United States Standards for Condition of Food Containers, 2481-2492 [2012-833]
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2481
Proposed Rules
Federal Register
Vol. 77, No. 11
Wednesday, January 18, 2012
This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 42
RIN 0581–AC52
[Doc. No. AMS–FV–08–0027; FV–05–332]
United States Standards for Condition
of Food Containers
Agricultural Marketing Service,
USDA.
ACTION: Proposed rule.
AGENCY:
The Agricultural Marketing
Service (AMS) proposes to amend the
regulations governing the United States
(U.S.) Standards for Condition of Food
Containers. The proposed revisions
would remove the Operating
Characteristic (OC) curves for on-line
sampling and inspection and make
other minor non-substantive changes.
These revisions are necessary in order to
provide standards that reflect current
industry practices.
DATES: Comments must be received on
or before March 19, 2012.
ADDRESSES: Interested persons are
invited to submit written comments or
comments on the Internet. Comments
may be sent to Lynne Yedinak, Food
Technologist, Processed Products
Division, Fruit and Vegetable Programs,
Agricultural Marketing Service, U.S.
Department of Agriculture, 1400
Independence Avenue SW., Room 0709,
South Building Stop 0247, Washington,
DC 20250–0247; FAX: (202) 690–1527;
or Internet: https://www.regulations.gov.
The current U.S. Standards for
Condition of Food Containers is
available through the address cited
below by accessing the Internet at:
https://www.access.gpo.gov/nara/cfr/
waisidx_00/7cfr42_00.html. All
comments should reference the
document number, date, and page
number of this issue of the Federal
Register. All comments will be posted
without change, including any personal
information provided. All comments
submitted in response to this notice will
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be included in the record and will be
made available to the public on the
Internet via: https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Lynne Yedinak at the above address,
Telephone: (202) 720–9939, Fax: (202)
690–1527, or email
FQAStaff@ams.usda.gov.
SUPPLEMENTARY INFORMATION:
Executive Order 12866 Regulatory
Flexibility Act
This proposed rule has been
determined to be not significant for
purposes of Executive Order 12866 and,
therefore, has not been reviewed by the
Office of Management and Budget.
Pursuant to requirements set forth in
the Regulatory Flexibility Act (RFA) (5
U.S.C. 601–612), AMS has considered
the economic impact of this action on
small entities. Accordingly, AMS has
prepared this initial regulatory
flexibility analysis.
The purpose of the RFA is to fit
regulatory action to the scale of business
subject to such actions in order that
small businesses will not be unduly or
disproportionately burdened. Food
manufacturers are determined to be
small businesses if they have 1,000 or
less employees per 13 CFR part 121.
There are approximately 22,058
establishments identified in the 2007
Economic Census as belonging to the
North American Industry Classification
System under the classification of ‘‘food
manufacturing’’ and any number of
these establishments could request their
product containers be inspected under
the provisions of the U.S. Standards for
Condition of Food Containers. Only 402
of these establishments would qualify as
small businesses under the definition
provided by the Small Business
Administration.
We have examined the economic
implications of this proposed rule on
small entities. Under the proposed rule,
utilization of the U.S. Standards for
Condition of Food Containers continues
to be voluntary. Small entities would
only incur direct costs when purchasers
of their packaged food products
stipulate in their procurement
documents that the food containers
should conform to the requirements of
the U.S. Standards for Condition of
Food Containers. Since the standards
were previously amended in May 1983,
innovations in packaging technologies
have provided an increasingly wide
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variety of acceptable new food
containers. These new food containers
are not represented by the current
standards. Accordingly, we believe that
the economic impact of this proposed
rule will be minimal because the
revisions are necessary in order to
provide standards that reflect current
industry practices. Finally, the changes
concerning removal of OC curves and
other non-substantive changes will have
no adverse impact on small or large
entities.
This rule would not impose any
additional reporting or recordkeeping
requirements on either small or large
establishments. In addition, the
Department has not identified any
relevant Federal rules that duplicate,
overlap, or conflict with the Standards.
AMS is committed to complying with
the E–Government Act, to promote the
use of the Internet and other
information technologies to provide
increased opportunities for citizen
access to Government information and
services, and for other purposes.
Executive Order 12988
The rule has been reviewed under
Executive Order 12988, Civil Justice
Reform. There are no administrative
procedures which must be exhausted
prior to any judicial challenge to the
provisions of this rule.
Background
The U.S. Standards for Condition of
Food Containers (Standards) currently
provide sampling procedures and
acceptance criteria for the inspection of
stationary lots of filled food containers,
which includes skip lot sampling and
inspection procedures. It also provides
on-line sampling and inspection
procedures for food containers during
production.
Stationary lot sampling is the process
of randomly selecting sample units from
a lot whose production has been
completed. This type of lot is usually
stored in a warehouse or in some other
storage facility and is offered for
inspection.
Skip lot sampling is a special
procedure for inspecting stationary lots
in which only a fraction of the
submitted lots are inspected. Skip lot
inspection can only be instituted when
a certain number of lots of essentially
the same quality have been
consecutively accepted.
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To be acceptable under the
examination criteria in the standards,
lots may contain only a limited number
of defects classified as minor, major, or
critical. Acceptance criteria are based on
sampling plans for different lot sizes
and levels of inspection such as normal,
reduced, or tightened. Defect tables
classify the severity of defects.
On-line sampling and inspection is a
procedure in which subgroups of
sample units or individual containers
are selected randomly from predesignated portions of production. The
acceptability of these portions of
production is determined by inspecting,
at the time of sampling, the subgroups
which represent these portions. For this
type of sampling, only portions of a lot,
rather than a whole lot, may be rejected.
This helps to identify trouble spots in a
production cycle quickly, and enables
the producer to make timely corrections.
This can reduce the corrective action
costs and the amount of product
destroyed as a result of packaging
problems.
These standards were developed for
use by Government agencies when
requested to certify filled primary
containers or shipping cases, or both, for
condition. The standards are
permissive, and they may be used in
their entirety or in part by private
parties as well.
AMS proposes to revise the Standards
to include:
(1) Separating Tables I, I–A, II, II–A,
III, III–A, and III–B of sampling plans for
normal, tightened, and reduced
inspection by the type of sampling plan
used (single or double), as well as
updating the Acceptable Quality Levels
(AQLs) for these tables; (2) Updating
Table IV—Metal Containers (Rigid and
Semi-Rigid), Table VI—Glass Containers
(currently Table V), Table VIII—Rigid
and Semi-Rigid Containers (Corrugated
or Solid Fiberboard, Chipboard, Wood,
Tetra Pak, Gable-Tops, Polymeric Trays,
etc.) (currently Table VI), Table IX—
Flexible Containers (Plastic Bags, Cello,
Paper, Textile, Laminated Multi-Layer
Pouch, Bag, etc.) (currently Table VII),
and Table XI—Defects of Label,
Marking, or Code (currently Table VIII)
to incorporate new defects and revise
existing defects to reflect new packaging
technologies such as aseptic packaging,
metal cans with easy open lids, and
plastic rings that hold several containers
together; (3) Adding new defect tables,
Table V—Composite Containers (SemiRigid Laminated or Multi-Layer
Paperboard Body with Metal, Plastic, or
Combination of Metal and Plastic Ends
and a Safety Seal Inside the Cap), Table
VII—Plastic Containers (Rigid and SemiRigid Bottles, Jars, Tubs, Trays, Pails,
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etc.), and Table XII—Interior Can
Defects; (4) removing the Operating
Characteristic (OC) curves; and (5) other
minor non-substantive changes to
clarify the text.
