[Federal Register Volume 64, Number 99 (Monday, May 24, 1999)]
[Rules and Regulations]
[Pages 27901-27905]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12882]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR 318 and 319
[Docket No. 94-015DF]
RIN 0583-AB82
Use of Soy Protein Concentrate, Modified Food Starch, and
Carrageenan as Binders in Certain Meat Products
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Direct final rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the
Federal meat inspection regulations to allow the use of soy protein
concentrate, both singly and in combination with modified food starch
or carrageenan, as a binder in cured pork products labeled ``Ham with
Natural Juices,'' ``Ham Water Added,'' and ``Ham and Water Product--X%
of Weight is Added Ingredients,'' and to increase the permitted use
level of modified food starch as a binder in ``Ham and Water Product--
X% of Weight is Added Ingredients'' products. These binders will be
used to reduce purging of the pumped brine solution from the products.
FSIS is proceeding with this direct final rule in response to petitions
submitted by Central Soya and the National Starch and Chemical Company
and informal requests from several food manufacturers.
DATES: This rule will be effective July 23, 1999, unless FSIS receives
written adverse comments within the scope of this rulemaking or written
notice of intent to submit adverse comments within the scope of this
rulemaking on or before June 23, 1999.
ADDRESSES: Submit adverse comments or notice of intent to submit
adverse comments within the scope of this rulemaking to: FSIS Docket
Clerk, DOCKET #94-015DF, U.S. Department of Agriculture, Food Safety
and Inspection Service, Cotton Annex, room 102, 300 12th Street, SW,
Washington, DC 20250-3700. Any written comments submitted in response
to this direct final rule and reference materials cited in this
document will be available for public inspection in the FSIS Docket
Room from 8:30 a.m. to 4:30 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Dr. Robert Post, Director, Labeling
and Additives Policy Division, Office of Policy, Program Development
and Evaluation, Food Safety and Inspection Service, U.S. Department of
Agriculture, Washington, DC 20250-3700; (202) 205-0279.
SUPPLEMENTARY INFORMATION:
Background
During the manufacturing of cured pork products labeled ``Ham with
Natural Juices,'' ``Ham Water Added,'' and ``Ham and Water Product--X%
of Weight is Added Ingredients,'' the products are pumped or injected
with a brine solution in an amount equal to various percentages of the
weight of the raw, unprocessed product. These pork products are
normally packaged in clear plastic and enclosed by a vacuum seal before
curing. As the brine purges from them during the curing process, it
settles in the package of the product. As a result, some retailers
remove and discard these products well before their shelf life
expiration date, creating economic losses for both industry and
consumers.
Section 318.7(c)(4) of the Federal meat inspection regulations
currently permits the use of soy protein concentrate as a binder in
sausage products at up to 3.5 percent of formulations and in spaghetti
with meatballs, chili con carne, and similar products at up to 8 or 12
percent, depending on the product in which it is used. Section
318.7(c)(4) of the Federal meat inspection regulations also permits the
use of modified food starch or carrageenan as a binder in cured pork
products, as provided in 9 CFR 319.104, at a level not to exceed 2
percent and 1.5 percent, respectively, of the product formulation, to
inhibit purging of brine solution. Section 319.104 provides for the use
of certain binders or extenders in ``Ham with Natural Juices,'' ``Ham
Water Added,'' and ``Ham and Water Product--X% of Weight is Added
Ingredients'' products.
Modified Food Starch
FSIS was petitioned by the National Starch and Chemical Company \1\
to amend the Federal meat inspection regulations to permit an increase
in the use level of modified food starch from 2 percent to 3.5 percent
of product formulation in cured pork products labeled as ``Ham Water
Added'' and ``Ham and Water Product--X% of Weight is Added
Ingredients'' to reduce and control purging of brine during product
retail shelf life. The petitioner contended that certain cured pork
products, i.e., those injected with brine solutions that remain in the
product, require higher levels of modified food starch than the
currently allowed level of 2 percent to accomplish purge reduction.
