9826 Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 101, 161, and 501

[Docket No. 92P–0441]

Food Labeling; Net Quantity of

Contents; Compliance

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

revise its human and animal food

labeling regulations that pertain to

declarations of net quantity of contents

on food packages. This action would

establish specific procedures for

checking conformance to net contents

labeling requirements nationwide, and

provide consumers with information

that accurately reflects the actual

contents of the package. These

procedures include analytical methods

for evaluating declarations in terms of

mass or weight, volume, and count.

FDA is also proposing to require that

food packed in a pressurized container

bear a declaration of the net mass or

weight of the contents expelled when

the instructions for use are followed,

and to clarify when net content

declarations expressed in terms of mass

or weight are to be based on the

contents without the packing medium

(i.e., drained weight). Further, the

agency is proposing to revise the

standard of identity for fresh oysters.

This proposal is based on petitions

submitted by the National Conference

on Weights and Measures (NCWM) and

on comments that FDA received on one

of these petitions.

DATES: Submit written comments by

June 2, 1997. Submit written comments

on the information collection

requirements by April 3, 1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857. Submit

written comments on the information

collection requirements to the Office of

Information and Regulatory Affairs,

OMB, New Executive Office Bldg., 725

17th St. NW., rm. 10235, Washington,

DC 20503.

FOR FURTHER INFORMATION CONTACT:

Loretta A. Carey, Center for Food Safety

and Applied Nutrition (HFS–158), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–5099.

SUPPLEMENTARY INFORMATION:

Preamble Outline

I. Background

A. General

B. Past Attempts to Define

‘‘Reasonable Variations’’

C. Preemption

D. The Impact of Preemption on Net

Contents Declarations

E. Food for Animals

II. The NCWM Petition

A. The Contents of the Petition

B. Comments on the NCWM

Handbook 133 Petition

C. Denial of Exemption from

Preemption

III. Suggestions to the Agency About

the Actions the Agency Should Take If

It Denied the Petition

IV. The Need for Rulemaking

V. The Foundation of the New

Proposed Rule

VI. Provisions of the Proposed Rule

A. Existing Provisions

1. Reference Temperatures

2. Accuracy Within Reasonable

Variations

3. Pressurized Containers

4. Mass or Weight of the Packing

Medium

B. New Provisions

1. Definitions

2. Sample Collection

3. Measuring Equipment

4. Analytical Procedures

5. Compliance Procedures

VII. The Impact on Other Rulemaking

Proceedings

VIII. Animal Products

IX. Analysis of Impacts

A. The Compelling Public Need for a

Regulation

B. Costs

C. Benefits

D. The Initial Regulatory Flexibility

Analysis

X. The Paperwork Reduction Act of

1995

XI. Environmental Impact

XII. References

Codified Text

I. Background

A. General

Since the earliest days that it applied

to food, Federal law has required that

the label of food in package form bear

an accurate statement of the quantity of

the contents of the package. On March

3, 1913, an amendment to the Food and

Drugs Act of 1906 required that

statements be accurate, but it provided

that ‘‘reasonable variations shall be

permitted, * * * by rules and

regulations’’ (37 Stat. 732). Under this

provision, FDA adopted regulations in

1914 that stated:

(i) The following tolerances and

variances from the quantity of the

contents marked on the package shall be

allowed:

(1) Discrepancies due exclusively to

errors in weighing, measuring, or

counting which occur in packing

conducted in compliance with good

commercial practice.

* * * * *

(3) Discrepancies in weight or

measure due exclusively to differences

in atmospheric conditions in various

places, and which unavoidably result

from the ordinary and customary

exposure of the packages to evaporation

or to the absorption of water.

Discrepancies under classes (1) * * *

of this paragraph shall be as often above

as below the marked quantity. The

reasonableness of discrepancies under

class (3) of this paragraph will be

determined on the facts in each case.

(Regulation 29(I) of the Rules and

Regulations for the Enforcement of the Food

and Drugs Act; see Food Inspection Decision

No. 154, Regulation of Marking the Quantity

of Food in Package Form, May 11, 1914)

When Congress passed the Federal

Food, Drug, and Cosmetic Act (the act)

in 1938, Congress retained much of the

earlier language concerning reasonable

variations. Section 403(e)(2) of the act

(21 U.S.C. 343(e)(2)) states that a food

shall be deemed to be misbranded if the

package does not bear a label containing

‘‘an accurate statement of the quantity of

the contents in terms of weight,

measure, or numerical count, provided

that under clause (2) of this paragraph

reasonable variations shall be permitted

* * *.’’

Under this provision, FDA’s current

labeling regulations in parts 101 (for

human food) and 501 (for animal food)

(21 CFR parts 101 and 501), specifically

§§ 101.105 (a) and (q), and 501.105 (a)

and (q) state:

(a) The principal display panel of a food

in package form shall bear a declaration of

the net quantity of contents. This shall be

expressed in the terms of weight, measure,

numerical count, or a combination of

numerical count and weight or measure. The

statement shall be in terms of fluid measure

if the food is liquid, or in terms of weight if

the food is solid, semisolid, or viscous, or a

mixture of solid and liquid; except that such

statement may be in terms of dry measure if

the food is a fresh fruit, fresh vegetable, or

other dry commodity that is customarily sold

by dry measure. * * *

* * * * * * *

(q) The declaration of net quantity of

contents shall express an accurate statement

of the quantity of contents of the package.

Reasonable variations caused by loss or gain

of moisture during the course of good

distribution practice or by unavoidable

deviations in good manufacturing practice

will be recognized. Variations from stated
Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules 9827

quantity of contents shall not be

unreasonably large.

Although §§ 101.105(q) and

501.105(q) make it clear that FDA

requires that firms include an accurate

statement of the quantity of contents of

the package, and that variations from

the stated quantity not be unreasonably

large, the regulations provide almost no

guidance about what constitutes an

‘‘accurate statement’’ of quantity, or

about what constitutes an

‘‘unreasonably large’’ variation.

However, §§ 101.105(q) and 501.105(q)

states that reasonable variations from

moisture loss or gain, and unavoidable

deviations in good manufacturing

practice (GMP), will be recognized.

These sections make it clear that an

individual package need not contain

exactly the amount of the product stated

on the label.

To ensure that net weight label

statements reflect the quantity of food in

a package with appropriate accuracy,

FDA conducts field examinations of

packaged products and has provided its

personnel with guidance on how to

conduct these examinations (Sec.

562.300 Compliance Policy Guides

Manual (CPG) 7120.19). FDA rarely, if

ever, conducts field examinations at a

retail store. Its investigators usually do

field examinations at food storage

warehouses or at manufacturing plants.

Agency employees examine 48

individual packages (e.g., retail units)

collected at random from the lot of the

food product being inspected. When a

field examination reveals that the

quantity declared on the label does not

accurately reflect the amount of the

product present in the packages, a

portion of the packages (a subsample) is

reevaluated in agency laboratories. If the

laboratory analysis confirms the finding

of the field examination, and the

average contents of the subsample is 1

percent or more short of the weight on

the label (short weight), agency likely

will consider regulatory action. The 1-

percent guideline serves to focus the

agency’s limited resources on those

instances in which the economic

deception is significant. FDA has not

provided guidance for assessing

compliance for net contents declarations

made in terms of volume or count.

B. Past Attempts to Define ‘‘Reasonable

Variations’’

In 1980, to provide more specific

guidance about what constitutes a

reasonable variation, FDA proposed to

revise its regulations concerning

declarations of net quantity of contents

on packages of human food (45 FR

53023, August 8, 1980) by doing the

following:

(1) Deleting the general provisions in

§ 101.105(q) that provide for

‘‘reasonable variations’’ caused (a) by

loss or gain of moisture during the

course of good distribution practice or

(b) by unavoidable deviations (other

than those from moisture loss) in GMP,

and

(2) Adding a new § 101.106 that

would specify the amount of

‘‘reasonable variation’’ that would be

permitted for: (a) Moisture loss in

specific foods and (b) unavoidable

deviations in all foods with declarations

of quantity in terms of weight.

The attempt to provide this guidance

did not prove practicable. Most of the 85

comments that FDA received on the

proposal either disapproved of it or

suggested major revisions. These

comments were predominantly from

industry and State and local

governments. Many comments asserted

that the proposed regulations were

unnecessary because no chronic short

weight problem with food commodities

had existed for more than a decade.

Some added that, without such a

problem, it would be improper for FDA

to revise existing regulations solely to

help State and local regulators in

making judgements about whether

variations from stated net weight

declarations were ‘‘reasonable.’’

Many industry comments contended

that the specific provisions of proposed

§ 101.106 could not be practicably

substituted for existing general

provisions of § 101.105(q).

Some comments objected that,

because the moisture loss provisions of

proposed § 101.106 were limited to such

a small number of food classes, an

enormous economic burden would be

placed on the affected industry. The

comments stated that manufacturers of

the large number of foods that were not

yet included in § 101.106 would be

forced to overfill food packages by

approximately 9 percent until FDA

revised § 101.106 to provide moisture

loss tolerances for them. The comments

advised that, in some cases, it would

take several years to gather data to

justify these revisions, and that, once

the data were gathered, it could take

several more years for FDA to issue the

revisions. The comments maintained

that overpacking during these time

periods would have large economic

consequences.

In addition, one comment suggested

that any specific maximum moisture

loss provisions might be taken by a

dishonest manufacturer as a license to

underfill down to the ‘‘legal’’ limit.

Weights and measures officials would

be unable to detect such intentional

underfillings because local inspectors

relying on the regulation would have to

assume that a variation that was within

the limit specified by the regulation was

the result of moisture loss. The

comment said that the violation could

only be detected through laboratory

analysis or by checking the product

before it left the manufacturer’s

premises. The comment stated that the

obvious losers in this situation would be

the consumer and the honest packer

who continued to deliver full value to

the consumer.

Other comments objected that

proposed § 101.106 was inadequate with

respect to unavoidable deviations (other

than those from moisture loss) that

resulted even though GMP was

followed. Some comments pointed out

that none of these provisions concerned

products whose declarations of quantity

of contents were expressed in terms of

volume or count. As a result, such

products would be permitted no

variation from their labeled declarations

of net quantity of contents. The

comments argued that such a situation

would be clearly contrary to the intent

of Congress.

Comments pointed out that the

proposed unavoidable deviations

provisions may also not be adequate for

certain bakery products. For example,

one comment contended that the net

weight of yeast-leavened products is

much more difficult to control than is

the net weight of liquids and fine

powders. The comment stated that

bakers could comply with the proposed

net weight provisions only with

substantial overpacking and significant

price increases.

Because FDA was concerned that

there were significant problems with

proposed § 101.106, and that this

regulation could have considerable

adverse economic impact on the

affected industry, the agency did not

issue a final rule in this matter. The

agency withdrew the proposed rule on

December 30, 1991 (56 FR 67440).

C. The Basis for Preemption

Section 403A of the act (21 U.S.C.

343–1) provides that State food labeling

requirements are preempted when they

are the type required by section 403 (b),

(c), (d), (e), (f), (h), (i)(1), (i)(2), (k), (q),

and (r) of the act but are not identical

to those requirements. It also preempts

any requirement for a food that is the

subject of a food standard of identity

established under section 401 of the act

(21 U.S.C. 341) that is not identical to

such standard of identity or that is not

identical to the requirement of section

403(g). FDA’s regulations that pertain to

net contents declarations of human and

animal food, which are issued under
9828 Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules

1 ‘‘Inspection lot,’’ for purposes of this document,

means the collection of packages from which the

sample is collected that consists of the same food,

with the same label (but not necessarily the same

production lot code or, in the case of random

packages, the same actual quantity), and from the

same packer.

authority of section 403(e) of the act, are

therefore preemptive of State and local

laws and regulations that pertain to net

contents declarations on human and

animal food.

Thus, Congress decided that even

though Federal requirements may

preempt more restrictive State

requirements in certain instances, the

net benefits from national uniformity in

these aspects of food labeling outweigh

any loss in consumer protection that

may occur as a result.

However, Congress also provided in

section 403A(b) of the act that States

may petition for an exemption from

preemption, and that FDA may initiate

rulemaking to grant such an exemption,

where the State rule:

(1) Would not cause any food to be in

violation of any applicable requirement

under Federal law,

(2) Would not unduly burden interstate

commerce, and

(3) Is designed to address a particular need

for information which need is not met by the

requirements of the sections referred to in

subsection (a).

In the Federal Register of January 6,

1993 (58 FR 2462), the agency issued

final regulations that set out the

procedures for the submission, and for

agency review, of petitions for

exemption from preemption, and the

information that the petitioner should

supply. Section 100.1 sets forth the

requirements that a State petition must

meet to justify an exemption from

preemption.

D. The Impact of Preemption on Net

Contents Declarations

FDA’s regulations that pertain to net

contents declarations on human and

animal foods are very general, and

typically, as stated above, the agency’s

enforcement of these regulations takes

place at the point of distribution or

manufacture. FDA’s sampling approach,

involving examination of 48 randomly

selected packages for each sample, often

cannot be used in retail stores, where an

inspection lot 1 may contain less than 48

packages. State and local regulatory

agencies, unlike FDA, focus their

enforcement efforts on retail stores. To

facilitate retail level inspections, they

may have adopted specific regulations

and policies that differ from FDA’s.

These differences include sampling

procedures that are more suitable to

retail inspection.

For example, to determine whether

net contents declarations are sufficiently

accurate, most State and local agencies

use a guide that is published by the

National Institute of Standards and

Technology (NIST). NIST is charged by

Congress with primary responsibility in

matters concerning weights and

measures. It maintains standard units of

weight and measure that serve as

authoritative references for the Federal

Government.

The NIST guide that is used by State

and local agencies is referred to as ‘‘NBS

Handbook 133—Third Edition’’ and is

entitled ‘‘Checking the Net Contents of

Packaged Goods’’ (Handbook 133) (Ref.

1). NIST has published four

supplements to this guide. With passage

of the 1990 amendments, many State

and local agencies have grown

concerned that some courts may rule

that they are preempted from following

some or all of their enforcement

procedures for net contents declarations

because Handbook 133 is not part of the

regulations that FDA has adopted to

implement section 403(e) of the act.

E. The Need for Consistent Test

Procedures for Human and Animal

Food

Historically, FDA has regulated the

labeling of food intended for animals

and of food intended for humans

similarly when and where appropriate.

For example, current animal food

labeling regulations regarding the

statement of identity, declaration of net

contents, listing of ingredients, and

declaration of name and address of

manufacturer, packer, or distributor are

identical to those for food for human

consumption with only minor

exceptions. This consistency in

approach reflects the act but also is an

attempt to provide consumers with

equivalent labeling information on

human and animal food. It also provides

one standard for the feed/food industry

and a common basis for the Government

to conduct its inspections. FDA is not

aware of any basis for deviating from

this approach with respect to

declarations of net quantity of contents.

II. The NCWM Petition for Exemption

From Preemption

A. The Contents of Petition

On November 9, 1992, NCWM

submitted a petition (Docket No. 92P–

0441) (the 1992 NCWM petition) on

behalf of officials representing most of

its State regulatory agency membership.

The petition requested that FDA grant to

those State and local governments that

use Handbook 133 an exemption from

Federal preemption for the net contents

declarations provisions in sections

403(e)(2), 502(b)(2), and 602(b)(2) of the

act (21 U.S.C. 343(e)(2), 352(b)(2), and

362(b)(2)) of the act for food, drugs, and

cosmetics. NCWM is a voluntary

standards-writing body whose

membership includes State and local

weights and measures officials, and

Federal Government, industry, and

consumer representatives. NCWM is

also an internationally recognized forum

for establishing uniformity in weights

and measures laws, regulations, and

procedures for testing the accuracy of

net contents declarations.

Handbook 133 contains procedures,

using statistical sampling techniques,

for determining whether packages of a

wide variety of commodities conform to

legal requirements for net contents

declarations. NCWM stated that

packaged products must meet two basic

requirements under Handbook 133:

(1) The average quantity of contents of

the packages in a lot, shipment, or

delivery must equal or exceed the

quantity printed on the label. The

sampling plans and random sample

selection criteria used to determine the

average quantity of contents are based

on practical sampling procedures that

are similar to those used in quality

control programs.

(2) The variation of individual

package contents from the labeled

quantity must not be ‘‘unreasonably’’

large. ‘‘Unreasonably’’ large variations

are identified through use of values that

Handbook 133 refers to as maximum

allowable variations (MAV’s). The

MAV’s cited in Handbook 133 are those

values below which errors are

‘‘unreasonable.’’ MAV’s are based on

field studies of actual variability in

packaging plants, warehouses, and retail

outlets. Product samples may not have

more than a permitted number of

packages (based on the number of

packages in the sample) with net

contents deviations below the labeled

contents that are more than the MAV’s.

MAV’s apply only to shortages in

package contents.

NCWM advised that 47 States use

Handbook 133 to conduct net contents

inspections of packaged goods. NCWM

contended that the requested exemption

would achieve, to the maximum extent

possible, national standardization in net

contents inspection procedures. It

asserted that manufacturers, packagers,

and consumers need the protection that

can be provided by the inspection

programs conducted by State and local

inspectors using Handbook 133. NCWM

advised that industry support for
Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules 9829

Handbook 133 has been

‘‘overwhelming.’’

NCWM claimed that, because of the

number of States that use Handbook

133, there is already considerable

uniformity among the States. It also

stated that procedures in Handbook 133

have not, and will not, cause any food

to be in violation of FDA requirements.

NCWM asserted that the use of

Handbook 133 in State and local

enforcement programs provides

legitimate and specific protection for

consumers in areas where FDA

resources and activities have

historically been limited; that Handbook

133 provides specific MAV’s and testing

procedures that are not set by Federal

law; and that Handbook 133 provides

clear and uniform notice to packers,

wholesalers, and retailers of net weight

compliance procedures and

requirements.

Therefore, according to NCWM, no

unreasonable burden on interstate

commerce exists under the current

system, and no burden, and no

significant economic impact, would

result if the exemption were granted. In

addition, NCWM maintained that

granting the requested exemption would

be consistent with the intention of the

1990 amendments to provide national

uniformity in certain aspects of food

labels and labeling.

B. Comments on the NCWM Handbook

133 Petition

In response to the submission of the

1992 NCWM petition, the Grocery

Manufacturers of America, Inc., the

American Bakers Association, the

American Frozen Food Institute, the

International Dairy Foods Association,

the National Food Processors

Association, the National Pasta

Association, and the Snack Food

Association joined to form the Food

Industry Weights and Measures Task

Force (Task Force). The Task Force

represents the majority of food

manufacturers in the United States.

On behalf of the Task Force, GMA

submitted a letter, dated June 4, 1993,

commenting on the petition. The Task

Force advised that it had previously

submitted a letter to NCWM conveying

its endorsement of NCWM’s petition

requesting the adoption of Handbook

133 for use as the standard throughout

the United States to ensure uniformity

in measurement procedures and

quantity declarations for all food

products. However, the Task Force

pointed out that the 1992 NCWM

petition had been filed before the

January 6, 1993, regulation on

exemptions from preemption was

published (58 FR 2462 at 2468). The

Task Force also expressed the opinion

that the petition could not succeed

because it does not meet all of the

criteria specified in the final regulation.

The Task Force explained that the

1992 NCWM petition does not itemize

or cite with required particularity each

petitioning State’s requirement that has

been preempted. The Task Force stated

that no more than 18 of the States that

joined in the filing of the petition have

enacted Handbook 133 as a final rule,

and that the remainder of the States that

joined in the filing of the petition have

requirements that are either not

described by the petition or are too

informal to support a citation. The Task

Force stated that these remaining States

have legal requirements that are

therefore different from Handbook 133

and that are most likely different from

FDA’s current net contents declaration

requirements. The Task Force

maintained that Handbook 133 is not

functioning as a nationally uniform

standard, and that the requirements of

the petitioners are so disparate and

undetermined that a blanket exemption

would be virtually meaningless.

C. Denial of Exemption From

Preemption

FDA is denying the petition for

exemption of Handbook 133 from

preemption because, as the Task Force

pointed out, the 1992 NCWM petition

was submitted before the publication of

the January 6, 1993, final rule, and it

does not satisfy all of the criteria

specified in the final rule. The petition

does not itemize or cite with required

particularity each petitioning State’s

requirement that has been preempted.

Furthermore, the petition does not

address several of the issues that a

petition is required to address under

§ 100.1, including: (1) Comparing the

costs of compliance with the State and

Federal requirements on the sale and

the price of the food product in

interstate commerce, and (2) the effect

of the State requirement on the

availability of the food product to

consumers. The petition also does not

include information showing that it is

practical and feasible for producers of

food products to comply with the State

requirement.

Further, with respect to drugs and

cosmetics, sections 502(b)(2) and

602(b)(2) of the act are not specifically

preemptive of State and local law as is

section 403(e) of the act. In addition,

there are no provisions under the act for

the agency to grant exemptions from

preemption of the drug and cosmetic

provisions.

III. Suggestions to the Agency About the

Actions the Agency Should Take if It

Denied the 1992 NCWM Petition

Although the Task Force

recommended that FDA deny the 1992

NCWM petition, it stressed that there is

a great need for a uniform, national

standard for ensuring that net contents

declarations are accurate. The Task

Force also pointed out that a national

standard could be most effectively

provided through FDA regulations that

would be preemptive of State and local

regulations. The Task Force stressed

that, without such a standard for

determining compliance for net contents

declarations, substantial burdens on

interstate commerce occur because

nonuniform labeling requirements

necessitate either a multiplicity of labels

or levels of fill to meet each of the

different requirements, or the

understating of the net contents

declaration sufficiently to meet the

‘‘most onerous State requirement.’’ It

stated that neither option serves the best

interests of consumers or packagers.

The Task Force stated that there are

major costs to industry, and ultimately

to consumers, associated with the

burdens on interstate commerce from

overfilling to meet the most stringent

requirements of State regulatory

agencies. The Task Force pointed out

that the agency’s August 8, 1980,

proposal (45 FR 53023 at 53026) advised

that a nationwide survey had revealed

that consumers routinely receive a 4-

percent overfill for the average of all

packaged foods purchased. That

proposal also advised that the GMA had

stated that a 4-percent overfill translates

into a 4-percent cost increase, and that

such a cost increase may involve added

annual costs in the billions of dollars

per year.

The Task Force requested that FDA

incorporate a modified Handbook 133

into its regulations. The Task Force

suggested a number of modifications

that it believed should be included in

any FDA-adopted version of Handbook

133. In subsequent comments on the

1992 NCWM petition in letters dated

June 24, 1994, and September 15 and

22, 1994, the Task Force reconfirmed its

belief that its suggested modifications

should be adopted, and it suggested

changes in FDA regulations to

implement some of those modifications.

The 1992 NCWM petition itself asked

that, if FDA decides to deny the

requested exemption, the agency join

with NCWM, NIST, and other Federal

agencies to harmonize all net content

requirements and test procedures using

Handbook 133 as the basis for such

work.
9830 Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules

After filing its petition, NCWM also

provided suggestions concerning

harmonization. The NIST Handbook 133

Working Group (the Working Group), a

committee of NCWM charged with the

responsibility of recommending changes

in Handbook 133, submitted a letter to

FDA (Docket No. 92P–0441), dated

November 15, 1993, commenting on the

petition. The Working Group requested

that FDA incorporate a modified

Handbook 133 into the agency’s

regulations if the agency denies the

petition. The Working Group suggested

a number of modifications to Handbook

133 that it believed would help FDA to

develop a revised version of Handbook

133. NCWM subsequently adopted the

suggested modifications, and NIST

published them in ‘‘Supplement 4,

October 1994’’ (the 1994 Handbook).

However, the agency points out that the

1994 Handbook has not yet been issued

as a new edition of Handbook 133. The

1994 Handbook consists of Handbook

133 and the substantive changes

provided in Supplement 4. The details

of sampling, analytical, and compliance

procedures of the 1994 Handbook are

contained in both documents. Although

the agency is denying the petition to

adopt modified Handbook 133, FDA has

considered Handbook 133 and the

changes provided in Supplement 4 very

carefully in developing this proposal.

IV. The Need for Rulemaking

Although many State and local

regulatory agencies do have

enforcement approaches patterned after

Handbook 133, NIST has stressed that

the approaches are not all uniform (Ref.

3). NIST pointed out that uniform

enforcement approaches may be assured

only where State and local regulatory

agencies use the most current version of

Handbook 133 (e.g., the 1994

Handbook). NIST advised, however, that

some State and local regulatory agencies

have not formally adopted the most

current version of Handbook 133 and

are using older versions. In addition,

NIST advised, not all State and local

agencies that use a particular version of

Handbook 133 conform with its

provisions. Further, as pointed out by

the Task Force and as acknowledged in

the 1992 NCWM petition, some State

and local jurisdictions do not use

Handbook 133 at all.

NIST pointed out the potential for

dramatically increased overfilling costs

without the agency formally adopting

the most current version of Handbook

133 as a standard. NIST stated:

Handbook 133 contains two widely varying

approaches with differing statistical bases for

determining whether contents declarations

are sufficiently accurate. In Handbook 133,

these approaches are designated as ‘‘Category

A’’ and ‘‘Category B’’ approaches. Both

approaches address the appropriate sample

size corresponding to the size of the

inspection lot, and the maximum number of

packages permitted to exceed the MAV

established for the package size that is being

examined. However, for most inspection lots,

especially the larger ones, sample sizes are

larger under the ‘‘Category A’’ approach than

under ‘‘Category B.’’ Also, only the ‘‘Category

A’’ approach provides correction factors that

must be used in a statistical evaluation of the

analytical findings to provide assurance that

the findings actually represent the fills that

are present throughout the entire inspection

lot. Under the ‘‘Category B’’ approach, the

absence of the correction factors means that

an inspection lot that is actually in

compliance could be found violative 50

percent of the time. Under the ‘‘Category A’’

approach, the same lot is likely to be found

violative only 3 percent of the time.

(Ref. 3)

NIST advised that before the 1994

Handbook, it was common practice for

State and local regulatory agencies to

use the ‘‘Category B’’ approach because

it is simpler to use and biased in favor

of consumers rather than industry (Ref.

3). Because of concern about the large

differences in the statistical bases

between the ‘‘Category A’’ and

‘‘Category B’’ approaches, the 1994

Handbook provides that the ‘‘Category

A’’ approach is to be used for all

situations where regulatory action may

result. The ‘‘Category B’’ approach is to

be used only in meat and poultry plants

that are subject to the jurisdiction of the

U.S. Department of Agriculture (USDA).

However, NIST pointed out that the

simplicity of the ‘‘Category B’’ approach

provides strong incentive for regulatory

agencies to continue using the

‘‘Category B’’ approach where they have

not formally adopted the most current

version of Handbook 133. Thus,

different jurisdictions may still have

significantly different enforcement

approaches. Furthermore, because some

State and local regulatory officials do

not use the ‘‘Category A’’ approach,

firms recognize that regulatory action

may be taken against inspection lots that

are actually in compliance.

Manufacturers are, therefore, as a

practical matter, forced to systematically

and significantly overfill their packages.

Although FDA has no data concerning

the extent of current overfilling, the

survey that it cited in 1980 (45 FR at

53023 at 53026) supports the Task

Force’s contention that expenses

associated with overfilling constitute a

significant burden on interstate

commerce. FDA notes that the same

survey suggests that the amount spent

on overfilling may be in the billions of

dollars annually. These expenditures

raise the price of the overfilled

packages. Thus, if adopted, the uniform

approach set out in this proposal should

reduce the amount of overfilling and the

increased prices associated with

overfilling.

Furthermore, the Task Force pointed

out that overfilling misleads consumers

about the nutrient content in a serving

of food. For example, the nutrition

labeling information on a food package

declares the nutrient profile of the food

in terms of the number of servings

present in a package. If a food package

is overfilled, a serving of a food contains

more nutrients (e.g., calories, fat, and

cholesterol) than is stated on the label.

Thus, a consumer attempting to reduce

intake of certain nutrients for health

reasons from an overfilled food package

would not recognize that nutrient

reductions are less than the consumer

would expect.

Based on these factors, the 1992

NCWM petition and the comments on

the 1992 NCWM petition, have

convinced the agency that the diversity

in approaches to enforcement of net

contents declaration labeling

requirements on foods among State and

local regulatory agencies has created

significant burdens on interstate

commerce.

As pointed out in section I.C. of this

document, Congress included

preemption provisions in the 1990

amendments to provide national

uniformity to facilitate interstate

commerce. Although FDA has no

authority to require State and local

agencies to adopt specific procedures

for enforcement of net contents

declaration labeling requirements, the

preemptive effect of the provisions that

FDA adopts will mean that, to the extent

that such agencies adopt requirements

that relate to net contents declarations,

they will have to adopt requirements

that are consistent with FDA’s

requirements. Given this fact, to the

extent that FDA identifies ‘‘reasonable

variations’’ in its regulations, the

affected industry will know when net

content deviations are likely to be

considered violative. Such knowledge

should help firms to reduce overfilling

of packages and should facilitate

interstate commerce by making the

establishment of uniform target fill

levels practicable for all package sizes.

FDA’s current approach to

declarations of net quantity of contents

of foods cannot practicably serve as a

national standard, however. Rather than

having regulations that identify

‘‘reasonable variations’’ for a variety of

situations, FDA relies on a case-by-case

approach for determining whether

variations are reasonable. With respect
Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules 9831

to assessments concerning whether an

inspection lot conforms to net contents

labeling provisions of the act, FDA looks

at analytical findings of each sample

and decides whether the statistical

characteristics of those findings support

a conclusion that the lot is violative.

The agency does not have an established

procedure for adjusting net contents

findings with correction factors such as

those in the ‘‘Category A’’ approach.

Admittedly, the guidance in FDA’s CPG

7120.19 (which directs FDA field

personnel to consider regulatory action

where the average contents of the

subsamples is 1 percent or more under

fill, i.e., less than the declared net

quantity of contents) may serve to

minimize the impact of the lack of such

correction factors, but, as mentioned

previously in this document, 1-percent

criterion in the CPG was intended only

to conserve agency resources.

Without an established procedure for

adjusting net contents findings with

correction factors, a case-by-case

approach would not be likely to

produce national uniformity because

each State and local enforcement agency

could set its own policy for determining

when variations are reasonable. For

example, different statistical approaches

might be used for concluding that a lot

is violative. There would be a

significant potential for such a situation

happening with the large number of

State and local regulatory agencies in

the United States. Moreover, as

mentioned previously in this document,

FDA’s sampling approach cannot be

used in retail stores, where inspection

lots often consist of less than 48 units.

In view of these facts, FDA finds that

there is a need to initiate rulemaking

proceedings on net contents

determinations.

FDA recognizes that the regulation

that it is proposing is prescriptive and

complex. Normally, in this time of

Government reinvention, this is not the

type of regulation that FDA would be

proposing. However, FDA tentatively

finds that to establish a uniform

national system under which

manufacturers can be assured net

quantity of contents will be tested the

same way regardless of the jurisdiction,

it must adopt detailed regulations. FDA

welcomes comment on this tentative

judgment.

One alternative that the agency

considered was to issue the detailed

provisions that are contained in the

proposed regulations as guidance rather

than as regulations. FDA has tentatively

concluded, however, that guidance

would not be effective to correct the

problems that both industry and NCWM

have asked FDA to address. Section

403A(a)(2) of the act (21 U.S.C. 343–

1(a)(2)) states that no State or political

subdivision of a State may establish a

requirement of the type required by

section 403(c) of the act that is not

identical to the requirement of such

section. Thus, apparently, in the

absence of a Federal regulation, State

and local jurisdictions could not adopt

regulations, even regulations that reflect

Federal guidance. Consequently, the

effect of an FDA decision to rely on

guidance rather than regulations would

be to continue the national, State, and

local systems that rely on case-by-case

determinations. Because such a system

would deprive consumers and industry

of the benefits listed above, FDA has

tentatively rejected this alternative.

However, the agency invites comments

on the appropriateness of this choice.

