[Federal Register Volume 62, Number 42 (Tuesday, March 4, 1997)]
[Proposed Rules]
[Pages 9826-9870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4956]


      

[[Page 9825]]

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Part II





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



_______________________________________________________________________



21 CFR Parts 101, 161, and 501



Food Labeling: Net Quantity of Contents; Compliance; Proposed Rule

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

[[Page 9826]]



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.

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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 Secs. 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

[[Page 9827]]

quantity of contents shall not be unreasonably large.

    Although Secs. 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, 
Secs. 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 Sec. 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 Sec. 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 Sec. 101.106 could not be practicably substituted for existing 
general provisions of Sec. 101.105(q).
    Some comments objected that, because the moisture loss provisions 
of proposed Sec. 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 Sec. 101.106 would be forced to 
overfill food packages by approximately 9 percent until FDA revised 
Sec. 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 Sec. 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 Sec. 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

[[Page 9828]]

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 <SUP>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.
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     <SUP>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.
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    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

[[Page 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 Sec. 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.

[[Page 9830]]

    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

[[Page 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.

[[Page 9832]]

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 Secs. 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 Secs. 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 Secs. 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 (Sec. 101.105(h)) and location requirements for such 
declarations (Sec. 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 Sec. 101.105(b)(2) and (g) 
into a new section. FDA is also redesignating Sec. 101.105 as 
Sec. 101.200 and moving it to a new subpart H of part 101. The proposed 
new section that FDA is creating out of Sec. 101.105(b)(2) and (g), 
proposed Sec. 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 Secs. 101.200 and 101.201, FDA is proposing to cross-
reference the provisions in part 101 in part 501 (proposed 
Sec. 501.105(g)).
    In addition to redesignating certain provisions that had appeared 
in Sec. 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, 
Secs. 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  deg.F 
(-17.8  deg.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  deg.C (-4  deg.F), the density of water is 0.993550 
grams (g) per cubic centimeter, and at 0  deg.C (+32  deg.F), the 
density of water is 0.9998425 g per cubic centimeter. Thus, 12 fluid 
ounces of frozen orange juice at 0  deg.C (+32  deg.F) would occupy 
354.9 millimeters (mL), but at -20  deg.C (-4  deg.F), it would occupy 
357.1 mL, a difference of 0.6 percent. Since defrosting freezers that 
cycle between -10 and +20  deg.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  deg.C, and placed it before 0  deg.F in proposed 
Sec. 101.201(a)(2)(i) and proposed Sec. 501.105(b)(2)(i).
    2. Accuracy Within Reasonable Variations
    As mentioned previously in this section of the document, paragraphs 
(g) and (q) of Secs. 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 Secs. 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 Secs. 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

[[Page 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 Secs. 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 Sec. 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 Sec. 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 aerosol-packaged 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 industry-wide 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 Sec. 101.105(a) as Sec. 101.200(a) and revise newly 
redesignated Sec. 101.200(a) and revise Sec. 501.105(a) to provide that 
a food packaged in a self-pressurized 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 Sec. 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 (Sec. 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 Sec. 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 Sec. 101.12 in 
determining whether net contents declarations must include the packing 
medium. Therefore, FDA is proposing to require in Sec. 101.200(a) that, 
except where the reference amount customarily consumed per eating 
occasion is in terms of drained solids in accordance with Sec. 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

[[Page 9834]]

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, Sec. 101.105(o) (which 
would be redesignated as Sec. 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 Sec. 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 Sec. 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 Sec. 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 = (<greek-S>(xi-x)2/(n-1))\1/2\ or equivalently (and primarily for 
calculations without a computer),
s = ((<greek-S>xi<SUP>2-(<greek-S>x<INF>i)<SUP>2/n)/(n-1))\1/2\.
    Where:
<greek-S> 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

[[Page 9835]]

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 Sec. 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 Sec. 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 Sec. 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 <SUP>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.
---------------------------------------------------------------------------

     <SUP>2 The 1994 Handbook's definition appears in Table 3-3 on 
page B-17 of the Handbook 133 portion, of the 1994 Handbook.
---------------------------------------------------------------------------