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\1\ A list of all data and information submitted to FSIS in
support of this direct final rule is attached at the end of this
document. The data are available for review in the FSIS Docket
Clerk's Office.
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According to research data submitted by the petitioner, a level of
2 percent modified food starch in a ``Ham Water Added'' product pumped
to contain 35 percent of the solution is sufficient to effectively
reduce purge. These data are also applicable to the use of modified
food starch in ``Ham with Natural Juices'' products. Once the level of
modified food starch is increased above 2 percent, and the pump level
remains the same (35 percent), the modified food starch will not
properly hydrate due to excessive competition for water. Therefore,
modified food starch is a self- limiting ingredient in products labeled
as ``Ham Water Added'' and ``Ham with Natural Juices.''
However, when the overall water level is increased in products
labeled ``Ham and Water Product--X% of Weight is Added Ingredients,''
the level of modified food starch must be increased because a level of
2 percent can only bind a limited quantity of water and is not adequate
to reduce the
[[Page 27902]]
purge of the pumped brine solution in such products during retail shelf
life. The increase in the use level of modified food starch in this
product from 2.0 percent to 3.5 percent is also consistent with the use
of other approved binders (e.g., whey protein concentrate, soy flour,
vegetable starch, wheat gluten, tapioca dextrin) in the formulation of
standardized meat food products. Hence, a use level of 3.5 percent
modified food starch in ``Ham and Water Product--X% of Weight is Added
Ingredient'' products is appropriate.
Food and Drug Administration (FDA) regulations list food starch-
modified as a direct food additive in 21 CFR 172.892 for use in food
when used in accordance with good manufacturing practices. In a letter
to FSIS dated January 15, 1999, FDA's Center for Food Safety and
Applied Nutrition indicated that ``FDA's food additive regulation for
the use of various food starches does not limit the levels of use in
foods.'' With two exceptions, FDA does not have a concern about
modified food starches listed in 21 CFR 172.892 for use in meat at
levels up to 3.5 percent. (Food starch bleached with calcium
hypochlorite may be used only as a component of batter in commercially
processed foods (Sec. 172.892(b)) and food starch esterified with 1-
octenyl succinic anhydride followed by treatment with beta amylase may
be used only in beverage and beverage bases (Sec. 172.892(d).)
Soy Protein Concentrate
Among the attributes of an effective meat binder is the ability to
provide good water absorption (i.e., control purge); good physical and
chemical stability; and the ability to emulsify fat and water.\2\ In
order for a protein to be a good binder, it must possess both
hydrophobic and hydrophilic properties. The proteins in meat are
effective in binding fat and water. Because soy protein ingredients
possess both hydrophobic and hydrophilic properties, and contain at
least 50 percent protein, they serve to boost the protein content of
meat and serve as excellent binders for meat products.\3\ Binders such
as soy proteins serve the same functions in structured (i.e., whole
muscle) products as they do as ingredients of formed ground and cubed
meat products, such as sausages \4\ (most binders may be used in
sausages up to a use level of 3.5 percent, Sec. 318.7(c)(4)).
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\2\ Handbook of Food Additives, 2nd Edition, Volume 1, page 425.
\3\ The Meat We Eat, 13th Edition, Interstate Publishers, Inc.,
1994, pages 806-809.
\4\ Ibid, pages 678-679.
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FSIS was petitioned by Central Soya to amend the Federal meat
inspection regulations to permit the use of soy protein concentrate at
a level of up to 3.5 percent in cured pork products labeled ``Ham Water
Added'' and ``Ham and Water Product--X% of Weight is Added
Ingredients'' to bind and reduce purge of the pumped brine solution
from the products. The technical data submitted by the petitioner
indicate that the addition of soy protein concentrate at levels of up
to 2 percent of the product formulation aids in water retention and
reduces purging of the pumped brine solution from ham and water
products. The addition of up to 3.5 percent soy protein concentrate,
however, further reduces purge. Based on the data, FSIS finds that the
purge reduction when 3.5 percent soy protein concentrate is used is
greater than that observed when 2 percent is used (based on statistical
analyses).
