Food Labeling; Net Quantity of Contents; Compliance
Federal RegisterMar 4, 1997
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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 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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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 = ((xi-x)2/(n-1))\1/2\ or equivalently (and primarily for
calculations without a computer),
s = ((xi2-(xi)2/n)/(n-1))\1/2\.
Where:
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 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.
---------------------------------------------------------------------------
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.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.
---------------------------------------------------------------------------
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.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.
---------------------------------------------------------------------------
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.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 1986.6 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.
---------------------------------------------------------------------------
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 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 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
0.39 mm ( 1/64 inch), and (2) that, for
measurements greater than 63.5 cm (25 in), measurement errors shall be
no greater than 2.5 mm ( 0.1 inch). NIST
recommended that FDA proposes to include provisions that reflect these
recommendations in the regulation.
FDA tentatively concludes that it should generally follow NIST's
recommendations in matters concerning weights and measures. FDA is
therefore proposing to adopt NIST's recommendations for standardization
of tapes and rulers.
For calipers and depth gauges used to determine the level of fill
in packages labeled by volume (headspace), the agency is also proposing
standardization criteria based on information provided by NIST (Ref 3).
NIST recommended that FDA establish an error limit of 50
micrometers for lengths of up to 400 mm; of 100
micrometers for lengths of 400 mm to 800 mm; and of 150
micrometers for lengths of 800 to 1,000 millimeters. NIST explained
that such a requirement is needed to ensure that measurement errors
attributable to these measuring instruments not adversely affect the
results of the test. NIST based its recommendation for these error
limits on the accuracy requirements for mechanical and electronic
calipers and depth gauges that the American Society of Mechanical
Engineers is considering including in its industry standard (ASME B89
1.14) (Ref. 7) for these devices.
FDA agrees with NIST that there is a need for standardization of
these devices and is deferring to NIST for the appropriate standards.
In proposed 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.
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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=((xi-x)2/(n-1))1/2.
Situation A: Inspection lot size: 250 packages
Package error range: 3 oz (-1.5 oz to +1.5 oz)
Package errors among the 12 packages within the sample: +1, -1.5, +0.5,
-1, +1, -1.5, -1.5, -1, +0.5, -1.5, +1.5, -1.5
Average package error: -0.42 oz
Calculation of SEL
Standard deviation (s): 1.203 sample correction factor (SCF) for sample
size of 12 from Table 1, 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 SEL=-0.42 oz
0.69 oz=-1.11 oz to 0.27 oz
Permitted Reasonable Variations in Average Net Weight
48 oz-1.11 oz to 48+0.27 oz=46.89 oz to 48.27 oz
Maximum Percent Shortage Within Reasonable Variations
1.11 divided by 48 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 SEL=-0.02
oz0.03 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 SEL=-0.32
oz0.32 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
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