V. The Foundation of the New Proposed

Rule

During its review of the 1994

Handbook, FDA tentatively concluded

that NCWM is correct. If the 1994

Handbook is appropriately modified, it

can serve as a national standard for

determining the accuracy of net

contents declarations. The statistical

base of the procedures for determining

compliance in this handbook is such

that there should be little need for

unnecessary overfilling of packages to

ensure compliance. Use of the detailed

sampling, analytical, and compliance

procedures in the 1994 Handbook can

minimize case-by-case decisions

affecting compliance testing and can

provide a basis to make uniform

guidance practicable. Further, the 1994

Handbook identifies ‘‘reasonable

variations’’ for both average and

individual fills, as well as some

moisture loss variations. In addition, the

1994 Handbook has been developed by

NCWM through a long-established

process, spanning approximately 30

years, and it is based on a consensus of

regulators, industry, and consumer

advocates. All of the published editions

of the NCWM Handbook have had

histories of successful implementation.

Because the 1994 Handbook has been

developed through this consensus

building process, FDA

findsconsiderable merit in the

suggestions by industry, NIST, and

NCWM that FDA adopt, as part of its

regulations, the testing procedures in

the 1994 Handbook, with some

appropriate revisions.

However, while the 1994 Handbook

does contain many desirable features,

there are some obstacles to the agency’s

incorporating the 1994 Handbook into

its regulations. Much of the material in

the 1994 Handbook is not necessary or

appropriate for agency rules on net

contents declarations on packaged food.

For example, there are many methods of

analysis in the 1994 Handbook for

products that are not foods or that are

not regulated by FDA. Further, there is

considerable background information

that would not need to be codified. Even

if FDA were to adopt the 1994

Handbook with a number of exceptions

for irrelevant provisions, the large

quantity of material (more than 250

pages), and the long list of exceptions

that the agency would have to include

with such adoption could be very

confusing to all affected parties. Thus,

FDA finds that it is not practicable to

adopt the 1994 Handbook in its entirety.

Nonetheless, many aspects of the

1994 Handbook can serve as the

foundation for regulations on net

quantity of contents. In view of the fact

that the Handbook 133 portion of the

1994 Handbook is already a widely used

national model, and that NIST was one

of the primary authors of Handbook 133

and the 1994 Handbook, FDA

tentatively concludes that it should use

the 1994 Handbook as a starting point

for its regulations. This approach was

suggested by the Task Force when it

requested that FDA incorporate

Handbook 133 in a modified form into

the agency’s regulations. Therefore, FDA

set out to craft a regulation based on the

1994 Handbook.

In developing specific provisions of

the proposed regulations, FDA worked

closely with NIST, as was suggested by

the petition and comments on the

petition. FDA used NIST as its primary

technical resource because of the

worldwide recognition of that agency’s

expertise in all issues concerning

weights and measures. Also, NIST’s

involvement in developing Handbook

133 and the 1994 Handbook has made

that agency uniquely qualified to help

in FDA’s review of the 1994 Handbook.

As mentioned in section III. of this

document, NCWM requested that FDA

include them in agency efforts to

establish national uniformity in net

contents requirements if the agency

decided to deny the requested

exemption. FDA did not grant this

request, however, because of concerns

that, given its diverse membership,

NCWM participation might create

procedural problems in developing this

proposal. However, NIST is extremely

active in NCWM. NIST’s involvement in

developing of this proposed rule, and

the significant NCWM technical

material in the 1994 Handbook, has

minimized the significance of FDA’s

decision not to have NCWM participate.
9832 Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules

VI. Provisions of the Proposed Rule

A. Existing Provisions

FDA examined its existing regulations

that pertain to declarations of net

contents for human and animal food in

§§ 101.105 and 501.105 to identify all

provisions that bear on the accuracy of

measurements and to determine what

revisions, if any, need to be made. The

agency found that §§ 101.105(b)(2), (g),

and (q) and 501.105(b)(2), (g), and (q)

contain information that bears on the

accuracy of measurements. The

remaining paragraphs in §§ 101.105 and

501.105 cover a broad range of topics

concerning declarations of net quantity

of contents that are not relevant to the

accuracy of measurements of content.

For example, type size requirements for

letters and numerals in declarations

(§ 101.105(h)) and location requirements

for such declarations (§ 101.105(f)) have

no bearing on the accuracy of the

quantity declaration.

Given the distinction between the

provisions that bear on accuracy of

quantity declarations and those that

bear on how those declarations are to be

presented, FDA has decided to move

§ 101.105(b)(2) and (g) into a new

section. FDA is also redesignating

§ 101.105 as § 101.200 and moving it to

a new subpart H of part 101. The

proposed new section that FDA is

creating out of § 101.105(b)(2) and (g),

proposed § 101.201, will contain the

other provisions that relate to the

accuracy of net contents declarations in

subpart H of part 101. The agency sees

no reason, however, to repeat the same

provisions in parts 101 and 501 when it

may cross-reference them. Accordingly,

with the exception of §§ 101.200 and

101.201, FDA is proposing to crossreference the provisions in part 101 in

part 501 (proposed § 501.105(g)).

In addition to redesignating certain

provisions that had appeared in

§ 101.105, FDA is proposing to make a

number of substantive changes in the

provisions that it is redesignating. A

description of these proposed changes

follows.

1. Reference Temperatures

Liquid food products may be held for

sale at room temperature or at other

colder temperatures that refrigerate the

products or cause them to be frozen.

Sections 101.105(b)(2) and 501.105(b)(2)

affect the accuracy of measurements by

specifying the temperatures at which

volume measurements of frozen,

refrigerated, and other liquid foods are

to be made to determine whether they

meet the net quantity of contents

requirements. These temperatures are to

approximate the temperature at which

the food is customarily sold. The

temperature at which the volume of

food is to be measured is referred to in

this proposal as the ‘‘reference

temperature.’’

The reference temperature affects

measurement accuracy because the

volume that is occupied by any food

varies with the temperature of the

product. Sections 101.105(b)(2) and

501.105(b)(2) and the 1994 Handbook

contain reference temperatures for

frozen, refrigerated, and other liquid

foods. Although there is consistency

between agency regulations and the

1994 Handbook for refrigerated foods

and other foods, §§ 101.105(b)(2) and

501.105(b)(2) provide that statements of

fluid measure for a frozen liquid food

shall express the volume ‘‘at the frozen

temperature.’’ However, the Handbook

133 portion of the 1994 Handbook

contains a frozen food reference

temperature of 0 °F (¥17.8 °C). Unless

FDA also establishes a specific reference

temperature for frozen liquid food,

considerable variation could occur in

volumetric measurement for the same

volume depending on the temperature

of the product at the time that it is

tested.

For example, it is possible to

approximate the behavior of liquids

with high water content by calculating

the volumetric changes predicted for

water: At ¥20 °C (¥4 °F), the density

of water is 0.993550 grams (g) per cubic

centimeter, and at 0 °C (+32 °F), the

density of water is 0.9998425 g per

cubic centimeter. Thus, 12 fluid ounces

of frozen orange juice at 0 °C (+32 °F)

would occupy 354.9 millimeters (mL),

but at ¥20 °C (¥4 °F), it would occupy

357.1 mL, a difference of 0.6 percent.

Since defrosting freezers that cycle

between ¥10 and +20 °F are used

routinely at retail outlets to store and

display frozen foods (Ref. 3), it is

important to define a reference

temperature for frozen liquids to ensure

that there is consistency and

predictability in the temperature at

which such products are tested. FDA is

therefore proposing to establish a

reference temperature for frozen food.

For consistency with reference

temperatures in the agency’s ongoing

metric labeling rulemaking proceedings

(see 58 FR 29716 May 21, 1993, and 58

FR 67444 December 21, 1993), the

agency has rounded the metric

temperature to the nearest whole

number, ¥18 °C, and placed it before 0

°F in proposed § 101.201(a)(2)(i) and

proposed § 501.105(b)(2)(i).

2. Accuracy Within Reasonable

Variations

As mentioned previously in this

section of the document, paragraphs (g)

and (q) of §§ 101.105 and 501.105 both

relate to accuracy of net quantity

declarations. These paragraphs are

somewhat redundant in that they both

require that the net contents declaration

be accurate. However, while paragraph

(g) requires that the declaration reveal

the quantity of food in the package

exclusive of wrappers and other

material packed therewith, paragraph

(q) provides that the net contents of an

individual package need not precisely

meet the labeled declaration. It

recognizes that reasonable variations

may be caused by loss or gain of

moisture during the course of good

distribution practice or by unavoidable

deviations in GMP. Paragraph (q) also

requires, however, that such variations

not be unreasonably large.

Given the basic redundancy in these

two paragraphs, FDA has tentatively

decided to combine them as

§§ 101.201(b) and 501.105(g) and to

remove paragraph (q) in both human

and animal food regulations. The

proposed paragraph, however, carries

forward the two basic aspects of the

current provisions. It requires that the

declaration of net quantity of contents

provide an accurate statement of the

quantity of contents of the package and

defines an accurate statement as one

that conforms to all requirements for the

declaration set forth in subpart H. It also

recognizes that there may be reasonable

variations in the net content

declarations and refers to §§ 101.240,

101.245, and 101.250 to define what

constitutes a ‘‘reasonable variation.’’

Although the proposed provisions of

subpart H establish the procedures and

analytical methodology that will, if

finalized, be used in enforcement

decisions by Federal, State, and local

regulatory agencies, manufacturers will

be free to use any alternate procedures

and analytical methodology that they

find appropriate. However, FDA

strongly recommends that

manufacturers use the same procedures

and analytical methodology that appear

in subpart H. Where firms elect to adopt

a different approach than the

recommended approach, firms would be

advised to compare their approach to

that in subpart H to ensure that their

approach produces similar results.

3. Pressurized Containers

Section 101.105(g) addresses what the

net contents declarations on pressurized

containers is to present. It states, in part:

* * * In the case of foods packed in

containers designed to deliver the food under

pressure, the declaration shall state the net

quantity of the contents that will be expelled

when the instructions for use as shown on
Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules 9833

the container are followed. The propellant is

included in the net quantity declaration.

Paragraph (g) does not address,

however, whether the declaration is to

be in terms of solid or fluid measure

when the product is expelled as a

gaseous suspension of fine solid or

liquid particles.

Aerosol-packaged products and

similar pressurized products are often

dispensed as suspensions. Sections

§§ 101.105(a) and 501.105(a) provide

that net contents declarations for food

products are to be in terms of fluid

measure if the product is liquid, and in

terms of weight if the product is solid,

semisolid, or viscous or a mixture of

solid and liquid. The agency has

interpreted § 101.105(a) with respect to

aerosols in the Fair Packaging and

Labeling Manual Guide 7563.7 (Guide

7563.7), which states:

We have not objected to the use of units

of volume to declare the net contents of

aerosol preparations that would be liquid if

not combined with the propellant, and a net

weight statement in avoirdupois units for

products that would be solids if not

combined with a propellant.

While this position is consistent with

§ 101.105(a), it is not consistent with the

Handbook 133 portion of the 1994

Handbook, which requires that such net

contents declarations be expressed in

terms of weight. The inconsistency

between Guide 7563.7 and Handbook

133 was brought to the agency’s

attention a number of years ago when

FDA received a petition from NCWM

(Docket No. 90P–0180) that requested,

in part, that FDA amend its regulations

for foods to require that declarations of

quantity of contents on aerosolpackaged products and on similar

pressurized packages be expressed in

terms of net mass or weight.

NCWM pointed out in that petition

that State and local regulatory agencies

have regulated these products on the

basis of net mass or weight for many

years. NCWM explained that, for aerosol

and other pressurized packages, an

expression of quantity in terms of mass

or weight is the only net contents

declaration that could practicably be

checked by regulatory inspection

officials and used successfully in the

packer’s filling operation. NCWM also

pointed out that it could be difficult for

consumers to make value comparisons

between similar products where some

are labeled in terms of volume, and

some are labeled in terms of mass or

weight. Further, NCWM advised that

because State and local officials have

long required net contents declarations

on self-pressurized containers to be in

terms of net mass or weight, such

declarations have become an industrywide practice. Consistent with State and

local requirements, the Handbook 133

portion of the 1994 Handbook provides

for net contents declarations on such

products only in terms of mass or

weight, with the expelled propellant

being included in the net contents

declaration.

Based on the arguments set forth in

the 1992 NCWM petition, the fact that

FDA knows of no human or animal

aerosol foods with net contents

declarations that are expressed in terms

of volume, and the fact that FDA is

using the 1994 Handbook as a starting

point for its regulations, the agency has

been persuaded to propose that net

contents declarations on aerosol foods

be expressed in terms of mass or weight.

This approach will apparently cause the

least amount of disruption in labeling,

while removing a significant

inconsistency between the agency and

State and local requirements.

Accordingly, the agency is proposing to

redesignate § 101.105(a) as § 101.200(a)

and revise newly redesignated

§ 101.200(a) and revise § 501.105(a) to

provide that a food packaged in a selfpressurized container shall bear a net

contents declaration in terms of the

mass or weight of the food and the

propellant that will be expelled when

the instructions for use as shown on the

container are followed.

4. Mass or Weight of the Packing

Medium

Section 101.105 does not address

when net contents declarations that are

expressed in terms of mass or weight are

to be declared as the mass or weight of

the contents without the packing

medium, which is commonly referred to

as the ‘‘drained mass or weight’’ or the

‘‘drained solids.’’ The agency tentatively

concludes that new § 101.200 should

address this matter.

For many years, FDA has advised

firms that the net contents declaration

should include the packing medium if

it is generally consumed as part of the

food. Conversely, where solid foods are

packed in a salt brine or other medium

that is always, or almost always,

discarded before serving, the agency has

expected that the label would disclose

the drained weight. For example, FDA’s

Fair Packaging and Labeling Manual

Guide 7699.2 states that the appropriate

net contents declarations for canned

artichokes, canned clams, canned

mushrooms, green olives in brine, and

canned wet-pack shrimp are in terms of

drained weight. However, the agency’s

case-by-case approach to determining

when a packing medium is always or

almost always discarded before serving

would be difficult to implement

uniformly if many different regulatory

agencies are making such assessments.

The congressional mandate for

national uniformity suggests that FDA

should provide more specific direction

in this matter. However, FDA notes that

it has already dealt with the issue of

when a food should be declared in

terms of its drained weight in its

regulation on serving sizes (§ 101.12).

The agency’s nutrition labeling

requirements provide for declaration of

nutrient information in terms of the

serving size based on the reference

amounts customarily consumed as set

forth in § 101.12, and that section

specifically provides for cases where the

reference amounts are in terms of

drained solids.

Thus, FDA no longer has to make

case-by-case assessments about whether

the packing medium is always or almost

always discarded before serving.

Instead, the agency can now refer to

§ 101.12 in determining whether net

contents declarations must include the

packing medium. Therefore, FDA is

proposing to require in § 101.200(a) that,

except where the reference amount

customarily consumed per eating

occasion is in terms of drained solids in

accordance with § 101.12, a food that is

packed or canned in liquid, and that is

required to bear a net contents

declaration in terms of weight, shall

bear a declaration expressed in terms of

the total net contents including the

liquid.

FDA points out that, for many years,

it has had a policy of permitting both

drained weight and net weight to be

stated on the principal display panel

(PDP) of a food label. However, some

State regulatory agencies prohibit both

drained weight and net weight from

appearing on the PDP of a label because

they consider one of the weight

declarations to be in conflict with

section 4(b) of the Fair Packaging and

Labeling Act (FPLA), which prohibits

qualifying words or phrases from

appearing with the required net

contents declaration. FDA advises that it

does not believe that its policy in this

regard conflicts in any way with section

4(b) of the FPLA.

Although neither the language of the

FPLA nor the regulations established

thereunder provide clear guidance, the

legislative history of the FPLA does. The

May 25, 1966, Senate Report No. 1186,

which addressed the meaning of the

prohibition of supplemental statements,

states:

Subsection 4(b) prohibits the qualification

of the separate net quantity statement by any

modifying words or phrases. However, a

supplemental statement of the net quantity of
9834 Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules

contents set apart from the separate net

quantity of contents, required by the bill,

may be modified by nondeceptive words or

phrases, so long as such words or phrases do

not tend to exaggerate the amount of the

commodity contained in the package. For

example, where a package contains a separate

net quantity statement in conformity with

promulgated regulations, such as ‘‘6 oz. net

weight,’’ the package could also contain in a

supplemental statement, apart from the

required net quantity statement, the phrase

‘‘6 oz. of fast acting X detergent’’ but could

not contain the statement ‘‘6 jumbo oz. of X

detergent’’ at any place on the package* * *.

From the above quote, it is obvious

that the required declaration of net

quantity may not contain statements

designed to imply that one product is

different in quantity from others

declaring the same net contents. It is

also obvious that Congress wanted the

required declaration to be separate from

supplemental statements designed to

promote product sales. FDA has a

regulation, § 101.105(o) (which would

be redesignated as § 101.200(o)), that is

intended to ensure that such separation

exists by permitting supplementary net

quantity statements on label panels

other than the PDP. However, there is

no indication in Senate Report No.

1186, or elsewhere in the legislative

history of the FPLA, that congressional

concern about a ‘‘supplementary

statement’’ was intended to encompass

other forms of nonmisleading

information about the quantity of

contents than the one required. To the

contrary, the broad congressional policy

declared in section 2 of the FPLA states:

‘‘Packages and labels should enable

consumers to obtain accurate

information as to the quantity of the

contents and should facilitate value

comparisons’’ (15 U.S.C. 1451).

Declaration of a statement of net

quantity of contents in terms of both

drained weight and net weight would

not be inconsistent with this policy

because such declarations advise

consumers of the amount of food and

the accompanying packing medium,

thereby assisting purchasing decisions.

Although the agency does not

consider it necessary to codify the

present policy of permitting both

drained weight and net weight to be

declared on the PDP of a food label,

FDA solicits comments on whether it

should codify this policy into its

regulations.

B. New Provisions

In response to suggestions from State

and local regulatory agencies and the

affected industry, FDA has tentatively

determined that, for national

uniformity, it should adopt new

regulations that set out the specific

details of the techniques and methods

that it will use in assessing the accuracy

of net contents declarations. The agency

turns now to those regulations.

1. Definitions

The 1994 Handbook, Appendix C has

a glossary that contains almost 100

different terms and their definitions to

help users follow its requirements. The

1994 Handbook also contains a number

of additional definitions in various

locations throughout the handbook.

With one exception, which is discussed

below, the definitions used in the 1994

Handbook have been accepted and used

by regulated industry and regulatory

agencies for a number of years.

FDA tentatively finds that any

regulations that it adopts based on this

proposal will profit if they include a

similar set of definitions. The

definitions will not only make the

regulations understandable, but they

will help to foster consistency with the

1994 Handbook. FDA is therefore

proposing, in § 101.205, to define a

number of terms that it has used in the

proposed regulations. FDA has drawn

heavily on the 1994 Handbook for these

definitions because of the long history

embodied in the 1994 Handbook, and

because the definitions were arrived at

by NCWM after consideration of the

views of both industry and regulatory

agencies.

The agency is not, however,

proposing to define all of the terms

defined in the 1994 Handbook because

some of the terms in the 1994 Handbook

pertain to products that FDA does not

regulate.

Where FDA is including terms in

proposed § 101.205 that are defined in

the 1994 Handbook, it is, for the most

part, incorporating the 1994 Handbook

definitions. The agency has, however,

made minor changes in the definitions

for clarity.

A few terms that are used in the

regulations, however, have either not

been defined in the 1994 Handbook or

are defined in the 1994 Handbook in a

way that is not fully satisfactory. A

discussion of these terms, and of the

definitions that FDA is proposing for

them, follows.

a. Sample standard deviation. In

§ 101.205(o), the agency is proposing to

adopt the following commonly

recognized definition for ‘‘sample

standard deviation:’’

Sample Standard Deviation (s) means

a statistic used as a measure of

dispersion (i.e., differences of

individual values from the mean) in a

sample. It is calculated as follows:

s = (Σ(xi¥x)2/(n¥1))1⁄2 or equivalently

(and primarily for calculations

without a computer),

s = ((Σxi2¥(Σxi)2/n)/(n¥1))1⁄2.

Where:

Σ means ‘‘the sum of,’’

xi means the ith individual package

error,

n means the sample size, and

x means the average of the package

errors, that is, the sum of the

package errors divided by the

number of packages in the sample.

This definition is a commonly

recognized definition for ‘‘sample

standard deviation’’ (Ref. 3).

FDA points out that it is proposing

the use of this definition for samples

collected using either of the random

selection approaches set forth in the

1994 Handbook. The 1994 Handbook

provides for the collection of a sample

through either: (1) A single-stage

approach of randomly selecting the

individual packages directly from the

lot, or (2) a multistage approach of first

randomly selecting the larger storage

units (e.g., cartons or pallets), followed

by random selection of the individual

packages. While the proposed definition

of ‘‘sample standard deviation’’ is

mathematically fully correct only where

the single-stage approach is used, FDA

has tentatively decided that the

definition can be used when a

multistage approach is used for three

reasons. First, NIST has recommended

its use in this circumstance (Ref. 3).

Second, its use will minimize the

complexity of these regulations. Third,

NIST advised (Ref. 3) that any errors

introduced by using this definition with

a sample collected using a multistage

approach will not be significant.

The single-stage approach is generally

used at retail locations on smaller lots

of packages that are not in cartons or on

pallets. The multistage approach is

generally used for larger lots, such as

those found in food storage warehouses

(e.g., in locations where foods are found

in shipping cases, containing 12, 24, or

48 individual packages, which are

typically stored on several different

pallets). In the first stage of a multistage

sampling approach, an official randomly

selects one or more pallets from all of

the pallets available from which to

collect samples. In the second stage, the

official randomly selects one or more

shipping cases from the selected pallets.

Finally, in the third stage the official

opens the shipping cases and randomly

selects individual packages from the

shipping cases for use as the sample

packages in determining lot compliance.

For a multistage approach, a more

complicated calculation of the standard
Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules 9835

2The 1994 Handbook’s definition appears in

Table 3–3 on page B–17 of the Handbook 133

portion, of the 1994 Handbook.

3See Chapter 2 and Table 2–1 in Appendix B of

the Handbook 133 portion of the 1994 Handbook.

deviation than the one that FDA is

proposing is theoretically appropriate.

For multistage samples, the average of

the package errors within each of the

larger storage units can be used to

determine the sample standard

deviation rather than the package errors

for each package regardless of the

storage unit in which the packages are

contained.

Nonetheless, FDA is proposing to

provide that the more simple approach

to computing sample standard deviation

be used. NIST recommended that FDA

not increase the level of complexity for

regulatory officials in calculating the

sample standard deviation (Ref. 3). NIST

said that any increase in complexity

would significantly increase the risk

that regulatory officials would make

mistakes in classifying an inspection lot

as violative, and that the difference in

the results obtained using the two

methods would be minor. Therefore,

NIST stated, it would not justify the

increased time and costs related to net

quantity of contents inspections if the

more complex calculation were

required. NIST also stated that the harm

that could result from the potential

mistakes caused by the increased

complexity of the calculation could far

exceed any benefits of calculating

standard deviation in a more

theoretically appropriate manner. Thus,

NIST recommended that FDA require

the use of the less complex approach for

determining sample standard deviation.

It pointed out that this approach is

normally used in the food industry for

statistical process quantity control.

FDA agrees with NIST and is

proposing in § 101.205(p) to define

‘‘sample standard deviation’’ based on

the less complex approach suggested by

NIST. FDA requests comments on the

adequacy of this proposed definition.

b. Gravimetric test procedure. FDA is

proposing in § 101.205(c) to define the

term ‘‘gravimetric test procedure’’ as an

analytical procedure that involves

measurement by mass or weight. The

proposed regulations contain a number

of different gravimetric procedures, and

the proposed definition should simplify

the description of these procedures by

eliminating the need to include a

lengthy discussion of measurement by

mass or weight. FDA requests comments

on whether there are any problems

created by this approach.

c. Dry animal food. In § 501.105(u),

FDA is proposing that the term ‘‘dry

animal food’’ mean animal food

packaged in paperboard boxes or kraft

paper bags that has 13 percent or less

moisture at time of pack. This definition

is derived from a definition of the term

‘‘Dry pet food’’ in the 1994 Handbook 2

that serves to designate a class of food

entitled to certain adjustments for

moisture loss that are discussed

subsequently in this preamble. As

proposed, FDA’s definition is the same

as that in the 1994 Handbook except

that the agency is proposing to use the

term to encompass all animal food

rather than only food used for pets. The

1994 Handbook does not contain any

indication as to what it precisely means

by the term ‘‘pet.’’ In view of the lack

of such specificity, and the fact that

FDA knows of no reason to differentiate

between pet and non-pet animal food,

the agency tentatively concludes that

the definition can apply to all animal

food.

According to NIST (Ref. 3), the 13-

percent moisture content limitation in

the proposed definition was developed

in cooperation with the Pet Food

Institute, a trade association that

represents a majority of the

manufacturers of pet foods. NIST stated

that NCWM developed the limitation for

dry animal food based on moisture loss

studies that were conducted using

products from several manufacturers.

The laboratory tests conducted as part of

those studies revealed that the

maximum moisture level of the

products used in the field studies was

less than 13 percent. NIST advised that

it was not aware of any concerns on the

part of packers over the NCWM

definition because it is only intended to

be used to identify the types of dry

animal foods subject to moisture loss

and serves no other purpose. Most

packers are required under many state

animal food laws and regulations to

provide moisture content information in

the guaranteed analysis displays on pet

food packages. Therefore, FDA is

proposing to adopt this definition.

2. Sample Collection

The 1994 Handbook provides that the

‘‘Category A’’ approach is to be used on

FDA regulated commodities for

determining whether net contents

declarations are sufficiently accurate.

The ‘‘Category A’’ approach addresses,

in part, the sample collection procedure

to be used for evaluation of the accuracy

of the net contents label declaration. For

this approach, the 1994 Handbook

provides that the size of the sample

taken depends on the size of the lots

being sampled.3 The handbook provides

for four basic sample sizes. Where the

lots consist of less than 12 packages, all

of the packages in the lot are included

in the sample. Where there are 12 to 250

packages, 12 packages are to be taken as

the sample. Where there are 251 to

3,200 packages, 24 packages are to be

taken as the sample. Where there are

more than 3,200 packages, 48 packages

are to be taken as the sample. All

packages in the sample are collected

through random selection procedures

that are discussed subsequently in this

preamble.

NIST pointed out in its letter to FDA

that the sample collection procedure

under the ‘‘Category A’’ approach can be

readily used for both retail and

wholesale inspections (Ref. 3). NIST

advised that sample collection under

this approach does not make

unreasonable demands on inspection

time through overly large sample sizes.

Furthermore, NIST pointed out that the

‘‘Category A’’ approach was developed

from a consensus position of the NCWM

after consideration of the views of both

regulators and the regulated industry.

NIST stressed that the ‘‘Category A’’

sample collection procedure is easy to

use and appropriate for use in verifying

the net quantity of contents of packaged

food at all levels of wholesale and retail

trade.

FDA tentatively agrees with NIST’s

assessment of the ‘‘Category A’’ sample

collection procedure in the 1994

Handbook. The practicability of

implementation of this procedure,

coupled with the consensus agreement

on the approach, have led FDA to

tentatively conclude that this procedure

represents a reasonable approach to

sampling. The agency is therefore

proposing to adopt, in § 101.210, the

Category A sample collection procedure

from the 1994 Handbook.

3. Measuring Equipment

One of the fundamental aspects of any

approach to ensuring that net contents

declarations on food packages are

accurate is to ensure that accurate

measurements are made. To this end,

FDA is proposing to address: (1)

Selection of appropriate measuring

equipment and (2) standardization of

that equipment to ensure that it is

accurate. FDA’s hope is that these

provisions will allow all affected parties

to have confidence in the measurements

made under the standard. FDA expects

that this confidence will mean that

regulatory agencies will be comfortable

in embracing and implementing the

approach set out in these regulations,

and that the regulated industry will be

able to establish uniform practicable

target fill levels for all package sizes,

regardless of the ultimate distribution

location, with confidence that the fill
9836 Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules

4See section 5.3.1, page 5–6 of the Handbook 133

portion of the 1994 Handbook.

levels will meet the local regulatory

standards. With uniform target fill

levels, firms should be able to

significantly reduce overfilling of

packages, thereby reducing production

costs and providing consumers with

more accurate nutritional information.

FDA notes that the 1994 Handbook

contains procedures for both the

selection and standardization of

measuring equipment. These procedures

pertain primarily to balances and

volumetric measures (i.e., measuring

devices for use in the measurement of

volumes of liquids, such as standard

measuring flasks, graduates, and

cylinders (see Chapters 2 through 5 of

the 1994 Handbook)). Many of these

procedures (or ‘‘tolerances’’ as the 1994

Handbook often refers to them) are

incorporated into the 1994 Handbook

through reference to the NIST Handbook

44 (Ref. 4) (referred to subsequently as

‘‘Handbook 44’’). Handbook 44 is

widely recognized as the national

standard for accuracy requirements for

scales and balances (Ref. 3). In addition,

both the 1994 Handbook and Handbook

44 contain instructions (or ‘‘test

procedures’’ as the 1994 Handbook

refers to them) for the calibration of

equipment to ensure that its accuracy is

consistent with measurement standards

maintained by NIST.

FDA sees considerable merit in the

1994 Handbook procedures for selection

and standardization of measuring

equipment. The agency has therefore,

with a very few exceptions (which are

discussed below where relevant to a

particular type of equipment), used

these procedures as the basis for the

equipment requirements in these

proposed regulations. A discussion of

these proposed requirements follows:

a. Equipment selection—i.

Thermometers. In § 101.215(a), FDA is

proposing to require that any

thermometer used in measuring net

contents (e.g., to bring a product to an

appropriate reference temperature

before measuring the volume) have

graduations no larger than 1° (2°

Fahrenheit). This proposed selection

criterion reflects the standard that

appears in Chapter 4 of the Handbook

133 portion of the 1994 Handbook. NIST

advised FDA (Ref. 3) that graduations

larger than these could mean that it

would not be possible to determine

whether the appropriate reference

temperature has actually been achieved,

and, consequently, significant

volumetric measuring errors could

occur. NIST also pointed out that this

criterion has been in Handbook 133 for

many years. NIST advised that this

criterion can be applied to any type of

thermometer (e.g., the commonly used

mercury-in-glass thermometer or

electronic device). FDA tentatively

concludes, based on these factors, that

1°C or 2°F constitute the appropriate

minimum graduations for thermometers

that are to be used under these

regulations.

ii. Linear measuring equipment. The

1994 Handbook contains no

requirements for selection criteria for

linear measuring equipment. However,

in its letter to FDA, NIST suggested (Ref.

3) that any regulations on ensuring the

accuracy of net quantity of contents

declarations should include provisions

on linear measuring devices because

such devices are used in a variety of

ways to determine net contents. For

example, depth gauges are used to

measure the headspace from the top of

a package to the level of the product,

and that distance is used to calculate the

volume of product in the package (see

analytical method in proposed

§ 101.225(f)).

NIST pointed out that while the 1994

Handbook contains no selection

requirements for linear measuring

equipment, it does contain a number of

recommendations for such selections.4

However, NIST expressed concern about

these recommendations. NIST’s concern

focused on the suggestion in Handbook

133 that a 36-inch ruler be used for

measurements of 25 inches or less, and

that a 100-foot tape be used for

measurements of greater than 25 (in).

NIST explained that these provisions

might be too inflexible in some

circumstances to be practicable. NIST

stated that it did not seem logical that

a 36-inch ruler that could be used for

measurements of 25 inches or less could

not also be used to measure a slightly

longer distance (e.g., 30 (in)). Thus,

NIST suggested that FDA adopt a

requirement for use of a tape or ruler of

appropriate length, with a minimum

graduation of 1/64 inch (or 0.5 milliliter

(mm)) or less for equipment of 25 (in)

or less or a minimum graduation of 0.1

inch (2 mm) for equipment of greater

than 25 (in), without any limit on the

distances that these devices can be used

to measure.

NIST stated that the requirement

should also express the 25-inch linear

criterion as a metric value of 63.5 cm,

explaining that the metric

recommendations in section 5.3.1 of

Handbook 133 are incorrect because of

an inadvertent conversion error (Ref. 3).

