies only to juice that is sold either as juice or for use
as an ingredient in beverages and not to any other fruit or vegetable
product."* This would specifically exempt frozen-juice-on-a-stick
products which would seem to be otherwise covered by the regulation. We
would ask that CFSAN clarify its position on this.

**E. Juice Hazard Analysis**

In Section IVA1.0, the Guidance indicates: *"you are required to
produce, for each type of juice, a written hazard analysis\...unless
different types of juice have identical hazards and control measures and
then they can be grouped in one hazard analysis."*

STOP objects to encouraging processors to believe that a HACCP plan can
simply be copy/pasted from one type of juice to another; this encourages
the juice processor to think that it is exempt from this task if it only
deems the juices as having identical hazards and control measures.
Perhaps, CFSAN wishes to imply that grapefruit and orange juice are so
similar that identical plans could be developed. If CFSAN has a good
example of how it believes this to be true, it should give a good
example.

In Section IVA2.0, the Guidance should give examples of control points
or failures in GMPs where contamination has resulted in outbreaks. This
can be an appendix with examples of contaminated fruit or contamination
in tanks or lack of testing. Examples of hazards that have caused
outbreaks make the concept of "reasonably likely to occur" more
concrete.

The Guidance is too abbreviated in Section IVC1.11, Enteric Microbial
Pathogens. Repeated outbreaks from unpasteurized juice were the
catalyzing factor that brought about the juice HACCP regulation.
However, as a processor reads section IVC1.0 , it would could reasonably
conclude that tin and lead, which alone are described in a page and a
half of text, and other chemical contaminants described in detail in
this document, are the critical safety issue in juice. CFSAN needs to do
a better job describing how pathogenic contamination arrives in juice.

For example, in section IVC1.25, the document states "Lead is especially
hazardous to young children." There is no such comparable statement
under Enteric Pathogens of the at-risk groups. Likewise, there is a long
description under tin and lead about how such chemical contamination has
come about. There is only a passing reference to contaminated produce in
the section on Enteric Pathogens. Likewise, there is a reference to a
specific type of produce, carrots, in the section on lead. There is no
similar description under Enteric Pathogens.

Unless CFSAN seeks to educate producers as to the reasons why the Juice
HACCP rule was developed, it will always have undermotivated compliance.
How can juice processors believe there own control points could be an
issue without access to examples of how similar control points and GMPs
have been an issue in the past?

To stress the import of this regulation, the Guidance *description
"Juices containing enteric microbial pathogens such as [E.
coli]{.underline} O157:H7, various [Salmonella]{.underline} species, and
the protozoan parasite [Cryptosporidium parvum]{.underline} have caused
serious foodborne illness outbreaks" should be followed with "resulting
in deaths."* This is very important. CFSAN should not encourage
processors to believe that this regulation is an exercise for the sake
of regulation but instead that it has very critical importance for
consumers.

To clarify the role of animal contamination, the *sentence "Because
these microorganisms inhabit the intestinal tracts of animals, they may
contaminate produce in environments where animals and manure may be
present"* should be changed to "These microorganisms inhabit the
intestinal tracts of animals; when animals and their manure or feces
share proximity in an environment, produce can become contaminated,
either directly or indirectly through such means as contaminated
irrigation water or runoff." It is important to identify indirect means
as well as to identify direct contamination means. Also, manure is
considered a term for the feces of farm animals and has positive
connotations; yet, contamination via the feces of wild animals has been
implicated in juice outbreaks. Hence, the need to clarify that the
source can be wild animals as well.

Section IVC1.12 Other Bacterial Hazards raises the topic of *Listeria
monocytogenes*. Neither in this section nor the section IVC2.0 do the
Guidelines describe that *Listeria monocytogenes* has a high fatality
rate amongst the elderly, causes neonatal death and results in
infections which can leave a newborn with brain damage. CFSAN needs to
describe the consequences of these infections. Otherwise, when the
Guidance describes *Listeria monocytogenes* as "ubiquitous in nature,"
it undermines the expression of the need for testing for the organism.

In Section IVC2.0 Evaluate All Potential Hazards, S.T.O.P. respectfully
requests that the paragraph on enteric pathogens be the first paragraph
in this section, as the need to control enteric pathogens is the primary
purpose behind the Juice HACCP Rule. The line "have caused serious
foodborne illness outbreaks due to consumption of contaminated juice"
should be followed by "which resulted in hospitalizations and death." It
would also be desirable to express how many outbreaks have been caused,
so that the sentence would read "have caused an identified x serious
foodborne illness outbreaks due to consumption of contaminated juice
which resulted in hospitalizations and death." Of course, a timeframe
would also then be desirable within the sentence.

**F. Control Measures**

In Section VB1.0 GAPS, the Guidance reads*: "However, if a hazard
originating from the agricultural environment is determined to be
reasonably likely to occur on your incoming fruit, pursuant to 21 CFR
120.8 (a), it must be identified in your hazard analysis and controlled
through your HACCP plan."* CFSAN should give examples of situations
which would concern juice producers: "such as the use of contaminated
irrigation water or pesticides mixed with river water" could be inserted
between "hazard" and "originating."