These revisions to existing tables,
addition of new tables, removal of OC
curves, and updating language in the
U.S Standards for Condition of Food
Containers would enable the standards
to be applicable to most types of food
containers and align the standards to
reflect current industry practices.
OC curves found in §§ 42.140, 42.141,
42.142, and 42.143 from Subpart E—
Miscellaneous, are proposed to be
completely removed. While these curves
show the ability of the various sampling
plans to distinguish between accepted
and rejected lots, it is our experience
that the inclusion of these curves is not
critical to use of the standards.
Furthermore, they are readily available
in literature and on the Internet. Also,
Standards for sampling plans including
OC Curves are currently available in 7
CFR part 43.
While incorporating the suggested
change received during the comment
period to the Standards, AMS
determined, after further analysis that
additional changes were essential to
properly reflect current industry
practice. These changes included:
Critical defect number one in Tables
IV—Metal Containers, VI—Glass
Containers, and IX—Flexible Containers
was incompletely written and reflected
inconsistencies with other defects listed
in each table; the organization of the
defects listed in Table IX—Flexible
Containers (Plastic, Cellophane, Paper,
Textile, Laminated Multi-Layer Pouch,
Bag, etc.) did not clearly categorize the
defects unique to thermostabilized
(heat-treated) products in flexible
containers; and that many plastic
containers currently utilized by food
manufacturers did not belong in Table
IX—Flexible Containers (Plastic,
Cellophane, Paper, Textile, Laminated
Multi-Layer Pouch, Bag, etc.) since they
maintain their shape when empty.
A proposed rule regarding the
revision of the U.S. Standards for
Condition of Food Containers was
published in the Federal Register on
November 19, 2009 [74 FR 59920]. A
comment period of sixty days was
issued which closed on January 19,
2010. AMS received and analyzed two
comments in regards to the proposed
revisions.
Comments
One commenter requested substances
such as BPA not be used in containers.
No changes were made based on this
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comment as it is outside the scope of the
rule.
The other commenter supported the
proposed rule revision and provided
statements regarding § 42.112—Defects
of containers. The commenter stated
that while Table IV of § 42.112 has
defects for ‘‘for’’ composite cans listed
as a subset of the metal can defects,
composite cans also exhibit defects
consistent with defects listed in Table
VI (Rigid and Semi-rigid containers).
The comment proposed a separate table
be added for composite cans extracting
the composite can defects from the two
current tables. Based on this comment,
AMS removed the composite
information in § 42.112 Table IV and
added an additional table to § 42.112,
Table V. Composite information from
Table VI was also included in the new
table.
AMS is reproposing the Standards
with a sixty-day comment period to
provide for all interested persons to
comment on AMS’ proposed
modifications. All written comments
received will be considered before a
final determination is made on this
matter.
List of Subjects in 7 CFR Part 42
Food packaging, Reporting and
recordkeeping requirements.
For the reasons set forth in the
preamble, 7 CFR part 42 is proposed to
be amended as follows:
PART 42—[AMENDED]
1. The authority citation for part 42
continues to read as follows:
Authority: Secs. 203, 205, 60 Stat. 1087, as
amended, 1090, as amended (7 U.S.C. 1622,
1624).
2. Section 42.102 is amended by:
a. Removing the definitions
‘‘Operating Characteristic Curve (OC
Curve)’’ and ‘‘Probability of acceptance
(a) For stationary lot sampling and (b)
For On-line Sampling’’.
b. Revising the definitions
‘‘Administrator’’, ‘‘Lot or inspection
lot’’, ‘‘Sample size (n)’’, ‘‘Stationary lot
sampling’’ to read as follows:
§ 42.102
Definitions, general.
*
*
*
*
*
Administrator. The Administrator of
the Agricultural Marketing Service
(AMS) of the Department or any other
officer or employee of the Agency who
is delegated, or who may be delegated
the authority to act in the
Administrator’s stead.
*
*
*
*
*
Lot or inspection lot. A collection of
filled food containers of the same size,
type, and style. The term shall mean
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‘‘inspection lot,’’ i.e., a collection of
units of product from which a sample is
to be drawn and inspected to determine
conformance with the applicable
acceptance criteria. An inspection lot
may differ from a collection of units
designated as a lot for other purposes
(e.g., production lot, shipping lot, etc.).
*
*
*
*
*
§ 42.106
Sample size (n). The number of
sample units included in the sample.
*
*
*
*
*
Stationary lot sampling. The process
of randomly selecting sample units from
a lot whose production has been
completed. This type of lot is usually
stored in a warehouse or in some other
storage facility and is offered in its
entirety for inspection.
*
*
*
*
*
[Amended]
3. In § 42.106, paragraph (a)(1),
remove the word ‘‘atributed’’ and add in
its place the word ‘‘attributed’’.
4. Revise § 42.109, to read as follows:
§ 42.109 Sampling plans for normal
condition of container inspection, Tables I
and I–A.
TABLE I—SINGLE SAMPLING PLANS FOR NORMAL CONDITION OF CONTAINER INSPECTION
Acceptable quality levels
Code
Origin inspection
Lot size ranges—number of
containers in lot
Sample
size
CA
CB
CC
CD
CE
......
......
......
......
......
6,000 or less .................................
6,001–12,000 ................................
12,001–36,000 ..............................
Over 36,000 ..................................
.......................................................
Other than origin inspection
Type of plan
Single
Single
Single
Single
Single
................
................
................
................
................
0.25
Ac
84
168
315
500
800
1.5
Re
0
1
2
3
4
1
2
3
4
5
Ac
3
5
8
12
18
6.5
Re
4
6
9
13
19
Ac
0.25
Re
9
16
28
42
64
Ac
10
17
29
43
65
Ac = Acceptance number.
Re = Rejection number.
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BILLING CODE 3410–02–P
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2.5
Re
0
1
2
3
4
1
2
3
4
5
Ac
4
7
13
18
27
10.0
Re
5
8
14
19
28
Ac
13
23
41
62
95
Re
14
24
42
63
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BILLING CODE 3401–02–C
5. Revise § 42.110, to read as follows:
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§ 42.110 Sampling plans for tightened
condition of container inspection; Tables II
and II–A.
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TABLE II—SINGLE SAMPLING PLANS FOR TIGHTENED CONDITION OF CONTAINER INSPECTION
Acceptable quality levels
Code
Origin inspection
Lot size ranges—number of
containers in lot
Sample
size
CB
CC
CD
CE
CF
......
......
......
......
......
6,000 or less .................................
6,001–12,000 ................................
12,001–36,000 ..............................
Over 36,000 ..................................
.......................................................
Other than origin inspection
Type of plan
Single
Single
Single
Single
Single
................
................
................
................
................