    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.<SUP>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.
---------------------------------------------------------------------------

     <SUP>3 See Chapter 2 and Table 2-1 in Appendix B of the 
Handbook 133 portion of the 1994 Handbook.
---------------------------------------------------------------------------

    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 Sec. 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

[[Page 9836]]

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 Sec. 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 deg. (2 deg. 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 deg.C or 2 deg.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 Sec. 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.<SUP>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.
---------------------------------------------------------------------------

     <SUP>4 See section 5.3.1, page 5-6 of the Handbook 133 portion 
of the 1994 Handbook.
---------------------------------------------------------------------------

    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 Sec. 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 Sec. 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 Sec. 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.

[[Page 9837]]

    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.<SUP>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.
---------------------------------------------------------------------------

    5 FDA also has imposed the 25-percent criterion on its field 
personnel for many years (see section 428.21 of FDA's Investigations 
Operations Manual).
---------------------------------------------------------------------------

    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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 
Sec. 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'' (Sec. 101.215(d)(2)(i)), which is conducted 
by applying mass standards to the

[[Page 9838]]

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'' (Sec. 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) (Sec. 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'' 
(Sec. 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 
Sec. 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 Sec. 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 Sec. 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 
Sec. 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.<SUP>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 
Sec. 101.215 because that standard focuses on the number of errors for 
rejection rather than the number of errors that are permitted.
---------------------------------------------------------------------------

     <SUP>6 Section 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.
---------------------------------------------------------------------------

    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 Sec. 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-to-date 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

[[Page 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 Sec. 101.215(e)(1), FDA is 
proposing to require that any stopwatch used in procedures for 
measuring net contents not have an error exceeding <plus-minus>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 Sec. 101.215(e)(2), FDA is 
proposing to require that any thermometer used in procedures for 
measuring net contents not have an error exceeding <plus-minus>1 deg. 
Celsius (2  deg.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 
<plus-minus>0.39 mm (<plus-minus> 1/64 inch), and (2) that, for 
measurements greater than 63.5 cm (25 in), measurement errors shall be 
no greater than <plus-minus>2.5 mm (<plus-minus> 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 <plus-minus> 50 
micrometers for lengths of up to 400 mm; of <plus-minus> 100 
micrometers for lengths of 400 mm to 800 mm; and of <plus-minus> 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 Sec. 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 Sec. 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 
Sec. 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 Sec. 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

[[Page 9840]]

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 
Sec. 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 Sec. 101.220, for volume in Sec. 101.225, for count in 
Sec. 101.230, and for tare in Sec. 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 Sec. 101.220, net mass or weight. As mentioned above, 
analytical procedures pertaining to net mass or weight appear in 
proposed Sec. 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 Sec. 101.220(a), which states 
that all measuring equipment must conform to Sec. 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 
Sec. 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 Sec. 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 Sec. 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

[[Page 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 
Sec. 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 Sec. 101.220, it 
will consider whether to propose to revise those regulations for 
consistency with Sec. 101.220 or to remove the procedures from those 
regulations.
    With respect to procedures for specific products, the agency is 
proposing in Sec. 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 Sec. 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 Sec. 101.225, volume. Proposed Sec. 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 Sec. 101.225(a), FDA is proposing to require that measuring 
equipment conform to Sec. 101.215, and that good weighing and measuring 
procedures be used for all measurements.
    The core procedures for net volume appear in proposed Sec. 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 Sec. 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 Sec. 101.201(a) for appropriate reference temperature) and

[[Page 9842]]

comparing the liquid level with the graduations on the measure.
    The procedure prescribed in proposed Sec. 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 
Sec. 101.225(c) could have significant errors. When product density is 
constant, however, the gravimetric procedure in proposed 
Sec. 101.225(c) is considerably faster than the procedure in proposed 
Sec. 101.225(b) because, under Sec. 101.225(c), most packages are 
simply weighed, while under Sec. 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 Sec. 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 Sec. 101.225(c) contain a 
provision prohibiting its use to determine net volume because the 
product density is not constant (see proposed Sec. 101.225(c)(3)(v)).
    NIST advised (Ref. 3) that proposed Sec. 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 Sec. 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  deg.C (33  deg.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  deg.F (0.56  deg.C) or below for kerosene 
in the AOAC procedure, provided that the food does not mix with the 
water.
    In Sec. 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 Sec. 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 Sec. 101.225 and the corresponding Handbook 133 
procedures. The difference concerns reference temperatures. As 
mentioned previously in this preamble, a

