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8/10/2019 Citizen Petition From National Pasta Association NPA and Millers National Federation MNF Hogan and Hartson
1/12
U.S. DEP RTMENT OF HE LTH ND HUM N SERVICES
FOOD ND DRUG DMINISTR TION
)
mending
the Standards
of
Identity )
for Enriched Macaroni and Noodle Products )
)
_______________________________)
Submitted
by
the
Docket No. __
National Pasta ssociation
and the
Millers
National Federation
N
8/10/2019 Citizen Petition From National Pasta Association NPA and Millers National Federation MNF Hogan and Hartson
2/12
Dockets Management
Branch
Food and Drug Administration
12420
Parklawn
Drive
Room 1-23
Rockville, Maryland
20857
Citizen s Petition
The undersigned the National
Pasta
Association
(NPA)
and
the
Millers'
National
Federation (MNF) submit this
petition
to request
that the
Food
and
Drug
Administration
(FDA) amend the
standards of identity
for
enriched
macaroni and noodle products. This petition is submitted pursuant to Section 401(i)
of
the
Federal Food, Drug and Cosmetic Act (FD C Act) (codified at 21 U.S.C.
341(i) (1982)).
NPA is
the national
trade organization
for the U.S.
pasta
industry
representing U.S. pasta manufacturers industry
suppliers
and
allied
industry
representatives. MNF is the national
trade association of
the wheat and rye flour
and durum milling industry . t
represents
companies whose mills grind wheat and
rye
into
flour
and durum into semolina
for
wholesale and retail bakeries the pasta
industry
the
institutional
food
business and
for
home use
in the
U.S.
and
abroad.
I
CTION REQUESTED
Petitioners hereby respectfully
request
that FDA
amend the
standards
of
identity for the
enriched macaroni
and noodle
products
found
at
21 C.F.R. Part
139
by replacing
the range
values at which
these
products
must
be
fortified with
single
values. Currently the
standards
of
identity
for
enriched macaroni
products
enriched nonfat milk macaroni products enriched
vegetable
macaroni
products
enriched noodle products and
enriched
vegetable noodle products require that the
food contain in each pound not less than 4
mg
and not
more than
5 mg
of
thiamine
8/10/2019 Citizen Petition From National Pasta Association NPA and Millers National Federation MNF Hogan and Hartson
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This
petition requests
that
the
standards of
identity
be revised by
replacing
the range values with
single values.
Specifically,
each
standard
should
be
revised to
state
such
food contains
in
each pound 5
mg
of
thiamine,
2.2
mg of
riboflavin,
34 mg
of niacin or
niacinamide,
and 16.5 mg of
iron. The specific
standards of
identity that are
covered by
this
petition, the
regulatory citation
that
will
be affected
and
the
proposed revisions
are summa rized in the
table
below.
Standardized Food
Enriched
Macaroni
Products
21 C.F.R. 139.115(a)(1)
Proposed
Revision
Delete
Each such food
contains in
each pound not
less
than 4 mg and not more than 5 mg of
thiamine,
not less
than 1. 7
mg
and not more than
2.2
mg of riboflavin, not
less than 27
mg and
not more
than 34 mg
of niacin
or
niacinamide,
and not less than 13
mg
and not
more
than 16.5
mg
of iron.
Replace with Each such food
contains
in each pound
5 mg of
thiamine,
2.2 mg of
riboflavin, 34 mg
of niacin
or niacinamide, and 16.5
mg
of iron.
Enriched Nonfat Milk Delete
Each such
food contains in
each
pound not less
Macaroni
Products
than
4 mg and not more
than
5 mg of
thiamine,
not less
than 1. 7 mg
and not more than 2.2
mg of riboflavin, not
21 C.F.R.
139.122(a)(3)
less
than
27
mg and
not
more
than
34
mg
of niacin or
niacinamide, and not less than 13
mg
and not more
than 16.5
mg
of
iron.
Enriched
Vegetable
Macaroni Products
21
C.F.R.
