November 11, 2002

Dockets Management Branch (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

> **Subject: Docket No. 02D-0333 - Draft Guidance for Industry**:
> **Juice** **HACCP** **Hazards and Controls Guidance, First Edition**

To the Dockets Management Branch

The International Dairy Foods Association and its constituent
organizations, the Milk Industry Foundation (MIF), the National Cheese
Institute (NCI) and the International Ice Cream Association (IICA) have
a combined membership of 600 dairy processors who produce eighty-five
percent of all dairy products. Almost 200 of these same members\'
process and package 10% of all juice drinks and 30% of the total orange
juice made from concentrate in the United States. Many of these products
are regulated under 21 CFR 120, Food and Drug Administration\'s Juice
Hazard Analysis Critical Control Point (HACCP) regulation. IDFA has been
preparing its members to comply with the Juice HACCP regulation through
an intensive training program of short courses since April, 2001 as well
as a number of individual company juice HACCP training programs. IDFA
supports FDA\'s issuance of additional guidance providing more details
and clarifying FDA\'s views regarding implementation of the Juice HACCP
regulation and provides the following comments on that guidance.

In general, IDFA is concerned that the Hazards and Controls Guide
arbitrarily deals with some potential hazards, requiring very
prescriptive control measures without making clear scientific basis for
identifying the hazards or controls. Processors will incur significant
additional costs to comply with recommendations in the Hazard and
Controls Guide that were not factored into the cost/benefit analysis in
the original Juice HACCP regulation. Moreover, IDFA believes these extra
costs will not result in significantly improving product safety.

Because the juice HACCP regulation does not clearly address the use of
voluntary prerequisite programs to reduce the likelihood of occurrence
of potential hazards, IDFA concludes that FDA has interpreted the Hazard
and Controls Guide to mean all hazards must be addressed by the
mandatory Sanitation Standard Operating Procedures (SSOPs) or at a
Critical Control Point (CCP). IDFA believes this approach is forced and
does not recognize the important and necessary role that prerequisite
programs play in laying the foundation for a solid HACCP program,
whether it applies to juices or any other food product. If a
processor\'s hazard analysis finds that a prerequisite adequately
reduces the likelihood of occurrence of a hazard, then FDA should accept
this and treat that prerequisite under the juice HACCP regulation in the
same manner as the mandatory SSOPs.

The Hazards Guide does not address potential hazards in a scientific
manner consistent with normal operating practices in the juice beverage
industry. The prerequisite programs, mandatory SSOPs and the hazard
analysis should dictate whether the likelihood of a potential hazard is
adequately reduced or whether a control measure is required, for
example:

> a\. Section IV. C.1.2 & 4.2, V.D.1.0 & 1.1, 1.2, Table 1, Table 2,
> VII.A.2.0, VII.B.1.0, Patulin: The Hazard Guide treats patulin as a
> hazard that needs to be controlled (1.1, third paragraph) by stating
> that patulin is a hazard reasonably likely to occur. However, IDFA is
> not aware of scientific literature or epidemiological studies that
> support that approach. Testing for patulin (IV.D.1.2), as recommended
> in the Hazard Guide to verify the CCP is problematic since only a
> limited number of laboratories have the capability and those that do
> take 24 to 36 hours to report results, very slow for determining
> process control. Current industry practice utilizes good agricultural
> practices, storage and processing conditions, and processor supplier
> control programs to achieve an acceptable reduction in the likelihood
> of occurrence of patulin, as a result the Hazard Guide should
> recognize that the likelihood of patulin\'s occurrence can be dealt
> with through the SSOP on adulteration or a supplier control
> prerequisite program.
>
> b\. Section IV.C.1.23, FD&C Yellow No.6: IDFA is aware of scientific
> information supporting the classification of Yellow No. 5 as a food
> intolerant substance, but cannot find any scientific basis for
> including Yellow No. 6. It should be removed from the list in the
> Hazards Guide and dealt with like any other ingredient, through
> labeling and appropriate levels of use.
>
> c\. Section IV.C.1.31 & E.1.1, Table 1, Glass Fragments: FDA\'s recall
> data, morbidity and mortality data from the Centers for Disease
> Control and other reports indicate that the practices of the bottling
> industry do not present public health problems associated with glass
> fragments, though under HACCP they should be considered a potential
> hazard. The Hazard Guide should provide guidance that recognizes glass
> fragments are a potential hazard that is not reasonably likely to
> occur and therefore can be addressed under the SSOP on adulteration.
> Supplier control, handling and cleaning of the glass containers,
> visual inspections, and bottle storage after filling can reduce the
> likelihood of occurrence to an acceptable level. Thus the hazard
> guides should not mandate a CCP control program for glass containers
> used for juices.
>
> d\. Section IV.C.1.32 & E.1.2, Table 1, Table 2, VII.A.2.0, 3.0, 4.0,
> Table 7, Metal Fragments: The same arguments apply to metal fragments.
> Metal fragments should be considered a potential hazard and the Hazard
> Guide should provide guidance that recognizes the SSOP on adulteration
> can address this hazard. Pre-operational inspections, equipment
> maintenance programs, visual inspection of processing equipment, and
> responding to consumer complaints together can reduce the likelihood
> of occurrence to an acceptable level making it unnecessary for the
> hazard guide to mandate a CCP control program for metal fragments in
> juices.