FDA does not currently list soy protein concentrate in its
regulations. However, FDA does not object to the use of soy protein
concentrate at levels up to 3.5 percent. In a letter to FSIS, dated
January 15 1999, FDA's Center for Food Safety and Applied Nutrition
said that ``while FDA has not ruled formally on the generally
recognized as safe (GRAS) status of soy protein, it has not challenged
determinations that such use is GRAS.''
Soy Protein Concentrate in Combination With Modified Food Starch
FSIS was petitioned by Central Soya to amend the Federal meat
inspection regulations to permit the use of soy protein concentrate in
combination with modified food starch at a level not to exceed 3.5
percent in cured pork products labeled ``Ham with Natural Juices,''
``Ham Water Added,'' and ``Ham and Water Product--X% of Weight is Added
Ingredients'' to bind and reduce the purge of the pumped brine solution
from the products.
The data submitted by the petitioner show that the lowest level of
use of a binder, such as soy protein concentrate or modified food
starch, needed to achieve the intended effect of water-holding may be
higher or lower when it is used in combination with another binder, as
compared to when it is used singly. The level of modified food starch
needed for water-holding in certain cured pork products falls between 2
percent or 3.5 percent when used singly. When used in combination with
soy protein concentrate, however, the level of modified food starch
must be 3.0 percent while the level of soy protein concentrate must be
0.5 percent of the product formulation. From single use to combination
use, the levels of modified food starch do not remain constant in terms
of water-holding effectiveness and purge control.
In combination, the binders work synergistically to attract and
hold water molecules. This synergistic effect is a function of the
chemical structure of the individual binders and the combined chemical
structure they form. The technical data submitted by the petitioner
establish that the combination of modified food starch at 3 percent of
the formulation and soy protein concentrate at 0.5 percent of the
formulation aids in water retention and effectively reduces purging of
the pumped brine solution from ham and water products.
Soy Protein Concentrate in Combination With Carrageenan
FSIS was also petitioned by Central Soya to amend the Federal meat
inspection regulations to permit the use of soy protein concentrate in
combination with carrageenan at a level not to exceed 1.5 percent of
the product formulation in cured pork products labeled ``Ham with
Natural Juices,'' ``Ham Water Added,'' and ``Ham and Water Product--X%
of Weight is Added Ingredients'' to bind and reduce purge of the pumped
brine solution from the products. The technical data submitted by the
petitioner demonstrate that the addition of carrageenan singly and in
combination with soy protein concentrate at levels not to exceed 1.5
percent of the formulation effectively reduces purging of pumped brine
from these cured pork products. Ham products containing carrageenan
singly and in combination with soy protein concentrate had
significantly less purge than ham products without soy protein
concentrate or carrageenan. The data clearly demonstrate that, when
used in combination, soy protein concentrate and carrageenan reduce
purge consistent with the current limitation on amounts of carrageenan
used singly. The data also demonstrate that any percentages may be used
in combining soy protein concentrate and carrageenan, as long as the
levels of those binders do not collectively exceed 1.5 percent of the
product formulation.
Gelatin
Over the years, FSIS has received several informal requests from
food manufacturers to allow the use of gelatin as a food ingredient in
certain emulsified cooked meat products, such as franks, sausages, and
luncheon meat. According to these requests, gelatin would be used as a
binder, singly or in
[[Page 27903]]
combination with other binders already allowed in franks, sausages, and
luncheon meat.