139.135(a)
Replace with
Each such
food contains
in each pound
5
mg
of thiamine, 2.2
mg
of riboflavin,
34 mg
of niacin
or
niacinamide,
and 16.5
mg of iron.
The
standard establishes
by reference,
the
nutrient
fortification requirements for enriched products. The
establishment
of single
values
in the standard of
identity
for enriched
macaroni
products,
therefore,
will
result in the adoption of single values for this standard.
8/10/2019 Citizen Petition From National Pasta Association NPA and Millers National Federation MNF Hogan and Hartson
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Replace
with
Each such
food
contains
in
each pound
5
mg of thiamine
2.2
mg of
riboflavin,
34 mg of niacin
or niacinamide and 16.5
mg of
iron.
Enriched
Vegetable
The
standard
establishes by
reference the nutrient
Noodle
Products
fortification
requirements
for
enriched products. The
establishment
of
single
values
in the standard
of
21 C.F.R.
139.165 a)
identity
for
enriched
noodle
products therefore
will
result in the adoption of single values
for
this standard.
II STATEMENT OF GROUNDS
FDA has recognized
that
uniformity in an
enriched
standardized food
can be
accomplished
by eliminating
ranges and
limiting
overages within good
manufacturing
practice.
Specifically,
FDA
has
established single values
for
enriched bread
rolls,
and
buns;
enriched
flour;
enriched self-rising
flour;
and
enriched macaroni products
with fortified protein.
The
existence of maximum and minimum values at
which
enriched
macaroni products
must be fortified is
creating
a
tremendous
burden
on
the
milling
and
pasta industries.
The
limitations of the
existing
technology
that
is
used to
enrich
the
semolina
used in macaroni and
noodle
products
make
it difficult to fall
within the narrow range mandated by the standards of
identity. The
rules for
determining
compliance
with the nutrition
values
declared on the
label
further
exacerbate
the problem because they do
not provide
flexibility in
declaring
the
quantity
of
the
enriched
nutrients.
Although
the quantity
of
naturally occurring
nutrients only must be within 80 percent of
the value
found
in a composite
sample
of the product
an
added nutrient must
be present in the composite
sample at
100
percent of
the level declared on the label.
Petitioners
therefore request
that
FDA amend
the
standards of
identity to
allow for
the use
of
single
values
for
enriched
macaroni and
noodle
products.
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III. RELIEF WARRANTED
A.
The
Current Standards are
Impracticable
The enrichment of the semolina used to make macaroni and noodle
products is done at
the
mill. There are numerous technological limitations which
make it difficult for the mill to produce a semolina
that
is homogeneously enriched.
For
example
the
particle
size for
milled
semolina is relatively
large
in comparison
to the enrichment mixture which is a very fine powder. The differences
in
particle
size make it difficult to distribute evenly the enrichment mixture through the
semolina.
Further the
vibrations of
the semolina
particles
caused during the
loading, transporting
and
unloading of the enriched semolina cause segregation of
the enrichment particle from
the
semolina making
it
less likely that
the
pasta
manufacturer
will receive a homogeneous product. Given
the inherent
limitations
in the technology used to enrich
the
semolina and to
transport the
enriched
semolina from the mill to the pasta manufacturer
it
is difficult to manufacture a
pasta
product that falls within
the
narrow ranges in
the
standard of
identity.
The recently
promulgated nutrition labeling regulations
further
complicate the problems faced by the pasta and milling industries.
The
regulations
contain detailed
compliance requirements for the nutrient
values that
are declared
in the nutrition
facts
panel. Compliance
is
determined
by
analyzing
a composite
sample of
the product.
J/
The nutrient level
found
in the composite
sample
must
equal the
value declared on
the label when
such nutrient
is
added to
the
product
while
naturally
occurring
nutrients
only
must
be
present in the
composite sample
at
a level
that
is within 80
percent of the
value declared on the nutrition
facts
panel.
1 /
The
establishment
of
a single
value
will eliminate
many
of
the
problems caused
by
the presence
of
a maximum and minimum value. t will
require
the millers to target a single level
rather
than a
range.