Also, NIST stated that the metric

expressions of maximum permitted

measurement errors in section 5.3.1 (i.e.,

0.4 mm and 2.5 mm) should be

expressed in terms of graduation values

commonly found on precision metric

tapes and rulers (i.e., 0.5 mm and 2

mm), rather than precise equivalents.

FDA is proposing in § 101.215 (b)(1)

and (b)(2) to adopt the requirements that

NIST suggested for tapes and rulers. As

discussed above, FDA has tentatively

determined that it will facilitate

interstate shipment of product, and thus

be of significant value, if the agency

established standards for equipment

used in determining the accuracy of net

quantity of contents declarations. Given

the well-recognized expertise of NIST

on weight and measure matters, FDA

considers it appropriate for the agency

to defer to NIST in the development of

those standards.

FDA is not proposing a standard for

selection of calipers and depth gauges

used to determine the level of fill in

packages labeled by volume

(headspace). NIST suggested only that a

caliper or a depth gauge used to make

such measurements be suitable in

design and measuring range, and that

the values of its smallest measurement

unit be suitable for the purpose for

which it is to be used. Neither NIST nor

FDA is aware of more specific criteria

that could be proposed for these

measuring instruments (Ref. 3). NIST

stated that specific requirements

regarding suitability would be difficult

to develop because of the broad range of

container sizes that could be

encountered in the marketplace.

Given the lack of specificity of NIST’s

suggestion, FDA is not proposing to

incorporate it in the agency’s

regulations, although the agency urges

regulatory officials and manufacturers to

adhere to the guidance contained in

NIST’s recommendation. FDA also

requests comments on whether there are

objective selection criteria that should

be used for calipers and depth gauges.

iii. Volumetric measuring equipment.

In § 101.215(c), the agency is proposing

the following selection criteria for

volumetric measuring equipment that

pertain to the graduations on, and the

size of, the equipment:

a. Size. In § 101.215(c)(1), FDA is

proposing to require that a volumetric

measure used in fluid volumetric

determinations be of such size that no

volume less than 25 percent of the

maximum capacity of the volumetric

measure is measured. For example, a

graduate with a capacity of 4 fluid

ounces could not be used to measure

volume of less than 1 fluid ounce. While

the proposed requirement may not be

readily apparent in the 1994 Handbook,

NIST advised (Ref. 3) that it is actually

present through incorporation by

reference of Handbook 44.
Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules 9837

5FDA also has imposed the 25-percent criterion

on its field personnel for many years (see section

428.21 of FDA’s Investigations Operations Manual).

In its letter to FDA, NIST advised

(Ref. 3) that, the criterion was developed

by NIST many years ago and has been

widely used by most State and local

regulatory agencies since its

development.5 The criterion is based on

the fact that when small amounts are

measured, the error that comes within

individual gradient can constitute a

rather large percentage of the product

measured. The 25-percent limit

provides a means of controlling this

factor.

NIST pointed out that section 4.44,

‘‘Graduates,’’ in Handbook 44 provides

tables specifying the design criteria for

graduates (one type of volumetric

measure) that limit their lower

measuring range. These tables use the

25-percent criterion as the basis for

prohibiting measurements below certain

capacities of the graduate.

b. Graduations. In § 101.215(c)(2),

FDA is proposing a selection criterion

for volumetric measuring equipment

that pertains to the maximum size of

each individual graduation appearing

on the volumetric measure. For such

graduations, the agency is proposing to

require that any volumetric equipment

have a maximum graduation value

related to the MAV. (As discussed

previously in this preamble, one of the

basic requirements of the 1994

Handbook is that the variation of

individual package contents from the

labeled quantity not be ‘‘unreasonably’’

large. The 1994 Handbook defines

unreasonably large deviations in terms

of the MAV, which varies with the size

of the package.) The proposed criterion,

which NIST advised has been in

Handbook 133 since 1981 (Ref. 3) and

has been widely accepted, requires that

volumetric measuring equipment have a

maximum graduation of no greater than

1⁄6 of the MAV for the labeled net

quantity of contents of the package

being measured. NIST explained in its

letter to FDA that the criterion is

intended to ensure that volumetric

measuring equipment can accurately

detect MAV deviations (Ref. 3).

NIST pointed out that frequently the 1⁄6 MAV criterion will not result in an

exact equivalent to most graduations

provided on volumetric measures.

Under such circumstances, the most

commonly used graduation should be

selected. For example, where a 100 mL

flask is to be used for a volumetric

measurement, proposed § 101.245(f)

(Table 3 ‘‘Liquid or Dry Volume MAV’s

for Individual Packages Labeled in

Metric Units’’) provides that the MAV

for the flask is 5.5 mL. When this MAV

is divided by 6, a graduation criterion of

0.917 mL results. Thus, graduations

smaller than 0.917 mL must be present

on the 100 mL volumetric measure.

NIST states that the most common

graduation on a flask conforming to

such a criterion would be a 0.5 mL

graduation. Flasks marked 0.1 mL

graduations could also be used but

would rarely be available. A 100 mL

buret marked with 0.1 mL graduations

could be used. Flasks marked only with

1 mL or larger graduations would not

meet the 1⁄6 MAV criterion.

Given the well-recognized expertise of

NIST on weight and measure matters, it

is appropriate for FDA to defer to NIST

in the development of this 1⁄6 criterion.

FDA tentatively concludes that the

graduations that will result under this

criterion will be adequate to enable

regulatory officials to make accurate and

fully informed judgments with respect

to the MAV. FDA is therefore proposing

to adopt the standard.

iv. Gravimetric measuring equipment.

In § 101.215(d), FDA is proposing

criteria for selecting gravimetric

measuring equipment. These criteria are

intended to ensure the appropriateness

of the equipment used to measure the

contents of the package being evaluated.

The proposed criteria are a reiteration of

those in the 1994 Handbook (including

references to Handbook 44 in the

Handbook 133 portion of the 1994

Handbook). FDA tentatively finds that

more criteria are needed to guide the

selection of gravimetric equipment than

are needed to guide the selection of

other types of measuring equipment

because of the great complexity of

gravimetric equipment. For gravimetric

equipment, not only must the

graduations on a balance be appropriate,

but the design of equipment must also

be appropriate for measurement of the

package. In addition, the equipment

must be functioning properly to make

the measurement, and many factors may

affect the way the equipment functions.

a. Gravimetric equipment design.

With respect to gravimetric equipment

design, proposed § 101.215(d)(1) (i) and

(ii) provide that the portion of the

balance on which the package is placed

for weighing (i.e., the load receiving

element) must be large enough to hold

the package and be of sufficient

weighing capacity for the package.

Proposed § 101.215(d)(1)(iii) requires

that, based on the 1994 Handbook, the

balance have a minimum number of

graduations, referred to as ‘‘scale

divisions’’ (i.e., 100). FDA is proposing

this number based on the 1994

Handbook (see page 2–11, Table 3 of

Handbook 44). NIST advised FDA that

at least 100 divisions are necessary to

permit reliable assessments of the

performance of a balance.

In addition, FDA is proposing a 1⁄6

MAV criterion for the maximum size of

the individual scale divisions. This

criterion is consistent with the 1⁄6 MAV

volumetric graduation criterion, and

FDA is proposing it for the same reasons

that underlie the volumetric graduation

criterion. Assessment of conformance

with this criterion will also be made in

a manner that is consistent with the

approach discussed previously for the

volumetric graduation criterion, except

that the appropriate gravimetric tables

(e.g., Tables 1 and 2 in the proposed

regulation would be used to determine

the MAV. NIST advised FDA that the

proposed 1⁄6 gravimetric criterion has

also been in Handbook 133 since 1981

(Ref. 3) and has been widely accepted.

b. Gravimetric equipment

performance. With respect to

gravimetric equipment performance,

FDA is proposing selection criteria that

will ensure that balances are sensitive

enough to measure small variations in

the net contents of different packages,

which may be made with different

packaging materials, without weighing

errors attributable to the balance that

would create an unfair bias concerning

the weighing results. These sensitivity

criteria will focus on ensuring that any

balance selected for making

measurements will not produce

unacceptable errors (subsequently

referred to as ‘‘rejection criteria’’) in a

variety of performance tests.

Details of four performance tests are

set forth in proposed § 101.215(d)(2).

The proposed provisions require that

the tests be performed before each

initial daily use, use at a new location,

or use in the presence of any indication

of abnormal equipment performance,

and that the balance be found in such

tests not to exceed the criteria in the

regulation for rejection. FDA is

proposing to require that the tests be

conducted before use of the balance

because the sensitivity of the measuring

device can be affected by handling and

transportation to the test location,

routine wear of mechanical or electrical

components, and environmental factors

at the test location such as temperature

and air currents.

All of the proposed tests involve

multiple weighings of test loads

consisting of a variety of calibrated test

weights (referred to as ‘‘mass

standards’’). The proposed procedures,

which reflect the procedures set forth in

section N.1., page 2–11, Handbook 44,

include an ‘‘increasing load test’’

(§ 101.215(d)(2)(i)), which is conducted

by applying mass standards to the
9838 Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules

6Section 3.1 of Handbook 133 incorporated the

criteria by referencing the tolerances described in

section T.N.3.2, page 2–22 of Handbook 44.

balance in increasing increments (e.g., 1,

2, 3, and 4 pounds (lb)—up to 10

percent more than the package gross

weight) and, for most types of balances,

a ‘‘decreasing load test’’

(§ 101.215(d)(2)(ii)), which is conducted

by reversing the increasing load test

procedure. In addition, FDA is

proposing a test involving off-center

loading (called a ‘‘shift test’’ in

Handbook 44) (§ 101.215(d)(2)(iii)), to

determine whether a balance accurately

weighs packages placed anywhere on

the load receiving element (e.g., the

scale platter or pans). Finally, FDA is

proposing a ‘‘repeatability performance

test’’ (§ 101.215(d)(2)(iv)), wherein mass

standards are weighed at least twice.

NIST stated in its letter to FDA (Ref.

3) that the proposed test procedures are

appropriate for balances used in

determining the net contents of

packaged food, and that these test

procedures are based on the procedures

in Handbook 44 for verifying the

accuracy of balances used in

supermarkets. NIST also advised that,

although there are four different

performance tests, only 2 to 3 minutes

are required to complete them. In fact,

NIST pointed out they are often looked

upon as simply one test comprised of

four different weighing procedures.

NIST explained that each of the four

different procedures is needed because

each duplicates one of the most

common ways that weighing devices are

used. NIST stated that improperly

functioning balances may not always

register the same quantity with

increasing and decreasing loads,

repeated weighings of the same

quantity, and weighings of the same

quantity in different locations of the

load receiving element. NIST stressed

that it is important to evaluate balance

performance using all common

weighing procedures that may be used.

To illustrate the long history of use and

acceptance of the proposed test

procedures, NIST pointed out (Ref. 3)

that similar test procedures were

published on January 31, 1945, by NIST

(then called the National Bureau of

Standards) in NBS Handbook H37,

‘‘Testing of Weighing Equipment.’’

As mentioned, FDA is proposing that

balances not have errors exceeding the

rejection criteria in any of the

performance tests. The agency sets out

the proposed rejection criteria in

proposed § 101.215(d)(3). Under this

provision, if the criteria are exceeded in

any individual weighing that is a part of

a performance test, the balance does not

meet the gravimetric selection criteria,

and the balance may not be used to

determine whether an inspection lot is

violative.

The gravimetric selection criterion

concerns the size of the error that will

trigger rejection when that error is

expressed in terms of a number of scale

divisions (see proposed

§ 101.215(d)(1)(iii)) on the balance. In

the 1994 Handbook, this criterion varies

according to the type of balance used

and the weight of the individual

package unit being tested. The 1994

Handbook expresses this criterion in

terms of two classes of balances that are

identified in Handbook 44 as Class II

and Class III balances. (Class I balances

pertain to the most precise type of

balances that are used primarily for

weighing precious stones. These

balances are not used for weighing

food.) Class II balances are analytical

balances which are generally found only

in laboratories. Class III balances are

generally used at supermarkets by

investigators in the field. A Class III

balance might have only 3,000 scale

divisions, whereas a Class II balance

might have more than 50,000 scale

divisions.

Proposed Table 1 in § 101.215(d)(3)(i)

is derived from the 1994 Handbook. It

contains directions on how to determine

the class of the balance based on value

of the smallest balance division and the

minimum and total number of balance

divisions. Proposed Table 2 in

§ 101.215(d)(3)(ii), which is also derived

from the 1994 Handbook, contains

directions on how to determine the

number of balance divisions for

rejection based on the class of the

balance and the weight of the package

in terms of the total number of balance

divisions.

The criteria for rejecting a balance

have been set forth in Handbook 133

since July 1986.6 According to NIST,

these criteria were developed in

conjunction with the Scale

Manufacturers Association, a national

trade association that represents the

majority of U.S. manufacturers of

weighing devices. Although FDA is

proposing the same criteria as those in

the 1994 Handbook, FDA is not

proposing to use the term ‘‘tolerance’’ to

identify the standard proposed in Table

2 in § 101.215 because that standard

focuses on the number of errors for

rejection rather than the number of

errors that are permitted.

c. Equipment standardization. FDA is

also proposing a category of

requirements that pertain to the

standardization of other types of

measuring equipment. NIST

recommended (Ref. 3), and FDA agrees,

that it is therefore appropriate that all

Federal requirements for

standardization incorporate the NIST

standard units of weight and measure.

Thus, FDA is proposing in § 101.215(e)

that all measuring equipment be

standardized to the NIST standard units

of measure.

As recommended by NIST (Ref. 3),

FDA is proposing that the

standardization take place through

either direct or indirect comparison

with NIST standards. For example, a

mass standard used in the field may be

compared to either the corresponding

NIST mass standard or to a mass

standard that has itself been directly

compared to the corresponding NIST

mass standard. NIST advised that the

comparison should be made in a

manner consistent with well-recognized

procedures developed by that agency.

Specifically, NIST recommended use of

calibration procedures found in NBS

Handbook 145, Handbook for the

Quality Assurance of Metrological

Measurements, November 1986 (Ref. 5),

for all measuring equipment other than

time measuring devices. For time

measuring devices, NIST recommended

use of its standard operating procedure

(SOP), Specifications and Tolerances for

Reference Standards and Field Standard

Weights and Measures, Specifications

and Tolerances for Field Standard

Stopwatches (Ref. 6).

NIST also advised, however, that

Handbook 145 is being updated to

include, in part, the SOP for

stopwatches. In view of current

updating of Handbook 145, FDA

tentatively concludes that it is not

necessary to propose procedures for

standardizing stopwatches. The agency

intends to incorporate the most up-todate version of the test procedure for

stopwatches in Handbook 145 in any

final rule that may issue based on this

proposed rule. If the anticipated

revision of Handbook 145 has not been

completed by the time of the final rule

is issued, FDA may rely on NIST’s SOP

for stopwatches in the final rule.

NIST recommended that, except for

volumetric glassware, the comparison to

NIST standards be made on a routine

basis (e.g., annually for equipment used

on a weekly basis) (Ref. 3). NIST also

advised that where neither Handbook

145 nor the SOP for stopwatches

specifically provides calibration

procedures for a particular type of

measuring device, the requirement that

calibration be done with a standard

traceable to NIST can be satisfied by

using nationally accepted standards and

procedures that are traceable to NIST.

NIST advised that calibration

certificates or reports of tests of
Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules 9839

equipment should be maintained by

FDA field offices to ensure that

appropriate calibration intervals are met

(Ref. 3).

Also, NIST provided guidance

concerning the amount of error that it

would consider acceptable in

calibration procedures for stop watches,

thermometers, linear measuring devices,

volumetric measures, and mass

standards (Ref. 3).

Because NIST is the Federal authority

in matters concerning weights and

measures, FDA tentatively concludes

that it should follow NIST’s

recommendations in these matters. By

following the recommendations of the

agency with the most expertise on these

matters in the Federal Government and

whose views are informed by regular

contacts with NCWM and the States,

FDA should be able to establish a

uniform national system that will be as

efficient and workable as possible. FDA

is therefore proposing to adopt NIST’s

recommendations for standardizing the

types of equipment enumerated in the

discussion that follows.

(i). Stopwatch standardization. In

§ 101.215(e)(1), FDA is proposing to

require that any stopwatch used in

procedures for measuring net contents

not have an error exceeding ±2 seconds

in a 3-hour time period. This proposed

requirement is a reiteration of the

provision on stopwatches that appears

on page 3–34, section 3.13.1 of the

Handbook 133 portion of the 1994

Handbook, except that the maximum

permissible error pertains to the error

during a 3-hour, rather than 2-hour time

period. NIST stated that, except for an

inadvertent typographical error,

Handbook 133 would contain a 3-hour

time period (Ref. 3). NIST explained

that the Handbook 133 stopwatch

criterion was based on Federal

Specification GG–S–764C, which

provides that a 3-hour time period be

used for standardization.

(ii). Thermometer standardization. In

§ 101.215(e)(2), FDA is proposing to

require that any thermometer used in

procedures for measuring net contents

not have an error exceeding ±1° Celsius

(2 °F). This proposed requirement

reflects the provision pertaining to

thermometers that appears on page 4–4,

section 4.2 of the Handbook 133 portion

of the 1994 Handbook.

(iii). Linear measure standardization.

The 1994 Handbook contains no

requirements for linear measure

standardization. As pointed out above,

however, NIST advised (Ref. 3) that the

proposal should include such

requirements because linear measuring

devices may be used in a variety of ways

to determine net contents. NIST advised

further that the 1994 Handbook does

contain a number of recommendations

for standardization of some linear

measuring devices (see section 5.3.1,

page 5–6 of the Handbook 133 portion

of the 1994 Handbook). NIST stated that

section 5.3.1 inch-pound

recommendations could serve as a basis

for requirements in the proposal

pertaining to tapes and rulers. The

recommendations provide, in part: (1)

That, for measurements of 63.5 cm (25

in) or less, measurement errors shall be

no greater than ±0.39 mm (± 1/64 inch),

and (2) that, for measurements greater

than 63.5 cm (25 in), measurement

errors shall be no greater than ±2.5 mm

(± 0.1 inch). NIST recommended that

FDA proposes to include provisions that

reflect these recommendations in the

regulation.

FDA tentatively concludes that it

should generally follow NIST’s

recommendations in matters concerning

weights and measures. FDA is therefore

proposing to adopt NIST’s

recommendations for standardization of

tapes and rulers.

For calipers and depth gauges used to

determine the level of fill in packages

labeled by volume (headspace), the

agency is also proposing standardization

criteria based on information provided

by NIST (Ref 3). NIST recommended

that FDA establish an error limit of ± 50

micrometers for lengths of up to 400

mm; of ± 100 micrometers for lengths of

400 mm to 800 mm; and of ± 150

micrometers for lengths of 800 to 1,000

millimeters. NIST explained that such a

requirement is needed to ensure that

measurement errors attributable to these

measuring instruments not adversely

affect the results of the test. NIST based

its recommendation for these error

limits on the accuracy requirements for

mechanical and electronic calipers and

depth gauges that the American Society

of Mechanical Engineers is considering

including in its industry standard

(ASME B89 1.14) (Ref. 7) for these

devices.

FDA agrees with NIST that there is a

need for standardization of these

devices and is deferring to NIST for the

appropriate standards. In proposed

§ 101.215(e)(3)(iii), Table 3, FDA is

proposing to adopt the error limits for

calipers and depth gauges that are

recommended by NIST.

(iv). Volumetric standardization. In

proposed § 101.215(e)(4), FDA is

proposing a requirement that any flask

or cylinder used in a procedure for

measuring net contents not exceed error

limits that vary according to the full

capacity that is measured by the device.

This proposed requirement reflects the

error limits for flasks and cylinders that

appear in Appendix I, page I–3 of the

Handbook 133 portion of the 1994

Handbook. These error limits have been

in Handbook 133 since before 1971 and

are widely accepted as reasonable and

appropriate. NIST advised FDA (Ref. 3)

that, although error limits should be

provided for both inch-pound and SI

units of measure (volumetric measures

may be graduated in either system of

measure), all error limits should be

expressed in terms of SI units only (i.e.,

mL) because metric measures are used

more frequently in laboratories where

standardization generally occurs.

Therefore, the error limits that FDA is

proposing in § 101.215, Table 4 are in SI

units. Also, NIST pointed out that the

error limits have been developed for

liquids at the reference temperature that

is closest to most common room

temperature so as to minimize the

adjustments in glassware and

calibration liquid temperature that will

have to be made to determine whether

error limits have been exceeded.

(v). Gravimetric standardization. In

§ 101.215(e)(5), FDA is proposing to

require that gravimetric measuring

equipment used to measure net contents

not exceed error limits that vary

according to the size of the individual

mass standard and the type of balance

(i.e., Class II or Class III) used for the

measurement. For Class III error limits,

the proposed requirement reflects the

error limits for field standard weights

that appear on pages I–1 and I–2 in

Appendix I of the Handbook 133

portion of the 1994 Handbook. These

widely recognized error limits have

been in Handbook 133 since 1981. As

with volumetric standardization, while

error limits need to be provided for both

in inch-pound and SI units of measure

(gravimetric measures may be graduated

in either system of measure), all error

limits are proposed to be expressed in

terms of SI units only (i.e., mL) because

metric measures are used more

frequently in laboratories where

standardization generally occurs.

For Class II balances, however, NIST

recommended (Ref. 3) that significantly

smaller error limits be adopted because

these balances can reliably measure far

smaller quantities than Class III

balances. NIST advised that, while it

had published some guidance

concerning appropriate error limits in

Class II balances (i.e., National Bureau

of Standards Circular 547, Section 1,

which is out of print), FDA should rely

on Tables X5.1 and X5.2 of American

Society of Testing and Materials

(ASTM) Standard Specification E 617–

91, Standard Specification for

Laboratory Weights and Precision Mass

Standards (Ref. 8) because the ASTM
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Tables are more current than Circular

547.

Given NIST’s expertise, FDA has

tentatively decided to accept its

recommendation. FDA is proposing to

include the ASTM values in Tables 5

and 6 for Class II balances and 7 and 8

for Class III in § 101.215(e)(5).

FDA requests comments on the

appropriateness of doing so.

4. Analytical Procedures

The 1994 Handbook provides specific

instructions for a wide variety of

methods of analysis for determining the

net contents of the packages in samples.

These methods are found in Chapters 3,

4, and 5 of the Handbook 133 portion

of the 1994 Handbook. The methods fall

into two broad categories. The first

category consists of general test methods

(referred to as ‘‘core methods’’ in this

preamble) that are for use for all

products. The 1994 Handbook contains

core methods of analysis for

determining net mass or weight, drained

mass or weight, volume, count, and tare

weight. The second category consists of

core test methods that have been

modified for use with specific products.

The 1994 Handbook contains modified

methods of analysis for determining the

net mass or weight of aerosols, vacuum

packed coffee, flour, and frozen foods.

Also, the 1994 Handbook contains

modified methods of analysis for

determining the drained mass or weight

of frozen foods and glazed raw seafood.

With respect to volume, the 1994

Handbook contains modified methods

of analysis for determining the net

contents of mayonnaise, salad dressing,

ice cream, frozen desserts, and fresh

oysters.

FDA sees considerable merit in the

1994 Handbook’s approach of providing

directions for the use of analytical

methodology because such directions

will help to ensure uniform

implementation of the methodology and

thus contribute significantly to uniform

enforcement. Without such directions,

there would be a significant opportunity

for analytical findings to differ among

those who perform the analysis. FDA

has therefore included in this proposal

specific instructions to follow with

respect to how to perform analytical

procedures. The instructions are derived

largely from methodology in the 1994

Handbook.

The agency is proposing procedures

for determining net mass or weight in

§ 101.220, for volume in § 101.225, for

count in § 101.230, and for tare in

§ 101.235. Consistent with methodology

in the 1994 Handbook, each of the

proposed sections sets out core

procedures for use for all foods. In

addition, the proposed sections on

determining mass or weight and on

determining volume include additional

procedures for use with specific foods

or for use in specific circumstances,

which are explained in the proposed

provisions.

Although the proposed methods have

been taken largely from the 1994

Handbook, FDA has made several

nonsubstantive changes for clarity and

brevity. For example, the 1994

Handbook contains a number of

methods for use only with certain

specific foods. As mentioned above,

these methods are generally core test

procedures that have been modified for

use with the particular food. These

modifications are intended to facilitate

the measuring process for the specific

foods. However, while the modifications

may be helpful for making the

measurement, many of the descriptions

of the modified methods include

detailed measuring instructions that are

not critical to achieving accurate

analytical results (Ref. 3). The agency’s

tentative view is that it would be

unnecessarily redundant to include

each of the specific modifications of

core methods in the regulation. Instead,

FDA is proposing the general core

procedures with some modifications for

clarity.

In addition, where the 1994

Handbook methods are consistent with

methodology in ‘‘Official Methods of

Analysis of the Association of Official

Analytical Chemists International

(AOAC),’’ 16th ed., 1995, FDA is

proposing to incorporate by reference

the appropriate AOAC method in the

regulation rather than the 1994

Handbook method because this

approach is consistent with the agency’s

general preference for using AOAC

methods. This preference is reflected in

21 CFR 2.19 of FDA’s regulations which

states that it is the policy of the agency

in its enforcement programs to utilize

AOAC methods where the analytical

method is not prescribed in a regulation.

Where the 1994 Handbook methods are

not consistent with AOAC methodology,

and the AOAC method appears to be

more appropriate than that in the 1994

Handbook, FDA is proposing to adopt

the AOAC method rather than the 1994

Handbook method. The combined use of

more general core methodology and the

incorporation of AOAC methods by

reference in the proposal makes the

proposed provisions significantly

shorter than the corresponding

provisions in the 1994 Handbook. As a

result, the proposed provisions should

be easier for affected parties to follow.

In a number of instances, FDA is

proposing methodology that differs

significantly from that in the 1994

Handbook. These differences are

specifically addressed as follows.

a. Proposed § 101.220, net mass or

weight. As mentioned above, analytical

procedures pertaining to net mass or

weight appear in proposed § 101.220,

which contains both general procedures

for making particular types of net mass

or weight determination for foods,

referred to as the ‘‘core procedures,’’

and more specific procedures for

determining the net mass or weight of

certain specific foods. Regardless of

which type of measuring procedure is

used, it will need to be performed on

appropriate equipment and in an

appropriate manner. FDA is proposing

to reflect this fact in § 101.220(a), which

states that all measuring equipment

must conform to § 101.215, and that

good weighing procedures must be used

for all measurements. FDA considered

proposing a prescriptive provision

setting forth specifically what good

weighing procedures must include.

However, the agency has tentatively

concluded that there are simply too

many factors that may affect what

procedures should be used for

determining weight in a particular

situation. FDA does, however, expect

that all weighings will be performed on

balances that: (1) Have been properly

leveled; (2) are maintained at a zero

reading when empty; (3) are properly

dried after each weighing of moist

packages (e.g., frost crystals on

packages); and (4) are used in a manner

that is consistent with the balance

manufacturer’s instructions.

The core procedure for net mass or

weight is set out in proposed

§ 101.220(b)(1). This provision describes

the general steps to follow in making

this type of measurement. FDA is

proposing that net mass or weight be

determined by subtracting the average

used tare mass or weight, determined in

accordance with § 101.235, from the

gross mass or weight of each package in

the sample. This core procedure has

been included in the Handbook 133

portion of the 1994 Handbook since

1981. Simply stated, what this provision

means is that to determine the net

weight of the contents of a package, it

is necessary to subtract the weight of the

packaging from the gross weight of the

package. The appropriateness of this

approach is clear as a matter of common

sense.

In § 101.200(b)(2), FDA is proposing a

specific procedure for determining net

weight of unglazed frozen seafoods and

vegetables. The proposed procedure is

incorporated by reference from the

‘‘AOAC,’’ 16th ed., 1995 section 963.26,

under the heading ‘‘Net Contents of
Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules 9841

Frozen Food Containers Procedure

1963.’’ The proposed procedure is not

identical to the procedure in Section

3.12, page 3–33 of the Handbook 133

portion of the 1994 Handbook.

(Handbook 133 advises that all frozen

products should be measured with the

core net weight procedure that appears

in that Handbook.) However, as stated

above, where AOAC procedures are

available, FDA is proposing to require

that those procedures be used, unless

the agency provides in this preamble a

reason for requiring other procedures.

Section 963.26 of Official Methods of

Analysis of the AOAC specifically

pertains to frozen vegetables and, by

reference in section 35.1.02(b) of this

AOAC analytical manual, to unglazed

frozen seafoods. FDA tentatively

concludes that use of the more specific

AOAC procedure is appropriate because

it clarifies that the weight of any frost

found inside the food package is added

to the weight of the seafood to

determine the net contents. (Frost inside

the package generally comes from the

liquid portion of the food, whereas frost

outside the package generally comes

from the atmosphere.)

The core procedure for determining

drained mass or weight appears in

proposed § 101.220(c)(1). This

procedure is similar to the core

procedure for net mass or weight in that

the drained weight is calculated by

subtraction of a tare weight from a gross

weight. However, under proposed

§ 101.220(c)(1), the tare weight is

calculated by including the weight of

any liquid drained from the product

with the weight of the other packaging

materials. The tare weight is measured

by placing the product on an

appropriate sieve that is positioned at

an appropriate angle on a receiving pan,

placing all packaging materials on that

same pan, draining the product for

exactly 2 minutes, and weighing the pan

after removal of the sieve containing the

product (proposed § 101.220(c)(1) (i) to

(iii)). This core procedure does not

directly measure the weight of the

drained food remaining in the sieve

used to drain the liquid from the food.

FDA developed the proposed

§ 101.220(c)(1) after close review of both

the drained weight core procedure in

section 3.10, page 3–24, of Handbook

133 and the existing AOAC procedures

for drained weight in ‘‘Official Methods

of Analysis of the AOAC,’’ 16th ed.,

1995, section 968.30, under the heading

‘‘Canned Vegetables Drained Weight

Procedure.’’ The drained weight

procedures in both documents are quite

similar, but there are some differences.

FDA is proposing to resolve the

differences by adopting some elements

from both documents for its core

procedure.

Both the AOAC procedure and the

Handbook 133 procedure provide for

drained weight determinations using a

203-mm (8-inch) U.S. No. 8 standard

test sieve for packages with net quantity

of contents of 1.36 kg (3 lb) or less and

a 12-inch (305 mm) U.S. No. 8 standard

test sieve for packages with net contents

greater than 1.36 kg (3 lb). However, the

Handbook 133 procedure does not

provide for use of a different size sieve

for canned tomatoes, as the AOAC

procedure does. The AOAC procedure

specifies that for canned tomatoes, a

U.S. No. 11.3-mm (7⁄16-inch) standard

test sieve is to be used. Given that

AOAC procedures are generally better

suited for FDA enforcement purposes

than Handbook 133, the agency is

proposing to require in

§ 101.220(c)(1)(ii) that drained weight

for canned tomatoes be determined with

a U.S. No. 11.3-mm (7⁄16-inch) standard

test sieve.

In one respect, however, the

Handbook 133 drained weight core

procedure is more appropriate than the

AOAC core procedure for canned

vegetables. The AOAC procedure is not

specific about how the drained solids

should be weighed. Thus, under the

AOAC procedure, weighings could be

made either (1) Through direct

weighings of the sieve with the drained

solids, followed by subtracting the

weight of the sieve, or (2) through

indirect weighings involving subtraction

of the weight of the drained liquid and

package tare weight from the package

gross weight. NIST has advised (Ref. 3)

that the 1994 Handbook procedure is

preferable because the indirect approach

provides less opportunity for continued

drainage of the solids after the specified

drain time. NIST explained that with

the indirect procedure, when the sieve

is removed the precise weight of the

drained liquid is obtained, whereas with

the direct approach, the solids continue

to drain during weighing, resulting in a

lower drained product weight.

FDA recognizes that, if it were to

permit use of both direct and indirect

drainage procedures, there would be an

opportunity for drained weights to differ

depending upon which procedure is

used. Such differences would be

contrary to the agency’s goal of

establishing a system that ensures that

there will be as much uniformity in

measurements as possible. Accordingly,

FDA is proposing to provide for only

indirect weighing in the drained weight

procedure in § 101.220(c)(1).