3\. Section V.C.1.1 & C.5.2 *Cryptosporidium parvum*: The Hazard Guide
assumes that water supplies used in processing apple juices can become
contaminated with *cryptosporidium parvum* and cites a National Food
Processor Association study as a reference for a 5-log reduction of
common juice pathogens. This study did not address *c. parvum*. However,
the hazard guide recommends doubling the study\'s recommended
pasteurization time to 6 seconds to provide a 5-log reduction for *c.
parvum* without any substantiating information. IDFA is not aware of any
scientific studies that have established a \"Z\" value for *c.*
*parvum*, preventing a sound scientific calculation or extrapolation to
establish an effective time and temperature relationship for eliminating
the organism. Farther scientific work is necessary, IDFA believes,
before the hazard guide can support increased pasteurization criteria to
achieve a 5-log reduction in *c. parvum*.

4\. Section IV.C.3.3 & 3.4, Table 1, Allergen Control: Section 120.8 (c)
of the Juice HACCP regulations states: *\"Sanitation controls may be
included in the HACCP plan. However, to the extent that they are
monitored in accordance with Section 120.6, they are not required to be
included in the HACCP plan.\"* Conversely, the Hazard Guide conveys a
strong bias in favor of control via a CCP: *\"We recommend that you
control such hazards under your HACCP plan, and not under your SSOPs . .
.\"*

Dairy plants have historically run juices and dairy products on the same
equipment, either processing the juices first or conducting enhanced
rinsing or complete cleaning if processing juices after dairy products.
As a result, the dairy industry has a history of preventing milk
proteins from entering juices. IDFA believes that as long as the
mandatory SSOP is effective and adequate records are available
documenting the SSOP, the potential hazard of milk residues in the juice
is not \"reasonably likely to occur.\" The hazard guide\'s
recommendation to inspect visually each piece of equipment prior to
startup (Section VII.C) is not practical since many pieces of equipment
and product pipelines are not easily disassembled. Additionally, to
occasionally swab food contact surfaces between milk product and juice
beverage runs would be more effective than conducting allergen tests of
already bottled juice beverages. Finally, the use of allergen test kits
to make a determination of effectiveness of the cleaning procedures is
dependent upon the performance and reliability of the test kit. But IDFA
is not aware that FDA has evaluated the claims of allergen test kit
manufacturers to provide sufficient confidence upon which to base
important safety decisions regarding allergens.

IDFA recommends that the Hazard Guide present these sections in a more
balanced fashion, as in the juice HACCP regulation. The proof of
effectiveness of a processors control system should be determined during
an FDA audit, not based on assumptions about \"reasonably likely to
occur.\"

5\. Section IV.C.5.31, Table 7, Pasteurization Equipment: Traditional
HTST systems used in the dairy industry and juice industry for achieving
a 5-log reduction in pathogens utilize a temperature recorder and
controller to establish a record on an almost continuous basis so that
product is diverted if the temperature falls below the critical limit.
However, the most commonly used positive displacement pumps or variable
speed centrifugal pumps have no visual point of reference to evaluate
flow rate, making it virtually impossible to obtain meaningful
information regarding the flow rate or timing of the pasteurization unit
during production. In addition, timing or flow rate does not fit the
definition of a critical limit for those systems without magnetic flow
meters. IDFA recommends that the juice Hazard Guide utilize the HTST
pasteurization model established by the NCIMS HACCP Committee, using
only temperature as a critical limit and deal with the flow rate or
timing of a traditional HTST system as part of calibration under
verification of a properly functioning pasteurization unit.