0.25
Ac
168
315
500
800
1,250
1.5
Re
0
1
2
3
4
Ac
1
2
3
4
5
6.5
Re
4
6
9
13
19
5
7
10
14
20
Ac
0.25
Re
11
19
28
42
63
Ac
12
20
29
43
64
2.5
Re
0
1
2
3
4
1
2
3
4
5
Ac
10.0
Re
5
8
12
18
26
6
9
13
19
27
Ac
Re
16
28
42
64
96
17
29
43
65
97
TABLE II–A—DOUBLE SAMPLING PLANS FOR TIGHTENED CONDITION OF CONTAINER INSPECTION
Acceptable quality levels
Code
Lot size ranges—
number of containers in
lot
Origin inspection
Type of
plan
Other than origin inspection
Sample size
0.25
Ac
1.5
Re
CB .......
6,000 or less .................
Double .......
1st—120 .......................
2d—60.
(*)
(*)
Total—180 ....................
(*)
(*)
CC .......
6,001–12,000 ................
Double .......
1st—168 .......................
2d—180.
0
2
Total—348 ....................
1
2
1st—228 .......................
2d—288.
0
Total—516 ....................
Ac
6.5
Re
Re
CE .......
12,001–36,000 ..............
Over 36,000 ..................
Double .......
Double .......
5
6
4
5
1
5
7
3
2
1st—456 .......................
2d—408.
Total—864 ....................
CD .......
2
Ac
0.25
Ac
2.5
Re
Ac
10.0
Re
10
(*)
(*)
2
12
13
(*)
(*)
5
7
13
0
2
2
8
21
22
1
2
9
2
7
8
17
0
3
3
9
10
29
30
2
0
4
5
10
21
28
3
4
14
15
44
45
6
Ac
Re
10
14
6
17
18
7
12
18
10
31
32
3
9
15
24
3
12
13
43
44
0
4
8
13
32
41
3
4
19
20
69
70
(*) = Reject on one or more defects.
§ 42.111 Sampling plans for reduced
condition of container inspection, Tables III
and III–A; and limit number for reduced
inspection, Table III–B.
6. Revise § 42.111, to read as follows:
TABLE III—SINGLE SAMPLING PLANS FOR REDUCED CONDITION OF CONTAINER INSPECTION
Acceptable quality levels
Code
Origin inspection
Lot size ranges—number of
containers in lot
Sample
size
CAA ....
CA ......
CB ......
CC ......
6,000 or less .................................
6,001–36,000 ................................
Over 36,000 ..................................
Other than origin inspection
Type of plan
Single
Single
Single
Single
................
................
................
................
0.25
Ac
29
84
168
315
1.5
Re
1
1
1
2
Ac
2
2
2
3
6.5
Re
1
3
5
8
2
4
6
9
Ac
0.25
Re
4
9
16
28
Ac
5
10
17
29
2.5
Re
1
1
1
2
Ac
2
2
2
3
10.0
Re
2
4
7
13
Ac
3
5
8
14
Re
5
13
23
41
6
14
24
42
TABLE III–A—DOUBLE SAMPLING PLANS FOR REDUCED CONDITION OF CONTAINER INSPECTION
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Acceptable quality levels
Code
Lot size ranges—
number of containers in
lot
Origin inspection
Type of
plan
0.25
Ac
CAA .....
6,001–36,000 ................
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Double .......
1.5
Re
Ac
6.5
Re
Ac
0.25
Re
Ac
2.5
Re
Ac
10.0
Re
Ac
Re
Double .......
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1st—18
2d—18.
0
2
0
2
1
4
0
2
0
3
2
5
Totals—36
CA .......
6,000 or less .................
Other than origin inspection
Sample size
1
2
1
2
5
6
1
2
2
3
6
7
1st—36,
0
2
0
4
2
7
0
2
0
4
3
9
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TABLE III–A—DOUBLE SAMPLING PLANS FOR REDUCED CONDITION OF CONTAINER INSPECTION—Continued
Acceptable quality levels
Code
Lot size ranges—
number of containers in
lot
Origin inspection
Type of
plan
Other than origin inspection
Sample size
0.25
Ac
1.5
Re
Ac
6.5
Re
Ac
0.25
Re
Ac
2.5
Re
Ac
10.0
Re
Ac
Re
2d—60.
Total........96
Over 36,000 ..................
Double .......
2
3
4
10
11
1
2
4
5
15
16
1st—120
2d—60.
0
2
2
6
10
14
0
2
3
7
14
19
Total—180
CB .......
1
1
2
5
6
17
18
1
2
8
9
25
26
TABLE III—B—LIMIT NUMBERS FOR REDUCED INSPECTION
Acceptable quality level
Number of sample units from last 10 lots inspected within 6 months
0.25
320–499 ...........................................................................................................................................
500–799 ...........................................................................................................................................
800–1,249 ........................................................................................................................................
1,250–1,999 .....................................................................................................................................
2,000–3,149 .....................................................................................................................................
3,150–4,999 .....................................................................................................................................
5,000–7,999 .....................................................................................................................................
8,000–12,499 ...................................................................................................................................
12,500–19,999 .................................................................................................................................
1.5
(*)
(*)
0
0
2
4
7
14
24
1
3
7
13
22
38
63
105
169
2.5
6.5
4
7
14
24
40
67
110
181
290
14
25
42
69
115
186
302
491
777
10.0
24
40
68
110
181
293
472
765
1207
* Denotes that the number of sample units from the last 10 inspection lots is not sufficient for reduced inspection for this AQL. In this instance
more than 10 inspection lots may be used for the calculations if; the inspection lots used are the most recent ones in sequence within the last 6
months, they have all been on normal inspection, and none has been rejected on original inspection.
7. Section § 42.112, is revised to read
as follows:
§ 42.112 Defects of containers: Tables IV,
V, VI, VII, VIII, IX, and X.
TABLE IV—METAL CONTAINERS (RIGID AND SEMI-RIGID)
Categories
Defects
Critical
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Type or size of container or component parts not as specified ..............................................................
Closure incomplete, not located correctly or not sealed, crimped, or fitted properly:
(a) Heat processed primary container ..............................................................................................
(b) Non-heat processed primary container ......................................................................................
(c) Other than primary container ......................................................................................................
Dirty, stained, or smeared container .......................................................................................................
Key opening metal containers (when required):
(a) Key missing .................................................................................................................................
(b) Key does not fit tab .....................................................................................................................
(c) Tab of opening band insufficient to provide accessibility to key ................................................
(d) Improper scoring (band would not be removed in one continuous strip) ..................................
Metal pop-top:
(a) Missing or broken pull tab ..........................................................................................................
(b) Missing or incomplete score line ................................................................................................
Flexible pop-top:
(a) Poor seal (wrinkle, entrapped matter, etc.) ................................................................................
(b) Short pull tab ...............................................................................................................................
(c) Missing pull tab ...........................................................................................................................
(d) Torn pull tab ................................................................................................................................
Open top with plastic overcap (when required):
(a) Plastic overcap missing ..............................................................................................................
(b) Plastic overcap warped (making opening or reapplication difficult) ...........................................
Outside tinplate or coating (when required):
(a) Missing or incomplete .................................................................................................................
(b) Blistered, flaked, sagged, or wrinkled .........................................................................................
(c) Scratched or scored ....................................................................................................................
(d) Fine cracks ..................................................................................................................................
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E:\FR\FM\18JAP1.SGM
18JAP1
Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Proposed Rules
2487
TABLE IV—METAL CONTAINERS (RIGID AND SEMI-RIGID)—Continued
Categories
Defects
Critical
Rust (rust stain confined to the top or bottom double seam or rust that can be removed with a soft
cloth is not scored a defect):
(a) Rust stain ....................................................................................................................................