[[Page 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 Sec. 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 Sec. 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  deg.C (0  deg.F) to -15  deg.C (5  deg.F) 
for frozen food, from 1.7  deg.C (35  deg.F) to 7.2  deg.C (45  deg.F) 
for refrigerated food, and from 20  deg.C (68  deg.F) to 22.7  deg.C 
(73  deg.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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 101.230(a) and the gravimetric count core procedure 
in Sec. 101.230(b). Where it may be used, the gravimetric procedure for 
net count is considerably faster than the procedure in proposed 
Sec. 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 
Sec. 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

[[Page 9844]]

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 Sec. 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 
Sec. 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.
---------------------------------------------------------------------------

    \7\ Section 5.1.3, page 5-3, of Handbook 133.
---------------------------------------------------------------------------

    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 
Sec. 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 Sec. 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 Sec. 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.

[[Page 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 Sec. 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 
Sec. 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

[[Page 9846]]

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 
Sec. 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 Sec. 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=(<greek-S>(x<INF>i-x)<SUP>2/(n-1))<SUP>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, Sec. 101.240:
0.5774 SEL=1.203 x 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 <plus-minus> SEL=-0.42 oz 
<plus-minus>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 x 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, 
Sec. 101.240: 0.5774 SEL=0.0458 x 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 <plus-minus> SEL=-0.02 
oz<plus-minus>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 x 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, Sec. 101.240: 0.5774
SEL=0.5448 x 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 <plus-minus>SEL=-0.32 
oz<plus-minus>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 x 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.

[[Page 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 Sec. 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,

[[Page 9848]]

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 Sec. 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, Sec. 101.240 provides step-by-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 
Sec. 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 Secs. 101.240(b)(2) and 101.250). 
FDA is proposing in proposed Sec. 101.250 to identify the extent to 
which moisture loss affects these violative findings. Under proposed 
Sec. 101.240(b)(2), the appropriate moisture allowance provided for the 
specific food in Sec. 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 Sec. 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

[[Page 9849]]

subject to proposed Sec. 101.245(e) from the average requirements of 
proposed Sec. 101.240. Proposed Sec. 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,<SUP>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.
---------------------------------------------------------------------------

    8 See section 5.2, page 54, Handbook 133.
---------------------------------------------------------------------------

    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 
Sec. 101.245(e), the section pertaining to the procedures for 
individual packages, rather than in Sec. 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 Sec. 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 Sec. 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

[[Page 9850]]

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 Sec. 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, Sec. 101.245 provides step-by-step instruction on how 
to determine the appropriate MAV for the labeled net quantity of 
contents using the appropriate table Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 101.210(b), the 
sample consists of less than 48 individual packages, proposed 
Sec. 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 
Sec. 101.210(b), the sample size consists of 48 individual packages, 
proposed Sec. 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 Sec. 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 time-consuming 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

[[Page 9851]]

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 Sec. 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 Sec. 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 Sec. 101.250(a)(2) for bakery products.
    In proposed Sec. 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 Sec. 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 Sec. 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

[[Page 9852]]

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 Sec. 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 Sec. 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 
Sec. 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 (Sec. 101.250(a)(4)). 
Further, the agency is proposing that if the food is not subject to 
moisture loss, no allowance is permitted (Sec. 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''

[[Page 9853]]

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-by-side 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 Sec. 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 <SUP>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.
---------------------------------------------------------------------------

    9 Section 1.5.2.3. of the Uniform Method of Sale of Commodities 
Regulation.
---------------------------------------------------------------------------