The agency notes that in the food

standard regulations on canned fruit (21

CFR part 145) and canned vegetables (21

CFR part 155) there are drained weight

procedures that are based on the direct

weighing procedure. If FDA adopts the

procedure set forth in § 101.220, it will

consider whether to propose to revise

those regulations for consistency with

§ 101.220 or to remove the procedures

from those regulations.

With respect to procedures for

specific products, the agency is

proposing in § 101.220(c)(2) to

incorporate by reference AOAC

procedures for determining drained

weight for glazed vegetables and frozen

seafood (except for frozen shrimp and

crab meat) (AOAC section 963.18),

frozen shrimp (AOAC section 967.13),

and frozen crab meat (AOAC sections

967.13 and 970.60) and, in § 101.220(d),

shucked oysters (AOAC section 953.11).

Corresponding procedures appear in

Handbook 133 in sections 3.14 (page 3–

35), 3.13 (page 3–35), and 4.16 (page 4–

43). The Handbook 133 procedures

differ from the AOAC procedures in

only two respects. First, section 3.13

provides for thawing the frozen shrimp

or crab meat in a plastic bag in a water

bath, whereas AOAC sections 967.13

and 970.60 provide for thawing the

product directly in the water bath at a

specific temperature without being

placed in any bag. In addition, section

4.16 of Handbook 133 provides for

draining the liquid from the shucked

oysters with a U.S. No. 8 standard test

sieve, whereas AOAC 953.11 provides

for draining this liquid with a custom

designed sieve referred to as ‘‘skimmer.’’

Again, without a specific reason to do

otherwise, FDA is proposing to require

that the AOAC procedure be followed.

b. Proposed § 101.225, volume.

Proposed § 101.225 contains both

general procedures for determining the

net volume of most foods and more

specific procedures for determining net

volume of specific foods.

In § 101.225(a), FDA is proposing to

require that measuring equipment

conform to § 101.215, and that good

weighing and measuring procedures be

used for all measurements.

The core procedures for net volume

appear in proposed § 101.225 (b) and

(c). Both procedures have been in

Handbook 133 since 1981 and are

widely recognized as valid and

appropriate methods (Ref. 3). They are

essentially the same as core procedures

appearing in chapter 4 of the Handbook

133 portion of the 1994 Handbook.

The procedure prescribed in proposed

§ 101.225(b) uses only a volumetric

measure to determine the net contents.

It involves pouring the entire contents

of a package into a volumetric measure

(see proposed § 101.201(a) for

appropriate reference temperature) and
9842 Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules

comparing the liquid level with the

graduations on the measure.

The procedure prescribed in proposed

§ 101.225(c) uses both a volumetric

measure and a balance to determine the

net contents, with most measurements

involving a gravimetric procedure for

net volume. Initially, the proposed

procedure requires that a test

demonstrate that individual packages

within the sample have constant

product density (weight/volume at the

appropriate reference temperature). For

this product density test, the same

measured amount of product from two

individual packages is weighed. Where

the weight is the same in both cases,

information from the weighings is used

to calculate the volumes of the

remaining individual packages of

product in the sample from the weights

of those packages. NIST explained (Ref.

3) that the product density test must

demonstrate the same measured weight

in both cases because only when

product density is constant among all of

the individual packages within the

sample may the weights of the packages

be used to calculate the volumes of

those packages. If used in other

circumstances, net volume

determinations made using proposed

§ 101.225(c) could have significant

errors. When product density is

constant, however, the gravimetric

procedure in proposed § 101.225(c) is

considerably faster than the procedure

in proposed § 101.225(b) because, under

§ 101.225(c), most packages are simply

weighed, while under § 101.225(b), all

packages must be opened, their contents

poured into a volumetric measure, and

the liquid level of these contents

compared with the graduations on the

measure.

NIST pointed out that although the

gravimetric procedure proposed in

§ 101.225(c) basically relies on constant

variability, some flexibility must be

provided for in the procedure because

most types of balances display weight in

the form of a digital reading that has

been rounded by computerized

components within the balance to the

nearest whole scale division (Ref. 3).

Thus, the balance may introduce

variation of as much as one-half scale

division. In the presence of such

balance variation, more than a one scale

division difference must be present to

conclude that differences in weights are

attributable to the food rather than to

the balance. Thus, NIST advised, only

where more than one scale division is

present between the 2 volumes weighed

in the product density test should

proposed § 101.225(c) contain a

provision prohibiting its use to

determine net volume because the

product density is not constant (see

proposed § 101.225(c)(3)(v)).

NIST advised (Ref. 3) that proposed

§ 101.225(c) may appear different from

the Handbook 133 gravimetric

procedure for volume to some affected

parties because of the presence of the

above stipulation that the procedure not

be used where more than a one scale

division difference between packages is

present. However, NIST pointed out

(Ref. 3) that Handbook 133 actually

needs this stipulation to be properly

updated. NIST explained that the

existing gravimetric procedure in

Handbook 133 was developed for the

types of scales and balances used by

weights and measures officials in the

1960’s and 1970’s, which did not have

the computerized components with the

capability of rounding to the nearest

whole scale division.

In § 101.225 (d), (e), (f), and (g), the

agency is proposing measuring

procedures for specific products. In

paragraphs (d) and (e), FDA is proposing

to incorporate by reference AOAC

procedures for determining net volume

for shucked oysters, clams, or scallops

and for ice cream and frozen desserts.

Corresponding procedures appear in

Handbook 133 in sections 4.16 (page 4–

43), and 4.15 (page 4.38). The Handbook

133 procedures differ in only a few

respects. For shucked oysters, clams, or

scallops, the AOAC procedure includes

specific procedures for preparing the

food for measurement that are not

contained in Handbook 133. For ice

cream and frozen desserts, the AOAC

procedure includes specific procedures

for handling and freezing the food that

are not included in Handbook 133. Also,

the AOAC procedure in Method I

(AOAC 968.14) provides that kerosene

is the immersion fluid for the

measurement, rather than cold water, as

provided for in Handbook 133.

NIST points out (Ref. 3) that there

could be significant problems for field

regulatory officials to safely transport

and handle kerosene. NIST stated that

kerosene is specified in the AOAC

procedure to ensure that the food will

not mix with the immersion liquid.

NIST also advised, however, that water

of 0.56 °C (33 °F) or below may be used

as the immersion liquid provided there

are no visual indications of mixing.

Based on NIST’s position on this

matter and the deference that it

considers to be due NIST, FDA

tentatively concludes that it should

permit the use of sufficiently cold water

for measuring the volume of ice cream

and frozen desserts. FDA is therefore

proposing to permit substitution of

water of 33 °F (0.56 °C) or below for

kerosene in the AOAC procedure,

provided that the food does not mix

with the water.

In § 101.225(f), FDA is proposing a

volumetric depth gauge procedure that

may be used to determine volume where

the food has a smooth and level

headspace (e.g., oils, syrups, and other

viscous liquids). The proposed

procedure involves determining the

headspace of the package at the point of

contact with the food using a depth

gauge; emptying, cleaning, and drying

the package; and determining the

amount of water necessary to refill the

package to the headspace present with

the food. The proposed procedure

reflects the procedure in section 4.6.1,

page 4–12, of the Handbook 133 portion

of the 1994 Handbook but with a few

differences because of the NIST

recommendations (Ref. 3).

FDA is proposing to require a 6-inch

bubble level rather than at least a 10-

inch level because NIST advised that 6-

inch levels are adequate for the

intended purpose and more commonly

available than 10-inch levels (Ref. 3).

Also, the agency is proposing no

restrictions on the size of the

micrometer depth gauge because the test

procedure can be used on a wide variety

of package sizes that may require the

use of depth gauge rods of different

lengths (Ref. 3). Further, section 4.6.1 of

Handbook 133 states that the size of the

micrometer measuring rod shall be 0 to

9 (in), but NIST recommended that no

size be stipulated. NIST advised that,

when this section of Handbook 133 was

written, NCWM intended to provide

guidance in selecting commonly

available equipment appropriate for use

in testing most products, but there was

no intent on the part of NCWM to limit

the procedure’s use to measurements of

less than 9 (in) (Ref. 3).

In § 101.225(g), FDA is proposing a

volumetric air space procedure that may

be used to determine volume where the

food does not have a smooth and level

headspace (e.g., mayonnaise). The

proposed procedure involves

determining the amount of air space

above the product in the package and

then the total container volume.

Subtracting the airspace volume from

the total container volume gives the

product volume. The proposed

procedure reflects section 4.8, p. 4–20

and section 4.14.2, p. 4–36, of the

Handbook 133 portion of the 1994

Handbook.

There is, however, one significant

difference between all of the procedures

proposed in § 101.225 and the

corresponding Handbook 133

procedures. The difference concerns

reference temperatures. As mentioned

previously in this preamble, a
Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules 9843

‘‘reference temperature’’ is the

temperature at which the fill of a food

sold by volume must meet the declared

net quantity of contents (see proposed

§ 101.205(m)). This temperature is

important in measurements to

determine the net volume because the

volume that is occupied by any food

varies with temperature. Where the

temperature falls below the reference

temperature, the volume decreases. As a

result, a product that contains the

declared net quantity of contents at the

reference temperature could measure

below the declared net quantity at a

reduced temperature. If a regulatory

official made a measurement at a

reduced temperature, an appropriately

labeled product might be considered

violative. Such a situation would be

unfair to the manufacturer. To prevent

this situation, Handbook 133 prohibits

measurement where product

temperatures are below the appropriate

reference temperature. Conversely,

measurement at a temperature higher

than the reference temperature could be

unfair to consumers, but Handbook 133

does not address this situation.

To be fair to both consumers and

manufacturers, the volumetric

methodology that FDA is proposing in

§ 101.225 provides that the food be

brought to the appropriate reference

temperature before measurement of its

volume. However, there is often no

practicable way to maintain the

reference temperature while all

subsamples are being measured. The

1994 Handbook provides for this

situation by advising that officials have

some flexibility with respect to these

temperatures in making fluid

measurements, but it does not specify

how much flexibility is appropriate.

Without any constraints on this

flexibility, there is reduced assurance of

uniformity of enforcement. However,

NIST suggested that one way to identify

an appropriate amount of flexibility

would be to specify those reference

temperature ranges at which there

would be no more impact in volume

measurements than 0.01 percent of the

measured volume (Ref. 3). NIST stated

that measurements should be performed

from ¥18 °C (0 °F) to ¥15 °C (5 °F) for

frozen food, from 1.7 °C (35 °F) to 7.2

°C (45 °F) for refrigerated food, and from

20 °C (68 °F) to 22.7 °C (73 °F) for other

foods. NIST explained that these

temperature ranges would afford needed

flexibility in making measurements (Ref.

3).

As the agency has stated repeatedly in

this document, it has tentatively

decided to follow all of NIST’s

recommendations on matters of weights

and measures. FDA is therefore

proposing to adopt NIST’s

recommendations for appropriate

reference temperature analytical ranges

in § 101.225(b)(1). Under this provision,

all measurements of net volume are to

be made at the NIST-recommended

temperatures, unless FDA has

specifically provided otherwise.

There is a second difference between

§ 101.225 and Handbook 133 concerning

measuring devices used ‘‘to deliver’’

liquids. All volumetric measures are

calibrated either ‘‘to deliver’’ or ‘‘to

contain’’ a volume of liquid. The

graduations of ‘‘to deliver’’ volumetric

measures represent the volume of liquid

in the vessel that can be poured from it.

The graduations of ‘‘to contain’’

volumetric measures represent the

volume of liquid in the vessel and do

not represent the volume of liquid that

can be poured from it (some liquid is

inevitably retained after pouring).

However, both types of measures

actually measure the same quantity, and

both types may be used to determine the

volume of any liquid, provided

appropriate procedures for use are

followed. With proper use, the accuracy

of the measurements from either type of

volumetric measure is equivalent.

‘‘To contain’’ volumetric measures

must be cleaned and dried between each

use because the measure was calibrated

and marked in comparison to a cleaned

and dried volumetric standard.

However, ‘‘to deliver’’ measures do not

have to be prepared in this manner

because they have been calibrated to

deliver a specific amount of liquid after

a specific drain time that is marked on

the measures. These measures only have

to undergo an initial wetting and

draining treatment. Section 4.3.c. of

Handbook 133 provides a set of

directions for preparing these measures

for use. The directions, which are

consistent with the recommendations of

NIST for such calibration (Ref. 3) have

been reiterated in proposed

§ 101.225(b)(2)(ii).

However, some manufacturers of

volumetric measures may use different

emptying and drainage times in

calibration procedures than those

currently in Handbook 133. Where they

do so, the manufacturer designates the

appropriate time for emptying

(including pouring out the liquid and

draining it) or draining (excluding the

time for pouring out most of the liquid)

the measure. (Most manufacturers that

do designate such a time, express it in

terms of a draining time (Ref. 3).) NIST

recommends that when a manufacturer

designated emptying or drainage time

appears on a measure, that time be used.

In view of this recommendation and

of the fact that it is logical to assume

that greater accuracy would consistently

result from following the manufacturer’s

recommendation, when it is present,

than more general procedures, FDA is

proposing in § 101.225(b)(2)(ii)(B) to

differ from Handbook 133 provisions by

requiring the use of the manufacturer’s

delivery recommendations when they

are present. FDA requests comment on

the appropriateness of its approach.

FDA points out that its Investigations

Operations Manual (IOM) directs its

personnel to use only ‘‘to contain’’

volumetric measures, whereas the

proposed provisions do not include this

restriction because of the

recommendations mentioned above by

NIST (Ref. 3). If FDA adopts this

proposal, the IOM will be modified to

reflect this change.

c. Proposed § 101.230, count. Chapter

5 of the Handbook 133 portion of the

1994 Handbook contains two core

procedures for checking net contents

declared by count. The procedure may

be used in all situations that involve

counting the contents of each individual

package. However, a gravimetric test

procedure may also be used to

determine count where product density

(weight/volume at the appropriate

reference temperature) is constant

among all of the individual packages

within the sample. (As discussed

previously in this preamble, gravimetric

procedures for other forms of expression

of net contents provide reliable results

only where product density does not

vary among individual food packages.)

FDA is proposing the Handbook 133

individual count as a core procedure in

§ 101.230(a) and the gravimetric count

core procedure in § 101.230(b). Where it

may be used, the gravimetric procedure

for net count is considerably faster than

the procedure in proposed § 101.230(a),

because most packages are simply

weighed rather than being subjected to

the procedure where all packages are

opened, and their contents individually

counted.

To determine whether the product

density is constant, proposed

§ 101.230(b)(1) prescribes a product

density test that requires that, for two

individual packages, the net contents be

weighed at the reference temperature

and individually counted. These values

are used to calculate the net weight of

the package with the labeled count. For

both packages, the labeled count must

be calculated to weigh the same amount.

As discussed previously in this

document, because most types of

balances may introduce some variation

in measurements from computerized

components that round to the nearest

whole scale division, more than a one

scale division difference must be
9844 Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules

7Section 5.1.3, page 5–3, of Handbook 133.

present to conclude that differences in

weights are attributable to the food

rather than to the balance. Thus, where

more than one scale division is present

between the two calculated weights of

the labeled count in this product

density test, proposed § 101.230(b)(1)(v)

prohibits the use of the gravimetric

procedure to determine net count

because the product density is not

constant.

Where more than one scale division is

not present, proposed § 101.230(b)(2)

contains a gravimetric measuring

procedure wherein the balance used in

the product density test is also used to

determine the net weights of the

individual packages in the sample, and

the product density is used to convert

the net weights to net counts. This

procedure reflects the core procedure

appearing in Chapter 5 7 of the

Handbook 133 portion of the 1994

Handbook. This procedure has been in

Handbook 133 since 1981.

The proposed procedure may appear

to be different from the Handbook 133

procedure because of the presence of the

stipulation against use of the procedure

where there is a two or more scale

divisions difference in the product

density test. However, NIST

recommended incorporating this

stipulation to update the Handbook 133

gravimetric procedure for net volume

(Ref. 3). As stated previously, the

Handbook 133 procedure was

developed for the types of scales and

balances used by weights and measures

officials in the 1960’s and 1970’s.

FDA points out that the core

procedures for count in proposed

§ 101.230 (a) and (b), if adopted, will be

used primarily for dietary supplements

in tablet, capsule, or other unit dosage

form rather than for food in

conventional food form. For such

dietary supplements, consumer value

comparisons are facilitated primarily by

information concerning the amount of

dietary ingredient in the unit form and

the number of such units in the food

package. A statement in terms of the net

weight alone is often of little practical

value to purchasing decisions. For

dietary supplements in unit form, FDA

generally requires that declarations of

net quantity be expressed in terms of net

count, with statements of net contents

in other forms being voluntary

expressions.

With respect to food in conventional

food form, only a few products (e.g.,

chewing gum) may express net contents

in terms of only count. The agency

solicits comments concerning whether it

should require that declarations of net

quantity of contents on dietary

supplements in unit form include

information concerning the amount of

dietary ingredient in a unit of the

supplement, as well as information in

terms of count.

d. Proposed § 101.235, tare. The

Handbook 133 portion of the 1994

Handbook defines ‘‘tare weight’’ as the

weight of a container, wrapper, or other

material that is deducted from the gross

weight to obtain the net weight. With

respect to other material that is

deducted from the gross weight,

regulatory officials have had differing

opinions concerning whether food

particles adhering to the container and

liquids from the food absorbed in the

container must be included in tare

weight. Because of a lack of agreement

in this area, Handbook 133 contains

definitions of tare to accommodate all

positions of the officials. Any of the

definitions may be used with the

gravimetric methods of analysis in

Handbook 133, and significant variation

in analytical findings may result from

this flexibility.

Handbook 133 contains definitions for

‘‘dry tare,’’ ‘‘dried used tare,’’ and ‘‘wet

tare.’’ ‘‘Dry tare’’ is defined as unused

tare that comprises all packaging

materials (including glue, labels, and

ties) that contain or enclose a product,

including prizes, gifts, coupons, or

decorations that are not part of the

product. ‘‘Dried used tare’’ is defined as

used tare for which an effort is made to

reconstruct the unused tare weight by

removing the food from the tare by

washing, scraping, wiping, ambient air

drying, or other techniques involving

more than ‘‘normal’’ household recovery

procedures but not including such

laboratory procedures as oven drying

because oven drying can damage the

tare material and result in invalid tare

determinations. ‘‘Wet tare’’ is defined as

used tare when no effort is made to

reconstruct unused tare weight. For wet

tare determinations, only readily

separable food product is removed. Wet

tare may include food particles that

adhere to packaging materials, as well as

fluids that may have been absorbed into

these materials. As a result, free flowing

fluids that have drained from the food

may not be included in the net mass or

weight of the food. With used wet tare,

there is a significant possibility that

there will be large variations in tare

weight (Ref. 3). These variations may

differ with the type of product,

packaging materials (e.g., with absorbent

packaging material), and handling and

storage conditions. Additional

variations in wet tare may be caused by

the procedures used to determine wet

tare, such as how long the product is

allowed to drain before it is removed

from the packaging and weighed.

NIST pointed out (Ref. 3) that these

variations make it difficult for packers

to set accurate fill levels because, in

most cases, they must overpack to

accommodate the largest possible wet

tare determination that could be found

with the product. Because of variations

in wet tare determinations and the fact

that dry tare is generally not available in

sampling locations such as warehouses

and retail stores, NIST recommended

(Ref. 3) that FDA require that tare

determinations be made with only dried

used tare.

In response to NIST’s

recommendation, and in view of the fact

that FDA has evaluated net contents

declarations with dried used tare for

many years, FDA is proposing in

§ 101.235(a) that only dried used tare be

used in quantity of contents

determinations. The agency is not

proposing that unused dry tare be

permitted because the agency is

proposing these rules for national

uniformity, and there may be some

weight differences in the two types of

dry tares from a variety of factors such

as absorbed packing medium. The

procedures that FDA is proposing for

determining dried used tare are those

that are currently set out in the 1994

Handbook. The agency considers them

appropriate because they have been

widely accepted by State and local

regulatory agencies and industry for

more than 30 years (Ref. 3).

With respect to how many tares must

be weighed to determine the average

tare that will be used in gravimetric

procedures to determine the net

contents, the Handbook 133 portion of

the 1994 Handbook provides for 2

approaches for determining the average

value. However, the 1994 Handbook

permits only one of these approaches to

be used. This approach is set out in

‘‘Alternative Tare Procedures,’’ in

section 2.11.4., page 2–22 of Handbook

133, with modifications made by the

1994 Handbook.

The ‘‘Alternative Tare Procedures’’

involve a 2-stage procedure. An initial

small tare sample size is weighed, and

the variation within the individual

packages of that initial sample is used

to make a decision on how many

additional individual packages must be

weighed before calculating the average

tare. The initial test is needed because

tare weight can vary considerably from

package to package (e.g., plastic buckets,

glass bottles, and metal cans). If this tare

variation is sizeable in comparison with

the net weight variation, the net weights

calculated for the sample packages can

be erroneous.
Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules 9845

To minimize erroneous findings, the

1994 Handbook identifies values of

ratios of the tare weight divided by the

net weight that will ensure that no more

than 5 percent of the gross weight

variation results from variation in tare.

(Before the 1994 Handbook revisions of

Handbook 133 were made, the

contribution of this variation in tare

could be 25 percent of the gross weight.

The contribution was limited because of

concern that tare errors might influence

the net weight results to too large a

degree.) In some cases, where there is a

large variation in package tare weights,

all of the packages in the sample may

have to be opened, and the average tare

determined using the tare values for

each of these packages.

NIST recommended that FDA adopt

the 1994 Handbook procedures for

determining the numbers of tare weights

to be obtained (Ref. 3). Again, because

FDA is not aware of any potential

problems with these procedures, and

because of NIST’s expertise, FDA has

tentatively decided to follow NIST’s

recommendation with respect to

appropriate tare weight. Therefore,

proposed § 101.235 (b) through (i)

incorporates a procedure for

determining fare weight that is modeled

after the 1994 Handbook.

5. Compliance Procedures

As explained previously, the 1994

Handbook uses the ‘‘Category A’’

approach to ascertain conformance with

net quantity labeling requirements. This

approach has two aspects: Procedures

for sample collection, and procedures

for using the package characteristics of

a sample to determine whether the

inspection lot is violative. The sample

collection aspect of the ‘‘Category A’’

approach, which was discussed earlier

in this preamble, serves as the basis for

FDA’s proposed § 101.210. This section

of the preamble pertains to the other

aspect of the ‘‘Category A’’ approach,

which may be characterized as

‘‘compliance procedures.’’ Compliance

procedures minimize the number of

case-by-case decisions by prescribing

specific steps to determine whether the

requirements for declarations of net

contents have been met.

a. Requirements pertaining to average

package fills. According to NIST (Ref.

3), the insistence in the 1994 Handbook

that the average quantity of contents of

the packages in a lot, shipment, or

delivery be equal to or exceed the

quantity printed on the label is the

primary tool for protecting consumers.

Most State and local regulatory actions

result from this aspect of the 1994

Handbook (Ref. 3). The focus on the

average quantity of contents provides

good assurance that, while individual

packages within an inspection lot may

fluctuate, on a lot basis, consumers will

receive the amount of food declared on

the label (Ref. 3).

i. Industry concern about average

requirements. The industry Task Force

stressed that it is concerned about

Handbook 133’s focus on average

quantity of contents because decisions

about whether regulatory actions are

warranted are usually made based on

inspection lots. The Task Force argued

that it is not appropriate to subject an

inspection lot to regulatory action based

solely on an average requirement

because if this is done, it will not be

possible to tell whether the problems

found in an inspection lot are the result

of underfilling or of the reasonable

variations permitted for a production lot

under section 403(e)(2) of the act. The

Task Force stressed that, within each

production lot, net contents will often

rise above and fall below the declared

net contents, but that the average net

contents of the production lot will meet

the declared net contents.

Given the fluctuations among

packages, however, the Task Force said

that inspection lots may not be

representative of their larger parent

production lots. The Task Force

explained that inspection lots are

generally small parts of much larger

production lots. Because of distribution

practices, the inspection lot usually

represents an interval of production and

not a random sample of the production

lot. Thus according to the Task Force,

the averaging out at the declared

contents level that occurs in the

production lot may not occur in the

inspection lot.

The Task Force expressed particular

concern over regulatory action based on

very small inspection lots. The Task

Force contended that net content

examinations of inspection lots should

be used primarily as ‘‘audit tools,’’ and

that actions against an inspection lot

should only be taken if a firm’s quality

control records show that there were

problems with the production lot at the

plant, or if access to such records is

denied to regulatory officials.

The Task Force also argued that FDA

should establish a statistically valid

sampling variation allowance that is not

reduced for small sample sizes. The

Task Force explained that even package

filling operations that comply with GMP

cannot guarantee that each inspection

lot with as few as 10 to 30 units will

always have the same average net

contents. The Task Force requested that

a sampling variation allowance based on

two standard deviations of the sample

mean be applied to all in-plant,

wholesale, and retail inspection

samples.

ii. NIST position on industry concern.

NIST maintained that it is fair to

industry for regulatory agencies to

follow the 1994 Handbook and to take

regulatory action against inspection lots

if they are found to be violative based

on samples analyzed using the average

requirement because of the

mathematical approach that undergirds

that requirement.

iii. Mathematical approach. The 1994

Handbook requires that a sample of the

inspection lot be drawn from the entire

inspection lot, using random selection

procedures. Such procedures are

necessary if a reliable mathematical

evaluation of net contents findings is to

be made. Random selection of the

sample means that, using the net

contents of the individual packages in

the sample, it is possible to derive a

reliable picture of the range of possible

average net contents values for the

inspection lot. The range of possible

average net contents values will be

correct 97 or more times out of 100 (or,

in statistical terms, with 97 or more

percent confidence).

The 1994 Handbook uses the range of

possible average net contents values for

the inspection lot to estimate the

uppermost average package error that

could be present in the inspection lot

with 97 or more percent confidence. (As

explained previously in this document,

the package error is the difference

between the measured net quantity of

contents and the labeled quantity on the

package.) If the package error calculated

using the 1994 Handbook is less than 0,

it would mean that the net contents of

a significant number of packages in the

inspection lot would not meet the

declared net contents, and that

inspection lot is violative.

Under the 1994 Handbook, the range

of possible average net contents values

for the inspection lot is calculated by:

(1) Determining the net contents of all

individual packages in the sample; (2)

Determining the package errors for all of

the individual packages in the sample

(again, the package error is the

difference between the measured net

quantity of contents and the labeled

quantity on the package); (3)

Determining the average package error

for the sample; and (4) Determining the

range statistic, that is, a value that,

when combined with the average

package error for the sample (by

addition to and subtraction from this

error), will be used to make a reliable

estimate of the range (i.e., the difference

between the greatest and smallest

values) of average package error values

that may be present in the inspection
9846 Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules

lot. The range statistic, is determined

by: (a) Determining the standard

deviation (s) of package errors within

the sample (s is a statistic used as a

measure of dispersion (i.e., differences

of individual values from the mean) in

a sample); (b) Selecting from a

mathematical table (found in Column 2

of Table 1 in proposed § 101.240) the

appropriate statistic that will be used to

account for the number of individual

packages in the sample. There is a 97

percent confidence incorporated in the

estimate of the range of possible

variations of average package error

within the inspection lot. (Any estimate

of the range of possible variations in

average package error within the

inspection lot using the average package

error of the sample will vary with the

sample size because the reliability of

such an estimate is greater as more

individual measurements are made. The

1994 Handbook refers to the statistic

that it uses to account for sample size

and the desired confidence as the

‘‘Sample Correction Factor’’ (SCF). The

SCF gets larger as the sample size gets

smaller. For the SCF values in Table 1

of proposed § 101.240, the level of

desired confidence for estimates about

the inspection lot is that they be correct

97 or more times out of 100 (or, in

statistical terms, with 97 or more

percent confidence). (The 97 percent

confidence aspect of the SCF statistic is

consistent with Task Force requests for

a sampling variation allowance based on

two standard deviations of the sample

mean.); and (c) Multiplying ‘‘s’’ by the

appropriate SCF to determine the range

statistic, that is the sample error limit

(SEL). The SEL is a statistical value that

allows for the uncertainty between the

average error for the sample and the

average error for the inspection lot.

The 1994 Handbook uses the SEL to

estimate the uppermost average package

error that could be present in the

inspection lot with 97 or more percent

confidence. This package error is

determined by adding the SEL to the

average package error of the sample. If

this uppermost average package error in

the inspection lot is less than 0, the

1994 Handbook, as stated above,

classifies the inspection lot violative.

iv. Fairness of the 1994 Handbook

approach. To illustrate fairness in the

1994 Handbook’s approach to

reasonable variations in the average net

quantity of contents in the inspection

lot, NIST referred to a number of

hypothetical sampling situations with

varying sample net weights (Ref. 3). All

of these situations pertained to

inspection lots with a total declared net

weight of 48 oz (3 lb) and with varying

package errors within a sample size of

12 individual packages. NIST advised

that because it used a computer for all

of its calculations in these situations,

the formula it used for determining the

standard deviations of the package

errors in each of the situations was

s=(∑(xi¥x)2/(n¥1))1/2.

Situation A: Inspection lot size: 250

packages

Package error range: 3 oz (¥1.5 oz to

+1.5 oz)

Package errors among the 12 packages

within the sample: +1, ¥1.5, +0.5,

¥1, +1, ¥1.5, ¥1.5, ¥1, +0.5,

¥1.5, +1.5, ¥1.5

Average package error: ¥0.42 oz

Calculation of SEL

Standard deviation (s): 1.203 sample

correction factor (SCF) for sample

size of 12 from Table 1, § 101.240:

0.5774 SEL=1.203×0.5774=0.69 oz

Compliance Status of Inspection Lot

Avg package error +

SEL=¥0.42+0.69=0.27 oz 0.27

meets the 0 or greater criterion

discussed above, so the lot is in

compliance

Permitted Reasonable Variations in

Package Errors

Estimation of Allowance for Reasonable

Variation Range Within Inspection

Lot = sample avg package error ±

SEL=¥0.42 oz ±0.69 oz=¥1.11 oz

to 0.27 oz

Permitted Reasonable Variations in

Average Net Weight

48 oz¥1.11 oz to 48+0.27 oz=46.89 oz

to 48.27 oz

Maximum Percent Shortage Within

Reasonable Variations

1.11 divided by 48×100=2.3%

Situation B: Inspection lot size: 250

packages: Package error range: 0.16

oz (¥0.17 oz to ¥0.01 oz) (note that

all errors are negative). Package

errors among the 12 packages

within the sample: ¥0.17, ¥0.01,

¥0.01, ¥0.01, ¥0.01, ¥0.01,

¥0.01, ¥0.02, ¥0.01, ¥0.02,

¥0.01, ¥0.01. Average package

error: ¥0.02 oz

Calculation of SEL

Standard deviation (s): 0.0458 SCF for

sample size of 12 from Table 1,

§ 101.240: 0.5774

SEL=0.0458×0.5774=0.03 oz

Compliance Status of Inspection Lot

Avg package error +

SEL=¥0.02+0.03=0.01 0.01 meets

the 0 or greater criterion, so lot is

in compliance

Permitted Reasonable Variations in

Package Errors

Estimation of Allowance for Reasonable

Variation Range Within Inspection

Lot = sample avg package error

± SEL=¥0.02 oz±0.03 oz=¥0.05 oz

to 0.01 oz

Permitted Reasonable Variations in

Average Net Weight

48 oz¥0.05 oz to 48+0.01 oz=47.95 oz

to 48.01 oz

Maximum Percent Shortage Within

Reasonable Variations

0.05 divided by 48×100=0.10%

Situation C: A small inspection lot, all

of which is included in the sample,

with mixed production codes (such

as those often found in retail

marketplace). Inspection lot size: 12

packages. Package error range: 1.49

oz (¥1.5 oz to ¥0.01 oz) (note that

all errors are negative). Package

errors among the 12 packages

within the sample: ¥1.50, ¥0.19,

¥0.5, ¥0.09,¥1.40, ¥0.03, ¥0.01,

¥0.02, ¥0.01, ¥0.01, ¥0.01,

¥0.02 Average package error:

¥0.32 oz

Calculation of SEL

Standard deviation (s): 0.5448 sample

correction factor (SCF) for sample

size of 12 from Table 1, § 101.240:

0.5774

SEL=0.5448×0.5774=0.32 oz

Compliance Status of Inspection Lot

Avg package error+SEL=¥0.32+

0.32=0.00 0.00 meets the 0 or

greater criterion, so lot is in

compliance

Permitted Reasonable Variations in

Package Errors

Estimation of Allowance for Reasonable

Variation Range Within Inspection

Lot=sample avg package error

±SEL=¥0.32 oz±0.32 oz=¥0.64 oz

to 0.00 oz

Permitted Reasonable Variations in

Average Net Weight

48 oz¥0.64 oz to 48+0.00 oz=47.68 oz

to 48.00 oz

Maximum Percent Shortage Within

Reasonable Variations

0.64 divided by 48×100=1.3%

NIST stated (Ref. 3) that these

illustrations disclose that the foundation

of the 1994 Handbook’s approach to

permitting reasonable variations in the

average net quantity of contents lies in

its evaluation of the significance of the

standard deviation (s) of package errors

within the sample.
Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules 9847

For small inspection lots (about

which the Task Force expressed the

greatest concern), NIST stated (Ref. 3)

that the 1994 Handbook’s approach

provides sufficient allowance for the

variations that are likely to occur.