(b) Pitted rust ....................................................................................................................................
Wet cans (excluding refrigerated containers) ..........................................................................................
Dent:
(a) Materially affecting appearance but not usability .......................................................................
(b) Materially affecting usability ........................................................................................................
Buckle:
(a) Not involving end seam ..............................................................................................................
(b) Extending into the end seam ......................................................................................................
Collapsed container .................................................................................................................................
Paneled side materially affecting appearance but not usability ..............................................................
Solder missing when required .................................................................................................................
Cable cut exposing seam ........................................................................................................................
Improper side seam .................................................................................................................................
Swell, springer, or flipper (not applicable to gas or pressure packed product or frozen products) .......
Leaker or blown container .......................................................................................................................
Frozen products only:
(a) Bulging ends 3⁄16-inch to 1⁄4-inch beyond lip ..............................................................................
(b) Bulging ends more than 1⁄4-inch beyond lip ...............................................................................
Metal drums: leaking filling seal (bung) swell 1 ................................................................................
1 Defect
Major
Minor
....................
....................
....................
....................
112
....................
209
....................
210
....................
....................
....................
113
211
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....................
....................
....................
....................
....................
....................
....................
2
3
....................
114
115
....................
116
117
118
....................
....................
212
....................
....................
213
....................
....................
....................
....................
....................
....................
....................
4
....................
119
120
214
....................
....................
classification depends on the severity of the defect.
TABLE V—COMPOSITE CONTAINERS (FIBERBOARD BODY WITH METAL LIDS OR METAL BOTTOMS, PLASTIC OR FOIL TOP
WITH CAP)
Categories
Defects
Critical
srobinson on DSK4SPTVN1PROD with PROPOSALS
Type or size of container or component parts not as specified ..............................................................
Closure incomplete, not located correctly or not sealed, crimped, or fitted properly: ............................
Dirty, stained, or smeared container .......................................................................................................
Easy open closure:
(a) Pull tab: .......................................................................................................................................
1. Missing or broken pull tab .....................................................................................................
2. Missing or incomplete score line ..........................................................................................
(b) Membrane top: ............................................................................................................................
1. Poor seal (wrinkle, entrapped matter, etc.) ..........................................................................
2. Short pull tab .........................................................................................................................
3. Missing pull tab .....................................................................................................................
4. Torn pull tab ..........................................................................................................................
(c) Open top with plastic overcap (when required): .........................................................................
1. Plastic overcap missing ........................................................................................................
2. Plastic overcap warped (making opening or reapplication difficult) .....................................
Outside tinplate or coating on ends (when required):
(a) Missing or incomplete .................................................................................................................
(b) Blistered, flaked, sagged, or wrinkled .........................................................................................
(c) Scratched or scored ....................................................................................................................
(d) Fine cracks ..................................................................................................................................
Collapsed container .................................................................................................................................
Paneled side materially affecting appearance but not usability ..............................................................
Leaker ......................................................................................................................................................
Wet or damp:
(a) Materially affecting appearance but not usability .......................................................................
(b) Materially affecting usability ........................................................................................................
Crushed or torn area:
1. Materially affecting appearance but not usability .........................................................................
2. Materially affecting usability .........................................................................................................
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E:\FR\FM\18JAP1.SGM
18JAP1
2488
Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Proposed Rules
TABLE VI—GLASS CONTAINERS (BOTTLES, JARS)
Categories
Defects
Critical
Type or size of container or component parts not as specified ..............................................................
Closure not sealed, crimped, or fitted properly:
(a) Heat processed ...........................................................................................................................
(b) Non-heat processed ....................................................................................................................
Dirty, stained, or smeared container .......................................................................................................
Chip in glass ............................................................................................................................................
Stone (unmelted material) in glass ..........................................................................................................
Pits in surface of glass ............................................................................................................................
Sagging surface .......................................................................................................................................
Bead (bubble within glass): .....................................................................................................................
(a) 1⁄8-inch to 3⁄16-inch in diameter ...................................................................................................
(b) Exceeding 1⁄8-inch in diameter ....................................................................................................
Checked ...................................................................................................................................................
Thin spot in glass ....................................................................................................................................
Blister (structural defect) ..........................................................................................................................
Bird swing (glass appendage inside container) ......................................................................................
Broken or leaking container .....................................................................................................................
Cap (nonheat processed):
(a) Cross-threaded ...........................................................................................................................
(b) Loose but not leaking .................................................................................................................
(c) Pitted rust ....................................................................................................................................
Cap (heat processed):
(a) Cross-threaded or loose .............................................................................................................
(b) Pitted rust ....................................................................................................................................
Sealing tape or cello band (when required):
(a) Improperly placed .......................................................................................................................
(b) Not covering juncture of cap and glass ......................................................................................
(c) Ends overlap by less than 1⁄2-inch ..............................................................................................
(d) Loose or deteriorating .................................................................................................................
Missing or torn outer safety seal .............................................................................................................
Inner safety seal—missing, torn, poor seal .............................................................................................
Major
Minor
None permitted.
1
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2
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101
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....................
....................
102
103
104
105
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....................
....................
....................
201
202
203
204
205
....................
206
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106
207
208
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4
....................
....................
107
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....................
108
109
110
111
112
209
....................
....................
....................
....................
....................
TABLE VII—PLASTIC CONTAINERS (RIGID AND SEMI-RIGID, BOTTLES, JARS, TUBS, TRAYS, PAILS, ETC.)
Categories
Defects
Critical
srobinson on DSK4SPTVN1PROD with PROPOSALS
Type or size of container or component parts not as specified ..............................................................
Closure not sealed, crimped, or fitted properly:
(a) Heat processed ...........................................................................................................................
(b) Non-heat processed ....................................................................................................................
Dirty, stained, or smeared container .......................................................................................................
Chip in plastic ..........................................................................................................................................
Un-melted gels in plastic .........................................................................................................................
Pits in surface of plastic ..........................................................................................................................
Sagging surface .......................................................................................................................................
Air bubble within plastic:
(a) 1⁄8-inch to 1⁄16-inch in diameter ...................................................................................................
(b) Exceeding 1⁄8-inch in diameter ....................................................................................................
Checked ...................................................................................................................................................
Thin spot in plastic ...................................................................................................................................
Blister (structural defect) ..........................................................................................................................
Broken or leaking container .....................................................................................................................
Cap (non-heat processed):
(a) Cross-threaded ...........................................................................................................................
(b) Loose but not leaking .................................................................................................................
Cap (heat processed), cross-threaded or loose ......................................................................................
Security seals:
(a) Closure ring missing ...................................................................................................................
(b) Missing or torn outer safety seal ................................................................................................
(c) Inner safety seal—missing, torn, or poor seal ............................................................................
(d) Sealing tape or cello band (when required):
1. Improperly placed ..................................................................................................................
2. Not covering juncture of cap and plastic ..............................................................................
3. Ends overlap by less than 1⁄2-inch ........................................................................................
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E:\FR\FM\18JAP1.SGM
18JAP1
2489
Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Proposed Rules
TABLE VII—PLASTIC CONTAINERS (RIGID AND SEMI-RIGID, BOTTLES, JARS, TUBS, TRAYS, PAILS, ETC.)—Continued
Categories
Defects
Critical
4. Loose or deteriorating ...........................................................................................................