    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 
Sec. 161.130(d).
    In addition, FDA is aware that the names for the species of oysters 
currently identified in Sec. 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 Sec. 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 Sec. 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 
Sec. 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 
Sec. 101.105 as Sec. 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 Sec. 101.105, the actual location in new Sec. 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 
Secs. 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 Sec. 501.105 in the same manner as it is 
proposing to revise Sec. 101.200 (current Sec. 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 Sec. 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 
Sec. 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 Sec. 501.105.
    The accuracy provisions for animal food regulations are slightly 
different from the provisions in proposed Sec. 101.200 for human food 
because of the previously discussed differences in the proposed animal 
and human food provisions. Instead, proposed Sec. 501.105 excepts 
provisions of Sec. 101.200 from incorporation with the rest of subpart 
H of part 101. Because proposed Sec. 501.105 contains all the 
provisions of proposed Sec. 101.201, FDA is also not incorporating the 
latter provision in Sec. 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

[[Page 9854]]

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 shucking-packing 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

[[Page 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 Secs. 101.200 through 101.250) is 
added, Sec. 101.105 of subpart G is redesignated as Sec. 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


Sec. 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 
Sec. 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

[[Page 9856]]

the liquids. Where the reference amount in Sec. 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 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 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.
* * * * *


Sec. 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  deg.C (0  deg.F);
    (2) In the case of refrigerated food that is sold in the 
refrigerated state, at 4  deg.C (40  deg.F); and
    (3) In the case of other foods, at 20  deg.C (68  deg.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.


Sec. 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=(<greek-S>(x<INF>i-x)<SUP>2/(n-1))<SUP>1/2 or equivalently (and 
primarily for calculations without a computer),
s=((<greek-S>x<INF>i<SUP>2-(<greek-S>x<INF>i)<SUP>2/n)/(n-1))<SUP>1/2.

Where:

<greek-S> means ``the sum of,''
x<INF>i 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 Sec. 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 (n<INF>t), 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

[[Page 9857]]

measurement of volumes of liquids (e.g., standard measuring flasks, 
graduates, cylinders, etc.).


Sec. 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.


Sec. 101.215  Measuring equipment.

    (a) Thermometer selection. Graduations on a thermometer shall be no 
larger than 1  deg.C (2  deg.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 equal-arm 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

[[Page 9858]]

[GRAPHIC] [TIFF OMITTED] TP04MR97.000



[[Page 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
[GRAPHIC] [TIFF OMITTED] TP04MR97.001


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                       
------------------------------------------------------------------------
                                    Minimum and total                   
   Value of smallest balance        number of balance      Balance class
          division \1\                  divisions                       
------------------------------------------------------------------------
1 milligram to 0.5 gram (g)....  Device has more than     II            
                                  100, but not more than                
                                  100,000 balance                       
                                  divisions.                            
0.1 g or more..................  Device has more than     II            
                                  5,000, but not more                   
                                  than 100,000 balance                  
                                  divisions.                            
0.1 g to 2 g...................  Device has more than     III           
0.0002 pound (lb) to 0.005 lb     100, but not more than                
0.005 ounce (oz) to 0.125 oz      10,000 balance                        
                                  divisions.                            
5 g or more....................  Device has more than     III           
0.01 lb or more                   500, but not more than                
0.25 oz or more                   10,000 balance                        
                                  divisions.                            
------------------------------------------------------------------------
\1\ On 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, <plus-minus> 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               
------------------------------------------------------------------------
                                                              Number of 
                                    Balance class III test     balance  
  Balance class II test load in         load in balance       divisions 
        balance divisions                  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
------------------------------------------------------------------------


[[Page 9860]]