NIST advised that the Situation C

illustration demonstrates that there is

little foundation to industry’s concern

that small inspection lots are at a

significant disadvantage under the 1994

Handbook. NIST explained that the

1994 Handbook includes, as requested

by the Task Force, an SEL that is not

reduced for small sample sizes. NIST

stated that the approach that is reflected

in proposed § 101.210 provides for

collection of smaller sample sizes for

smaller inspection lots (e.g., 12

individual packages for an inspection

lot of 250 packages versus 48 individual

packages for an inspection lot of more

than 3,200 packages). As stated above,

smaller sample sizes result in larger

SCF’s and, in turn, in larger SEL’s. The

larger SEL’s permit greater adjustment

of the average sample net quantity of

contents before application of the 0 or

greater criterion for the average sample

package error that is discussed above.

As a result, it is more likely that a small

inspection lot with an underweight

average will be accepted than that the

lot will be rejected.

NIST pointed out (Ref. 3) that because

those firms that pack with greater

variability from a variety of sources,

including poor quality control, will get

larger correction allowances than firms

packing with smaller variability, firms

with poor quality control might get

undue benefit from the 1994 Handbook

approach to calculating the SEL.

However, NIST advised also that it

knows of no way to prevent larger

allowances under such circumstances.

FDA solicits comments about alternative

approaches that might prevent a firm

from taking advantage of the proposed

allowances. In the absence of contrary

information, however, FDA’s tentative

view is that abuse of the approach in the

1994 Handbook would not be likely

because firms have far more to gain from

savings from better quality control of

product filling practices than from a

larger SEL.

Further, NIST pointed out that the

Situation C illustration demonstrates

that small lots are likely to be permitted

reasonable variations from inclusion of

different manufacturing codes in the

inspection lot. NIST explained (Ref. 3)

that including of multiple

manufacturing codes in the same

inspection lot significantly increases the

chance of an inspection lot sample

having a larger standard deviation than

would occur with a single code because

different codes are generally packaged at

different times and possibly by different

filling machines. Differing codes may

well mean that portions of the

inspection lot were packaged days,

weeks, or even months apart. Under

such circumstances, there is an

increased likelihood that differences in

filling practices cause larger variability

between individual fills within the

packages included in the sample,

thereby driving the standard deviation

upward with a corresponding increase

in the SEL.

NIST points out, however, that the

1994 Handbook’s manner of calculating

SEL, which provides for reasonable

variations for small inspection lots, is

not consistent with well recognized

academic approaches to determining

appropriate sampling variation

allowances. Such academic approaches

(Ref. 9) provide that the size of the

sampling variation allowance be

reduced as the percent of the lot that is

sampled is increased. For example,

when inspection lots are 100 percent

sampled, the SEL would always be 0.

However, under the 1994 Handbook, the

SEL would rarely, if ever, be 0. As a

result, the 1994 Handbook provides for

significant sampling variation

allowance. In the previously discussed

Situation C illustration, the SEL of 0.32

oz would mean that a sample with every

package fill below the labeled package

fill would be classified as in

compliance.

However, NIST advised that large

permitted variations in small

inspections lots are not inconsistent

with consumer protection because

where any but the smallest shipments

are involved, there would be little

practical impact on the SEL reduction.

For example, the SEL is reduced by only

5 percent with inspection lots of 125

units and, with inspection lots of 3200,

the SEL is reduced by only 1 percent

(Ref. 3). Accordingly, FDA tentatively

concludes that this inconsistency with

academic approaches should not affect

its decision to propose the 1994

Handbook approach for determining the

SEL. FDA suggests, however, that

regulatory officials should attempt to

collect samples from the largest

inspection lots practicable to minimize

the impact of the large variations that

are permitted in small inspection lots.

For large inspection lots, fairness

under the 1994 Handbook’s approach

results primarily from the way the SEL

reduces the probability that

nonviolative lots will be rejected.

Furthermore, the 1994 Handbook

restricts violative findings to the

inspection lot, even where arguments

could be made for broader applicability.

For example, NIST has pointed out (Ref.

3) that if the inspection lot is found to

be in violation after application of the

SEL, and if the inspection lot is

composed or made up of packages

randomly selected from the entire

production lot, then there is every

reason to believe that the production lot

as a whole was in violation. However,

NIST advises that the 1994 Handbook

does not suggest regulatory action

against the production lot under such

circumstances. NIST stated that restraint

under such circumstances further

illustrates that it is not unfair to

industry to base regulatory action on

inspection lots.

v. Practicability. NIST maintained

(Ref. 3) that it would be impracticable

for regulatory attention to be focused on

the production lot instead of the

inspection lot. NIST explained that the

designation of the production lot may be

artificial because it is, in fact, often only

a segment of continuous production.

The segment may be large or small,

depending upon whether the packager

uses more than one code during a day.

NIST advised that in the United States,

the only restriction on the definition of

the production lot for net contents

purposes is one established by USDA

for meat and poultry products. Meat and

poultry package production lots can

consist of no more than 8 hours’

production. Generally, however, the

definition is left entirely to the

manufacturer or may be dictated by

other considerations (such as tracing

batches of ingredients that are

susceptible to spoilage or

contamination). In the European Union,

by contrast, a production lot is defined

as no more than 10,000 packages (Ref.

10).

In addition, it is not unusual for U.S.

firms to be shipping packages from a

given production lot out of a plant while

more packages from that same lot are

still being produced. Thus, according to

NIST (Ref. 3), it is common not to be

able to sample from an entire

production lot, even when the sample is

taken at the packaging location.

Therefore, if actions were to be taken

only against production lots, NIST

suggested that it would be necessary to

circumscribe what would constitute a

production lot. Also, it would be

necessary that the lot be held for some

period of time, so that regulatory

officials would have an opportunity to

take a random sample of the entire

production lot.

vi. FDA’s tentative position about

industry concern. FDA points out that

the language of section 403(e)(2) of the

act charges the Secretary of Health and

Human Services and, by delegation,
9848 Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules

FDA with the responsibility of ensuring

that food packages have an ‘‘accurate’’

quantity of contents declaration, but

that the act states also that reasonable

variations shall be permitted. The first

aspect of section 403(e)(2) protects

consumers from being misled about

package net contents and facilitates

retail value comparisons. The second

aspect protects industry by making clear

that this requirement is to be enforced

in a reasonable manner. Neither aspect

of this provision is subordinated to the

other. Thus, the agency must attempt to

strike an appropriate balance between

the interests of consumers and of

industry in any approach to enforcing

section 403(e) that it adopts.

As previously discussed in this

preamble, FDA has tentatively

concluded that the diversity in

approaches to enforcement of net

contents declaration labeling

requirements on foods among State and

local regulatory agencies has created

significant burdens on interstate

commerce. Firms shipping a product to

several States must overfill their

products to meet the most stringent

State’s requirement. Some adjustment in

the balance between consumer and

industry interests in net contents

declarations is therefore necessary to

alleviate the burden on industry that is

produced by this diversity in

approaches.

Further, to the extent that FDA

identifies in its regulations what are

‘‘reasonable variations’’ under section

403(e)(2) of the act, the affected industry

will be in a better position to judge at

what point contents deviations are

likely to be considered violative. Such

knowledge should help firms reduce

overfilling of packages and should

facilitate interstate commerce by making

the establishment of more uniform

target fill levels practicable for all

package sizes. Also, consumers will be

better informed about the amount of

food that they are purchasing.

FDA does not agree, however, that net

content examinations of inspection lots

should be used only as ‘‘audit tools.’’

The agency is not persuaded that there

is an inequity to the affected industry

from a regulatory approach that focuses

on the inspection lot when it is an

increment of a much larger production

lot. FDA tentatively finds that NIST has

presented persuasive evidence that the

mathematical approach in the 1994

Handbook is fair when used on

inspection lots of all sizes. Thus this

approach together with the large

individual package variations permitted

by the large MAV’s, permits reasonable

variations in the average net quantity of

contents. FDA is not aware of any

Federal, State, or local regulatory

officials that have ever attempted to

follow the production lot regulatory

approach that is suggested by the Task

Force. Most State regulations require

that the average of the ‘‘lot, shipment, or

delivery’’ meet or exceed the labeled net

contents (Ref. 3). In practice, all

inspection agencies at Federal, State,

and local government levels, including

FDA, inspect what is available for

inspection and do not determine what

might have originally comprised the

shipment or delivery. Even where the

same production lot codes are inspected

at the manufacturing plant, inspection

agencies focus only on the compliance

of the packages from which the sample

was taken, not whether the production

lot complied. This focus is necessary

because the sample will not necessarily

be taken from the entire production lot.

For example, as NIST pointed out, a

production lot may take hours to

package, and shipments of the earliest

packaged portions of that production lot

may be shipped before the entire lot has

been packaged. Thus, the entire

production lot may not be available for

inspection.

FDA therefore tentatively concludes

that it is appropriate for regulatory

action to be based solely on evaluations

of inspection lots. The agency

tentatively concludes that acting on this

basis is the only practicable way of

providing meaningful levels of

consumer protection from net quantity

violations. It would not be practicable to

require that industry hold a production

lot for a specified period of time. Such

a requirement would likely be a

significant hardship for firms, who

frequently must fill orders without

delay. Without such a requirement,

however, focusing on the production lot

could not provide any consumer

protection because such lots will likely

be distributed before the agency has an

opportunity to examine it.

vii. Proposed compliance procedures;

average requirements. Accordingly,

FDA is proposing in § 101.240 to adopt

the 1994 Handbook Category A

compliance procedures for average net

contents requirements. Most aspects of

the proposed compliance procedures are

taken directly from the 1994 Handbook,

although FDA has made a number of

nonsubstantive changes for clarity and

brevity. The proposed provisions

identify specifically when inspection

lots are to be classified as violative

because of average package errors in

weighing, measuring, or counting.

Again, the package error is the

difference between the measured net

quantity of contents and the labeled

quantity on the package.

As proposed, § 101.240 provides stepby-step instructions on how to calculate

the average package error, and, when

this average error is a negative value,

how to make adjustments in the average

error to determine whether the error is

sufficiently large to cause the inspection

lot from which the sample is taken to be

considered violative. Two adjustments

in the average error are provided for in

§ 101.240. One adjustment involves

calculation of the standard deviation

and using that value to calculate, as

discussed above, the highest possible

estimate of average net contents within

the inspection lot.

The other adjustment in the average

error involves making an allowance for

moisture loss that may have taken place

in the samples selected for measurement

(proposed §§ 101.240(b)(2) and

101.250). FDA is proposing in proposed

§ 101.250 to identify the extent to which

moisture loss affects these violative

findings. Under proposed

§ 101.240(b)(2), the appropriate

moisture allowance provided for the

specific food in § 101.250 is added to

the average package error after it has

been adjusted by the SEL.

viii. Exemption from average

requirements. NIST has advised FDA

(Ref. 3) that, for statistical reasons, the

compliance of an inspection lot

containing packages labeled in terms of

count of 50 items or less should not be

based on a determination of an average

count. NIST stated that their

statisticians have advised them that

normal distribution does not reliably

occur until counts exceed 50. NIST

explained that many packages labeled

by count, for example, ‘‘10 sticks’’ of

gum, do not have a normal distribution

around a mean value. This failure

derives from the fact that there are

either 10 sticks in a package of gum, or

there are fewer than 10 sticks (no matter

how rarely this might occur). The

package is constructed such that it

cannot hold 11 sticks. Because only

negative package errors can occur, it

will not be possible to obtain an average

net contents meeting the declared net

contents where any shortage in net

contents is present.

After the count exceeds 50 units,

however, there is no reason for package

construction to prevent positive package

errors, and average package counts may

reasonably be expected to meet labeled

packaged counts. For these reasons,

FDA is proposing an exemption in the

first sentence of § 101.240 for packages

labeled with net contents declarations of

50 or less units from average net

contents requirements. (The agency is

proposing to exempt packages with a

declaration in terms of count that are
Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules 9849

8See section 5.2, page 54, Handbook 133.

subject to proposed § 101.245(e) from

the average requirements of proposed

§ 101.240. Proposed § 101.245(e)

imposes requirements for declarations

in terms of count where the declaration

is 50 items or less.)

In view of the fact that an average

requirement would not be appropriate

for packages labeled in terms of a count

of 50 units or less, and the fact that

MAV’s are relatively crude measures of

unavoidable deviations, FDA is

concerned that some compliance

criterion be included in these

regulations for such packages to provide

adequate consumer protection.

NIST pointed out (Ref. 3) that the

1994 Handbook contains a unique

approach for dealing with this problem,8

and that this approach is valid even

though packages may not be subject to

package errors. For all sample sizes, the

1994 Handbook contains specific limits

on the number of packages in the

sample that may have any shortage. The

limits are: (1) For samples of 2 through

12 packages—no more than 1 package,

(2) For samples of 24 packages—no

more than 2 packages, and (3) For

samples of 48 packages—no more than

3 packages.

NIST suggested that FDA adopt the

1994 Handbook’s approach to this

problem. The presence in the Handbook

133 portion of the 1994 Handbook of the

same specific limits on the number of

packages in the sample that may have

any shortage in count indicates that the

suggested approach is an accepted

means of providing consumer protection

where net contents are in terms of

count, and the declared count is 50 or

fewer units. Its presence in Handbook

133 also evidences a long history of use

of the limits by State and local

regulatory agencies. Thus, FDA has

incorporated the suggested compliance

criteria into the proposed regulation.

Because the proposed compliance

criteria do not address average fill

requirements, FDA is proposing to

include them in § 101.245(e), the section

pertaining to the procedures for

individual packages, rather than in

§ 101.240, the section pertaining to

compliance procedures for average fills.

FDA requests comment on this

proposed approach.

b. Requirements pertaining to

individual package fills. As mentioned

above, the 1994 Handbook provides that

the variation of individual package

contents below the labeled quantity may

not be ‘‘unreasonably’’ large. The

handbook identifies ‘‘unreasonably’’

large errors through MAV’s, and the

handbook contains MAV’s for a wide

variety of package sizes.

NIST advised FDA (Ref. 3) that it

developed the MAV’s for NCWM in the

1970’s based on net contents tests of

thousands of samples of common

package sizes of food and nonfood items

that were labeled primarily by weight,

volume, or count. The tests were made

only on inspection lots whose average

net contents equaled or exceeded the

labeled net contents because NIST

believed that such lots were more likely

to have been packaged under GMP than

lots with average net contents below the

declared weight. NIST wanted to

identify MAV’s from data generated

using packages prepared in accordance

with GMP to avoid development of

unreasonably lenient individual

compliance criteria. NIST looked for

identifiable correlations between the

package sizes and amount of variation

from labeled net contents. NIST found

no such correlations, noting only that

the percent variation from labeled

contents appeared slightly larger with

smaller package sizes than with larger

package sizes.

In view of the lack of significant

identifiable correlations, NIST

developed MAV’s based on the data

available for each specific package size

tested. For each size, a variation was

derived that would be an MAV that

would encompass the largest variation

below the labeled quantity that an

individual package might be expected to

have 99 percent of the time. The specific

derivation of these MAV’s was complex,

but NIST developed them in a manner

that may be closely compared to the

procedure of prohibiting only those

deviations that are 3 standard deviations

or more below the labeled quantity (see

previous discussion of standard

deviation). NIST acknowledged (Ref. 3)

that development of MAV’s in this

manner resulted in crude measures of

unavoidable deviations, but it stressed

that such measures provide some

uniform control for unreasonably large

individual deviations. NIST stressed

that such control is preferable to no

control or to case-by-case evaluations of

the acceptability of each large

individual deviation. NIST also pointed

out that the crude nature of MAV’s is

offset by the fact that the primary tool

for protecting consumers in the 1994

Handbook is the principle that the

average net contents in the sample must

meet or exceed the label declaration.

NIST recommended (Ref. 3) that FDA

propose to adopt the MAV’s in the 1994

Handbook. One State agency, however,

asserted that Handbook 133 MAV’s are

too lenient, and that FDA should adopt

more stringent (i.e., smaller) values for

the MAV’s. The State submitted a list of

smaller MAV values for consideration

but did not provide evidence that these

MAV’s were developed using data

collected on a national basis, or that the

suggested values represent current

packaging practices.

FDA has considered that the original

data on which NIST based its MAV

values were collected in the 1970’s, and

that packagers have become more

sophisticated in their ability to reduce

packaging variations. The agency

recognizes that because MAV’s are

crude measures of unavoidable

deviations, it would be best if MAV’s

could be revised in accordance with

current technology in the food industry.

However, limited resources prevent

FDA from undertaking the extensive

studies needed to do so at this time.

Moreover, FDA does not believe that it

is appropriate to propose the tighter

MAV’s submitted by the State regulatory

agency in view of the lack of evidence

that these MAV’s would prove

practicable on a national level.

Further, FDA points out that the 1994

Handbook does, to some degree, make

the MAV’s more stringent than they

were in Handbook 133 before the 1994

revisions. Before the 1994 revisions,

Handbook 133 permitted differing

numbers of units to exceed the MAV’s,

depending upon the sample size, before

the product was deemed out of

compliance. The permitted numbers

varied from 0, for samples consisting of

30 or fewer units, to 7, for samples

consisting of 250 units. Handbook 133

provided that sample sizes of 50 units

were permitted 2 MAV’s. The 1994

Handbook permits no more than 1 MAV

for the largest sample sizes of 48 units.

Thus, the 1994 Handbook decreases by

at least 50 percent the maximum

number of MAV’s permitted to be found

in a sample.

Accordingly, the agency is proposing

in § 101.245(f), consistent with the

recommendation of NIST, to adopt the

MAV’s in the 1994 Handbook. However,

the agency is not proposing MAV’s for

count for packages with 50 or fewer

units because, as pointed out by NIST,

such MAV’s would serve no practical

purpose. For such packages, as

discussed previously, FDA is proposing

in § 101.245(e) that, if more than 1

package from a sample of 12 or less

contains less than the labeled count

where the inspection lot size is 250

packages or less; if more than 2

packages from a sample of 24 packages

contain less than the labeled count

where the inspection lot size is between

251 to 3200 packages; or if more than 3

packages from a sample of 48 packages

contain less than the labeled count
9850 Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules

where the inspection lot is more than

3200 packages, the inspection lot be

classified as violative.

c. Proposed compliance procedures;

individual requirements. As explained

above, FDA is proposing in § 101.245, to

adopt the 1994 Handbook Category A

compliance procedures for individual

weight requirements. FDA has taken

most aspects of the proposed

compliance procedures directly from

the 1994 Handbook. However, the

agency has made a number of

nonsubstantive changes for clarity and

brevity.

As proposed, § 101.245 provides stepby-step instruction on how to determine

the appropriate MAV for the labeled net

quantity of contents using the

appropriate table § 101.245(f) (i.e.,

Tables 1 and 2 for mass or weight,

Tables 3 and 4 for liquid or dry volume,

and Table 5 for count except where the

count is 50 units or fewer, where MAV’s

are not applicable). Where there are any

negative package errors and moisture

loss adjustments that are provided for in

§ 101.250, the errors are adjusted with

the appropriate allowance for that food

by adding the allowance to each of the

negative errors. For example, if the

labeled package size on a package of

frozen fruit is 2 lb, and a 1-percent

moisture loss allowance is permitted

under § 101.250, the MAV of 0.07 lb

from Table 2 is increased by adding 0.02

lb to give an adjusted MAV of 0.09 lb.

Once the MAV is determined,

proposed § 101.245(d) identifies those

situations in which the occurrence of

package errors larger than the MAV

cause the inspection lot to be violative.

Where an inspection lot is sufficiently

small that under proposed § 101.210(b),

the sample consists of less than 48

individual packages, proposed

§ 101.245(d)(1) provides that the sample

is violative if it contains any negative

package errors that exceed the MAV or

adjusted MAV, as appropriate, for the

labeled net quantity of contents. Where

an inspection lot is sufficiently large

that under proposed § 101.210(b), the

sample size consists of 48 individual

packages, proposed § 101.245(d)(2)

provides that the sample is violative if

it contains more than 1 negative package

error that exceeds the MAV or adjusted

MAV, as appropriate, for the labeled net

quantity of contents. As explained

previously in this preamble, the agency

is proposing limits on individual

package fills for packages with

declarations of net quantity in terms of

count that have 50 or fewer units in lieu

of average net quantity requirements.

Because these limits are more stringent

than any MAV limits would be, no

practical purpose would be served by

identifying MAV’s for such packages.

Consequently, the agency is proposing

in § 101.245(d)(1) that such packages be

exempt from the above violative MAV

criteria.

d. Impact of compliance procedures

on existing policy. FDA intends that the

procedures that it adopts as a result of

this rulemaking, if any, will supersede

FDA’s CPG 562.300 (formerly CPG

7120.19), which directs FDA field

personnel to consider regulatory action

where the average contents of the

subsamples is 1 percent or more short

weight. FDA intends to revoke the CPG

at the time that it publishes a final rule

in this proceeding.

e. Section 101.250, moisture loss—i.

Background. As mentioned previously

in this preamble, current FDA

regulations permit reasonable variations

for moisture loss but do not define

limits for such variations. The agency

has tried to deal with the issue of how

to define the limits on variations for

many years. FDA’s Quantity of Contents

Compendium contains the results of

studies that date back to the early 1940’s

to determine variations because of

moisture loss.

The agency attempted to use

information from its moisture loss

studies to establish limits for moisture

loss in its 1980 proposal (45 FR 53023,

August 8, 1980). However, there was

considerable opposition to that

proposal. Comments objected because

the proposed moisture loss allowances

were for only a small number of food

classes, because it would be very timeconsuming and expensive to develop

data to justify new allowances, and

because firms would have to overfill

packages until rulemaking was

completed. There was also concern that

any specific maximum moisture loss

provision might be taken by the

dishonest manufacturer as a license to

underfill down to the ‘‘legal’’ limit.

Because FDA was concerned that there

were significant problems with the

regulation that it proposed, and that

there could be considerable adverse

economic impact on the affected

industry, the agency did not issue a

final rule in this matter.

In 1988, NCWM attempted to deal

with this issue on a product by-product

basis by including in Handbook 133 its

‘‘gray area’’ approach. Under this

approach, any product found short

weight in excess of the ‘‘gray area’’ limit

would be subject to legal action. If the

product is found short weight but

within the ‘‘gray area’’ limit, the

inspecting agency would take additional

steps (such as comparing of laboratory

moisture determinations at the time of

sampling and at the time of pack from

quality control records) to determine

whether the product is short weight

because of underweighing at the time of

pack or because of ‘‘reasonable’’

moisture loss that occurred during

distribution.

The 1994 Handbook includes ‘‘gray

area’’ limits for two foods regulated by

FDA—flour and dry pet food (hereafter

referred to as ‘‘dry animal food’’). For

both products, the ‘‘gray area’’ limit is

3 percent. NIST advised FDA (Ref. 3)

that NCWM considered two approaches

in developing these limits. Under one

approach, products would be permitted

the maximum loss that could be

expected to occur throughout the shelf

life of the product. Under the other

approach, which was the one ultimately

adopted by NCWM, a lower, negotiated

limit would be established. For

example, some studies in dry regions of

the United States showed that flour and

dry pet food lose from 6- to 9-percent

moisture on store shelves. In more

humid regions of the United States,

some studies showed that these

products lose from 1- to 2-percent

moisture. NIST advised that the 3-

percent limits that were ultimately set

by NCWM were supported by the pet

food industry through the Pet Food

Institute and the flour industry through

the Millers National Federation.

FDA agrees with the NCWM approach

of establishing a limit on cognizable

moisture loss somewhere between the

maximum loss and the minimum loss

that occurs throughout the shelf life of

the product. It would not be practical to

establish a multiplicity of limits to

reflect the humidity swings that occur

in the different parts of the United

States throughout the seasons and from

year to year. Also, it would not be fair

to consumers in more humid areas of

the country to establish limits based on

losses in the driest areas of the country

(where the largest moisture losses

generally occur) because large

allowances for moisture loss would be

provided where very little losses would

occur given the high humidity. The

NCWM approach represents a rational

approach for dealing with moisture loss

in all areas of the United States. It

provides reasonable, but not total, relief

to the affected industry.

Even though FDA sees considerable

merit in the ‘‘gray area’’ approach in the

1994 Handbook, the agency does not

believe that it would be practicable for

it to adopt this approach. The agency

does not have authority under the act to

obtain the quality control records at the

point of pack to determine whether

underweighing actually takes place.

Moreover, limits for only two foods

have been established. Even though, as
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NIST has advised, limits are being

developed for rice and pasta, there are

simply too few limits established for

foods subject to moisture loss for this

approach to be viable at this time.

Accordingly, FDA is not incorporating

the ‘‘gray area’’ approach into this

proposal.

ii. The Proposed approach. While

FDA and some State and local agencies

attempt to make case-by-case

allowances for variations in moisture

loss, other State and local agencies take

the position that no allowances are

permitted because FDA has not

provided specific guidance concerning

appropriate allowances. Even though

the latter position is arguably not

consistent with section 403(e)(2) of the

act, it is not uncommon for regulatory

agencies to employ it (Ref. 3). In large

measure, the regulated industry appears

to have decided not to contest the lack

of allowances for moisture where

agencies have chosen not to permit such

allowances. Thus, firms shipping foods

subject to moisture loss to jurisdictions

that do not make allowances for such

loss may be incurring significant costs

from overfilling, or they may be being

subjected to regulatory action. Based on

these facts, FDA tentatively concludes

that the current case-by-case approach

to providing moisture loss variations

has not produced the type of consistent

results that are necessary to facilitate

interstate commerce.

Although the regulated industry

objected to FDA’s 1980 attempts to

define reasonable variations for

moisture loss, in view of the above

problems, industry response may be

more positive if a more practicable

approach is presented. FDA has

therefore revisited the possibility of

defining these variations and concluded

that it should again propose to define

what would constitute a reasonable

variation but with significantly more

flexibility than it proposed in 1980.

FDA’s tentative view is that it is

appropriate and practicable to establish

a regulatory approach for net contents

declarations that is tied to whether the

inspection takes place at the point of

manufacture or at some other location.

For inspections at the point of

manufacture, the agency is proposing

that measurements be made of the

accuracy of the net contents declaration.

Because inspections at the point of

manufacture would mean that there was

no opportunity for any moisture loss to

have taken place, no allowance for

moisture loss would be provided. Such

inspections would deter firms from

underfilling to the extent of the

allowances that FDA is proposing to

establish for inspections that occur

outside the plant.

The agency is proposing to establish

moisture loss allowances, similar to

those established by NCWM for flour

and dry animal food, that reflect

available moisture loss information. The

allowances will serve to guide all

affected parties about maximum

permissible moisture losses. State and

local regulatory agencies will be able to

use these allowances in conducting

inspections at both retail and wholesale

marketplaces. These allowances will

provide both the regulatory agencies

and the industry with objective

standards for determining whether an

inspection lot is violative. Thus, this

two pronged approach, which uses

standards tied to the place at which the

inspection occurs, will protect both

consumers and the regulated industry.

iii. At point of pack. FDA tentatively

concludes that, as a general rule, no

allowance for moisture loss is

reasonable at the point of manufacture.

Clearly, at the time that products come

off the production line, the contents

declaration should be accurate. At that

time, regulatory officials may reliably

determine whether firms are attempting

to take undue advantage of any moisture

loss allowance that has been

established.

However, regulatory officials may

often encounter product at the point of

pack that has been stored before

shipment to other locations. The agency

recognizes that allowances for moisture

loss are appropriate after some period of

storage. In view of the multiplicity of

foods that may be subject to moisture

loss and the agency’s limited resources,

however, it would be difficult for FDA

to establish minimum storage times for

each commodity before moisture loss

might affect the contents measurement.

FDA asked NIST how other regulatory

agencies have resolved this problem.

NIST advised the agency that a number

of European countries permit no

moisture loss within the first 7 days

following the end of the date of pack

(Ref. 3) and recommended that FDA

adopt a similar approach. Because NIST

believes that this European approach

has merit, the agency has provided in

the proposed § 101.250(a)(1) that no

allowance for moisture loss will be

made if the food (other than a fresh

bakery product for reasons discussed

subsequently in this preamble) is

weighed within 7 days following the

end of the day of pack.

However, a number of comments on

the 1980 proposal pointed out that fresh

bakery products may suffer moisture

loss within a very short time after

production, and that such products

often have a short shelf life (often as

little as 3 to 5 days). As a result, FDA

tentatively concludes that fresh bakery

products should not be subjected to the

7-day no moisture loss rule at point of

pack. The agency is therefore proposing

to permit no moisture loss only within

1 day following the end of the day of

pack for fresh bakery products in

§ 101.250(a)(2). Bakery products other

than fresh baked breads, buns, rolls, and

muffins will, as proposed, be subjected

to the 7-day no moisture loss rule at

point of pack. The agency solicits

comments about the impact of proposed

§ 101.250(a)(2) for bakery products.

In proposed § 101.250(b), FDA is

providing that after one day, fresh baked

breads, buns, rolls, and muffins would

still be in compliance if they lost 1

percent of their moisture. This

allowance is based on data submitted in

response to the 1980 proposal.

In proposed § 101.250(c), FDA is

permitting a 3-percent moisture loss for

these products after 7 days following the

end of the day of pack. This proposed

allowance is based on the data available

from NIST (see discussion below). FDA

is proposing to permit a similar

moisture loss for dry animal food (see

§ 501.105(g)).

NIST advised that there may be many

other foods that also suffer moisture loss

within very short time periods after

production, and that such products also

have a short shelf life. Further, NIST

advised that the 1-day period may be

too rigid for some fresh bakery products.

NIST was not able to identify these

products but did suggest an alternative

approach that it considered practicable

and that could justify allowance of

moisture loss on a more specific product

basis at the point of pack or any other

storage location. The approach that

NIST suggested involved moisture loss

data collection at the manufacturing

plant followed by storage for specific

time periods in specific locations and by

measurements of the net quantity of

contents (Ref. 3).

According to NIST, the collection

could take place on a daily basis under

environmental conditions similar to

those that exist where the packages

under inspection are stored (e.g., if the

product is typically placed in a sealed

case on a pallet and shrink wrapped, the

control lots would be stored under those

conditions, rather than under laboratory

conditions). NIST suggested that the

data be based on at least 3 control lots,

with each lot consisting of at least 12

randomly selected individual packages

that are collected on the same day, and

consisting of at least 48 randomly

selected individual packages in the 3

lots combined. NIST advised that
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individual packages should be weighed

upon collection and then daily (or

hourly in the case of rapid dramatic

moisture loss) throughout the duration

of the study. The moisture loss

allowance should be calculated with a

97-percent level of confidence.

NIST pointed out also that where

moisture loss varies with climatic

changes in environmental conditions,

the data should be collected at an

appropriate time to justify a finding of

moisture loss. For example, where an

inspection is made of current

production at a food processing plant in

the middle of July, and moisture loss

varies significantly from winter to

summer, data collected in January

cannot be relied on to establish or

calculate moisture loss during the

inspection.