6\. Table 2. The table asks the processor to answer the questions about
whether any potential hazards are significant without providing any
guidance as to how to evaluate \"significant.\" Decisions regarding
potential hazards should be made according to the likelihood of them
occurring or whether they are \"reasonably likely to occur\" as
explained in Section IV.C.3.1 & 3.2 of the draft Hazards and Controls
Guide. Without guidance, processors will be forced into subjective and
challengeable decisions. Also, while there are many formats currently
for hazard analysis tables, it is important that the format assist the
HACCP team in sorting out the potential hazards, their likelihood of
occurrence, and control measures, if needed. A much simpler format and
decision tree are attached for your review and consideration.

7\. Highlights Section, note under definition for Verification, Section
III.B.3.0: Section 120.13 of the HACCP regulation recommends training
for a number of activities required of the processor, but also
recognizes experience. The draft Hazards and Controls Guide, in a number
of other locations, uses the term \"trained individual\" without also
referencing experience as an equally acceptable alternative. This could
be misunderstood by readers and should be handled as presented in the
original juice HACCP regulation or as in Section B.2.0 of the Hazard
Guide. The real proof of a processor\'s ability to comply with the
regulation should be based on the outcome of an FDA audit, not on how
much training employees received.

IDFA would also like to take this opportunity to make a few general
comments on the Juice HACCP Regulator Training document and the training
session FDA held October 30. In some instance, this training establishes
new policies on minimum acceptable requirements that IDFA believes
should be removed from the document and issued as guidance to the
industry.

1\. General, Interviewing Employees: Many processors have an employee
policy that limits access to production employees to reduce disruption
during production. This document should acknowledge that and recommend
FDA investigators work with plant management to arrange times for
interviews with specific employees.

2\. Chapters 3 and 4, Performing Your Own Hazard Analysis: The
recommendation for an FDA investigator to conduct his or her own hazard
analysis will be very time consuming, if done properly. The investigator
must know and understand the plant layout, processing steps,
ingredients, and potential hazards. All three of which can be unique to
a particular processing location. IDFA understands that this
recommendation is based on the seafood HACCP, but that program does not
require a processor to have a written hazard analysis, making sense for
the FDA investigator to develop one. This is not the case under the
juice HACCP regulation. The processor must have a written hazard
analysis so there is no need for the FDA investigator to develop his or
her own. Moreover, the processor\'s hazard analysis and HACCP plan are
the documents that the FDA investigator should be auditing against, not
the investigator\'s own hazard analysis.

3\. Chapter 10, Records Falsification: Uncharacteristically regular,
unusually constant, or unusually neat are arbitrary falsification
indicators and they may in fact reflect very good records systems. This
section needs to have more practical suggestions, less subjective and
easier to measure.

4\. Chapter 11, Daily Monitoring:

> a\. The frequency of every 4 hours for determination of the SSOP on
> safety of water, condition and cleanliness of the food contact
> surfaces and prevention of cross contamination is arbitrary and not
> based on actual need or processing conditions. This arbitrary
> timeframe should be deleted for a more general explanation.
>
> b\. The monitoring of employee health conditions daily, before the
> start of production, is not practical. During the start of production,
> only a few of the production workers are usually present. This
> mandatory SSOP should be monitored and documented by employee
> training, company policies and production supervisor oversight, not a
> daily \"cuts, sneezing and cough\" inspection.
>
> c\. The requirement of a daily pest control monitoring record may not
> be practical. The real proof of an effective plant pest control
> program is to review the records and evaluate the conditions of the
> plant, not require a daily record.
>
> d\. The example \"Daily Sanitation Report\" includes a column for \"4
> Hour Time\" and \"8 Hour Time\". This may create an expectation in the
> mind of the FDA investigator to demand 4 and 8 hour records, when
> there is no reason to use a particular frequency. We strongly
> encourage a removal of these arbitrary timeframes that do not provide
> any more certainty regarding monitoring of mandatory SSOPs.

