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> 202.857.0610 (P)  202.331.9686 (F) 
> [www.tunafacts.com](http://www.tunafacts.com/)

October 17, 2003

Division of Dockets Management\
Food and Drug Administration\
5630 Fishers Lane

Room 1061 (HFA-305)\
Rockville, MD 20852

> RE: Citizens Petition to Amend Canned Tuna
>
> Standard of Identity, 21CFR161.190
>
> Docket Number 94P-0286

Dear Dockets Management:

We request that the following information be added and included in the
record of Docket Number-94P-0286, a Citizens Petition (the Petition)
filed by the US Tuna Foundation (USTF), requesting Amendments to the
Canned Tuna Standard of Identity (Standard), 21CFR161.190.

In order to provide evidence that the proposed Amendments to the
Standard (the proposed Amendments) will promote product quality and
enhance the honesty and fair dealing with canned tuna consumers, the
members of USTF (domestic processors of canned tuna) offer the attached
data and the following comments. The data and comments clearly
demonstrates:

-   The benefits of eliminating the use of Hydrolyzed Protein and
    controlling the amount of extractives in the vegetable broth in
    canned tuna products.

-   That under the proposed Amendments the consumer will be able to
    determine the actual amount of fish in canned tuna products from the
    Principal Display Panel (PDP).

-   That under the proposed Amendments the consumer will be able to test
    canned tuna products to determine if the drained weight displayed on
    the PDP is accurate.

[Background:]{.underline}

The USTF has proposed several amendments to the current Standard. The
purpose of the original Petition (submitted on July 25, 1994) was to
amend the fill of container requirements from a "pressed cake"
methodology to a "drained weight" methodology. On May 6, 2001, we
proposed additional amendments to the Standard to better define fill of
container requirements, greatly improve the consumers ability to measure
the fill of container (require drained weight on the PDP), and modify
optional ingredients to

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improve product quality (eliminate the use of hydrolyzed protein and
limit the amount of vegetable extractives in vegetable broth).

The current Standard requires the fill of container to be determined
using a pressed cake methodology. This is an archaic measuring process
that requires the use of specially designed equipment. No other country
in the world uses this methodology to test for fill of container on food
products. In addition, the equipment for measuring pressed cake is not
available to consumers.

Under the proposed Amendments, the fill of container will be determined
by drained weight methodology, and there will be a declaration of the
drained weight on the PDP. The consumer will be able to readily
ascertain how much tuna is in the can by merely examining the PDP. In
addition, the consumer may determine the veracity of the drained weight
found on the PDP by just draining the product themselves.

Under current law canned tuna serving sizes must be labeled on the basis
of drained weight. However, the current Standard only requires that the
PDP show the net weight (tuna plus liquid) of the product. The proposed
Amendments require that the PDP include both the net weight [and the
drained weight]{.underline}, giving the consumer a better understanding
as to the amount of actual fish in the canned tuna product. We submit
that this will promote honesty and fair dealing with consumers of canned
tuna products.

The current broth requirements in 21CFR161.190(a)(6)(v) states:

> "Vegetable broth in an amount not in excess of 5 percent of the volume
> capacity of the container, such broth to consist of a minimum of 0.5
> percent by weight of vegetable extractives and to be prepared from two
> or more of the following vegetables: Beans, cabbage, carrots, celery,
> garlic, onions, parsley, peas, potatoes, green bell peppers, red bell
> peppers, spinach, and tomatoes."

Under the current Standard, there is no limit to the amount of
"vegetable extractives" (VE) that may be added to the amount of
allowable vegetable broth. Excessive amounts of extractives in the broth
may allow for water to be retained in the flesh of the fish.

Our proposed Amendments limit the amount of VE in the broth and
eliminate the use of hydrolyzed protein. The new Standard will require
the dry weight of vegetable extractives in the aqueous broth solution to
be at least 0.025 percent but no more than 0.6 percent of the label net
weight of the container.

The proposed Amendments will further promote honesty and fair dealing
with consumers because the regulatory standard by which the fill of
container is measured will be more stringent. The current Standard
requires that the [average]{.underline} of 24 cans be no less than a
minimum value based on the water capacity of the can. The proposed
Amendments mandate that the average of 24 cans be no less than a minimum
value of the labeled net

US Tuna Foundation

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weight of the container and that the weight of each can be above a
minimum allowable value (MAV)[^1].

[Test Samples:]{.underline}

The US Tuna Foundation, through its members, the US domestic processors
of canned tuna, analyzed test samples of generic canned tuna to
determine:

-   How the current Standard's broth allowances could affect the minimum
    fish fill requirements and the ability to comply with pressed cake
    measurement;

-   How the proposed Amendment's broth allowances would affect the
    minimum fish fill requirements and the ability to comply with
    drained weight methodology.