Closure not sealed, crimped, or fitted properly.
Major
....................
111
Minor
....................
TABLE VIII—RIGID AND SEMI-RIGID CONTAINERS—CORRUGATED OR SOLID FIBERBOARD, CHIPBOARD, WOOD, ASEPTIC,
POLYMERIC TRAYS, ETC.
[Excluding metal, glass, and plastic]
Categories
Defects
Critical
Major
srobinson on DSK4SPTVN1PROD with PROPOSALS
Type or size of container or component parts not as specified ..............................................................
Component part missing ..........................................................................................................................
Closure not sealed, crimped, or fitted properly:
(a) Primary container ........................................................................................................................
(b) Other than primary container ......................................................................................................
Dirty, stained, or smeared container .......................................................................................................
Wet or damp (excluding ice packs):
(a) Materially affecting appearance but not usability .......................................................................
(b) Materially affecting usability ........................................................................................................
Moldy area ...............................................................................................................................................
Crushed or torn area:
(a) Materially affecting appearance but not usability .......................................................................
(b) Materially affecting usability ........................................................................................................
Separation of lamination (corrugated fiberboard):
(a) Materially affecting appearance but not usability .......................................................................
(b) Materially affecting usability ........................................................................................................
Product sifting or leaking .........................................................................................................................
Nails or staples (when required):
(a) Not as required, insufficient number or improperly positioned ...................................................
(b) Nails or staples protruding ..........................................................................................................
Glue or adhesive (when required); not holding properly, not covering area specified, or not covering
sufficient area to hold properly:
(a) Primary container ........................................................................................................................
(b) Other than primary container ......................................................................................................
Flap:
(a) Projects beyond edge of container more than 1/4-inch .............................................................
(b) Does not meet properly, allowing space of more than 1/4-inch ................................................
Sealing tape or strapping (when required):
(a) Missing. .......................................................................................................................................
(b) Improperly placed or applied ......................................................................................................
Missing component (straw, etc.) ..............................................................................................................
Aseptic containers:
Missing re-sealable cap or tab ................................................................................................................
Inner or outer safety seal—missing, torn, poor seal ...............................................................................
Thermostabilized polymeric trays:
Tray body:
(a) Swollen container ........................................................................................................................
(b) Tear, crack, hole, abrasion through more than one layer of multi-layer laminate for the tray ..
(c) Presence of delamination in multi-layered laminate ...................................................................
(d) Presence of any permanent deformation, such that deformed area is discolored or roughened in texture ..............................................................................................................................
Lid material:
(a) Closure seal not continuous along tray flange surface ..............................................................
(b) Foldover wrinkle in seal area extends into the closure seal such that the closure seal is reduced to less than 1/8-inch ..........................................................................................................
(c) Any impression or design on the seal surfaces which conceals or impairs visual detection of
seal defects ...................................................................................................................................
(d) Areas of ‘‘wave-like’’ striations or wrinkles along the seal area that spans the entire width of
seal ................................................................................................................................................
(e) Abrasion of lid material:
1. Within 1⁄16-inch of food product edge of seal such that barrier layer is exposed ................
2. Greater than 1⁄16-inch from food product edge of seal that barrier layer is exposed ..........
(f) Presence of entrapped matter within 1⁄16-inch of the food product edge of seal or entrapped
moisture or vapor with 1⁄16-inch of the food product edge of seal that results in less than 1⁄16inch of defect free seal width at the outside edge .......................................................................
(g) Presence of any seal defect or anomaly (for example, entrapped moisture, gases, etc.) within 1⁄16-inch of food product edge of seal ......................................................................................
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E:\FR\FM\18JAP1.SGM
18JAP1
2490
Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Proposed Rules
TABLE VIII—RIGID AND SEMI-RIGID CONTAINERS—CORRUGATED OR SOLID FIBERBOARD, CHIPBOARD, WOOD, ASEPTIC,
POLYMERIC TRAYS, ETC.—Continued
[Excluding metal, glass, and plastic]
Categories
Defects
Critical
(h) Closure seal width less than 1⁄8-inch .................................................................................................
Major
....................
....................
Minor
216
TABLE IX—FLEXIBLE CONTAINERS (PLASTIC, CELLOPHANE, PAPER, TEXTILE, LAMINATED MULTI-LAYER POUCH, BAG, ETC.)
Categories
Defects
Critical
srobinson on DSK4SPTVN1PROD with PROPOSALS
Type or size of container or component parts not as specified ..............................................................
Closure not sealed, crimped, stitched, or fitted properly:
(a) Heat processed primary container ..............................................................................................
(b) Non-heat processed primary container ......................................................................................
(c) Other than primary container ......................................................................................................
Dirty, stained, or smeared container .......................................................................................................
Unmelted gels in plastic ..........................................................................................................................
Torn or cut container or abrasion (non-leaker):
(a) Materially affecting appearance but not usability .......................................................................
(b) Materially affecting usability ........................................................................................................
Moldy area ...............................................................................................................................................
Individual packages sticking together or to shipping case (tear when separated) .................................
Not fully covering product ........................................................................................................................
Wet or damp (excluding ice packs):
(a) Materially affecting appearance but not usability .......................................................................
(b) Materially affecting usability Over wrap (when required): ..........................................................
(a) Missing ........................................................................................................................................
(b) Loose, not sealed, or closed ......................................................................................................
(c) Improperly applied .......................................................................................................................
Sealing tape, strapping, or adhesives (when required):
(a) Missing ........................................................................................................................................
(b) Improperly placed, applied, torn, or wrinkled .............................................................................
Tape over bottom and top closures (when required):
(a) Not covering stitching .................................................................................................................
(b) Torn (exposing stitching) ............................................................................................................
(c) Wrinkled (exposing stitching) ......................................................................................................
(d) Not adhering to bag:
1. Exposing stitching .................................................................................................................
2. Not exposing stitching ...........................................................................................................
(e) Improper placement ....................................................................................................................
Product sifting or leaking:
(a) Non-heat processed ....................................................................................................................
(b) Heat processed ...........................................................................................................................
Flexible pop-top:
(a) Poor seal (wrinkle, entrapped matter, etc.) reducing intact seal to less than 1⁄16-inch .............
(b) Short pull tab (materially affecting usability) ...............................................................................
(c) Missing pull tab ...........................................................................................................................
(d) Torn pull tab (materially affecting usability) ................................................................................
Missing component (straw, etc.) ..............................................................................................................
Two part container (poly lined box or bag in box):
(a) Outer case torn ...........................................................................................................................
(b) Poly liner:
1. Missing ..................................................................................................................................
2. Improper closure ...................................................................................................................
Missing ‘‘zip lock’’ (re-sealable containers) .............................................................................................
Loss of vacuum (in vacuum-packed) ......................................................................................................
Pre-formed containers:
(a) Dented or crushed area ..............................................................................................................
(b) Deformed container ....................................................................................................................
Missing re-sealable cap ...........................................................................................................................
Inner or outer safety seal—missing, torn, poor seal ...............................................................................
Air bubble in plastic .................................................................................................................................
Thermostabilized products (includes but not limited to tubes, pouches, etc.):
Foldover wrinkle in seal area (thermostabilized pouches):
(a) Extends through all plies across seal area or reduces seal less than 1⁄16-inch ........................