FDA agrees that the proposed rule

should permit firms to gather

justification for more specific moisture

loss allowances where firms believe that

it would be in their best interest to do

so. Accordingly, FDA is proposing in

§ 101.250(d) to permit firms to

determine more specific allowances in

the manner suggested by NIST. As

proposed, these allowances would not

be limited to the point of pack if firms

wish to gather data to demonstrate that

allowances are justified at other

locations. FDA is proposing that the

data to support an allowance be

gathered in the manner suggested by

NIST and described above.

iv. Other than point of pack. FDA has

reexamined all old moisture loss data

that it has collected to determine which

commodities may be subject to moisture

loss and the amount of loss that might

be expected. Most of this data appears

in FDA’s Quantity of Contents

Compendium (Ref. 11) which contains a

variety of data collected from the 1920’s

through the 1970’s. The agency also

consulted with NIST about which

commodities have come to the attention

of State and local agencies because of

moisture loss. Moisture loss has been

identified with flour, pasta, rice, cheese

and cheese products, dried fruits and

vegetables, fresh and frozen fruits and

vegetables, coffee beans, and bakery

products (Ref. 3). Of all of these

commodities, the extent of moisture loss

variations is best known for flour. In

fact, very little is known about the

extent of moisture loss for most of the

other commodities. However, because of

NCWM’s work, considerable reliable

data support an allowance limit of 3

percent for flour (as well as dry animal

food) (Ref. 12).

For other commodities, data are

considerably less dependable, either

because of the age of the studies for the

commodities or because of the limited

scope of the studies. In its 1980

proposal, FDA proposed to establish an

allowance of 1 percent for frozen fruits

and frozen vegetables in certain

packaging based on data in the Quantity

of Contents Compendium. NIST advised

(Ref. 3) that representatives of the frozen

food industry believe that a 1-percent

allowance for that industry is

reasonable. Also, a comment on the

1980 proposal from a trade association

representing the bakery industry stated

that fresh bread, buns, and rolls are

subject to a moisture loss of only about

1 percent. FDA is therefore proposing a

new § 101.250(b) to provide a 1-percent

allowance for frozen fruits and

vegetables when they are weighed more

than 7 days following the end of the day

of pack, and for fresh bread, buns, and

rolls when they are weighed more than

1 day, but less than 7 days, following

the end of the day of pack.

Except for flour, dry animal food,

frozen fruit and vegetables, and fresh

bread, buns, and rolls, FDA is not aware

of data that would permit the agency to

estimate specifically what allowances

should be provided for each of the other

commodities identified as undergoing

moisture loss during distribution. Some

data were submitted in 1980 that

showed moisture losses for other

products of as high as 20 percent, but

the person submitting these data stated

that, in the studies in which the data

were derived, the packaging of the

products had been punctured to permit

moisture loss. FDA advises that such

deviations from actual marketing

conditions make these studies of

dubious value.

However, because NIST has

thoroughly evaluated the need for

allowances in one major food

commodity (i.e., flour, Ref. 12) and has

concluded that a significant moisture

loss allowance must be provided, and

because, as explained above, many other

food commodities also need some

allowance for moisture loss, the agency

tentatively finds that it must take some

action to establish allowances for those

commodities that are subject to moisture

loss problems until sufficient data are

provided by the affected industries.

Accordingly, FDA is proposing in

§ 101.250(c) that the commodities that it

identified above as undergoing moisture

loss during distribution be provided

with the same 3-percent allowance that

it is proposing for flour more than 7

days following day of pack.

The proposed allowance is a crude

estimate of reasonable variations for

commodities other than flour. FDA’s

tentative view is that the allowance is

not too lenient because packers are

subject to inspection at the point of

pack. The agency recognizes, however,

that point of pack inspection of foreign

firms may not be likely. Thus it hopes

that, during the comment period,

interested parties will develop and

submit data on which it can establish

reliable moisture loss allowances. The

agency suggests that firms interested in

developing such data work closely with

NCWM, which has expertise in this

area.

Nonetheless, some restriction on the

proposed allowances for moisture loss

seems warranted based on the type of

packaging. Certainly, no allowance

should be made where the food is

packaged in an air tight container (e.g.,

cans, glass bottles, food enclosed in

paraffin). FDA is therefore proposing

that foods in such containers will not be

permitted any moisture allowance

(§ 101.250(a)(4)). Further, the agency is

proposing that if the food is not subject

to moisture loss, no allowance is

permitted (§ 101.250(a)(3)).

C. Oysters

The traditional method of sale for

packaged raw oysters out of the shell

(‘‘shucked’’) is by fluid volume

(consumer-sized packages are sold by

the pint) rather than by drained weight.

Given this traditional trade practice, to

facilitate value comparisons, FDA

tentatively concludes that it needs to

establish a limit on the amount of free

liquid in packages of oysters. Without

such a limit, poor manufacturing and

packaging practices may result in

excessive water in shucked oyster

packages. NIST explained that shucked

oysters sold by fluid volume are often

packed by methods that can introduce

excessive water into the package (Ref.

3). For example, water may be

introduced by:

(1) Storing the shucked oysters in an

ice slush before packing;

(2) Cleaning the shucked oysters for a

several-hour period with aerated water;

and

(3) Not draining the oysters as they

are being placed in the package; or

(4) Adding the oysters to containers

that already have water in them.

NIST advised that NCWM has found

that these practices are widespread and

particularly prevalent in the warmer

months (Ref. 3). NIST pointed out that

without enforceable controls on the

amount of free liquid in the containers,

only continuous inspection could

practicably control these practices.

NIST stated that commercial oyster

buyers often specify a minimum net

weight for oysters in an attempt to

control poor packaging practices (e.g.,

some buyers specify a ‘‘4-pound gallon’’
Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules 9853

9Section 1.5.2.3. of the Uniform Method of Sale

of Commodities Regulation.

or a ‘‘6-pound gallon,’’ meaning there

has to be 4 or 6 lbs of oysters in a

gallon). However, the packages are not

marked as to the amount of solids.

In addition, packages that have more

fluid and less solids cannot be visually

identified, even when sitting side-byside with packages containing

significantly lesser amounts of free

liquid. Studies conducted by the

Virginia Department of Agriculture have

shown that observers could not identify

packages that contained only 15-percent

free liquid from those that contained 60

percent (Ref. 3). (NIST stated that

although NCWM recognizes that other

similar shellfish products (e.g., scallops)

may have similar problems as oysters, it

was not aware that adequate studies

have been performed to justify

establishing a limit on the amount of

free liquid in packages of those

products.)

Although FDA limits the amount of

free liquid in packaged raw oysters to 5

percent § 161.130(c)(2)(ii) (21 CFR

161.130(c)(2)(ii)), this limit can only be

enforced at the packing plant. As a

result, for many years there has been a

significant void in surveillance

activities concerning the free liquid

requirement. Seafood trade associations

have advised FDA that, although

western U.S. oysters have low amounts

of free liquid, southeastern U.S. oysters

typically have between 5- and 15-

percent moisture (Ref. 3). Retail market

studies conducted by State weights and

measures agencies over a 2-year period

in 1989 and 1990 at the request of

NCWM found that packagers could meet

a 15-percent limit in free liquid (Ref. 3).

NIST has advised that, in 1991,

NCWM adopted a standard of fill for

fresh oysters that are removed from the

shell that limits the free liquid to 15-

percent by weight (Ref. 3).

For this reason, NCWM adopted the

15-percent criterion 9 to limit the free

liquid to a reasonable and specific level.

NIST recommends (Ref. 3) that, for

national uniformity, FDA revise its

regulations to permit no more than 15-

percent free liquid in shucked oysters.

FDA tentatively agrees with the

recommendation of NIST that a 15-

percent criterion should be established.

Accordingly, the agency is proposing to

add this limit to the standard of identity

for oysters in § 161.130(d).

In addition, FDA is aware that the

names for the species of oysters

currently identified in § 161.130 are

outdated (i.e., Ostrea gigas, O. virginica,

and O. lurida). These names need to be

revised to maintain consistency with

accepted scientific nomenclature set

forth in American Fisheries Society

Special Publication 16, ‘‘Common and

Scientific Names of Aquatic

Invertebrates From the United States

and Canada: Mollusks’’ (Ref. No. 13). In

that publication, the respective

scientific names of these species names

appear as ‘‘Crassostrea gigas, C.

virginica, and Ostreola conchaphila.’’

FDA is therefore proposing to revise

§ 161.130 to reflect the updated

nomenclature. FDA emphasizes that this

proposed change will not have any

substantive impact on the food standard

for oysters. The proposed change does

not change the oyster species covered by

§ 161.130.

VII. The Impact on Other Rulemaking

Proceedings

FDA points out that, in the Federal

Register of May 21, 1993 (58 FR 29716),

and December 21, 1993 (58 FR 67444),

it proposed revisions to § 101.105 to

accommodate new statutory

requirements for declaration of net

contents in metric units and to

reorganize existing provisions of

contents labeling provisions for clarity.

Except for redesignating § 101.105 as

§ 101.200 and the specific changes

proposed in this document, FDA does

not intend that the earlier proposals be

affected by this rulemaking. Because the

earlier proposals initiated a

reorganization of § 101.105, the actual

location in new § 101.200 of the

proposed provisions may differ from

that identified in this proposal.

Although FDA is not addressing the

changes initiated in the May 21, 1993,

and December 21, 1993, proposals in

this preamble, the agency points out

that it proposed to change the headings

of all quantity of contents regulations

from ‘‘Declaration of net quantity of

contents when exempt’’ to ‘‘Declaration

of net quantity of contents.’’ Thus, any

confusion about ‘‘when exempt’’ in the

heading of proposed §§ 101.200 and

501.105 will be addressed in rulemaking

based on the May 21, 1993, and

December 21, 1993, proposals.

VIII. Animal Products

As mentioned in section VI.A. of this

document above, FDA considers it

logical to continue to have the same

requirements for human and animal

food with respect to declarations of net

quantity of contents. The agency sees no

reason to reiterate all of the same

provisions in both parts 101 and 501

when it can cross-reference those

provisions in part 101 that pertain to net

contents in part 501. To that end, the

agency is proposing to revise § 501.105

in the same manner as it is proposing to

revise § 101.200 (current § 101.105) and

to cross-reference all remaining changes.

In addition, as stated in section VI.A. of

this document, FDA is proposing to

define ‘‘dry animal food’’ in proposed

§ 501.105(u).

However, FDA is proposing one

difference in how quantity of contents is

declared on human and animal food.

The difference pertains to whether, for

an animal food packed in liquid with a

net contents declaration in terms of

weight, the liquid should be included in

the net weight declared. For human

food, FDA is proposing in § 101.220(c)

procedures for measuring drained

weight. The focus on drained weight

derives from the provisions of the act on

nutrition labeling and, specifically, on

serving size, which focuses on the

amount of food customarily consumed.

There are no equivalent provisions in

the animal food labeling regulations.

Section 403(q) of the act, on nutrition

labeling, only applies to food intended

for human consumption. In view of the

lack of such a reference regulation, and

the fact that FDA knows of no need to

address requirements concerning liquid

packing media in animal food, FDA is

not proposing a parallel provision on

drained weight in § 501.105.

The accuracy provisions for animal

food regulations are slightly different

from the provisions in proposed

§ 101.200 for human food because of the

previously discussed differences in the

proposed animal and human food

provisions. Instead, proposed § 501.105

excepts provisions of § 101.200 from

incorporation with the rest of subpart H

of part 101. Because proposed § 501.105

contains all the provisions of proposed

§ 101.201, FDA is also not incorporating

the latter provision in § 501.105.

IX. Analysis of Impacts

FDA has examined the economic

implications of the proposed rule as

required by Executive Order 12866 and

the Regulatory Flexibility Act (5 U.S.C.

601–612). Executive Order 12866 directs

agencies to assess all costs and benefits

of available regulatory alternatives and,

when regulation is necessary, to select

the regulatory approach which

maximizes net benefits (including

potential economic, environmental,

public health and safety effects;

distributive impacts; and equity).

Executive Order 12866 classifies a rule

as significant if it meets any one of a

number of specified conditions,

including having an annual effect on the

economy of $100 million or adversely

affecting in a material way a sector of

the economy, competition, or jobs, or if

it raises novel legal or policy issues. If

a rule has a significant impact on a
9854 Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules

substantial number of small entities, the

Regulatory Flexibility Act requires

agencies to analyze options that would

minimize the economic impact of the

rule on small entities. FDA finds that

this proposed rule is not a significant

rule as defined by Executive Order

12866. The agency acknowledges that

some provisions of this rule may have

significant impact on a substantial

number of small entities. Finally, the

agency, in conjunction with the

administrator of the Office of

Management and Budget (OMB), finds

that this is not a major rule for the

purpose of congressional review (Pub. L.

104–121).

A. The Compelling Public Need for a

Regulation

FDA is proposing this rule in order to

establish specific procedures for

checking conformance to net contents

labeling requirements. As discussed

previously in this preamble, the

preemptive nature of regulations

pertaining to net contents results in

these procedures being the only ones

that State and local jurisdictions can

adopt if they decide to ensure the

accuracy of net contents declarations.

State and local jurisdictions are likely to

bring a degree of rigor to enforcement of

these standards that reflects the

preferences of the populations that they

represent. However, there is no reason

to believe that consumers in different

jurisdictions have different preferences

about the specific statistical methods for

determining conformance to net

contents labeling requirements. Further,

to the extent that FDA defines

‘‘reasonable variations’’ in its

regulations, the affected industry will

know at what point contents deviations

would be considered violative. Such

knowledge should help firms to reduce

overfilling of packages and facilitate

interstate commerce by making the

establishment of more uniform target fill

levels practicable for all package sizes.

Currently food packagers selling food in

interstate commerce must meet different

standards for determining quantity of

fill in different jurisdictions, depending

on the analytical method of determining

compliance used in each jurisdiction.

FDA is proposing to establish provisions

to remedy this situation.

B. Costs

Because the requirements in this

proposed rule would allow industry to

reduce overfilling of package contents,

the agency believes that, except possibly

for the amendment to the oyster

standard discussed in section VIII.B. of

this document, this proposal will cause

no compliance costs to be incurred by

industry. To the extent that this

proposal will preempt the current

activities of State and local agencies,

these entities may incur some costs of

switching to the new method of

determining compliance with these fill

rules. For example, some State and local

agencies may need to retrain some

inspectors.

FDA has no information on the

potential need for retraining or the costs

of retraining. However, the agency

believes these costs will be small

because the measures that FDA is

proposing are generally consistent with

those of NCWM, which are used by

most of the States.

The agency is proposing to amend the

standard of identity for oysters to limit

the amount of free liquid to 15 percent.

The agency has no data on the extent to

which shellfish shippers pack oysters

with more than 15-percent free liquid.

However, the agency believes that this

does not occur frequently, and that the

cost of complying with the proposed

standard will be small. This conclusion

is based on information from NIST

stating that, because NCWM adopted a

15-percent free liquid standard, there

have been no reports of widespread

complaints about the moisture content

of shucked oysters. The agency requests

comment on the cost complying with

this proposed standard.

C. Benefits

An important benefit of this proposed

rule is in establishing a uniform

standard for determining compliance

with accuracy requirements for net

contents declarations across the national

food market. A food packager

considering entering a market in a State

different from those to which it

currently ships will not need to be

concerned with determining whether it

will need to adjust the degree to which

it fills its packages. The same standard

will apply in all States. Another benefit

may be to consumers of food in single

serving packages. In using the nutrition

information on the nutrition labels,

consumers will have information that

more accurately reflects the actual

contents of the package if the degree of

package overfill is reduced.

D. The Initial Regulatory Flexibility

Analysis

If finalized, this rule will establish a

national standard for enforcing net

contents declarations. Given that the

standard for net contents declarations

that FDA is proposing, except possibly

for the amendment to the oyster

standard discussed in section VIII.D. of

this document, will impose no

compliance costs on industry, the

agency believes that there will be no

significant impact from these provisions

on a substantial number of small

businesses. However, because there is

some uncertainty related to the costs of

compliance, FDA is voluntarily doing

this Initial Regulatory Flexibility

Analysis. The agency requests

comments on its judgment.

The only provision of this proposed

rule that may have a significant impact

on a substantial number of small

businesses is the proposed amendment

of the standard of identity for shucked

oysters, which, if adopted, will establish

a ceiling on the amount of free liquid at

15 percent by mass or weight. There are

approximately 400 shellfish shuckingpacking or repacking plants in the

United States on the Interstate Certified

Shellfish Shippers List (ICSSL) for

November 1995. There are

approximately 100 foreign shellfish

shucking-packing or repacking plants

that ship to the United States on the

ICSSL for the same period. With few

exceptions, these are single plant

businesses, and all of the businesses

have fewer than 500 employees. The

agency has no data on the extent to

which shellfish shippers pack oysters

with more than 15-percent free liquid.

However, it seems likely that excessive

filling with free liquid does not occur

frequently based on information from

NIST stating that since NCWM adopted

a 15-percent free liquid standard, there

have been no reports of widespread

complaints about the moisture content

of shucked oysters. The agency requests

comment on the impact of this

provision on small shellfish shippers.

FDA has several alternatives to the

proposed limit of 15-percent free liquid

by mass or weight for shucked oysters.

The agency could establish a lower limit

or a higher limit. Shellfish shippers

have a cost incentive to ship the

maximum allowable amount of free

liquid in shucked oysters. Therefore, the

higher the limit set by regulation, the

more free liquid packages will contain.

For this reason, the agency wants to

avoid setting an unnecessarily high

limit on free liquid. The agency requests

comment on the impact of various limits

on free liquid on small shellfish

shippers.

Another approach could be to require

label declaration of the percent free

liquid, by mass or weight, in the

package. The advantages of such a

policy are: (1) That the standard is less

prescriptive, (2) that consumers are

informed by the label as to the amount

of free liquid in the package, and (3) that

processors are not penalized for

shipping packages with less free liquid

than their competitors, but instead they
Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules 9855

are given an incentive to reduce the

amount of moisture in the package. The

disadvantages of such a policy are: (1)

That frequent label changes may be

necessary to accurately label packages

where the amount of free liquid varies,

(2) that the process of measuring the

amount of free liquid with enough

frequency to ensure that the packages

are labeled accurately may be costly,

and (3) that it permits what many

consider to be a deceptive practice to

continue. The agency requests

comments and suggestions on

alternatives to the proposed limit of 15-

percent free liquid by mass or weight.

X. The Paperwork Reduction Act of

1995

FDA tentatively concludes that this

proposed rule contains no reporting,

recordkeeping, or other third party

disclosure requirements. Thus, there is

no ‘‘information collection’’

necessitating clearance by the Office of

Management and Budget. FDA

tentatively concludes that the moisture

loss study described in section 101.250

would generally not be presented to the

agency unless, during the course of an

investigation, questions have been

raised about underfill. Thus the

moisture loss study would be exempt

from Paperwork Reduction Act (PRA)

requirements under 5 CFR 1320.4. To

ensure the accuracy of this tentative

conclusion, FDA is asking for comment

on whether this proposed rule to

establish procedures for determining

whether label net quantity of content

statements are accurate imposes any

paperwork burden.

XI. Environmental Impact

The agency has determined under 21

CFR 25.24(a)(11) that this action is of a

type that does not individually or

cumulatively have a significant effect on

the environment. Therefore, neither an

environmental assessment nor an

environmental impact statement is

required.

XII. References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday

through Friday.

1. U.S. Department of Commerce, National

Bureau of Standards, ‘‘NBS Handbook

133-Third Edition,’’ ‘‘Checking the Net

Contents of Packaged Goods;’’

Supplement, September 1990; Suppl. 2,

October 1991; and Suppl. 3 October

1992; U.S. Government Printing Office,

Washington, DC, 20402–9325.

2. NIST Handbook 133, 3d ed., Supplement

4, U.S. Government Printing Office,

Washington, DC, 20402–9325, October

1994.

3. NIST letter to FDA, December 12, 1996.

4. NIST Handbook 44, ‘‘Specifications,

Tolerances and Other Technical

Requirements for Weighing and

Measuring Devices’’, October, 1994.

5. NBS Handbook 145, Handbook for the

Quality Assurance of Metrological

Measurements, Superintendent of

Documents, U.S. Government Printing

Office, Washington DC 20402, November

1986.

6. Specifications and Tolerances for

Reference Standards and Field Standard

Weights and Measures, Specifications

and Tolerances for Field Standard

Stopwatches (undated).

7. American Society of Mechanical Engineers

Voluntary Standard Designated as ASME

B89 1.14.

8. American Society of Testing and Materials

Standard specification E 617–91,

Standard Specification for Laboratory

Weights and Precision Mass Standards.

9. Fuller, Wayne A., Sample and Surveys,

American Mathematical Society Short

Course on Modern Statistics: Methods

and Application, San Antonio, TX, pp. 1

to 18, 1980.

10. United Kingdom, Department of Trade,

‘‘Code of Practical Guidance for Packers

and Importers, Weights and Measures

Act,’’ Issue No. 1, pp. 10 to 12, 1979.

11. ‘‘Quantity of Contents Compendium,’’

June 1966.

12. NBS Special Publication 734, ‘‘Report of

the 72d National Conference on Weights

and Measures,’’ pp. 63 and 64, 83 and

84, 141, and 148 to 157, 1987.

13. American Fisheries Society Special

Publication 16, ‘‘Common and Scientific

Names of Aquatic Invertebrates From the

United States and Canada: Mollusks.’’

List of Subjects

21 CFR Part 101

Food labeling, Incorporation by

reference, Nutrition, Reporting and

recordkeeping requirements.

21 CFR Part 161

Food grades and standards, Frozen

foods, Seafood.

21 CFR Part 501

Animal foods, Labeling, Packaging

and containers, Reporting and

recordkeeping requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, it is proposed that

21 CFR parts 101, 161, and 501 be

amended as follows:

PART 101—FOOD LABELING

1. The authority citation for 21 CFR

part 101 continues to read as follows:

Authority: Secs. 4, 5, 6 of the Fair

Packaging and Labeling Act (15 U.S.C. 1453,

1454, 1455); secs. 201, 301, 402, 403, 409,

701 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 331, 342, 343, 348, 371).

2. New Subpart H (consisting of

§§ 101.200 through 101.250) is added,

§ 101.105 of subpart G is redesignated as

§ 101.200 of new subpart H, and newly

redesignated 101.200 is amended by

revising the section heading, paragraphs

(a) and (b), and by removing and

reserving paragraph (q), to read as

follows:

Subpart H—Net Quantity of Contents

Sec.

101.200 Declaration of net quantity of

contents.

101.201 Accuracy of net quantity

declaration.

101.205 Definitions.

101.210 Sample collection.

101.215 Measuring equipment.

101.220 Analytical procedures, net mass or

weight.

101.225 Analytical procedures, volume.

101.230 Analytical procedures, count.

101.235 Tare determination.

101.240 Compliance procedures; average

requirement.

101.245 Compliance procedures; maximum

variations.

101.250 Maximum allowance for moisture

loss.

Subpart H—Net Quantity of Contents

§ 101.200 Declaration of net quantity of

contents.

(a) The principal display panel of a

food in package form shall bear a

declaration of the net quantity of

contents. This declaration shall be

expressed in the terms of weight,

measure, numerical count, or a

combination of numerical count and

weight or measure. If the food is liquid

the declaration must be expressed in

terms of fluid measure. If the food is

solid, semisolid, or viscous, or a mixture

of solid and liquid the declaration shall

be expressed in terms of weight. If the

food is a fresh fruit, fresh vegetable, or

other dry commodity that is customarily

sold by dry measure the declaration

statement may be expressed in terms of

dry measure. Except as provided for in

§ 101.12, a food that is packed or canned

in liquid, and is required to bear a

contents declaration in terms of weight,

shall bear a declaration expressed in

terms of the total net contents including
9856 Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules

the liquids. Where the reference amount

in § 101.12 is declared in terms of

drained solids, the contents declaration

shall be in terms of drained weight. If

the food is packaged in a selfpressurized container, the statement

shall be in terms of the mass or weight

of the food and the propellant that will

be expelled when the instructions for

use as shown on the container are

followed. If there is a firmly established

general consumer usage or trade custom

of declaring the contents of a liquid by

weight, or a solid, semisolid, or viscous

product by fluid measure, it may be

used. Whenever the Food and Drug

Administration determines that an

existing practice of declaring net

quantity of contents by weight, measure,

numerical count, or a combination in

the case of a specific packaged food

does not facilitate value comparisons by

consumers and offers an opportunity for

consumer confusion, it will by

regulation designate the appropriate

term or terms to be used for such

commodity.

(b)(1) Statements of weight shall be in

terms of avoirdupois pound and ounce.

(2) Statements of fluid measure shall

be in terms of the U.S. gallon of 231

cubic inches and quart, pint, and fluid

ounce subdivisions thereof.

(3) Statements of dry measure shall be

in terms of the U.S. bushel of 2,150.42

cubic inches and peck, dry quart, and

dry pint subdivisions thereof.

* * * * *

§ 101.201 Accuracy of net quantity

declaration.

(a) In making volume measurements,

the measurement shall be made:

(1) In the case of frozen food that is

sold and consumed in a frozen state, at

¥18 °C (0 °F);

(2) In the case of refrigerated food that

is sold in the refrigerated state, at 4 °C

(40 °F); and

(3) In the case of other foods, at 20 °C

(68 °F).

(b) The declaration of net quantity of

contents shall provide an accurate

statement of the quantity of contents of

the package. For purposes of this

section, an accurate statement is one

that conforms to all requirements for the

declaration set forth in this subpart.

Sections 101.240, 101.245, and 101.250

of this subpart describe what constitutes

a reasonable variation in net content

declarations that is the result of loss or

gain of moisture during the course of

good distribution practice or by

unavoidable deviations in good

manufacturing practice. All net contents

measurements shall be made in

accordance with the procedures and

methodology set forth in this subpart.

Any net quantity of contents

declarations that overstate the amount

of product in the container by an

amount that is more than that can be

attributed to a reasonable variation

under these regulations will misbrand

the product under section 403(e) of the

Federal Food, Drug, and Cosmetic Act.

§ 101.205 Definitions.

For the purposes of this subpart the

following definitions apply:

(a) Drained mass or weight means the

mass or weight of solid or semisolid

food representing the contents of a

package obtained after a prescribed

method for removal of the liquid has

been employed.

(b) Dried used tare means the mass or

weight of a container, wrapper, or other

material (e.g., glazing on frozen seafood)

that is deducted from the gross mass or

weight of a package to obtain the net

mass or weight. The tare mass or weight

comprises all packaging materials

(including glue, labels, ties, etc.) that

contain or enclose a food, as well as all

packaging materials (including prizes,

gifts, coupons, decorations, etc.) that are

not part of the food. The food is

removed from the tare by washing,

scraping, wiping, ambient air drying,

and other techniques involving more

than ‘‘normal’’ household recovery

procedures, but not including such

laboratory procedures as oven drying.

(c) Gravimetric test procedure means

an analytical procedure that involves

measurement by mass or weight.

(d) Gross mass or weight means the

combined mass or weight of the package

including its contents, packing

materials, labels, etc.

(e) Inspection lot means the collection

of packages from which the sample is

collected that consists of the same food,

with the same label (but not necessarily

the same lot code, or in the case of

random content packages the same

actual quantity), from the same packer.

(f) Maximum allowable variation

(MAV) means the value of the largest

deviation of net quantity of contents

below the labeled declaration of net

quantity of contents that, where the

sample consists of less than 48

individual units, is reasonable for any

individual unit, or, where the sample

consists of 48 units, is reasonable for

any more than one individual unit.1

(g) Net quantity of contents means

that quantity of packaged food (e.g., in

terms of mass or weight, volume, or

numerical count) remaining after all

necessary deductions of the tare mass or

weight from the gross mass or weight.

(h) Net mass or weight means the

mass or weight of solid or semisolid

food plus any liquid that accompanies

the food.

(i) Package error means the difference

between the measured net quantity of

contents of an individual package and

the declared net quantity of contents on

the package label. When the individual

package contains less net contents than

the declared net contents, the difference

is referred to as the ‘‘negative package

error.’’

(j) Random sample means that every

package in the lot has an equal chance

of being selected as part of the sample.

(k) Range means the difference

between the largest value and the

smallest value in any set of numbers.

(l) Reference temperature means the

temperature at which the fill of a food

sold by volume must meet the declared

net quantity of contents.

(m) Sample means a random sample

of a group of packages taken from a

larger collection of packages and

providing information that can be used

as a basis for making a decision

concerning the larger collection of

packages or of the package production

process.

(n) Sample size means the number of

packages in a sample.

(o) Sample standard deviation (s)

means a statistic used as a measure of

dispersion (i.e., differences of

individual values from the mean) in a

sample. It is calculated as follows:

s=(Σ(xi¥x)2/(n¥1))1/2 or equivalently

(and primarily for calculations

without a computer),

s=((Σxi

2¥(Σxi)2/n)/(n¥1))1/2.

Where:

Σ means ‘‘the sum of,’’

xi means the ith individual package

error,

n means the sample size, and

x means the average of the package

errors, that is, the sum of the

package errors divided by the

number of packages in the sample.

(p) Sample error limit (SEL) means a

statistical value that allows for the

uncertainty between the average error

for the sample and the average error for

the inspection lot with a 97-percent

level of confidence. It is computed by

multiplying a factor appropriate for the

sample size (found in column 2 of Table

1, of § 101.240) times the sample

standard deviation.

(q) Tare sample means the packages

selected for use in determining the

average used tare mass or weight.

(r) Total tare sample size (nt), means

the number of packages used to

determine the average used tare mass or

weight.

(s) Volumetric measure means a

measuring device for use in the
Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules 9857

measurement of volumes of liquids (e.g.,

standard measuring flasks, graduates,

cylinders, etc.).

§ 101.210 Sample collection.

The following procedures shall be

used to collect samples for determining

the net quantity of contents of packaged

food:

(a) Determine the number of packages

in the inspection lot;

(b) Find the inspection lot size in

column 1 of Table 1 of this section, and

determine the appropriate sample size

from column 2 of Table 1; and

TABLE 1.—SAMPLING PLANS

Column 1

inspection lot size

Column 2

sample size

11 packages or less .............. All packages.

12 to 250 packages ............... 12 packages.

251 to 3,200 packages .......... 24 packages.

More than 3,200 packages ... 48 packages.

(c) Select a random sample of the

packages from the inspection lot.

§ 101.215 Measuring equipment.

(a) Thermometer selection.

Graduations on a thermometer shall be

no larger than 1 °C (2 °F).

(b) Linear equipment selection. (1) A

tape or ruler used to measure

dimensions of 63.5 centimeter (25

inches) or less shall be at least as long

as the distance to be measured and

flexible enough for the measurement

and shall have a minimum graduation of

0.5 millimeter (or 1⁄64 inch) or less.

(2) A tape or ruler used to measure

dimensions of more than 63.5

centimeters (25 inches) shall be at least

as long as the distance to be measured

and flexible enough for the

measurement and shall have a

minimum graduation of 2 millimeters

(1⁄16 inch).

(c) Volumetric equipment selection.

Volumetric equipment shall meet the

following requirements:

(1) A volumetric measure used in

fluid volumetric determinations shall be

of such size with respect to the labeled

net quantity of contents of the package

that no volume less than 25 percent of

the maximum capacity of the volumetric

measure is measured; and

(2) Have graduations that are not

greater than 1⁄6 of the maximum

allowable variation (MAV) for the

labeled net quantity of contents of the

package being measured.

(d) Gravimetric equipment selection.