The test samples were produced using the following protocol:

After frozen skipjack loins were thawed, the cans were filled according
to the targeted fill weights. The vegetable extractives used for the
preparation of the broth were a commonly used commercial product. The
vegetable broth was mixed to a specific concentration and added to the
tuna cake in a liquid form by volume depending on the amount of dry
weight of the vegetable extractives targeted for each can. Potable water
was added in such an amount to prevent scorching and to meet retort and
broth standards. All cans were weighed and the fill weights were
recorded on the can or on a sheet as "known fill samples." Retort times
were typical for the fill weights and media added. The canned products
were commercially sterile.

Twenty-four cans for each variable combination were collected from a
normal production environment. Two variable combinations were produced.
Variable combination One had a targeted fill weight of tuna of 3 ounces
and 4 gm of VE. Variable combination Two had a targeted fill weight of
tuna of 3.9 ounces and 1 gm of VE. The one gram of VE is equivalent to
the maximum amount of the dry weight of vegetable extractives allowed in
the proposed Amendments.

The pressed weights and drained weights were analyzed at least 24 hours
after retorting but within one week of retorting.

-   Pressed weights were analyzed by the method outlined in the current
    Standard using a Luthi press weight machine.

-   Drained weights were analyzed with the method specified in the
    proposed Amendments \--the tuna was drained on a No. 8 sieve for two
    minutes. This method is based on the Food and Drug Administration's
    (FDA) Nutrition Labeling and Education Act labeling regulations. The
    FDA stated in the final rule, "Food Labeling; Serving Size;
    Technical Amendments,"[^2] that the method for

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> draining canned tuna will be the method as outlined by the Association
> of Official Analytical Chemists (AOAC) -- "The Agency uses AOAC
> methodology in resolving compliance issues. Therefore, draining for
> two minutes on a No. 8 sieve is acceptable for draining fish and other
> food products."

[Results:]{.underline}

Attached are two tables which outline the results of the analyses: Table
1, "USTF-SOI Test Sample Results, Pressed Wt -- 3 oz Fill Weight Target
-- 4 gm VE," and Table 2, "USTF -- SOI Test Sample Results, Drained Wt
-- 1 gm VE."

The column headings and abbreviations in the tables are as follows:

Date

Var Combo -- Variable combination

-   1 = 3 ounces fill weight target with 4 grams of vegetable
    extractives

-   2 = 3.9 ounces fill weight target with 1 gram of vegetable
    extractives

    Rep -- Number of replicates

    N -- Sample size

    Avg -- Average

    FillWt -- Fill weight

    StdDev -- Standard deviation

PrsWt -- Pressed weight

NetWt -- Net weight

DrnWt -- Drained weight

Gm VE -- Grams of dry vegetable extractive per 6 oz can

The highlighted portions of Table 1 indicate when the average of 24 cans
would meet the pressed cake requirement. The highlighted portions of
Table 2 indicate when the average of 24 cans, with no cans falling below
the minimum, would meet the drained weight requirement if the proposed
Amendments were adopted.

[Discussion:]{.underline}

The test samples from Table 1 are product that could potentially be
produced today under the existing Standard. The samples included 4 grams
dry weight of vegetable extractives.

The pressed cake requirement was met with as little as 2.98 ounces of
skipjack. These results show how unreliable pressed cake measurements
are. The average fill weights were between 2.9 and 3.03 ounces, yet the
pressed cake results were between 2.74 and 3.46 (almost three-quarters
of an ounce between the lowest and highest).

The test samples in Table 2 show canned tuna product packed under the
requirements of the proposed Amendments. The 1 gram VE is equivalent to
0.6% of the labeled net

US Tuna Foundation

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weight of the can, which is the maximum amount of VE allowed under the
proposed Amendments. Table 2 results indicate that drained weight is a
much more reliable measurement than pressed cake.

Test samples of the two variables were left with the Office of Seafood.
If additional samples are needed, we will supply them.

In conclusion, the test results presented in the attached two tables
clearly demonstrate that the proposed Amendments will promote product
quality and enhance honesty and fair dealing with canned tuna consumers.
We respectfully request that the proposed Amendments be expeditiously
approved.

Sincerely,

David G. Burney

Executive Director

Attachments: Table 1

> Table 2

cc: Phil Spiller, CFSAN-OS

Tony Brunetti, CFSAN-OS

[^1]: NIST Handbook 133;
    <http://ts.nist.gov/ts/htdocs/230/235/h1334.htm>

[^2]: [Federal Register]{.underline}, Vol. 158, pages 44047 and 44048.