Because the millers are
targeting a
single
value it will be easier for the pasta manufacturer
to
develop a
8/10/2019 Citizen Petition From National Pasta Association NPA and Millers National Federation MNF Hogan and Hartson
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result
in overfortification
because overages
will be acceptable only to
the
extent that
they are within
good
manufacturing
practices.
B. Single Level Requirements Would Better
Serve
Industry and
the Consumer
1. Historical Precedent
Supports the
Replacement of
Ranges with Single Values
FDA
has
eliminated the maximum
and
minimum values
in other
standardized foods such as enriched flours. On
May
24, 1941, FDA established a
standard of identity
for
enriched
flour
that contained minimum and maximum
levels for
thiamine,
riboflavin,
niacin and
iron.
f}j
Thirty years
later, FDA
published a
proposed
rule that would eliminate the ranges and replace them with
single
values in order
to
insure uniformity
and
maximum benefit
to
the
consumer. fl /
FDA
chose single levels similar to
the
originally established
maximum levels.
On
February 11, 1974, the
agency finalized
the
single
level
proposal
with respect to thiamine, riboflavin, and niacin. J
FDA did not
finalize a single level for
iron
fortification
of 20 mg per
pound
until
1981.
fi
The
agency originally
had
proposed
in
1971 a
significant
increase in
the
iron
fortification i.e., 40 mg
per
pound).
8 1 After holding
a hearing
on
the appropriate fortification levels for iron, the agency concluded that additional
fortification
of
flour and bread beyond what is
necessary
to replace
iron lost in
the
milling process had not been shown to be an efficient way of reaching those
segments
of
the population in need
of
iron supplementation.
10/
The
agency
also
fl 6 Fed. Reg. 2555 May 24, 1941).
fl /
36 Fed. Reg. 2307 4-75
(December
3 1971).
8/10/2019 Citizen Petition From National Pasta Association NPA and Millers National Federation MNF Hogan and Hartson
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-
stated that there
were
no
adequate
studies showing the
safety of
increased
iron
levels
in bread,
especially
with respect
to
hemochromatosis
and
thalassemia.
After the
hearing,
FDA published a proposal changing the
iron
requirement in
enriched
flour to a single level requirement
of 20 mg per pound with
provisions for overages within current good manufacturing practices. 12/ FDA
explained that
matters
of
good manufacturing
practice would continue
to
be judged
on
the basis of
the
factors
involved,
including
technology,
nutrient
deterioration,
and the
appreciation of these
factors
by
the man ufacturer in its food processing and
quality
control procedures. 13/
2. A
Single Level Requirements Would Ensure Uniformity
and
Maximize the Benefits to Consumers
FDA
eliminated the maximum
and
minimum values in the
standards
of identity
for
enriched
flours to
insure
uniformity and
to
maximize
the benefits
to
the consumer. 14/ The standards ofidentity for
enriched
macaroni and noodle
products have similar purposes and designs
as the
standards of identity
for
enriched
flours
and breads.
Further,
eliminating
the minimum
and
maximum
levels
in the macaroni
standard
would serve
the
agency s
broad-based
goal
of
greater
product uniformity
and
make
the
standards
for
enriched
macaroni and
noodle
products consistent with those of other enriched
foods.
Product
uniformity
would result
because
the millers would target a single
value
for enrichment
rather
than a
range.
The
agency
explained that
the requirement for adequate studies applies in
situations where serious concern about
the
safety of
a
proposed ingredient has been
8/10/2019 Citizen Petition From National Pasta Association NPA and Millers National Federation MNF Hogan and Hartson
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3 The Elimination of the
Maximum
Value Will Not Result in
Over Fortification
The elimination of
the
maximum values
will
not
result in
overfortification
of enriched macaroni
and noodle
products because
overages will be
limited to
amounts
within
good
manufacturing practices.
As
recognized
by
FDA,
matters
of
good manufacturing practices will be
judged
on the
technology
involved,
nutrient
deterioration
and
appreciation
of these
factors
by
the manu facturer in
its
food processing
and quality control procedures.
15/
When amending the standards of identity
for
enriched
flours
and
enriched bread FDA
recognized
that
the
limitations
on overages would prevent
overfortification
of products.