    (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 <plus-minus>2 seconds in a 3-hour time period;
    (2) Thermometer standardization. A thermometer shall not have an 
error exceeding <plus-minus>1  deg.C (2  deg.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 <plus-minus>0.39 millimeter 
(<plus-minus>\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 
<plus-minus>2 millimeter (<plus-minus>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          
------------------------------------------------------------------------
                                                             Error limit
               Measured length in millimeters                     in    
                                                             micrometers
------------------------------------------------------------------------
0 to 400...................................................  <plus-minus
                                                                    >50 
400 to 800.................................................  <plus-minus
                                                                   >100 
800 to 1000................................................  <plus-minus
                                                                   >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\          
------------------------------------------------------------------------
                                                        Error limits for
Capacity at 20  deg.C (68  deg.F)   Error limits for       individual   
                                    the full capacity     graduations   
------------------------------------------------------------------------
50 milliliter (mL) cylinder......  <plus-minus>0.3     <plus-minus>0.3  
                                    mL<plus-minus>      mL              
2 fluid ounces (59 mL) cylinder..  <plus-minus>0.3 mL  <plus-minus>0.30 
                                                        mL              
100 mL flask.....................  <plus-minus>0.2 mL  <plus-minus>0.06 
                                                        mL              
1 gill (118 mL) flask............  <plus-minus>0.2 mL  <plus-minus>0.10 
                                                        mL              
200 mL flask.....................  <plus-minus>0.3 mL  <plus-minus>0.10 
                                                        mL              
\1/2\ pint (236 mL) flask........  <plus-minus>0.3 mL  <plus-minus>0.10 
                                                        mL              
250 mL flask.....................  <plus-minus>0.3 mL  <plus-minus>0.10 
                                                        ml              
1 pint (473 mL) flask............  <plus-minus>0.4 mL  <plus-minus>0.15 
                                                        mL              
500 mL flask.....................  <plus-minus>0.5 mL  <plus-minus>0.15 
                                                        mL              
1 quart (946 mL) flask...........  <plus-minus>0.7 mL  <plus-minus>0.30 
                                                        mL              
1,000 mL flask...................  <plus-minus>0.8 mL  <plus-minus>0.22 
                                                        mL              
\1/2\ gallon (1,892 mL) flask....  <plus-minus>1.0 mL  <plus-minus>0.30 
                                                        mL              
2,000 mL flask...................  <plus-minus>1.2 mL  <plus-minus>0.33 
                                                        mL              
1 gallon (3,785 mL) flask........  <plus-minus>1.2 mL  <plus-minus>0.30 
                                                        mL              
------------------------------------------------------------------------
\1\ For volumetric measures less than 50 mL, full capacity error limits 
  do not apply. For these volumetric measures apply <plus-minus>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 <plus-minus>0.02 percent of nominal capacity for error  
  limits at full capacity and <plus-minus>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 Inch-Pound Mass Standards Used To Test   
                       Tolerance Class II Balances                      
------------------------------------------------------------------------
          Mass standard in pounds            Error limits in  milligrams
------------------------------------------------------------------------
100.......................................  <plus-minus>910             
50........................................  <plus-minus>450             
25........................................  <plus-minus>23              
10........................................  <plus-minus>91              
5.........................................  <plus-minus>45              
2.........................................  <plus-minus>18              
1.........................................  <plus-minus>9               
0.5.......................................  <plus-minus><greek-K>4.5    
0.2.......................................  <plus-minus>1.8             
0.1.......................................  <plus-minus>1.1             
0.05......................................  <plus-minus>0.77            
0.02......................................  <plus-minus>0.45            
0.01......................................  <plus-minus>0.34            
0.005.....................................  <plus-minus>0.27            
0.002.....................................  <plus-minus>0.19            
0.001.....................................  <plus-minus>0.15            


    Table 5.--Error Limits for Inch-Pound Mass Standards Used To Test   
                 Tolerance Class II Balances--Continued                 
------------------------------------------------------------------------
          Mass standard in ounces            Error limits in  milligrams
------------------------------------------------------------------------
8.........................................  <plus-minus>4.5             
4.........................................  <plus-minus>2.3             
2.........................................  <plus-minus>1.3             
1.........................................  <plus-minus>0.86            
0.5 (\1/2\)...............................  <plus-minus>0.59            
0.25 (\1/4\)..............................  <plus-minus>0.43            
0.2.......................................  <plus-minus>0.38            
0.125 (\1/8\).............................  <plus-minus>0.31            
0.1.......................................  <plus-minus>0.29            
0.0625 (\1/16\)...........................  <plus-minus>0.24            
0.05......................................  <plus-minus>0.23            
0.03125 (\1/32\)..........................  <plus-minus>0.19            
0.02......................................  <plus-minus>0.17            
0.015625 (\1/64\).........................  <plus-minus>0.15            
0.01......................................  <plus-minus>0.14            
------------------------------------------------------------------------