(b) Does not extend through all plies and effective seal to is 1⁄16-inch or greater ..........................
Incomplete seal (thermostabilized pouches) ...........................................................................................
Non-bonding seal (thermostabilized pouches) ........................................................................................
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E:\FR\FM\18JAP1.SGM
18JAP1
2491
Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Proposed Rules
TABLE IX—FLEXIBLE CONTAINERS (PLASTIC, CELLOPHANE, PAPER, TEXTILE, LAMINATED MULTI-LAYER POUCH, BAG,
ETC.)—Continued
Categories
Defects
Critical
Laminate separation in body of pouch or in seal within 1⁄16-inch of food product edge:
(a) If food contact layer is exposed ..................................................................................................
(b) If food contact surface is exposed after manipulation or laminate separation expands after
manipulation ..................................................................................................................................
(c) If lamination separation is limited to isolated spots that do not propagate with manipulation or
is outer ply separation in seal within 1⁄16-inch of food product edge of seal ...............................
Flex cracks (cracks in foil layer only) ......................................................................................................
Swollen container ....................................................................................................................................
Blister (in seal) reducing intact seal to less than 1⁄16-inch ......................................................................
Compressed seal (overheated to bubble or expose inner layer) reducing intact seal to less than 1⁄16inch .......................................................................................................................................................
Stringy seal (excessive plastic threads showing at edge of seal area) ..................................................
Contaminated seal (entrapped matter) reducing intact seal to less than 1⁄16-inch .................................
Seal creep (product in pouch ‘‘creeping’’ into seal) reducing intact seal to less than 1⁄16 inch .............
Misaligned or crooked seal reducing intact seal to less than 1⁄16-inch ...................................................
Seal formed greater than 1-inch from edge of pouch (unclosed edge flaps) .........................................
Waffling (embossing on surface from retort racks; not scorable unless severe) ...................................
Poor or missing tear notch (when required) ............................................................................................
Major
Minor
10
....................
....................
....................
118
....................
....................
....................
11
12
....................
....................
....................
....................
220
221
....................
....................
13
....................
14
15
16
....................
....................
....................
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222
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223
224
225
TABLE X—UNITIZING (PLASTIC OR OTHER TYPE OF CASING/UNITIZING)
Categories
Defects
Major
Not specified method .......................................................................................................................................................
Missing tray (when required) ...........................................................................................................................................
Missing shrink wrap (when required) ..............................................................................................................................
Loose or improperly applied wrap ...................................................................................................................................
Torn or mutilated .............................................................................................................................................................
Off-center wrap (does not overlap both ends) ................................................................................................................
8. Section 42.113 is revised to read as
follows:
§ 42.113
code.
Minor
101
102
103
....................
....................
....................
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201
202
203
Defects of label, marking, or
TABLE XI—LABEL, MARKING, OR CODE
Categories
Defects
Major
Not specified method .......................................................................................................................................................
Missing (when required) ..................................................................................................................................................
Loose or improperly applied ............................................................................................................................................
Torn or mutilated .............................................................................................................................................................
Torn or scratched, obliterating any markings on the label ..............................................................................................
Text illegible or incomplete ..............................................................................................................................................
Incorrect ...........................................................................................................................................................................
In wrong location .............................................................................................................................................................
9. Add § 42.114 to read as follows:
srobinson on DSK4SPTVN1PROD with PROPOSALS
§ 42.114 Procedures for Evaluating Interior
Container Defects.
(a) Sections 42.101 through 42.136 of
this part provide procedures for
determining lot conformance with the
U.S. Standards for Condition of Food
Containers. This determination is based
on the examination of the external
characteristics of the food containers.
(b) As an option, if a user of the
inspection service requests to have the
VerDate Mar<15>2010
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Jkt 226001
interior characteristics of containers
examined, and apply these results in the
determination of lot acceptability, the
defects listed in Table XII of this section
may be used.
(c) The determination of lot
acceptability based on internal
container defects shall be independent
of the determination of lot acceptability
for U.S. Standards for Condition of Food
Containers. A user of the inspection
service may choose to require
inspection for internal can defects as
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well as inspection for U.S. Standards for
Condition of Food Containers.
(d) If a user of the inspection service
requests an examination for internal
container defects in addition to an
official USDA/USDC inspection for
product quality and/or U.S. grade, the
containers opened by the official
inspection service for inspection of
product quality and/or U.S. grade will
be used for examination of interior
container defects. The minimum sample
size for evaluation of interior container
E:\FR\FM\18JAP1.SGM
18JAP1
2492
Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Proposed Rules
defects will be 13 containers. As a
result, additional containers will be
required if the inspection for quality or
U.S. grade calls for fewer than 13
containers. Table XIII of this section
provides acceptance numbers for
internal container defects for selected
sample sizes.
TABLE XII—INTERIOR CONTAINER DEFECTS
Categories
Defects
Major
De-tinning in metal container materially affecting usability .............................................................................................
De-tinning in metal container not materially affecting usability .......................................................................................
Black spots in metal container ........................................................................................................................................
Enamel missing (when required) in metal container .......................................................................................................
Enamel breakdown in metal container material affecting usability .................................................................................
Enamel cracked in metal container material not affecting usability ................................................................................
Interior of container damaged materially affecting usability ............................................................................................
Interior of container damaged not materially affecting usability ......................................................................................
Other anomaly (ies) of the interior of the container (metal, plastic, paper, rigid, etc.) that materially affects usability
Other anomaly (ies) of the interior of the container (metal, plastic, paper, rigid, etc.) that materially affects appearance but not usability ...................................................................................................................................................
TABLE XIII—ACCEPTANCE NUMBERS
FOR INTERNAL CONTAINER DEFECTS
Major
Total
Interior
defects
Sample size
(n = number of
containers)
Interior
defects
Ac
n—13
n—21
n—29
n—38
n—48
n—60
................
................
................
................
................
................
Re
0
1
1
2
2
2
Ac
1
2
2
3
3
3
Re
2
3
4
5
6
7
3
4
5
6
7
8
Dated: January 10, 2012.
David R. Shipman,
Acting Administrator, Agricultural Marketing
Service.
[FR Doc. 2012–833 Filed 1–17–12; 8:45 am]
BILLING CODE 3410–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 172, 173, 178, and 180
[Docket No. FDA–2010–F–0320]
United States Pharmacopeial
Convention; Filing of Food Additive
Petition; Amendment
AGENCY:
Food and Drug Administration,
HHS.
srobinson on DSK4SPTVN1PROD with PROPOSALS
ACTION:
Notice of petition.
The Food and Drug
Administration (FDA) is amending the
filing notice for a food additive petition
filed by the U.S. Pharmacopeial
Convention requesting that the food
additive regulations that incorporate by
reference food-grade specifications from
prior editions of the Food Chemicals
SUMMARY:
VerDate Mar<15>2010
17:14 Jan 17, 2012
Jkt 226001
Codex (FCC) be amended to incorporate
by reference food-grade specifications
from the FCC, 7th Edition.
DATES: Submit either electronic or
written comments on the petitioner’s
environmental assessment by February
17, 2012.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Mical E. Honigfort, Center for Food
Safety and Applied Nutrition (HFS–
265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740–3835, (240) 402–1278.
SUPPLEMENTARY INFORMATION: In a notice
published in the Federal Register on
August 10, 2010 (75 FR 48353), FDA
announced that a food additive petition
(FAP 0A4782) had been filed by U.S.
