Citizen Petition From National Pasta Association NPA and Millers National Federation MNF Hogan and Hartson

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


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


3/12

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.


4/12

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.


5/12

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


6/12

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).


7/12

-

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


8/12

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


9/12

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.


10/12

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

~ ~ ~ ~


11/12

-

-

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


12/12

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

Citizen Petition From National Pasta Association NPA and Millers National Federation MNF Hogan and Hartson

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