   Table 6.--Error Limits for SI Mass Standards Used To Test Tolerance  
                            Class II Balances                           
------------------------------------------------------------------------
        Mass standard in kilograms           Error limits in  milligrams
------------------------------------------------------------------------
50........................................  <plus-minus>1000            
25........................................  <plus-minus>500             
20........................................  <plus-minus>400             
10........................................  <plus-minus>200             
5.........................................  <plus-minus>100             
2.........................................  <plus-minus>40              
1.........................................  <plus-minus>20              
                                                                        
------------------------------------------------------------------------
          Mass standard in grams             Error Limits in milligrams 
------------------------------------------------------------------------
                                                                        
500.......................................  <plus-minus>10              
300.......................................  <plus-minus>6               
200.......................................  <plus-minus>4               
100.......................................  <plus-minus>2               
50........................................  <plus-minus>1.2             
30........................................  <plus-minus>0.90            
20........................................  <plus-minus>0.70            
10........................................  <plus-minus>0.50            
5.........................................  <plus-minus>0.36            
2.........................................  <plus-minus>0.26            
1.........................................  <plus-minus>0.20            
                                                                        
------------------------------------------------------------------------
        Mass standard in milligrams          Error Limits in milligrams 
------------------------------------------------------------------------
                                                                        
500.......................................  <plus-minus>0.16            
300.......................................  <plus-minus>0.14            
200.......................................  <plus-minus>0.12            
100.......................................  <plus-minus>0.10            
50........................................  <plus-minus>0.085           
30........................................  <plus-minus>0.075           
20........................................  <plus-minus>0.070           
10........................................  <plus-minus>0.060           
5.........................................  <plus-minus>0.055           
2.........................................  <plus-minus>0.05            
1.........................................  <plus-minus>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.

[[Page 9861]]



    Table 7.--Error Limits for Inch-pound Mass Standards Used To Test   
                      Tolerance Class III Balances                      
------------------------------------------------------------------------
          Mass standard in pounds               Error limits in grams   
------------------------------------------------------------------------
100.......................................  <plus-minus>4.5             
50........................................  <plus-minus>2.3             
25........................................  <plus-minus>1.1             
20........................................  <plus-minus>0.91            
10........................................  <plus-minus>0.45            
                                                                        
------------------------------------------------------------------------
                                             Error limits in milligrams 
------------------------------------------------------------------------
                                                                        
5.........................................  <plus-minus>230             
2.........................................  <plus-minus>91              
1.........................................  <plus-minus>70              
0.5.......................................  <plus-minus>45              
0.2.......................................  <plus-minus>18              
0.1.......................................  <plus-minus>9.1             
0.05......................................  <plus-minus>4.5             
0.02......................................  <plus-minus>1.8             
0.01......................................  <plus-minus>1.5             
0.005.....................................  <plus-minus>1.2             
0.002.....................................  <plus-minus>0.87            
0.001.....................................  <plus-minus>0.7             
                                                                        
------------------------------------------------------------------------
          Mass standard in ounces            Error limits in milligrams 
                                                                        
------------------------------------------------------------------------
                                                                        
8.........................................  <plus-minus>45              
4.........................................  <plus-minus>23              
2.........................................  <plus-minus>11              
1.........................................  <plus-minus>5.4             
0.5 (\1/2\)...............................  <plus-minus>2.8             
0.25 (\1/4\)..............................  <plus-minus>1.7             
0.2.......................................  <plus-minus>1.6             
0.125 (\1/8\).............................  <plus-minus>1.3             
0.1.......................................  <plus-minus>1.3             
0.0625 (\1/16\)...........................  <plus-minus>1.1             
0.05......................................  <plus-minus>1.0             
0.03125 (\1/32\)..........................  <plus-minus>0.87            
0.02......................................  <plus-minus>0.75            
0.015625 (\1/64\).........................  <plus-minus>0.69            
0.01......................................  <plus-minus>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........................................  <plus-minus>5               
20........................................  <plus-minus>2               
10........................................  <plus-minus>1               
5.........................................  <plus-minus>0.5             
2.........................................  <plus-minus>0.2             
1.........................................  <plus-minus>0.1             
                                                                        