Pharmacopeial Convention, 12601
Twinbrook Pkwy., Rockville, MD 20852.
The petition proposes that certain food
additive regulations, which incorporate
by reference food-grade specifications
from prior editions of the FCC, be
amended to incorporate by reference
food-grade specifications from the FCC,
7th Edition.
Under 21 CFR 171.1(c)(H), either a
claim of categorical exclusion under
§ 25.30 (21 CFR 25.30) or 21 CFR 25.32
or an environmental assessment under
21 CFR. 25.40 is required to be
submitted in a food additive petition. A
claim of categorical exclusion under
§ 25.30(i) was submitted with the
petition, which applies to corrections
and technical changes in regulations.
The Agency reviewed the claim of
categorical exclusion submitted by the
petitioner and stated in the original
PO 00000
Frm 00012
Fmt 4702
Sfmt 4702
Minor
101
....................
....................
102
103
....................
104
....................
105
....................
201
202
....................
....................
203
....................
204
....................
....................
205
filing notice its determination that,
under § 25.30(i), the proposed action
was of a type that does not individually
or cumulatively have a significant effect
on the human environment, and
therefore, neither an environmental
assessment nor an environmental
impact statement is required.
However, upon further review of the
petition, the Agency has decided that
the actions being requested in the
petition are neither corrections nor
technical changes, and, therefore, the
categorical exclusion in § 25.30(i) is not
applicable for the proposed action. The
Agency informed the petitioner of this
decision, who subsequently submitted
an environmental assessment.
The potential environmental impact
of this petition is being reviewed. To
encourage public participation
consistent with regulation issued under
the National Environmental Policy Act
(40 CFR 1501.4(b)), the Agency is
placing the environmental assessment
submitted with the petition that is the
subject of this notice on public display
at the Division of Dockets Management
(see DATES and ADDRESSES) for public
review and comment.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
FDA will also place on public display
any amendments to, or comments on,
the petitioner’s environmental
assessment without further
announcement in the Federal Register.
If, based on its review, the Agency finds
that an environmental impact statement
E:\FR\FM\18JAP1.SGM
18JAP1
]]>Agencies
[Federal Register Volume 77, Number 11 (Wednesday, January 18, 2012)]
[Proposed Rules]
[Pages 2481-2492]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-833]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 /
Proposed Rules
[[Page 2481]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 42
RIN 0581-AC52
[Doc. No. AMS-FV-08-0027; FV-05-332]
United States Standards for Condition of Food Containers
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Agricultural Marketing Service (AMS) proposes to amend the
regulations governing the United States (U.S.) Standards for Condition
of Food Containers. The proposed revisions would remove the Operating
Characteristic (OC) curves for on-line sampling and inspection and make
other minor non-substantive changes. These revisions are necessary in
order to provide standards that reflect current industry practices.
DATES: Comments must be received on or before March 19, 2012.
ADDRESSES: Interested persons are invited to submit written comments or
comments on the Internet. Comments may be sent to Lynne Yedinak, Food
Technologist, Processed Products Division, Fruit and Vegetable
Programs, Agricultural Marketing Service, U.S. Department of
Agriculture, 1400 Independence Avenue SW., Room 0709, South Building
Stop 0247, Washington, DC 20250-0247; FAX: (202) 690-1527; or Internet:
https://www.regulations.gov. The current U.S. Standards for Condition of
Food Containers is available through the address cited below by
accessing the Internet at: https://www.access.gpo.gov/nara/cfr/waisidx_00/7cfr42_00.html. All comments should reference the document number,
date, and page number of this issue of the Federal Register. All
comments will be posted without change, including any personal
information provided. All comments submitted in response to this notice
will be included in the record and will be made available to the public
on the Internet via: https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Lynne Yedinak at the above address,
Telephone: (202) 720-9939, Fax: (202) 690-1527, or email
FQAStaff@ams.usda.gov.
SUPPLEMENTARY INFORMATION:
Executive Order 12866 Regulatory Flexibility Act
This proposed rule has been determined to be not significant for
purposes of Executive Order 12866 and, therefore, has not been reviewed
by the Office of Management and Budget.
Pursuant to requirements set forth in the Regulatory Flexibility
Act (RFA) (5 U.S.C. 601-612), AMS has considered the economic impact of
this action on small entities. Accordingly, AMS has prepared this
initial regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory action to the scale of
business subject to such actions in order that small businesses will
not be unduly or disproportionately burdened. Food manufacturers are
determined to be small businesses if they have 1,000 or less employees
per 13 CFR part 121.
There are approximately 22,058 establishments identified in the
2007 Economic Census as belonging to the North American Industry
Classification System under the classification of ``food
manufacturing'' and any number of these establishments could request
their product containers be inspected under the provisions of the U.S.
Standards for Condition of Food Containers. Only 402 of these
establishments would qualify as small businesses under the definition
provided by the Small Business Administration.
We have examined the economic implications of this proposed rule on
small entities. Under the proposed rule, utilization of the U.S.
Standards for Condition of Food Containers continues to be voluntary.
Small entities would only incur direct costs when purchasers of their
packaged food products stipulate in their procurement documents that
the food containers should conform to the requirements of the U.S.
Standards for Condition of Food Containers. Since the standards were
previously amended in May 1983, innovations in packaging technologies
have provided an increasingly wide variety of acceptable new food
containers. These new food containers are not represented by the
current standards. Accordingly, we believe that the economic impact of
this proposed rule will be minimal because the revisions are necessary
in order to provide standards that reflect current industry practices.
Finally, the changes concerning removal of OC curves and other non-
substantive changes will have no adverse impact on small or large
entities.
This rule would not impose any additional reporting or
recordkeeping requirements on either small or large establishments. In
addition, the Department has not identified any relevant Federal rules
that duplicate, overlap, or conflict with the Standards.
AMS is committed to complying with the E-Government Act, to promote
the use of the Internet and other information technologies to provide
increased opportunities for citizen access to Government information
and services, and for other purposes.
Executive Order 12988
The rule has been reviewed under Executive Order 12988, Civil
Justice Reform. There are no administrative procedures which must be
exhausted prior to any judicial challenge to the provisions of this
rule.
Background
The U.S. Standards for Condition of Food Containers (Standards)
currently provide sampling procedures and acceptance criteria for the
inspection of stationary lots of filled food containers, which includes
skip lot sampling and inspection procedures. It also provides on-line
sampling and inspection procedures for food containers during
production.
Stationary lot sampling is the process of randomly selecting sample
units from a lot whose production has been completed. This type of lot
is usually stored in a warehouse or in some other storage facility and
is offered for inspection.
Skip lot sampling is a special procedure for inspecting stationary
lots in which only a fraction of the submitted lots are inspected. Skip
lot inspection can only be instituted when a certain number of lots of
essentially the same quality have been consecutively accepted.
[[Page 2482]]
To be acceptable under the examination criteria in the standards,
lots may contain only a limited number of defects classified as minor,
major, or critical. Acceptance criteria are based on sampling plans for
different lot sizes and levels of inspection such as normal, reduced,
or tightened. Defect tables classify the severity of defects.