5\. The October 30 training for FDA investigators was generally very
good in IDFA\'s opinion. A few answers were overly prescriptive or
utilized seafood HACCP guidance, and thus were not consistent with the
juice HACCP regulation or with current HACCP philosophy. Examples
include,

> a\. The requirement that a processor have records that the product
> side of a plate heat exchanger in the HTST cooling section be at a
> higher pressure than on the cooling media side is not a requirement in
> the Juice HACCP regulation or in any nationally recognized milk
> pasteurization system. IDFA is not aware of data that shows this is a
> public health problem.
>
> b\. The illustration of an investigator tracking pasteurizer seal
> numbers through the records system may lead trainees to require all
> seals be numbered. This is not commonly done in the industry or
> required. This segment of the video training should be modified or
> qualified in training material.
>
> c\. The illustration of an investigator tracking operational limits
> through the records system may lead trainees to expect processors to
> use operating limits instead of critical limits as a measure of CCP
> control. This could result in confusion by a trainee and should be
> modified or qualified in training material.

In summary, the dairy industry looks forward to cooperating with FDA as
enforcement of the juice HACCP regulation begins. We encourage
redrafting and issuance of the guidance documents as soon as possible so
the industry can properly implement the juice HACCP regulation without
delay. IDFA hopes FDA current HACCP philosophy and its practical
application will be incorporated into FDA\'s enforcement plans and the
training of field investigators so the industry is not limited to past
approaches that may have become outdated and limited in their
effectiveness. The regulation of any HACCP program must place the
responsibility for a safe food supply on the shoulders of the processing
industry and minimize or eliminate arbitrary performance standards that
do not have a scientific basis.

With best personal regards, I am

Sincerely,

Greg Frazier Allen R. Sayler

Senior Vice President Director, Regulatory Affairs/International
Standards

International Dairy Foods Association International Dairy Foods
Association

> **NO** N **NO** **YES** **NO**

**YES**

**YES**

**NO**

**YES**

**NO**

**YES NO**

**YES** **NO**

**Hazard Analysis Summary Table**

Product
Name:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Plant Name:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Date:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Plant
Address:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

+-----+---------+----------+-------------------------+---------------+
| **P | ##      | **Q1. Is | **Q2. Identify the      | **Q3 -- Q6.   |
| roc |         | the      | Prerequisite Program or | Does a        |
| ess | ##      | hazard   | procedure that reduces  | control       |
| St  |         | id       | the likelihood of       | measure exist |
| ep/ | ## *I   | entified | occurrence of the       | at this step  |
| I   | dentify | at this  | hazard to ensure that   | to prevent,   |
| ngr |  the sp | step of  | control at this step is | reduce or     |
| edi | ecific* | su       | not necessary.**        | eliminate the |
| ent |         | fficient |                         | likely        |
| or  | ## *Pot | li       |                         | occurrence of |
| I   | ential  | kelihood |                         | a hazard to   |
| npu | Hazard* | of       |                         | an acceptable |
| t** |         | oc       |                         | level?**      |
|     | -       | currence |                         |               |
|     |   **Bio | to       |                         | **If "yes",   |
|     | logical | warrant  |                         | document as a |
|     |         | its      |                         | CCP**         |
|     |   (B)** | co       |                         |               |
|     |         | ntrol?** |                         | **If "no",    |
|     | -   **C |          |                         | indicate      |
|     | hemical | -   **If |                         | where this    |
|     |         |          |                         | will          |
|     |   (C)** | \"yes\", |                         | happen.**     |
|     |         |     then |                         |               |
|     | -   **P |          |                         |               |
|     | hysical |  proceed |                         |               |
|     |         |     to   |                         |               |
|     |   (P)** |     Q3** |                         |               |
|     |         |          |                         |               |
|     |         | -   **If |                         |               |
|     |         |          |                         |               |
|     |         |  \"no\", |                         |               |
|     |         |     stop |                         |               |
|     |         |     and  |                         |               |
|     |         |          |                         |               |
|     |         | document |                         |               |
|     |         |     at   |                         |               |
|     |         |     Q2** |                         |               |
+=====+=========+==========+=========================+===============+
|     |         |          |                         |               |
+-----+---------+----------+-------------------------+---------------+
|     |         |          |                         |               |
+-----+---------+----------+-------------------------+---------------+
|     |         |          |                         |               |
+-----+---------+----------+-------------------------+---------------+
|     |         |          |                         |               |
+-----+---------+----------+-------------------------+---------------+
|     |         |          |                         |               |
+-----+---------+----------+-------------------------+---------------+