FDA evaluated the safety of gelatin under a comprehensive safety
review in an effort to decide whether it can affirm that the use of
gelatin is generally recognized as safe (GRAS). In May 1993, FDA
published a tentative final rule on the GRAS status of gelatin as a
direct human food ingredient (58 FR 27959). FDA has not finalized that
tentative final rule. Therefore, FSIS is not providing for the use of
gelatin as a food ingredient in certain emulsified cooked meat
products. If and when FDA finalizes its review of the safety of the use
of gelatin, FSIS will reconsider whether to permit the use of gelatin
in emulsified meat products.
After reviewing the petitioners' technical data and information,
FSIS is amending 9 CFR 318.7(c)(4) to permit the use of soy protein
concentrate at a level not to exceed 3.5 percent of product
formulation; permit the use of soy protein concentrate in combination
with carrageenan or modified food starch at levels not to exceed 1.5
percent and 3.5 percent (3 percent modified food starch, .5 percent soy
protein concentrate), respectively; and increase the use level of
modified food starch from 2 percent to 3.5 percent of product
formulation in ``Ham and Water Product--X% of Weight is Added
Ingredients'' products. FSIS is also amending section 319.104(d) to
permit the use of combined binders in cured pork products.
Use of soy protein concentrate, modified food starch, and
carrageenan will not affect the protein fat-free determinations for the
products to which they are added. All added proteins, such as those
contributed by soy protein concentrate, modified food starch, and
carrageenan, are subtracted from the total protein of the finished
product before calculating the protein fat-free value of the product.
Pursuant to 9 CFR 318.7(a)(2)(iii), the Administrator, FSIS, has
determined based upon the above data that the use of these binders will
not render the products in which they are used adulterated or
misbranded or otherwise not in compliance with the requirements of the
Federal Meat Inspection Act, and that their use in these products at
these levels is functional and suitable for the product and will be at
the lowest level necessary to accomplish the stated technical effect.
Manufacturers opting to use soy protein concentrate singly or in
combination with either modified food starch or carrageenan will be
required to list the binders in the products' ingredients statements by
common or usual names in order of decreasing predominance by weight (9
CFR 317.2(f)(1)). This requirement will necessitate modification of
labels, which can be done generically and printing of new labels.
However, for manufacturers opting to increase their use of modified
food starch from 2 to 3.5 percent, new labels will not be required for
cured pork products labeled ``Ham and Water Product--X% of Weight is
Added Ingredients'' that presently contain modified food starch,
provided that the increase in the use level of the modified food starch
does not change the order of predominance in the ingredients statement
of product labels.
Executive Order 12988
This direct final rule has been reviewed under Executive Order
12988, Civil Justice Reform. This direct final rule: (1) preempts all
state and local laws and regulations that are inconsistent with this
rule; (2) has no retroactive effect; and (3) does not require
administrative proceedings before parties may file suit in court
challenging this rule.
Executive Order 12866 and Regulatory Flexibility Act
This direct final rule has been determined to be not significant
and, therefore, has not been reviewed by OMB.
Effect on Small Entities
The Administrator, FSIS, has made a determination that this direct
final will not have a significant economic impact on a substantial
number of small entities, as defined by the Regulatory Flexibility Act
(5 U.S.C. 601). This direct final rule will permit the use of soy
protein concentrate singly and in combination with either modified food
starch or carrageenan as a binder or binders in cured pork products
labeled ``Ham with Natural Juices,'' ``Ham Water Added,'' and ``Ham and
Water Product--X% of Weight is Added Ingredients,'' and allow an
increase in the use level of modified food starch from 2 percent to 3.5
percent to control purging of the pumped brine solution from ``Ham and
Water Product--X% of Weight is Added Ingredients'' products during
shelf life.