More
importantly
the limitation on overages
has
been
proven
to
be an effective
control because
overfortification
of enriched
flours
did not
result
after
eliminating the maximum
level
in
the
standards of identity. Therefore
the
limitation on
overages will prevent the overfortification of
enriched macaroni
and noodle
products.
C Petitioners Request that
FD
dopt the Maximum Values in
the
Currents
Standards
of
Identity as
the
Single
Value
When FDA amended the standards
of
identity for enriched flours, the
agency proposed
levels close to the
maximum
amount
allowed by
the
original
standards. 16/ That the maximum
values
are appropriate for
enriched
macaroni
and
noodle
products
further is
supported by
the
use of such values in
the
standard
for
enriched macaroni products with
fortified
protein
the
only
standardized
enriched macaroni product that
contains
single values rather than
a
range.
17/
The
standard
of
identity for
enriched macaroni
with fortified protein requires
that
one
pound
of
product contain
5
milligrams of thiamine
2.2
milligrams of
riboflavin, 34
8/10/2019 Citizen Petition From National Pasta Association NPA and Millers National Federation MNF Hogan and Hartson
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milligrams of niacin or niacinamide,
and 16.5
milligrams ofiron. 18 Petitioners,
therefore,
request
that
the same
single
values
be
adopted in the
standards
for
the
other enriched macaroni and noodle products.
D
conomic
Impact
An
economic
impact statement
under 21 C.F.R.
10.30 b) is
not
required
at
this time.
CONCLUSION
The
establishment
of
single
values
for
adding thiamine,
riboflavin,
niacin
and iron
to
enriched macaroni
and noodle
products would
ensure
uniformity
and maximize consumer benefits.
Moreover, FDA
precedent establishes that
the
elimination of
the
maximum
and
minimum values
is
appropriate.
Further, the
elimination of
the maximum value will not result
in overfortification because
overages
will
be
limited
to good
manufacturing practices.
Petitioners,
therefore,
request
that
FDA establish single
values
in
the
standards
of
identity for enriched
macaroni products,
enriched nonfat
milk
macaroni
products,
enriched
vegetable
macaroni
products,
enriched
noodle products, and
enriched
vegetable noodle
products.
8/10/2019 Citizen Petition From National Pasta Association NPA and Millers National Federation MNF Hogan and Hartson
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The undersigned certify
that
to
the
best of their knowledge
this
petition
includes all
information
and
views
on which
the petition
relies
and
that
it
includes representative
data and
information
known to
the
petitione r which are
unfavorable to the petition.
Respectfully submitted
National
Pasta
Association
~ ~ ~ ~
8/10/2019 Citizen Petition From National Pasta Association NPA and Millers National Federation MNF Hogan and Hartson
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-
-
ENVIRONMENT L IMP CT
The
National Pasta Association (NPA) and the Millers National
Federation submitted a citizens petition
on November
15, 1994 requesting the Food
and Drug Administration (FDA) to amend the standard of identity for numerous
enriched macaroni and noodle products. The petition inadvertently failed to include
an
environmental impact
section.
The action
requested by the petition
is
not
expected to
have
a significant effect
on
the quality of the
human
environment and is
subject to categorical exclusion
under
21 C.F.R. 25.24(a)(11).
The
undersigned certifies
that
the
information
presented in this
request for exclusion from an environmental impact is true accurate and complete
to the best
of
the knowledge
of
the firm
or agencies responsible
for
preparation
of
the environmental assessment.
Martin
J.
Hahn
Hogan Hartson
Counsel to National Pasta Association
Date:
t___i_/_
Q_ _[_f
:__Y
8/10/2019 Citizen Petition From National Pasta Association NPA and Millers National Federation MNF Hogan and Hartson
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HOGAN HARTSON
L L P
COLUMBIA SQUARE
555
THIRTEENTH STREET NW
WASHINGTON DC 20004 1109
Dockets
Management
Branch
Food and Drug
Admnis t ra t ion
1242
Parklawn Drive oom l -23
Rockvi l le M
2 857