------------------------------------------------------------------------
          Mass standard in grams             Error limits in milligrams 
                                                                        
------------------------------------------------------------------------
500.......................................  <plus-minus>70              
300.......................................  <plus-minus>60              
200.......................................  <plus-minus>40              
100.......................................  <plus-minus>20              
50........................................  <plus-minus>10              
20........................................  <plus-minus>4               
10........................................  <plus-minus>2               
5.........................................  <plus-minus>1.5             
2.........................................  <plus-minus>1.1             
1.........................................  <plus-minus>0.9             


   Table 8.--Error Limits for SI Mass Standards Used to Test Tolerance  
                      Class III Balances--Continued                     
------------------------------------------------------------------------
        Mass standard in kilograms           Error limits in milligrams 
------------------------------------------------------------------------
500.......................................  <plus-minus>0.72            
300.......................................  <plus-minus>0.61            
200.......................................  <plus-minus>0.54            
100.......................................  <plus-minus>0.43            
50........................................  <plus-minus>0.35            
30........................................  <plus-minus>0.30            
20........................................  <plus-minus>0.26            
10........................................  <plus-minus>0.21            
5.........................................  <plus-minus>0.17            
2.........................................  <plus-minus>0.12            
1.........................................  <plus-minus>0.10            
------------------------------------------------------------------------

Sec. 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 
Sec. 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 Sec. 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 deg. to 20 deg. 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

[[Page 9862]]

 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.


Sec. 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 
Sec. 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 Sec. 101.201(a), within the following temperature 
ranges:
    (i) In the case of frozen food, -18  deg.C (0  deg.F) to -15  deg.C 
(5  deg.F);
    (ii) In the case of refrigerated food, 1.7  deg.C (35  deg.F) to 
7.2  deg.C (45  deg.F); or
    (iii) In the case of other foods, 20  deg.C (68  deg.F) to 22.7 
deg.C (73  deg.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 deg. 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 (<plus-minus> 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 Sec. 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 (vol<INF>std) 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 vol<INF>std 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

[[Page 9863]]

 accordance with provisions of Sec. 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 (Vol<INF>std) 
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 <INF>avg);
    (iii) Calculate the average net mass or weight of the labeled 
volume (avg. wt v<INF>1) of the food using the formula:

Avg. wt v<INF>1=(net wt<INF>avg/vol<INF>std)  x  labeled volume of net 
contents;

    (iv) Calculate the ``nominal gross mass or weight'' (nom. gr. wt) 
using the formula:

Nom. gr. wt = avg wt v<INF>1 + 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 (vol<INF>std)]

    (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  deg.F (0.56  deg.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 Sec. 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 
<plus-minus>0.05 millimeter (<plus-minus>0.002 inch). The outer edge 
should be beveled at a 30 deg. 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 Sec. 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.


Sec. 101.230  Analytical procedures, count.

    The following procedures shall be used to determine the net 
quantity of

[[Page 9864]]

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 Sec. 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 Sec. 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 <INF>avg) and the average net mass or weight 
(net wt <INF>avg);
    (iii) Calculate the average net mass or weight of the labeled count 
(ave. wt c<INF>1) of the food using the formula:

Avg. wt c<INF>1 = (net wt<INF>avg/count<INF>avg)  x  labeled count of 
net contents;

    (iv) Calculate the ``nominal gross mass or weight'' (nom. gr. wt) 
using the formula:

Nom. gr. wt = avg wt c<INF>1 + 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 
wt<INF>avg)] multiplied by [average of count of paragraph (b)(2) 
(count<INF>avg)]