Gravimetric equipment shall meet the

following requirements:

(1) A balance may only be used if it

has the following features:

(i) It has a load receiving element of

sufficient dimensions to hold the

packages during weighing;

(ii) It has a load receiving element of

sufficient weighing capacity for the

package size being tested;

(iii) It has at least 100 scale divisions,

and each division is no larger than 1⁄6

of the MAV for the package size being

weighed. The total number of scale

divisions on the balance is calculated by

dividing the scale or balance capacity by

the minimum scale division (e.g., a scale

or balance with a capacity of 5,000

grams and a minimum scale division of

0.1 gram has 50,000 scale divisions);

(2) Before each initial daily use, use

at a new location, or use in the presence

of any indication of abnormal

equipment performance, the balance

shall be found not to exceed the

rejection criteria of paragraph (d)(3)(ii)

of this section in all measurements

made as part of the following

performance tests, which use mass

standards that have been calibrated in

accordance with paragraph (e) of this

section:

(i) For all types of balances, conduct

an ‘‘increasing load performance test’’

with all test loads centered on the load

receiving element. The test shall start

with the scale on zero and progress with

increasing test loads to an upper

‘‘maximum test load’’ of approximately

10 percent more than the gross mass or

weight of the package to be weighed. At

least four test loads of approximately

equal value shall be used to test the

device up to the ‘‘maximum test load,’’

and the accuracy of the balance shall be

determined at each test load;

(ii) For all types of balances, other

than one with a beam indicator or equalarm balance, conduct a ‘‘decreasing load

performance test’’ with all test loads

centered on the load receiving element.

The test shall use the same test loads

used in the ‘‘increasing load

performance test’’ of paragraph (d)(3)(i)

of this section and shall start at the

‘‘maximum test load.’’ The test loads

shall be removed from the load

receiving element in the reverse order of

the increasing load test until all test

loads are removed and the accuracy of

the balance determined at each test

load; and

(iii) For all types of balances, conduct

an ‘‘off-center load performance test’’

with the test loads located as follows:

(A) Except for an equal arm balance,

no test loads are centered on a load

receiving element. The test shall use a

test load equal to one-half of the

‘‘maximum test load’’ used for the

‘‘increasing load performance test’’ of

paragraph (d)(3)(i) of this section. The

test load shall be placed in the center of

four separate quadrants, equidistant

between the center and edge of the load

receiving element and the accuracy of

the balance determined in each

quadrant. For example, where the load

receiving element constitutes a rectangle

or circle, the test load would be placed

in the center of the circles in the

following diagrams:

BILLING CODE 4160–01–P
9858 Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules
Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules 9859

(B) For an equal arm balance, both load receiving elements are tested with the same test loads on both elements

at the same time. The test shall use test loads equal to one-half of the ‘‘maximum test load’’ used for the ‘‘increasing

load performance test’’ of paragraph (d)(3)(i) of this section. On one receiving element, the test load is centered on

the load receiving element. On the other load receiving element, the test load is instead placed in the center of four

separate quadrants, equidistant between the center and edge of the load receiving element and the accuracy of the

balance determined in each quadrant. This test is repeated with the positions of the test loads switched between load

receiving elements. For example, in the first half of the test, the test load would be placed in the center of the

circles in the following diagram:

BILLING CODE 4160–01–P

BILLING CODE H160–01–C

(iv) For all types of balances, conduct

a ‘‘repeatability performance test’’ with

the ‘‘maximum test load’’ centered on

the load receiving element. The

‘‘maximum test load’’ shall be weighed

at least twice, and the accuracy of the

balance determined with each

measurement;

(3) A balance may only be used if it

does not have an error that exceeds the

number of smallest units of measure

(i.e., balance divisions) for rejection

established by the procedures set forth

below:

(i) Determine in Table 1 of this section

the Class of the balance that is

appropriate in light of the minimum

balance division and the total number of

balance divisions to be used for the net

contents measurement. For example,

with a balance with a minimum balance

division of 1 gram and 50,000 total

balance divisions the appropriate

tolerance class is ‘‘Class II’’;

TABLE 1.—BALANCE CLASSES

Value of smallest balance division 1 Minimum and total number of balance divisions Balance

class

1 milligram to 0.5 gram (g) ............................................................. Device has more than 100, but not more than 100,000 balance

divisions.

II

0.1 g or more .................................................................................. Device has more than 5,000, but not more than 100,000 balance

divisions.

II

0.1 g to 2 g .....................................................................................

0.0002 pound (lb) to 0.005 lb

0.005 ounce (oz) to 0.125 oz

Device has more than 100, but not more than 10,000 balance divisions.III

5 g or more .....................................................................................

0.01 lb or more

0.25 oz or more

Device has more than 500, but not more than 10,000 balance divisions.III

1On some balances, manufacturers have designated a verification balance division for testing purposes. Where the verification balance division is less than or equal to the minimum balance division, the verification division shall be used instead of the minimum balance division. Where

balances are made for use with standard test weights (e.g., an equal arm balance), the smallest test weight used for the measurement is the

minimum balance division.

(ii) Determine in Table 2 of this section the number of balance divisions for rejection that is appropriate for the

test load and the balance class to be used for the net contents measurement. For example, with a test load of up

to 20,000 balance divisions and a Class II balance, ± 2 is the appropriate number of balance divisions for rejection.

In this situation, the balance may not be used if it has an error of two balance divisions in any of the performance

tests set forth in paragraph (d)(3) of this section;

TABLE 2.—BALANCE DIVISIONS FOR REJECTION

Balance class II test load in balance divisions Balance class III test load in balance divisions

Number of

balance divisions for

rejection

0 to 5,000 ...................................................................................... 0 to 500 ........................................................................................ 1

5,001 to 100,000 ........................................................................... 501 to 4,000 ................................................................................. 2

Not Applicable ............................................................................... 4,001 or more ............................................................................... 3
9860 Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules

(e) Accuracy standardization. When

compared directly or indirectly to

standards provided by the National

Institute of Standards and Technology

(NIST), all equipment identified in this

paragraph shall be standardized before

initial use in accordance with the

calibration instructions set forth in NBS

Handbook 145, Handbook for the

Quality Assurance of Metrological

Measurements, which is incorporated

by reference in accordance with 5 U.S.C.

551(a) and 1 CFR part 51. Copies of this

publication may be obtained from the

Superintendent of Documents, U.S.

Government Printing Office,

Washington, DC 20402, or may be

examined at the Center for Food Safety

and Applied Nutrition’s Library, 200 C

St. SW., rm. 3321, Washington, DC, or

at the Office of the Federal Register, 800

North Capitol St. NW., suite 700,

Washington, DC. Except for volumetric

glassware, the comparison to NIST

standards shall be done on a routine

basis (e.g., annually for equipment used

on a weekly basis). The standardization

shall ensure that the equipment does

not have an error that exceeds the

following rejection criteria:

(1) Stop-watch standardization. A

stop-watch shall not have an error

exceeding ±2 seconds in a 3-hour time

period;

(2) Thermometer standardization. A

thermometer shall not have an error

exceeding ±1 °C (2 °F);

(3) Linear measure standardization.

(i) A tape or ruler used to measure

dimensions of 63.5 centimeters (25

inches) or less shall not have a

measurement error greater than ±0.39

millimeter (±1⁄64 inch);

(ii) A tape or ruler used to measure

dimensions of more than 63.5

centimeters (25 inches) shall not have a

measurement error greater than ±2

millimeter (±0.1 inch); and

(iii) A caliper or depth gauge shall not

exceed the error limits in Table 3 of this

section.

TABLE 3.—ERROR LIMITS FOR

CALIPERS AND DEPTH GAUGES

Measured length in millimeters

Error

limit in

micrometers

0 to 400 ........................................... ±50

400 to 800 ....................................... ±100

800 to 1000 ..................................... ±150

(4) Volumetric standardization. An

error in volumetric measuring

equipment shall not exceed the error

limits in Table 4 of this section; and

TABLE 4.—Error Limits for Flasks and

Cylinders 1

Capacity at 20 °C

(68 °F)

Error limits

for the full

capacity

Error limits

for individual graduations

50 milliliter (mL)

cylinder.

±0.3 mL± ±0.3 mL

2 fluid ounces (59

mL) cylinder.

±0.3 mL ±0.30 mL

100 mL flask ......... ±0.2 mL ±0.06 mL

1 gill (118 mL)

flask.

±0.2 mL ±0.10 mL

200 mL flask ......... ±0.3 mL ±0.10 mL 1⁄2 pint (236 mL)

flask.

±0.3 mL ±0.10 mL

250 mL flask ......... ±0.3 mL ±0.10 ml

1 pint (473 mL)

flask.

±0.4 mL ±0.15 mL

500 mL flask ......... ±0.5 mL ±0.15 mL

1 quart (946 mL)

flask.

±0.7 mL ±0.30 mL

1,000 mL flask ...... ±0.8 mL ±0.22 mL 1⁄2 gallon (1,892

mL) flask.

±1.0 mL ±0.30 mL

2,000 mL flask ...... ±1.2 mL ±0.33 mL

1 gallon (3,785 mL)

flask.

±1.2 mL ±0.30 mL

1For volumetric measures less than 50 mL,

full capacity error limits do not apply. For

these volumetric measures apply ±0.10 mL to

individual graduations. For a capacity intermediate between two capacities listed below

the tolerances prescribed for the lower capacity shall be applied. For volumes greater than

3,785 mL (1 gallon) apply ±0.02 percent of

nominal capacity for error limits at full capacity

and ±0.3 percent of the minimum graduation

for error limits for individual graduations.

(5) Gravimetric standardization. (i)

Errors in mass standards used to test

Class II balances, as described in

paragraph (d) of this section, shall not

exceed the error limits in Tables 5 and

6 of this section.

TABLE 5.—ERROR LIMITS FOR INCHPOUND MASS STANDARDS USED TO

TEST TOLERANCE CLASS II BALANCES

Mass standard in

pounds

Error limits in

milligrams

100 ............................. ±910

50 ............................... ±450

25 ............................... ±23

10 ............................... ±91

5 ................................. ±45

2 ................................. ±18

1 ................................. ±9

0.5 .............................. ±Κ4.5

0.2 .............................. ±1.8

0.1 .............................. ±1.1

0.05 ............................ ±0.77

0.02 ............................ ±0.45

0.01 ............................ ±0.34

0.005 .......................... ±0.27

0.002 .......................... ±0.19

0.001 .......................... ±0.15

TABLE 5.—ERROR LIMITS FOR INCHPOUND MASS STANDARDS USED TO

TEST TOLERANCE CLASS II BALANCES—CONTINUED

Mass standard in

ounces

Error limits in

milligrams

8 ................................ ±4.5

4 ................................ ±2.3

2 ................................ ±1.3

1 ................................ ±0.86

0.5 (1⁄2) ...................... ±0.59

0.25 (1⁄4) .................... ±0.43

0.2 ............................. ±0.38

0.125 (1⁄8) .................. ±0.31

0.1 ............................. ±0.29

0.0625 (1⁄16) ............... ±0.24

0.05 ........................... ±0.23

0.03125 (1⁄32) ............. ±0.19

0.02 ........................... ±0.17

0.015625 (1⁄64) ........... ±0.15

0.01 ........................... ±0.14

TABLE 6.—ERROR LIMITS FOR SI

MASS STANDARDS USED TO TEST

TOLERANCE CLASS II BALANCES

Mass standard in kilogramsError limits in

milligrams

50 .............................. ±1000

25 .............................. ±500

20 .............................. ±400

10 .............................. ±200

5 ................................ ±100

2 ................................ ±40

1 ................................ ±20

Mass standard in

grams

Error Limits in

milligrams

500 ............................ ±10

300 ............................ ±6

200 ............................ ±4

100 ............................ ±2

50 .............................. ±1.2

30 .............................. ±0.90

20 .............................. ±0.70

10 .............................. ±0.50

5 ................................ ±0.36

2 ................................ ±0.26

1 ................................ ±0.20

Mass standard in

milligrams

Error Limits in

milligrams

500 ............................ ±0.16

300 ............................ ±0.14

200 ............................ ±0.12

100 ............................ ±0.10

50 .............................. ±0.085

30 .............................. ±0.075

20 .............................. ±0.070

10 .............................. ±0.060

5 ................................ ±0.055

2 ................................ ±0.05

1 ................................ ±0.05

(ii) Errors in mass standards used to

test tolerance Class III balances, as

described in paragraph (d) of this

section, shall not exceed the error limits

in Tables 7 and 8 of this section.
Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules 9861

TABLE 7.—ERROR LIMITS FOR INCHPOUND MASS STANDARDS USED TO

TEST TOLERANCE CLASS III BALANCES

Mass standard in

pounds Error limits in grams

100 ............................. ±4.5

50 ............................... ±2.3

25 ............................... ±1.1

20 ............................... ±0.91

10 ............................... ±0.45

Error limits in

milligrams

5 ................................. ±230

2 ................................. ±91

1 ................................. ±70

0.5 .............................. ±45

0.2 .............................. ±18

0.1 .............................. ±9.1

0.05 ............................ ±4.5

0.02 ............................ ±1.8

0.01 ............................ ±1.5

0.005 .......................... ±1.2

0.002 .......................... ±0.87

0.001 .......................... ±0.7

Mass standard in

ounces

Error limits in

milligrams

8 ................................. ±45

4 ................................. ±23

2 ................................. ±11

1 ................................. ±5.4

0.5 (1⁄2) ...................... ±2.8

0.25 (1⁄4) .................... ±1.7

0.2 .............................. ±1.6

0.125 (1⁄8) .................. ±1.3

0.1 .............................. ±1.3

0.0625 (1⁄16) ............... ±1.1

0.05 ............................ ±1.0

0.03125 (1⁄32) ............. ±0.87

0.02 ............................ ±0.75

0.015625 (1⁄64) ........... ±0.69

0.01 ............................ ±0.60

TABLE 8.—ERROR LIMITS FOR SI

MASS STANDARDS USED TO TEST

TOLERANCE CLASS III BALANCES

Mass standard in kilograms Error limits in grams

50 .............................. ±5

20 .............................. ±2

10 .............................. ±1

5 ................................ ±0.5

2 ................................ ±0.2

1 ................................ ±0.1

Mass standard in

grams

Error limits in

milligrams

500 ............................ ±70

300 ............................ ±60

200 ............................ ±40

100 ............................ ±20

50 .............................. ±10

20 .............................. ±4

10 .............................. ±2

5 ................................ ±1.5

2 ................................ ±1.1

1 ................................ ±0.9

TABLE 8.—ERROR LIMITS FOR SI

MASS STANDARDS USED TO TEST

TOLERANCE CLASS III BALANCES—

CONTINUED

Mass standard in kilogramsError limits in milligrams

500 ............................ ±0.72

300 ............................ ±0.61

200 ............................ ±0.54

100 ............................ ±0.43

50 .............................. ±0.35

30 .............................. ±0.30

20 .............................. ±0.26

10 .............................. ±0.21

5 ................................ ±0.17

2 ................................ ±0.12

1 ................................ ±0.10

§ 101.220 Analytical procedures, net mass

or weight.

The following procedures shall be

used to determine the net quantity of

contents of packaged foods labeled in

terms of mass or weight:

(a) Make all measurements with

equipment that conforms to § 101.215.

Good weighing procedures shall be used

to ensure accurate results (e.g., operate

scales or balances in accordance with

the manufacturers instructions, and

conduct tests in locations where the

environment does not adversely affect

results);

(b)(1) The following core procedure

shall be used to determine net mass or

weight, except where a different specific

procedure is provided for in paragraph

(b)(2) of this section:

(i) Determine the gross mass or weight

of the package;

(ii) Determine the average used tare

mass or weight in accordance with

provisions of § 101.235; and

(iii) Determine net mass or weight by

subtracting the average used tare mass

or weight determined in (b)(1)(ii) of this

section from the gross mass or weight of

each package in the sample.

(2) For unglazed frozen seafoods and

vegetables, the method prescribed for

unglazed frozen foods in the ‘‘Official

Methods of Analysis of the Association

of Official Analytical Chemists

International,’’ 16th ed., 1995, section

963.26, under the heading ‘‘Net

Contents of Frozen Food Containers

Procedure 1963,’’ which is incorporated

by reference in accordance with 5 U.S.C.

551(a) and 1 CFR part 51, shall be used

to determine net mass or weight. Copies

may be obtained from the Association of

Official Analytical Chemists

International, 481 North Frederick Ave.,

suite 500, Gaithersburg, MD 20877–

2504, or may be examined at the Center

for Food Safety and Applied Nutrition’s

Library, 200 C St. SW., rm. 3321,

Washington, DC, or at the Office of the

Federal Register, 800 North Capitol St.

NW., suite 700, Washington, DC.

(c)(1) The following core procedure

shall be used to determine drained mass

or weight except where a different

specific procedure is provided for in

paragraph (c)(2) of this section:

(i) Determine and record the

following:

(A) The tare mass or weight of the

receiving pan; and

(B) The gross mass or weight of each

individual package of the sample;

(ii) Use a 203 millimeters (8 inch) U.S.

No. 8 standard test sieve for packages

with net quantity of contents of 1.36

kilograms (3 pounds) or less, or a 305

millimeters (12 inch) U.S. No. 8

standard test sieve for packages with net

contents greater than 1.36 kilograms (3

pounds); except that, for canned

tomatoes obtain either a 203 millimeters

(8 inch) or 305 millimeters (12 inch) (as

appropriate) U.S. No., 11.3 millimeters

(7⁄16 inch) standard test sieve;

(iii) Pour the contents of the package

into the appropriate dry sieve with the

receiving pan beneath it; incline the

sieve at an angle of 17° to 20° to

facilitate drainage. Do not shake or shift

material on the sieve. Drain exactly 2

minutes;

(iv) Immediately weigh the receiving

pan, liquid, wet container, and any

other tare material (do not include

weight of sieve and food). Record this

value as the total tare mass or weight for

the package and receiving pan;

(v) Subtract the tare mass or weight of

the receiving pan determined according

to paragraph (c)(1)(i) of this section from

the mass or weight obtained in

paragraph (c)(1)(iv) of this section to

obtain the tare mass or weight (which

includes the mass or weight of the

liquid packing medium);

(vi) Subtract the tare mass or weight

determined according to paragraph

(c)(1)(v) of this section from the

appropriate package gross mass or

weight determined according to

paragraph (c)(1)(i) of this section to

obtain the net weight of that package.

Determine the package error by

subtracting the net mass or weight from

the labeled mass or weight; and

(vii) Repeat the procedure provided

for in paragraphs (c)(1)(ii) through

(c)(1)(vi) of this section for the

remaining packages in the sample.

Clean and dry the sieve and receiving

pan between measurements on each

package.

(2) The following procedures shall be

used to determine drained mass or

weight for the foods noted. The

procedures in this paragraph shall be

conducted in accordance with the

specified section ‘‘Official Methods of
9862 Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules

Analysis of the Association of Official

Analytical Chemists International,’’ 16th

ed., 1995, which is incorporated by

reference in accordance with 5 U.S.C.

552(a) and 1 CFR part 51. Copies may

be obtained from the Association of

Official Analytical Chemists

International, 481 North Frederick Ave.,

suite 500, Gaithersburg, MD 20877–

2504, or may be examined at the Center

for Food Safety and Applied Nutrition

Library, 200 C St. SW., rm. 3321,

Washington, DC, or at the Office of the

Federal Register, 800 North Capitol St.

NW., suite 700, Washington, DC:

(i) For glazed vegetables and for

frozen seafood, except for frozen shrimp

and crabmeat, the method prescribed for

glazed seafoods in section 963.18, under

the heading ‘‘Net Contents of Frozen

Seafoods,’’ which is incorporated by

reference in accordance with 5 U.S.C.

552(a) and 1 CFR part 51.

(ii) For frozen shrimp and crabmeat,

the method prescribed for frozen shrimp

and crabmeat in section 967.13, under

the heading ‘‘Drained Weight of Frozen

Shrimp and Crabmeat,’’ which is

incorporated by reference in accordance

with 5 U.S.C. 552(a) and 1 CFR part 51.

(iii) For frozen crabmeat, the method

prescribed for in paragraph (c)(2)(ii) or

the method prescribed for frozen

crabmeat in section 970.60, under the

heading ‘‘Drained Weight of Frozen

Crabmeat,’’ which is incorporated by

reference in accordance with 5 U.S.C.

552(a) and 1 CFR part 51.

(d) For shucked oysters, the percent of

liquid by weight that is removed by

draining shall be determined by using

the method prescribed for such foods in

section 953.11, under the heading

‘‘Drained Liquid from Shucked

Oysters,’’ which is incorporated by

reference in accordance with 5 U.S.C.

552(a) and 1 CFR part 51. The

availability of this incorporation by

reference is given in paragraph (c)(2) of

this section.

§ 101.225 Analytical procedures, volume.

The following procedures shall be

used to determine the net quantity of

contents of packaged foods labeled in

terms of volume:

(a) Conduct all measurements on

equipment that conforms to § 101.215

Good weighing and measuring

procedures shall be used to ensure

accurate results (e.g., operating scales or

balances in accordance with the

manufacturer’s instructions, and

conducting tests in locations where the

environment does not adversely affect

results).

(b) The following procedure shall be

used to determine net volume, except

where a different procedure is provided

for in paragraphs (c), (d), (e), and (f) of

this section:

(1) Bring the package and its food to

the appropriate temperature as set forth

in § 101.201(a), within the following

temperature ranges:

(i) In the case of frozen food, ¥18 °C

(0 °F) to ¥15 °C (5 °F);

(ii) In the case of refrigerated food, 1.7

°C (35 °F) to 7.2 °C (45 °F); or

(iii) In the case of other foods, 20 °C

(68 °F) to 22.7 °C (73 °F).

(2) Prepare a clean volumetric

measure of appropriate capacity for use;

(i) If the volumetric measure is

calibrated on a ‘‘to contain’’ basis,

immediately before each measurement,

the volumetric measure shall be dried.

(ii) If the volumetric measure is

calibrated on a ‘‘to deliver’’ basis,

immediately before each use, the

volumetric measure shall be filled with

water to a point slightly below the top

graduation on the neck. Start a

stopwatch and invert the volumetric

measure gradually, so that the walls are

splashed as little as possible, to

approximately an 85° angle and

completely empty the volumetric

measure.

(A) If the volumetric measure is

marked with a standardized emptying

time, hold the measure in the inverted

position until the stopwatch indicates

that the entire standardized time has

expired, and touch off the drop of water

that adheres to the tip.

(B) If no standardized emptying time

is provided, pour the food in a steady

stream so that virtually all of the

product is delivered within 30 seconds

(± 5 seconds). If a drainage time is

designated by the manufacturer for the

volumetric measure, hold the

volumetric measure in the inverted

position until any time designated on

the measure has elapsed, or until the

stopwatch indicates that 10 seconds

have elapsed beyond the time necessary

to completely empty the container.

Touch off the drop of water that adheres

to the tip.

(iii) If the food effervesces or foams

when opened or poured (such as

carbonated beverages), add two drops of

a defoaming agent to the bottom of the

volumetric measure before filling with

the food.

(iv) For additional measurements of a

food, use water to wash or rinse and

prepare the volumetric measure

between each measurement of liquid

food from the sample packages (dry or

drain the volumetric measure as

described in paragraph (b)(2)(i) or

(b)(2)(ii) of this section, as appropriate);

(3) If the food requires mixing for

uniformity, it should be mixed before

opening each package (e.g., in

accordance with any shaking

instructions specified on the package

label);

(4) Empty the food into the volumetric

measure holding the package in a nearly

vertical position, but tipping so that the

bottom of the container will drain. Drain

the container into the volumetric

measure for 1 minute after the stream of

liquid breaks into drops; and

(5) Position the volumetric measure

vertically with the surface of the liquid

at eye level. For foods that are clear

liquids, place a shade of some dark

material immediately below the

meniscus and read volume from the

lowest point of the meniscus. For foods

that are opaque liquids, read volume

from the center of the top rim of the

liquid surface.

(c) Except where a different procedure

is provided for in paragraphs (d) and (e)

of this section, the following gravimetric

procedure may be used to determine net

volume if the product density

requirements of this paragraph are met:

(1) Select a volumetric measure equal

to or one size smaller than the labeled

volume and determine the tare mass or

weight of the measure;

(2) Prepare the package and

volumetric measure for measurement by

following the provisions of paragraphs

(b)(1), (b)(2), and (b)(3) of this section;

(3) Determine acceptability of the food

density variation on two packages

selected for tare determination in

accordance with provisions of § 101.235

as follows:

(i) Determine the gross mass or weight

of the first food package;

(ii) Pour an amount of the food from

the first food package into a volumetric

measure exactly to a specified mark on

the neck of the measure. The amount of

the food that is elected to be poured is

referred to as the volume standard

(volstd) for this procedure;

(iii) Weigh the filled volumetric

measure and subtract the tare mass or

weight of the measure to obtain the net

mass or weight of the food;

(iv) Determine the net mass or weight

of the volstd of the food from a second

package using the procedure in

paragraph (c)(3)(iii) of this section; and

(v) If the difference between net mass

or weight of both packages exceeds one

division of the scale or balance, the net

quantity of contents may not be

determined by the gravimetric

procedure in this paragraph; instead,

use the totally volumetric procedure

provided for in paragraph (b) of this

section;

(4) Determine the ‘‘nominal gross

mass or weight’’ as follows:

(i) Determine the average used tare

mass or weight of the sample in
Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules 9863

accordance with provisions of

§ 101.235. Include the packages used to

determine acceptability of this

procedure as part of the tare;

(ii) Use the net mass or weight of the

known volume (Volstd) as determined in

paragraphs (c)(3)(iii) and (c)(3)(iv) of

this section and calculate the average of

the two values for the average net mass

or weight (net wt avg);

(iii) Calculate the average net mass or

weight of the labeled volume (avg. wt

v1) of the food using the formula:

Avg. wt v1=(net wtavg/volstd) × labeled

volume of net contents;

(iv) Calculate the ‘‘nominal gross mass

or weight’’ (nom. gr. wt) using the

formula:

Nom. gr. wt = avg wt v1 + average used

tare mass or weight;

(v) Weigh the remaining packages in

the sample;

(vi) Subtract the nominal gross mass

or weight from the gross mass or weight

of each package to obtain package errors

in terms of weight;

(vii) Calculate the average error of the

sample (i.e., the total error divided by

the sample size); and

(viii) If the average error is a negative

number, calculate package error for each

package in terms of volume using the

formula:

Package error (volume) = [package error

in weight] divided by [average

weight of both standard volumes of

paragraph (c)(3) of this section (net

wt avg)] multiplied by [volume of

standard volume (volstd)]

(d) For shucked oysters, clams, or

scallops, use the method prescribed for

such foods in the ‘‘Official Methods of

Analysis of the Association of Official

Analytical Chemists International,’’ 16th

ed., 1995, section 937.08, under the

heading ‘‘Volume of Shucked Oysters,

Clams or Scallops,’’ which is

incorporated by reference in accordance

with 5 U.S.C. 552(a) and 1 CFR part 51.

Copies may be obtained from the

Association of Official Analytical

Chemists International, 481 North

Frederick Ave., suite 500, Gaithersburg,

MD 20877–2504, or may be examined at

the Center for Food Safety and Applied

Nutrition Library, 200 C St. SW., rm.

3321, Washington, DC, or at the Office

of the Federal Register, 800 North

Capitol St. NW., suite 700, Washington,

DC;

(e) The volume displacement

procedure prescribed for ice cream and

frozen desserts in the ‘‘Official Methods

of Analysis of the Association of Official

Analytical Chemists International,’’ 16th

ed., 1995, section 968.14, under the

heading ‘‘Weight per Unit Volume of

Packaged Ice Cream’’ Method I, which is

incorporated by reference in accordance

with 5 U.S.C. 551(a) and 1 CFR part 51.

Copies may be obtained from the

Association of Official Analytical

Chemists International, 481 North

Frederick Ave., suite 500, Gaithersburg,

MD 20877–2504, or may be examined at

the Center for Food Safety and Applied

Nutrition Library, 200 C St. SW., rm.

3321, Washington, DC, or at the Office

of the Federal Register, 800 North

Capitol St. NW., suite 700, Washington,

DC. This procedure may be used to

determine volume where appropriate;

except that water of 33 °F (0.56 °C) or

below may be used rather than the

kerosene displacement liquid in that

procedure, provided that the food does

not mix with the ice water;

(f) The volumetric depth gauge

procedure set forth below may be used

to determine volume where the food has

a smooth and level headspace (e.g., oils,

syrups, and other viscous liquids):

(1) Make all measurements on a

surface that appears to be level when

tested with a bubble level that is at least

15 centimeters (6 inches) in length;

(2) Bring the temperature of both the

food and the water to be used to

measure the volume of the food to the

appropriate temperature provided for in

§ 101.201(a), achieving a temperature

within the range designated in

paragraph (b)(1) of this section;

(3) Determine the headspace of the

package at the point of contact with the

food using a depth gauge with a fully

rounded rather than a pointed rod end.

If necessary, the package shall be

supported to prevent the bottom of the

container from distorting;

(4) Empty, clean, and dry the package;

(5) Refill the container with distilled

water measured from a volumetric

measure to the original food headspace

level found in paragraph (f)(3) of this

section until the water touches the

depth gauge; and

(6) Determine amount of water used

in paragraph (f)(5) of this section to

obtain the volume of the food and

calculate the ‘‘package error’’ for that

volume;

(g) The volumetric air space

procedure set forth in this paragraph

may be used to determine volume where

the food does not have a smooth and

level headspace (e.g., mayonnaise):

(1) Acquire the following equipment

specifically for use in this procedure:

(i) 500-milliliter buret;

(ii) Rubber bulb syringe; and

(iii) Plastic Disks three-millimeter (1/

8 inch) thick disks with diameters to

correspond to the seat diameter or larger

than the brim diameter of each

container tested. Diameter tolerance is

±0.05 millimeter (±0.002 inch). The

outer edge should be beveled at a 30°

angle with the horizontal to 0.8

millimeter (1⁄32 inch) thick at the edge.

There should be a 20-millimeter (3/4

inch) diameter hole through the center

of the disk and a series of 1.5-millimeter

(1⁄16 inch) diameter holes 25 millimeters

(1 inch) from the outer edge. All edges

should be smooth;

(2) Make all measurements on a

surface that appears to be level when

tested with a bubble level that is at least

15 centimeter (6 inch) in length;

(3) Bring the temperature of both the

food and the water used to measure the

volume of the food to the appropriate

temperature designated in § 101.200(b)

within the tolerances provided for in

paragraph (b)(1) of this section;

(4) Open the first package and place

a disk larger than the package container

opening over the opening;

(5)(i) Add water to the container using

flask (or flasks), graduate, or buret

corresponding to labeled capacity of the

container. If it appears that the contents

of the flask may overfill the container,

do not empty the flask. Add water until

all of the air in the container has been

displaced and the water begins to rise in

the center hole of the disk. Stop the

filling procedure when the water fills

the center disk hole and domes up

slightly due to the surface tension;

(ii) If the water dome breaks on the

surface of the disk, the container has

been overfilled and the test is void; dry

the container and start over; and

(iii) Do not add additional water after

the level of the water dome has

dropped;

(6) Record the amount of water used

to fill the container and subtract 1

milliliter (0.03 fluid ounce) (this is the

amount of water in the disk hole) to

obtain the air space capacity;

(7) Empty, clean, and dry the package

container;

(8) In accordance with procedures set

forth in paragraph (5) of this section,

refill the package container with water

measured from a volumetric measure to

the maximum capacity of the package

and record the amount of water used as

the container volume; and

(9) From the container volume in

paragraph (g)(8) of this section, subtract

the air space capacity in paragraph (g)(6)

of this section to obtain the volume of

the food and calculate the ‘‘package

error’’ for that volume, where ‘‘Package

error’’ equals labeled volume minus the

measured volume of the food.

§ 101.230 Analytical procedures, count.