This direct final rule will impose no new requirements on small
entities. Use of soy protein concentrate, carrageenan, and modified
food starch as binders in certain meat products is voluntary. However,
manufacturers opting to use these binders will be required to revise
their product labels to show their presence in the ingredients
statement. These manufacturers may also be required to submit the
labels to FSIS for approval, unless they meet the conditions of generic
labeling approval (9 CFR 317.5 and 381.133). However, labels will not
have to be revised for increasing the use level of modified food starch
in ``Ham and Water Product--X% of Weight is Added Ingredients''
products that presently contain modified food starch, provided the
increase does not change the order of predominance in the ingredient
statement.
Currently, there are approximately 1,079 establishments producing
``Ham with Natural Juices,'' ``Ham Water Added,'' and ``Ham and Water
Product--X% of Weight is Added Ingredients.'' All small entities
producing these products and certain products classified as emulsified
meat that choose to use soy protein concentrate, carrageenan, or
modified food starch in the manner and at the levels established by
this direct final rule will be affected by it. Decisions by individual
manufacturers concerning whether to use these binders in the proposed
manner would be based on their conclusions that the benefits outweigh
the implementation costs.
Paperwork Requirements
Abstract: FSIS has reviewed the paperwork and recordkeeping
requirements in this direct final rule in accordance with the Paperwork
Reduction Act. This direct final rule requires manufacturers opting to
use soy protein concentrate, singly or in combination with either
modified food starch or carrageenan, as binders and extenders in
certain meat products to revise their product labels and submit them to
FSIS for approval. However, labels will not have to be revised for
increasing the use level of modified food starch in ``Ham and Water
Product--X% of Weight is Added Ingredients'' products that presently
contain modified food starch, provided the increase in the use level
does not change the order of predominance of the ingredients.
Estimate of Burden: Establishments must develop product labels in
accordance with the regulations. To receive approval of the labels,
establishments must complete FSIS Form 7234-1. FSIS program employees
review FSIS Form 7234-1 to ensure that the information on the labels
complies with the regulations. FSIS estimates that it will take 60
minutes to design and develop modified product labels in accordance
with this direct final rule and, in instances where labels cannot be
[[Page 27904]]
generically approved by establishments, 15 minutes to prepare FSIS Form
7234-1 and submit it, along with the sketch label, to FSIS.
Respondents: Meat establishments.
Estimated number of Respondents: 1,079.
Estimated number of Responses per Respondent: FSIS estimates that
each establishment would modify about 2 product labels.
Estimated Total Annual Burden on Respondents: 2,698 hours.
Comments are invited on: (a) whether the proposed collection of
information is necessary for the proper performance of the functions of
the Agency, including whether the information will have practical
utility; (b) the accuracy of the Agency's estimate of the burden of the
proposed collection of information including the validity of the
methodology and assumptions used; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of collection of information on those who are to
respond, including through use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology. Comments may be sent to Lee Puricelli,
Paperwork Specialist, see address above, and Desk Officer for
Agriculture, Office of Information and Regulatory Affairs, Office of
Management and Budget, Washington, DC 20253.
List of Subjects
9 CFR Part 318
Food Additives, Meat Inspection.
9 CFR Part 319
Food Labeling, Meat Inspection.
For the reasons set out in the preamble, 9 CFR parts 318 and 319
are amended as follows:
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND
PREPARATION OF PRODUCTS
1. The authority citation for part 318 continues to read as
follows:
Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695, 7 CFR
2.18, 2.53.
2. In section 318.7(c)(4), under the Class of substance ``Binders
and extenders,'' after the entry for ``xanthan gum,'' the substances
``carrageenan'' and ``food starch modified'' are revised, and
immediately after the substance ``food starch modified'' add a new
entry for the substance ``soy protein concentrate'' to read as follows:
Sec. 318.7 Approval of substances for use in the preparation of
products.
* * * * *
(c) * * *
(4) * * *
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Class of substance Substance Purpose Products Amount
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* * * * * * *
Binders and extenders.............. Carrageenan.......... To prevent purging of Cured pork products as Not to exceed 1.5 percent of product
brine solution. provided in 9 CFR formulation; permitted in
319.104(d). combination only with soy protein
concentrate, combination not to
exceed 1.5 percent of product
formulation; in accordance with 21
CFR 172.620, 172.623 and 172.626.