Sec. 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 (n<INF>t) 
listed in Table 1 of this section for the different sample sizes (n) as 
follows:
    (b) Select an initial tare sample size (``n<INF>it'') 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 (n<INF>it) and the range of masses or weights of 
the tare samples (abbreviated as ``R<INF>t''). 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 ``R<INF>c''). For random weight 
packages ``R<INF>c'' 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 
(R<INF>c) to the range of masses or weights in the initial tare sample 
size (R<INF>t) (i.e., divide R<INF>c by R<INF>t);
    (g) From Table 1 of this section, determine the total tare sample 
size corresponding to the R<INF>c/R<INF>t ratio determined in paragraph 
(f) (e.g., if the ratio of R<INF>c/R<INF>t 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 R<INF>c/R<INF>t 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 n<INF>t)                            
----------------------------------------------------------------------------------------------------------------
                                                                 Number of packages in sample \1\               
                                                ----------------------------------------------------------------
                  Ratio R<INF>c/R<INF>t                        n=12               n=24                      n=48          
                                                ----------------------------------------------------------------
                                                    n<INF>it=2        n<INF>it=2        n<INF>it=3        n<INF>it=2        n<INF>it=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

[[Page 9865]]

                                                                                                                
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.                                              

Sec. 101.240  Compliance procedures; average requirement.

    Except where the sample contains packages with a declaration in 
terms of count that is subject to Sec. 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 2 
                                                                sample  
                    Column 1 sample size                      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
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

[[Page 9866]]

classified violative; except that, if the sample consists of a product 
for which a moisture loss allowance has been established in 
Sec. 101.250, the appropriate allowance percent (A%) provided for in 
that section shall be used to calculate an adjusted sample error limit 
(SEL<INF>adj) according to the formula:

SEL<INF>adj = s  x  SCF + (A%  x  labeled contents/100)


Sec. 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 
Sec. 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.                                
----------------------------------------------------------------------------------------------------------------


[[Page 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
------------------------------------------------------------------------
                                                                        
(1) 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       1\1/8\
More than 2.14 to 2.48 lb.....................         .078       1\1/4\
More than 2.48 to 2.76 lb.....................         .086       1\3/8\
More than 2.76 to 3.20 lb.....................         .094       1\1/2\
More than 3.20 to 3.90 lb.....................          .11       1\3/4\
More than 3.90 to 4.70 lb.....................          .12            2
More than 4.70 to 5.80 lb.....................          .14       2\1/4\
More than 5.80 to 6.80 lb.....................          .15       2\1/2\
More than 6.80 to 7.90 lb.....................          .17       2\3/4\
More than 7.90 to 9.40 lb.....................          .19            3
More than 9.40 to 11.70 lb....................          .22       3\1/2\
More than 11.70 to 14.30 lb...................          .25            4
More than 14.30 to 17.70 lb...................          .28       4\1/2\
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............................                          
(1)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..........................................    0.5<SUP>1.                                                 
More than 3 to 8 mL...................................    1.0<SUP>1.                                                 
More than 8 to 15 mL..................................    1.5<SUP>1.                                                 
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.                                                    

[[Page 9868]]

                                                                                                                
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.                          
----------------------------------------------------------------------------------------------------------------
<SUP>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 (cubic                            
 Labeled volume  (fluid ounces)    Liquid MAV (fluid ounce)           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       1,155 to 1,444...........  14.4                    
                                   quantity.                 1,444 to 1,631...........  16.2                    
                                                             More than 1,631..........  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.                                                           

[[Page 9869]]

                                                                                                                
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.                                                      
----------------------------------------------------------------------------------------------------------------

Sec. 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:


Sec. 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:


Sec. 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

[[Page 9870]]

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  deg.C (0  deg.F);
    (ii) In the case of refrigerated food that is sold in the 
refrigerated state, express the volume at 4  deg.C (40  deg.F);
    (iii) In the case of other foods, express the volume at 20  deg.C 
(68  deg.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 Secs. 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 Sec. 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