Section VC1.1 again refers to *Listeria monocytogenes*. Newspaper
articles have indicated that unpasteurized juice manufactured by Odwalla
in the year prior to its outbreak was contaminated with Listeria. If
CFSAN has not yet conducted tests on the growth of Listeria in
unpasteurized juices, it should. If CFSAN has data on the presence of
Listeria in unpasteurized juices, it should mention it in this section.
This might be an alternate section where CFSAN can identify the
consequences of *Listeria* infections, as recommended in Section E.

In Section VC2.0, the Guidance states: *"You may extract juice from the
fruit in one location and ship the untreated juice to another plant for
processing (i.e., to achieve the 5-log pathogen reduction requirement)
and packaging. If you do this you should obtain assurance that the juice
will be given the required 5-log treatment at the other processing
location."* The language in these two sentences is ambiguous,
particularly the reference to the "other processing location." It would
be better to replace the word "another" with "a second," and then
replace the word "other" with "second" to clarify to which plants CFSAN
is referring.

Section VC5.2 describes the need for higher temperatures owing to
recently determined data related to survival of *Cryptosporidium
parvum.* Safe Tables Our Priority appreciates that, with the new data
coming to light, CFSAN has made the effort to explain the need for
control of this parasite as well as the bacteria.

In Section VC5.32, the Guidance says: *"The effectiveness of given UV
treatment conditions may vary from one juice to another."* It would be
appropriate for CFSAN to say that "the effectiveness of given UV
treatment conditions varies with the opacity of the juice and therefore
may vary between different types of juices." This is a fact. By saying
"may" vary, CFSAN implies that it is uncertain that this is the case.

In Section VD1.2, the Guidance reads: *"Generally in HACCP, wherever you
rely on guarantees or certificates from suppliers to control a hazard,
there is a need to couple these types of controls with a strong
verification procedure, such as visiting the farm periodically or
periodically testing the juice."* Owing to the suggestion two paragraphs
above this (that a small processor can "accomplish this by ensuring that
his apple pickers have been instructed not to harvest fallen fruit"),
CFSAN might add to the above quote the suggestion that "a small
processor who harvests apples from his own orchard" should inspect
whether his workers are adhering to the instructions as well.

In section VD1.2 as well, CFSAN should suggest that the use of
blacklight in visually scanning the incoming fruit to determine whether
the fruit is dirtier than is visible to the naked eye might help in
culling inappropriate product.

**G. Example Documents**

In Table 4 (Not from Concentrate Pasteurized Orange Juice), the example
might be more compelling if it included controls for bulk juice obtained
from outside of the U.S. Otherwise, perhaps it would be possible to
demonstrate such as an additional table.

In Table 5, Excerpts from Summary HACCP Plan (For Pasteurized
Refrigerated Apple Juice), under Critical Control Point 1, the receiving
manager should also reject the fruit if it demonstrates that the
guarantee required by the processor has not been followed. The receiving
manager should also cull the fruit that appears to be damaged because of
microbial control issues.

Also in Table 6 Example HACCP Plan for Fresh Orange Juice, the *phrase
"Review of required testing for biotype 1 [E. coli]{.underline}"* might
better be expressed as "Conduct sample testing of biotype 1 E. coli for
verification of process." In general, the need to conduct testing of
juice to verify that the process has not failed its microbial
contamination purpose is not well highlighted in the Guidance. For
example, testing the juice for microbial contamination is not described
under Procedures/Steps for Fresh Orange Juice (VIIA3.0), nor is patulin
testing described under the Procedures/Steps for Pasteurized
Refrigerated Apple Juice. It would be desirable to see microbial testing
described in text in these sections.

**H. Recalls and Traceback**

Over time, in various documents related to juice safety and other HACCP
programs, CFSAN has made recommendations for processors to follow in
order to implement a recall. While this Guidance document might not seem
at first glance as a place to gather that information together, it is,
in fact, the ideal vehicle for transferring that basic information. As
processors go through and revise the documentation and recording
procedures for the juice they produce, they would be well advised to
create a batch identification system that would perform well under a
recall. Many smaller processors do not have such a process and are
unaware of what the best practices are for successfully distinguishing
between batches. S.T.O.P. strongly recommends that CFSAN add a page to
this document supporting processors in additional voluntary record
keeping like batch identification, which would facilitate their followup
on a breakdown in the HACCP process.

Likewise, the Guidance provides little information about how to address
already-distributed product that is subsequently determined to have been
subject to a breakdown of the HACCP process. CFSAN needs to fill in this
important blank.

**III. In Conclusion**

CFSAN's Juice HACCP Hazards and Controls Guidance First Edition is an
important first step in the direction of explaining and clarifying the
Juice HACCP regulation. With attention focused on a few more critical
areas that are not easily understood in reading the regulations, the
Guidance could be improved. We look forward to reviewing the next
version of the document.

Sincerely,

Laurie Girand

Juice Programs Manager

S.T.O.P. - Safe Tables Our Priority