The following procedures shall be

used to determine the net quantity of
9864 Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules

contents of packaged foods labeled in

terms of count:

(a) Count each unit in each package of

the sample to determine the net quantity

of contents of packaged foods labeled in

terms of count; or

(b) If the product density

requirements of paragraph (b)(1) of this

paragraph are met, the following

gravimetric procedure may be used to

determine count:

(1) Determine acceptability of the food

density variation on two packages

selected for tare determination in

accordance with provisions of § 101.235

as follows:

(i) Determine the gross mass or weight

of the first food package;

(ii) Open the package and determine

the net weight and the exact number of

food units in the first food package;

(iii) Calculate the weight of the

labeled count of the package using the

formula:

Weight of labeled count=[labeled count]

divided by [count found] multiplied

by [net weight];

(iv) Determine the weight of the

labeled count of the food from a second

package using the procedure set forth in

paragraph (b)(1) (i) to (iii) of this

section;

(v) If there is a difference between net

mass or weight of the weight of the

labeled count calculated from the two

packages that exceeds one division of

the scale or balance, the net quantity of

contents may not be determined by the

gravimetric procedure in this paragraph;

instead, use the procedure provided for

in paragraph (a) of this section;

(2) Determine the ‘‘nominal gross

mass or weight’’ as follows:

(i) Determine the average used tare

mass or weight of the sample in

accordance with provisions of

§ 101.235. Include the packages used to

determine acceptability of this

procedure as part of the tare;

(ii) With the two determinations of

count and net mass or weight of that

count as determined in paragraph (b)(1)

of this section, calculate the average

count (count avg) and the average net

mass or weight (net wt avg);

(iii) Calculate the average net mass or

weight of the labeled count (ave. wt c1)

of the food using the formula:

Avg. wt c1 = (net wtavg/countavg) ×

labeled count of net contents;

(iv) Calculate the ‘‘nominal gross mass

or weight’’ (nom. gr. wt) using the

formula:

Nom. gr. wt = avg wt c1 + average used

tare mass or weight;

(3) Weigh the remaining packages in

the sample;

(4) Subtract the nominal gross mass or

weight from the gross mass or weight of

each package to obtain package errors in

terms of weight;

(5) Calculate the average error of the

sample (i.e., the total error divided by

the sample size); and

(6) If the average error is a negative

number, calculate package error for each

package in terms of count using the

formula:

Package error (count) = [package error in

weight] divided by [average weight

of both known counts of paragraph

(b)(2) of this section (net wtavg)]

multiplied by [average of count of

paragraph (b)(2) (countavg)]

§ 101.235 Tare determination.

The following procedures shall be

used to make tare determinations for the

net quantity of contents of packaged

foods:

(a) If the net quantity of contents is

determined by weighing, an average

dried used tare mass or weight shall be

used to determine net mass or weight,

unless the dried used tare mass or

weight of each package in the sample is

determined individually. If the

inspection lot consists of 11 packages or

less, the average dried used tare mass or

weight shall be computed with 2 tare

samples. If the inspection lot consists of

12 or more packages the average used

tare mass or weight shall be computed

with 2 tare samples except, if the

package is made of glass, or if it is an

aerosol container, and the sample size is

24 or 48 packages, 3 tare samples shall

be used to compute the average dried

used tare mass. Under other situations,

the average dried used tare mass or

weight shall be computed using the tare

sample size (nt) listed in Table 1 of this

section for the different sample sizes (n)

as follows:

(b) Select an initial tare sample size

(‘‘nit’’) as specified in paragraph (a) of

this section to determine if additional

tare samples are required. Any of the

sample packages may be used as tare

samples;

(c) Determine the gross mass or

weight for each tare sample;

(d) Determine the tare mass or weight

of each package in the initial tare

sample (nit) and the range of masses or

weights of the tare samples (abbreviated

as ‘‘Rt’’). If the range in the mass or

weights of the initial tare sample is zero,

no additional tare samples must be

taken;

(e) Determine the net mass or weight

of each package and, except for random

weight packages, the range of net masses

or weights in the initial tare sample

(abbreviated as ‘‘Rc’’). For random

weight packages ‘‘Rc’’ is determined

using the range of the package errors in

the initial tare sample, not the range of

net masses or weight;

(f) Calculate the ratio of the range of

net masses or weights (Rc) to the range

of masses or weights in the initial tare

sample size (Rt) (i.e., divide Rc by Rt);

(g) From Table 1 of this section,

determine the total tare sample size

corresponding to the Rc/Rt ratio

determined in paragraph (f) (e.g., if the

ratio of Rc/Rt is 3.72, the sample size is

48, and the initial tare sample size is 2,

the total tare sample size is 10). Where

the number of packages listed in the

Table 1 of this section for Rc/Rt equals

the initial tare sample size, the initial

tare sample shall serve as the total tare

sample; and

(h) Determine the average dried used

tare mass or weight by adding the mass

or weight of all of the tare samples

required for the total tare sample size

and divide that value by the total

number of tare samples.

(i) TABLE 1.—TOTAL TARE SAMPLE SIZE (ABBREVIATED AS nt)

Ratio Rc/Rt

Number of packages in sample 1

n=12 n=24 n=48

nit=2 nit=2 nit=3 nit=2 nit=3

0.2 or less ................................................................................................. 12 24 24 48 48

0.21–0.40 .................................................................................................. 12 23 23 46 46

0.41–0.60 .................................................................................................. 11 22 22 44 44

0.61–0.80 .................................................................................................. 10 21 21 41 41

0.81–1.00 .................................................................................................. 10 19 19 38 38

1.01–1.20 .................................................................................................. 9 18 18 35 35

1.21–1.40 .................................................................................................. 8 16 16 32 32
Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules 9865

(i) TABLE 1.—TOTAL TARE SAMPLE SIZE (ABBREVIATED AS nt)—Continued

Ratio Rc/Rt

Number of packages in sample 1

n=12 n=24 n=48

nit=2 nit=2 nit=3 nit=2 nit=3

1.41–1.60 .................................................................................................. 7 15 15 29 29

1.61–1.80 .................................................................................................. 7 13 13 27 27

1.81–2.00 .................................................................................................. 6 12 12 24 24

2.01–2.20 .................................................................................................. 5 11 11 22 22

2.21–2.40 .................................................................................................. 5 10 10 20 20

2.41–2.60 .................................................................................................. 4 9 9 18 18

2.61–2.80 .................................................................................................. 4 8 8 16 16

2.81–3.00 .................................................................................................. 4 7 7 15 15

3.01–3.20 .................................................................................................. 3 7 7 13 13

3.21–3.40 .................................................................................................. 3 6 6 12 12

3.41–3.60 .................................................................................................. 3 6 6 11 11

3.61–3.80 .................................................................................................. 3 5 5 10 10

3.81–4.00 .................................................................................................. 2 5 5 10 10

4.01–4.20 .................................................................................................. 2 4 4 9 9

4.21–4.40 .................................................................................................. 2 4 4 8 8

4.41–4.60 .................................................................................................. 2 4 4 8 8

4.61–4.80 .................................................................................................. 2 4 4 7 7

4.81–5.00 .................................................................................................. 2 3 3 7 7

5.01–5.20 .................................................................................................. 2 3 3 6 6

5.21–5.40 .................................................................................................. 2 3 3 6 6

5.41–5.60 .................................................................................................. 2 3 3 5 5

5.61–5.80 .................................................................................................. 2 3 3 5 5

5.81–6.00 .................................................................................................. 2 2 3 5 5

6.01–6.20 .................................................................................................. 2 2 3 5 5

6.21–6.40 .................................................................................................. 2 2 3 4 4

6.41–6.60 .................................................................................................. 2 2 3 4 4

6.61–6.80 .................................................................................................. 2 2 3 4 4

6.81–7.00 .................................................................................................. 2 2 3 4 4

7.01–7.20 .................................................................................................. 2 2 3 3 3

7.21–7.40 .................................................................................................. 2 2 3 3 3

7.41–7.60 .................................................................................................. 2 2 3 3 3

7.61–7.80 .................................................................................................. 2 2 3 3 3

7.81–8.00 .................................................................................................. 2 2 3 3 3

8.01–8.20 .................................................................................................. 2 2 3 3 3

8.21–8.40 .................................................................................................. 2 2 3 3 3

More than 8.40 ......................................................................................... 2 2 3 2 3

1 Including those already opened for initial tare determination.

§ 101.240 Compliance procedures;

average requirement.

Except where the sample contains

packages with a declaration in terms of

count that is subject to § 101.245(e), or

where the sample consists of only one

package, the determination as to

whether the declaration of net quantity

of contents on the packages in an

inspection lot is violative under section

403(e) of the Federal Food, Drug, and

Cosmetic Act is to be made using the

procedures set forth below:

(a) Calculate the average error of the

sample (i.e., the sum of the individual

minus and plus package errors divided

by the sample size);

(1) If the average error is zero or a

positive number, the sample conforms

with the average requirement;

(2) If the average error is a negative

number, use the following procedure to

determine the sample error limit (SEL):

(i) Calculate the sample standard

deviation; and

(ii) Obtain the sample correction

factor (SCF) from column 2 of Table 1

of this section for the appropriate

sample size;

TABLE 1.—SAMPLE CORRECTION

FACTORS (SCF)

Column 1 sample size

Column 2

sample correction factor

1 package ................................. Apply

Individual

package

requirement

(maximum

allowable

variation

(MAV)

2 packages ............................... 1.414

3 packages ............................... 1.155

4 packages ............................... 1.000

5 packages ............................... 0.8944

6 packages ............................... 0.8165

7 packages ............................... 0.7559

8 packages ............................... 0.7071

TABLE 1.—SAMPLE CORRECTION

FACTORS (SCF)—Continued

Column 1 sample size

Column 2

sample correction factor

9 packages ............................... 0.6667

10 packages ............................. 0.6325

11 packages ............................. 0.6030

12 packages ............................. 0.5774

24 packages ............................. 0.4082

48 packages ............................. 0.2887

(b) Multiply the sample standard

deviation(s) by the SCF to calculate the

SEL;

(1) If the average error, disregarding

the minus sign, is a smaller number

than or equal to the SEL computed in

paragraph (b) of this section, the sample

complies with this section.

(2) If the average error, disregarding

the minus sign, is a larger number than

the SEL computed in paragraph (b) of

this section, the inspection lot shall be
9866 Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules

classified violative; except that, if the

sample consists of a product for which

a moisture loss allowance has been

established in § 101.250, the appropriate

allowance percent (A%) provided for in

that section shall be used to calculate an

adjusted sample error limit (SELadj)

according to the formula:

SELadj = s × SCF + (A% × labeled contents/

100)

§ 101.245 Compliance procedures;

maximum variations.

An inspection lot shall be classified

violative if the net quantity of contents

of the sample does not conform to the

individual package requirements as

determined by the procedures set forth

below:

(a) Determine amount of each negative

package error in the sample;

(b)(1) In accordance with the

appropriate table in paragraph (f) of this

section (i.e., Tables 1 and 2 for mass or

weight; Tables 3 and 4 for liquid or dry

volume; and Table 5 for count except

where the count is 50 units or less

where MAV’s are not applicable),

determine the MAV for the labeled net

quantity of contents;

(2) Where an allowance for moisture

content change is permitted in § 101.250

the MAV shall be adjusted to provide

for the change by adding the percent of

the labeled mass or weight attributable

to the moisture change to the MAV (e.g.,

if the labeled package size is 2 pounds,

and a 1-percent moisture loss could

reasonably be expected, the MAV of

0.07 pound from Table 2 of this section

is increased by adding 0.02 lb to give an

adjusted MAV of 0.09 lb);

(c) Determine the number of negative

package errors that exceed the MAV or

adjusted MAV, as appropriate, for the

labeled net quantity of contents;

(d)(1) Except where the sample

contains packages with a declaration in

terms of count that is subject to

paragraph (e) of this section, any

negative package error found in

accordance with paragraph (c) of this

section results in the inspection lot

being classified violative if the sample

consists of less than 48 packages;

(2) Except where the sample contains

packages with a declaration in terms of

count that is subject to paragraph (e) of

this section, more than one negative

package error found in accordance with

paragraph (c) of this section results in

the inspection lot being classified

violative if the sample consists of 48

packages;

(e) For declarations in terms of count

where the declaration is 50 items or

less, if more than 1 package from a

sample of 12 or less contains less than

the labeled count where the inspection

lot size is 250 packages or less; or if

more than 2 packages from a sample of

24 packages contain less than the

labeled count where the inspection lot

size is between 251 to 3,200 packages;

or if more than 3 packages from a

sample of 48 packages contain less than

the labeled count where the inspection

lot is more than 3,200 packages, the

inspection lot shall be classified as

violative; and

(f) The Tables of MAV’s are as

follows:

TABLE 1.—MASS MAV’S FOR INDIVIDUAL PACKAGES LABELED IN METRIC UNITS

Metric units

Labeled mass or weight in grams (g) or kilograms (kg) MAV in grams

Less than 36 g .................................................................................................................................................. 10 percent of labeled quantity.

From 36 to 54 g ................................................................................................................................................ 4.

More than 54 to 82 g ........................................................................................................................................ 5.

More than 82 to 118 g ...................................................................................................................................... 7.

More than 118 to 154 g .................................................................................................................................... 9.

More than 154 to 209 g .................................................................................................................................... 11.

More than 209 to 263 g .................................................................................................................................... 13.

More than 263 to 318 g .................................................................................................................................... 15.

More than 318 to 381 g .................................................................................................................................... 16.

More than 381 to 426 g .................................................................................................................................... 18.

More than 426 to 490 g .................................................................................................................................... 20.

More than 490 to 572 g .................................................................................................................................... 22.

More than 572 to 635 g .................................................................................................................................... 24.

More than 635 to 698 g .................................................................................................................................... 25.

More than 698 to 771 g .................................................................................................................................... 27.

More than 771 to 852 g .................................................................................................................................... 29.

More than 852 to 971 g .................................................................................................................................... 32.

More than 971 g to 1.125 kg ............................................................................................................................ 35.

More than 1.125 to 1.35 kg ............................................................................................................................... 40.

More than 1.35 to 1.60 kg ................................................................................................................................. 45.

More than 1.60 to 1.80 kg ................................................................................................................................. 50.

More than 1.80 to 2.10 kg ................................................................................................................................. 55.

More than 2.10 to 2.64 kg ................................................................................................................................. 65.

More than 2.64 to 3.08 kg ................................................................................................................................. 70.

More than 3.08 to 3.80 kg ................................................................................................................................. 80.

More than 3.80 to 4.40 kg ................................................................................................................................. 85.

More than 4.40 to 5.20 kg ................................................................................................................................. 100.

More than 5.20 to 6.80 kg ................................................................................................................................. 115.

More than 6.80 to 8.20 kg ................................................................................................................................. 130.

More than 8.20 to 10.60 kg ............................................................................................................................... 145.

More than 10.60 to 14.30 kg ............................................................................................................................. 170.

More than 14.30 to 19.25 kg ............................................................................................................................. 200.

More than 19.25 to 24.70 kg ............................................................................................................................. 230.

More than 24.70 kg ........................................................................................................................................... 2 percent of labeled quantity.
Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules 9867

TABLE 2.—WEIGHT MAV’S FOR INDIVIDUAL PACKAGES LABELED IN INCH-POUND UNITS

Inch-pound units

Labeled mass or weight in Pounds (lb) or Ounces (oz) Pounds MAV

ounces

10 percent of labeled

quantity

0.08 lb or less, 1.28 oz or less.

More than 0.08 to 0.12 lb

More than 1.28 to 1.92 oz ............................................................................................................................................... 0.008 1⁄8

More than 0.12 to 0.18 lb

More than 1.92 to 2.88 oz ............................................................................................................................................... .012 3⁄16

More than 0.18 to 0.26 lb

More than 2.88 to 4.16 oz ............................................................................................................................................... .016 1⁄4

More than 0.26 to 0.34 lb

More than 4.16 to 5.44 oz ............................................................................................................................................... .020 5⁄16

More than 0.34 to 0.46 lb

More than 5.44 to 7.36 oz ............................................................................................................................................... .024 3⁄8

More than 0.46 to 0.58 lb

More than 7.36 to 9.28 oz ............................................................................................................................................... .028 7⁄16

More than 0.58 to 0.70 lb

More than 9.28 to 11.20 oz ............................................................................................................................................. .032 1⁄2

More than 0.70 to 0.84 lb

More than 11.20 to 13.44 oz ........................................................................................................................................... .036 9⁄16

More than 0.84 to 0.94 lb

More than 13.44 to 15.04 oz ........................................................................................................................................... .040 5⁄8

More than 0.94 to 1.08 lb

More than 15.04 to 17.28 oz ........................................................................................................................................... .044 11⁄16

More than 1.08 to 1.26 lb ................................................................................................................................................ .048 3⁄4

More than 1.26 to 1.40 .................................................................................................................................................... .052 13⁄16

More than 1.40 to 1.54 lb ................................................................................................................................................ .056 7⁄8

More than 1.54 to 1.70 lb ................................................................................................................................................ .060 15⁄16

More than 1.70 to 1.88 lb ................................................................................................................................................ 0.064 1

More than 1.88 to 2.14 lb ................................................................................................................................................ .070 11⁄8

More than 2.14 to 2.48 lb ................................................................................................................................................ .078 11⁄4

More than 2.48 to 2.76 lb ................................................................................................................................................ .086 13⁄8

More than 2.76 to 3.20 lb ................................................................................................................................................ .094 11⁄2

More than 3.20 to 3.90 lb ................................................................................................................................................ .11 13⁄4

More than 3.90 to 4.70 lb ................................................................................................................................................ .12 2

More than 4.70 to 5.80 lb ................................................................................................................................................ .14 21⁄4

More than 5.80 to 6.80 lb ................................................................................................................................................ .15 21⁄2

More than 6.80 to 7.90 lb ................................................................................................................................................ .17 23⁄4

More than 7.90 to 9.40 lb ................................................................................................................................................ .19 3

More than 9.40 to 11.70 lb .............................................................................................................................................. .22 31⁄2

More than 11.70 to 14.30 lb ............................................................................................................................................ .25 4

More than 14.30 to 17.70 lb ............................................................................................................................................ .28 41⁄2

More than 17.70 to 23.20 lb ............................................................................................................................................ .31 5

More than 23.20 to 31.60 lb ............................................................................................................................................ .37 6

More than 31.60 to 42.40 lb ............................................................................................................................................ .44 7

More than 42.40 to 54.40 lb ............................................................................................................................................ .50 8

More than 54.40 lb ........................................................................................................................................................... 4.2 percent of labeled

quantity

TABLE 3.—LIQUID OR DRY VOLUME MAV’S FOR INDIVIDUAL PACKAGES LABELED IN METRIC UNITS

Metric units

Labeled volume in milliliters (mL) or liters (L) MAV in mL

3 mL or less ...................................................................................................................................................... 0.51.

More than 3 to 8 mL ......................................................................................................................................... 1.01.

More than 8 to 15 mL ....................................................................................................................................... 1.51.

More than 15 to 22 mL ..................................................................................................................................... 2.

More than 22 to 67 mL ..................................................................................................................................... 3.5.

More than 67 to 126 mL ................................................................................................................................... 5.5.

More than 126 to 170 mL ................................................................................................................................. 7.5.

More than 170 to 222 mL ................................................................................................................................. 9.

More than 222 to 347 mL ................................................................................................................................. 11.

More than 347 to 503 mL ................................................................................................................................. 15.

More than 503 to 621 mL ................................................................................................................................. 18.

More than 621 to 798 mL ................................................................................................................................. 22.

More than 798 to 917 mL ................................................................................................................................. 26.

More than 917 to 1.153 L ................................................................................................................................. 30.

More than 1.153 to 1.627 L .............................................................................................................................. 37.
9868 Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules

TABLE 3.—LIQUID OR DRY VOLUME MAV’S FOR INDIVIDUAL PACKAGES LABELED IN METRIC UNITS—Continued

Metric units

Labeled volume in milliliters (mL) or liters (L) MAV in mL

More than 1.627 to 2.041 L .............................................................................................................................. 44.

More than 2.041 to 2.514 L .............................................................................................................................. 52.

More than 2.514 to 3.046 L .............................................................................................................................. 59.

More than 3.046 to 4.732 L .............................................................................................................................. 74.

More than 4.732 to 5.489 L .............................................................................................................................. 89.

More than 5.489 to 7.098 L .............................................................................................................................. 104.

More than 7.098 to 8.044 L .............................................................................................................................. 118.

More than 8.044 to 10.173 L ............................................................................................................................ 133.

More than 10.173 to 11.593 L .......................................................................................................................... 148.

More than 11.593 to 16.561 L .......................................................................................................................... 177.

More than 16.561 to 18.927 L .......................................................................................................................... 207.

More than 18.927 to 23.659 L .......................................................................................................................... 237.

More than 23.659 to 26.734 L .......................................................................................................................... 266.

More than 26.734 L ........................................................................................................................................... 1 percent of labeled quantity.

1 Use laboratory glassware.

TABLE 4.—LIQUID OR DRY VOLUME MAV’S FOR INDIVIDUAL PACKAGES LABELED IN INCH-POUND UNITS.

Inch-pound units

Labeled volume

(fluid ounces)

Liquid MAV (fluid

ounce)

Labeled volume

(cubic inches)

Dry MAV

(cubic inches)

0.50 or less ................................................................................................................... (1) ........................ 0.18 or less ......... 0.03

More than 0.50 to 0.75 ................................................................................................. 0.06 ..................... 0.18 to 0.49 ........ 0.06

More than 0.75 to 2.25 ................................................................................................. 0.13 ..................... 0.49 to 0.92 ........ 0.09

More than 2.25 to 4.25 ................................................................................................. 0.19 ..................... 0.92 to 1.35 ........ 0.11

More than 4.25 to 5.75 ................................................................................................. 0.25 ..................... 1.35 to 4.06 ........ 0.23

More than 5.75 to 7.5 ................................................................................................... 0.31 ..................... 4.06 to 7.67 ........ 0.34

More than 7.5 to 11.75 ................................................................................................. 0.38 ..................... 7.67 to 10.38 ...... 0.45

More than 11.75 to 17 .................................................................................................. 0.50 ..................... 10.38 to 13.54 .... 0.56

More than 17 to 21 ....................................................................................................... 0.63 ..................... 13.54 to 21.21 .... 0.68

More than 21 to 27 ....................................................................................................... 0.75 ..................... 21.21 to 30.68 .... 0.90

More than 27 to 31 ....................................................................................................... 0.88 ..................... 30.68 to 37.90 .... 1.13

More than 31 to 39 ....................................................................................................... 1.00 ..................... 37.90 to 48.73 .... 1.35

More than 39 to 55 ....................................................................................................... 1.25 ..................... 48.73 to 55.95 .... 1.58

More than 55 to 69 ....................................................................................................... 1.50 ..................... 55.95 to 70.38 .... 1.80

More than 69 to 85 ....................................................................................................... 1.75 ..................... 70.38 to 99.26 .... 2.26

More than 85 to 103 ..................................................................................................... 2.0 ....................... 99.26 to 124.5 .... 2.71

More than 103 to 160 ................................................................................................... 2.5 ....................... 124.5 to 153.4 .... 3.2

More than 160 to 185.6 ................................................................................................ 3.0 ....................... 153.4 to 185.9 .... 3.6

More than 185.6 to 240 ................................................................................................ 3.5 ....................... 185.9 to 288.8 .... 4.5

More than 240 to 272 ................................................................................................... 4.0 ....................... 288.8 to 335.0 .... 5.4

More than 272 to 344 ................................................................................................... 4.5 ....................... 335.0 to 443.1 .... 6.3

More than 344 to 392 ................................................................................................... 5.0 ....................... 443.1 to 490.9 .... 7.2

More than 392 to 560 ................................................................................................... 6.0 ....................... 490.9 to 620.8 .... 8.1

More than 560 to 640 ................................................................................................... 7.0 ....................... 620.8 to 707.4 .... 9.0

More than 640 to 800 ................................................................................................... 8.0 ....................... 707.4 to 1,011 .... 10.8

More than 800 to 904 ................................................................................................... 9.0 ....................... 1,011 to 1,155 .... 12.6

More than 904 .............................................................................................................. 1 percent of labeled quantity.1,155 to 1,444 ....

1,444 to 1,631 ....

More than 1,631

14.4

16.2

1 percent of labeled quantity.

1 Convert to metric units and use laboratory glassware.

TABLE 5.—COUNT MAV’S FOR INDIVIDUAL PACKAGES LABELED BY COUNT

Labeled count MAV

51 to 83 ............................................................................................................................................................. 2.

84 to 116 ........................................................................................................................................................... 3.

117 to 150 ......................................................................................................................................................... 4.

151 to 200 ......................................................................................................................................................... 5.

201 to 240 ......................................................................................................................................................... 6.

241 to 290 ......................................................................................................................................................... 7.

291 to 345 ......................................................................................................................................................... 8.

346 to 400 ......................................................................................................................................................... 9.

401 to 465 ......................................................................................................................................................... 10.

466 to 540 ......................................................................................................................................................... 11.
Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules 9869

TABLE 5.—COUNT MAV’S FOR INDIVIDUAL PACKAGES LABELED BY COUNT—Continued

Labeled count MAV

541 to 625 ......................................................................................................................................................... 12.

626 to 725 ......................................................................................................................................................... 13.

726 to 815 ......................................................................................................................................................... 14.

816 to 900 ......................................................................................................................................................... 15.

901 to 990 ......................................................................................................................................................... 16.

991 to 1,075 ...................................................................................................................................................... 17.

1,076 to 1,165 ................................................................................................................................................... 18.

1,166 to 1,250 ................................................................................................................................................... 19.

1,251 to 1,333 ................................................................................................................................................... 20.

More than 1,333 ................................................................................................................................................ 1.5 percent of labeled count rounded off to the nearest whole number.

§ 101.250 Maximum allowances for

moisture loss.

Reasonable variations caused by the

loss or gain of moisture in packaged

foods are permitted as specified in this

section. The following maximum

allowances for moisture loss, expressed

as a percentage of the labeled net

quantity of contents, are permitted:

(a) No allowance for moisture loss

will be made if:

(1) A food, other than a fresh bakery

product, is weighed within 7 days

following the end of the day of pack,

except where the packer provides

documentation of moisture loss during

this time period, and the documentation

has been produced in a manner that

complies with paragraph (d) of this

section; or

(2) A fresh bakery product is weighed

within 1 day following the end of the

day of pack, except where the packer

provides documentation of moisture

loss during this time period, and the

documentation has been produced in a

manner that complies with paragraph

(d) of this section; or

(3) The food is not listed in

paragraphs (b) or (c) of this section and

thus is not subject to moisture loss; or

(4) The food is packaged in an air

tight container (e.g., cans, glass bottles,

enclosed in paraffin);

(b) One percent for the following

foods: Frozen fruit and frozen vegetables

more than 7 days following the end of

the day of pack and fresh baked breads,

buns, rolls, and muffins more than 1

day, but less than 7 days, following the

end of the day of pack;

(c) Three percent for the following

foods more than 7 days following the

day of pack: Flour, pasta, rice, cheese

and cheese products, dried fruits and

vegetables, fresh fruits and vegetables,

coffee beans, and bakery products other

than fresh baked breads, buns, rolls, and

muffins; and

(d) A percent based on data that, upon

request, is provided to an agency

investigator to establish the moisture

loss; provided that, the data are gathered

through an approach that includes, but

is not limited to, all of the following

features:

(1) The data are based on 3 control

lots with each lot consisting of at least

12 randomly selected individual

packages that are collected on the same

day, and the total number of randomly

selected individual packages in the 3

lots is at least 48;

(2) Each of the individual packages in

the control lots is identified and

weighed at the time of collection;

(3) All control lots are stored at

various locations in the storage site

under the same conditions, which are

typical for storage of the product (e.g.,

if the product is typically placed in a

sealed case on a pallet and shrink

wrapped, the control lots must be stored

under those conditions, rather than

under laboratory conditions);

(4) All individual packages in the

control lots are weighed daily

throughout the entire duration of the

study;

(5) The maximum allowance for

moisture loss is the average percent

moisture loss that would be expected

with a 97-percent level of confidence for

the number of days of storage in view

of the individual package weighings in

all control lots for those days; and

(6) Where moisture loss varies with

climatic changes in environmental

conditions, the data are collected at an

appropriate time to justify the moisture

loss. For example, where an inspection

is made of current production at a food

processing plant in the middle of July,

and moisture loss varies significantly

from winter to summer, data collected

in January cannot be used to document

moisture loss during the inspection.

PART 161—FISH AND SHELLFISH

3. The authority citation for 21 CFR

part 161 continues to read as follows:

Authority: Secs. 201, 401, 403, 409, 701,

721 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 341, 343, 348, 371, 379e).

4. Section 161.130 is amended by

revising paragraph (c)(1) and adding

new paragraph (d) to read as follows:

§ 161.130 Oysters.

* * * * *

(c) * * *

(1) ‘‘Shell oysters’’ means live oysters

of any of the species, Crassostrea gigas,

Crassostrea virginica, and Ostrea

conchaphila, in the shell, which, after

removal from their beds, have not been

floated or otherwise held under

conditions that result in the addition of

water.

(2) [Reserved]

(d) The oysters shall not have more

than 15-percent liquid by weight after

packing.

PART 501—ANIMAL FOOD LABELING

5. The authority citation for 21 CFR

Part 501 continues to read as follows:

Authority: Secs. 4, 5, 6 of the Fair

Packaging and Labeling Act (15 U.S.C. 1453,

1454, 1455); secs. 201, 301, 402, 403, 409,

701 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 331, 342, 343, 348, 371).

6. Section 501.105 is amended by

revising paragraphs (a),(b), and (g) and

by adding new paragraph (u) to read as

follows:

§ 501.105 Declaration of net quantity of

contents.

(a) The principal display panel of a

food in package form shall bear a

declaration of the net quantity of

contents. This shall be expressed in the

terms of weight, measure, numerical

count, or a combination of numerical

count and weight or measure. If the food

is liquid the declaration shall be in

terms of fluid measure. If the food is

solid, semisolid, or viscous, or a mixture

of solid and liquid the declaration shall

be expressed in terms of weight. If the

food is a fresh fruit, fresh vegetable, or
9870 Federal Register / Vol. 62, No. 42 / Tuesday, March 4, 1997 / Proposed Rules

other dry commodity that is customarily

sold by dry measure the declaration

statement may be expressed in terms of

dry measure. If the food is packaged in

a self-pressurized container, the

statement shall be in terms of the mass

or weight of the food and the propellant

that will be expelled when the

instructions for use as shown on the

container are followed. If there is a

firmly established general consumer

usage and trade custom of declaring the

contents of a liquid by weight, or a

solid, semisolid, or viscous product by

fluid measure, it may be used.

Whenever the Food and Drug

Administration determines that an

existing practice of declaring net

quantity of contents by weight, measure,

numerical count, or a combination in

the case of a specific packaged food

does not facilitate value comparisons by

consumers and offers opportunity for

consumer confusion, it will by

regulation designate the appropriate

term or terms to be used for such

commodity.

(b)(1) Statements of weight shall be in

terms of avoirdupois pound and ounce.

(2) Statements of fluid measure shall

be in terms of the U.S. gallon of 231

cubic inches and quart, pint, and fluid

ounce subdivisions thereof, and shall:

(i) In the case of frozen food that is

sold and consumed in a frozen state,

express the volume at -18 °C (0 °F);

(ii) In the case of refrigerated food that

is sold in the refrigerated state, express

the volume at 4 °C (40 °F);

(iii) In the case of other foods, express

the volume at 20 °C (68 °F);

(3) Statements of dry measure shall be

in terms of the U.S. bushel of 2,150.42

cubic inches and peck, dry quart, and

dry pint subdivisions thereof.

* * * * *

(g) The declaration of net quantity of

contents shall provide an accurate

statement of the quantity of contents of

the package. For purposes of this

section, an accurate statement is one

that conforms to all requirements for the

declaration set forth under part 101 of

this chapter except for §§ 101.200 and

101.201. Sections 101.240, 101.245, and

101.250 of this chapter identify what

constitutes a reasonable variation in net

content declarations that is the result of

loss or gain of moisture during the

course of good distribution practice or

by unavoidable deviations in good

manufacturing practice. Maximum

allowance for moisture loss as permitted

under § 101.250(c) applies to dry animal

food. All net contents measurements

shall be made in accordance with the

procedures and methodology set forth in

part 101 of this chapter. Any net

quantity of contents declarations that

overstate the amount of product in the

container by an amount that is more

than that can be attributed to a

reasonable variation under these

regulations will misbrand the product

under section 403(e) of the Federal

Food, Drug, and Cosmetic Act.

* * * * *

(u) ‘‘Dry animal food’’ means animal

food packaged in paperboard boxes or

kraft paper bags that has 13 percent or

less moisture at time of pack.

Dated: January 30, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–4956 Filed 3–3–97; 8:45am]

BILLING CODE 4160–01–P