Food starch modified. ......do.................. ......do.................. Not to exceed 2 percent of product
formulation in ``Ham Water Added''
and ``Ham with Natural Juices''
products; not to exceed 3.5 percent
of product formulation in ``Ham and
Water Product--X% of Weight is
Added Ingredients'' products;
permitted in combination only with
soy protein concentrate, with
combination of modified food starch
at 3 percent of product formulation
and soy protein concentrate at 0.5
percent of product formulation; in
accordance with 21 CFR 172.892.
Soy protein To prevent purging of Cured pork products as Not to exceed 3.5 percent of product
concentrate. brine solution. provided in 9 CFR formulation; permitted in
319.104(d). combination only with modified food
starch, with combination of
modified food starch at 3 percent
of product formulation and soy
protein concentrate at 0.5 percent
of product formulation; permitted
in combination only with
carrageenan, combination not to
exceed 1.5 percent of product
formulation.
* * * * * * *
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PART 319--DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION
3. The authority citation for part 319 continues to read as
follows:
Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C.601-695, 7 CFR
2.18, 2.53.
4. The second sentence of Sec. 319.104(d) is revised to read as
follows:
Sec. 319.104 Cured pork products.
* * * * *
(d) * * * Unless explicitly provided for in Sec. 318.7(c)(4), these
binders are not permitted to be used in combination with another such
binder approved for use in cured pork products. * * *
Done at Washington, DC, on: May 14, 1999.
Thomas J. Billy,
Administrator.
Attachment 1
References
1. March 1, 1994 letter and data from the National Starch and
Chemical Company, Bridgewater, NJ, to the Food Safety and Inspection
Service, supporting an increase in the use of modified food starch
from 2 to 3.5 percent of product formulation to control the
[[Page 27905]]
purge of brine in ``Ham Water Added'' and ``Ham and Water Product--
X% of Weight is Added Ingredients.''
2. Food Safety and Inspection Service Policy Memo 121B, Labeling
of Modified, Substitute Versions of Fresh (Species) Sausage,
Hamburger, or Ground Beef Products with Added Ingredients Used to
Replace Fat that Qualify for Use of Certain Nutrient Content Claims
Associated with a Reduction in Fat Content, January 20, 1995.
3. Food Safety and Inspection Service Policy Memo 123, Modified
Breakfast Sausage, Cooked Sausage, and Fermented Sausage Products
Identified by a Nutrient Content Claim and a Standardized or
Traditional Name, January 20, 1995.
4. December 30, 1996 letter and data from the Central Soya
Company, Inc., Fort Wayne, IN, to the Food Safety and Inspection
Service, supporting the use of soy protein concentrate, a
combination of soy protein concentrate and modified food starch, and
a combination of soy protein concentrate and carrageenan to control
the purge of brine in ``Ham Water Added'' and ``Ham and Water
Product--X% of Weight is Added Ingredients.''
5. Functionality of Soy Protein Concentrate in Injected and
Tumbled Ham, Central Soya Company, Inc., Fort Wayne, IN, Linda
Wells-Beck and George Rakes, 1995-1996.
6. Functionality of Soy Protein Concentrate and Food Starch-
Modified in Injected and Tumbled Ham, Central Soya Company, Inc.,
Fort Wayne, IN, Linda Wells-Beck and George Rakes, 1995-1996.
7. January 15, 1999 letter from the Food and Drug Administration
(FDA), Center for Applied Nutrition and Safety, to the Food Safety
and Inspection Service, stating that FDA is not concerned about the
use of modified food starches listed in 21 CFR 172.892, including
soy protein concentrate, in meat at levels up to 3.5 percent.
[FR Doc. 99-12882 Filed 5-21-99; 8:45 am]
BILLING CODE 3410-DN-P