On-line sampling and inspection is a procedure in which subgroups
of sample units or individual containers are selected randomly from
pre-designated portions of production. The acceptability of these
portions of production is determined by inspecting, at the time of
sampling, the subgroups which represent these portions. For this type
of sampling, only portions of a lot, rather than a whole lot, may be
rejected. This helps to identify trouble spots in a production cycle
quickly, and enables the producer to make timely corrections. This can
reduce the corrective action costs and the amount of product destroyed
as a result of packaging problems.
These standards were developed for use by Government agencies when
requested to certify filled primary containers or shipping cases, or
both, for condition. The standards are permissive, and they may be used
in their entirety or in part by private parties as well.
AMS proposes to revise the Standards to include:
(1) Separating Tables I, I-A, II, II-A, III, III-A, and III-B of
sampling plans for normal, tightened, and reduced inspection by the
type of sampling plan used (single or double), as well as updating the
Acceptable Quality Levels (AQLs) for these tables; (2) Updating Table
IV--Metal Containers (Rigid and Semi-Rigid), Table VI--Glass Containers
(currently Table V), Table VIII--Rigid and Semi-Rigid Containers
(Corrugated or Solid Fiberboard, Chipboard, Wood, Tetra Pak, Gable-
Tops, Polymeric Trays, etc.) (currently Table VI), Table IX--Flexible
Containers (Plastic Bags, Cello, Paper, Textile, Laminated Multi-Layer
Pouch, Bag, etc.) (currently Table VII), and Table XI--Defects of
Label, Marking, or Code (currently Table VIII) to incorporate new
defects and revise existing defects to reflect new packaging
technologies such as aseptic packaging, metal cans with easy open lids,
and plastic rings that hold several containers together; (3) Adding new
defect tables, Table V--Composite Containers (Semi-Rigid Laminated or
Multi-Layer Paperboard Body with Metal, Plastic, or Combination of
Metal and Plastic Ends and a Safety Seal Inside the Cap), Table VII--
Plastic Containers (Rigid and Semi-Rigid Bottles, Jars, Tubs, Trays,
Pails, etc.), and Table XII--Interior Can Defects; (4) removing the
Operating Characteristic (OC) curves; and (5) other minor non-
substantive changes to clarify the text.
These revisions to existing tables, addition of new tables, removal
of OC curves, and updating language in the U.S Standards for Condition
of Food Containers would enable the standards to be applicable to most
types of food containers and align the standards to reflect current
industry practices.
OC curves found in Sec. Sec. 42.140, 42.141, 42.142, and 42.143
from Subpart E--Miscellaneous, are proposed to be completely removed.
While these curves show the ability of the various sampling plans to
distinguish between accepted and rejected lots, it is our experience
that the inclusion of these curves is not critical to use of the
standards. Furthermore, they are readily available in literature and on
the Internet. Also, Standards for sampling plans including OC Curves
are currently available in 7 CFR part 43.
While incorporating the suggested change received during the
comment period to the Standards, AMS determined, after further analysis
that additional changes were essential to properly reflect current
industry practice. These changes included: Critical defect number one
in Tables IV--Metal Containers, VI--Glass Containers, and IX--Flexible
Containers was incompletely written and reflected inconsistencies with
other defects listed in each table; the organization of the defects
listed in Table IX--Flexible Containers (Plastic, Cellophane, Paper,
Textile, Laminated Multi-Layer Pouch, Bag, etc.) did not clearly
categorize the defects unique to thermostabilized (heat-treated)
products in flexible containers; and that many plastic containers
currently utilized by food manufacturers did not belong in Table IX--
Flexible Containers (Plastic, Cellophane, Paper, Textile, Laminated
Multi-Layer Pouch, Bag, etc.) since they maintain their shape when
empty.
A proposed rule regarding the revision of the U.S. Standards for
Condition of Food Containers was published in the Federal Register on
November 19, 2009 [74 FR 59920]. A comment period of sixty days was
issued which closed on January 19, 2010. AMS received and analyzed two
comments in regards to the proposed revisions.
Comments
One commenter requested substances such as BPA not be used in
containers. No changes were made based on this comment as it is outside
the scope of the rule.
The other commenter supported the proposed rule revision and
provided statements regarding Sec. 42.112--Defects of containers. The
commenter stated that while Table IV of Sec. 42.112 has defects for
``for'' composite cans listed as a subset of the metal can defects,
composite cans also exhibit defects consistent with defects listed in
Table VI (Rigid and Semi-rigid containers). The comment proposed a
separate table be added for composite cans extracting the composite can
defects from the two current tables. Based on this comment, AMS removed
the composite information in Sec. 42.112 Table IV and added an
additional table to Sec. 42.112, Table V. Composite information from
Table VI was also included in the new table.
AMS is reproposing the Standards with a sixty-day comment period to
provide for all interested persons to comment on AMS' proposed
modifications. All written comments received will be considered before
a final determination is made on this matter.
List of Subjects in 7 CFR Part 42
Food packaging, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, 7 CFR part 42 is
proposed to be amended as follows:
PART 42--[AMENDED]
1. The authority citation for part 42 continues to read as follows:
Authority: Secs. 203, 205, 60 Stat. 1087, as amended, 1090, as
amended (7 U.S.C. 1622, 1624).
2. Section 42.102 is amended by:
a. Removing the definitions ``Operating Characteristic Curve (OC
Curve)'' and ``Probability of acceptance (a) For stationary lot
sampling and (b) For On-line Sampling''.
b. Revising the definitions ``Administrator'', ``Lot or inspection
lot'', ``Sample size (n)'', ``Stationary lot sampling'' to read as
follows:
Sec. 42.102 Definitions, general.
* * * * *
Administrator. The Administrator of the Agricultural Marketing
Service (AMS) of the Department or any other officer or employee of the
Agency who is delegated, or who may be delegated the authority to act
in the Administrator's stead.
* * * * *
Lot or inspection lot. A collection of filled food containers of
the same size, type, and style. The term shall mean
[[Page 2483]]
``inspection lot,'' i.e., a collection of units of product from which a
sample is to be drawn and inspected to determine conformance with the
applicable acceptance criteria. An inspection lot may differ from a
collection of units designated as a lot for other purposes (e.g.,
production lot, shipping lot, etc.).
* * * * *
Sample size (n). The number of sample units included in the sample.
* * * * *
Stationary lot sampling. The process of randomly selecting sample
units from a lot whose production has been completed. This type of lot
is usually stored in a warehouse or in some other storage facility and
is offered in its entirety for inspection.
* * * * *
Sec. 42.106 [Amended]
3. In Sec. 42.106, paragraph (a)(1), remove the word ``atributed''
and add in its place the word ``attributed''.
4. Revise Sec. 42.109, to read as follows:
Sec. 42.109 Sampling plans for normal condition of container
inspection, Tables I and I-A.
Table I--Single Sampling Plans for Normal Condition of Container Inspection
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acceptable quality levels
-----------------------------------------------------------------------------------------------
Lot size ranges-- Origin inspection Other than origin inspection
Code number of Type of plan -----------------------------------------------------------------------------------------------
containers in lot 0.25 1.5 6.5 0.25 2.5 10.0
Sample ------------------------------------------------------------------------------------
size Ac Re Ac Re Ac Re Ac Re Ac Re Ac Re
--------------------------------------------------------------------------------------------------------------------------------------------------------
CA........... 6,000 or less....... Single............. 84 0 1 3 4 9 10 0 1 4 5 13 14
CB........... 6,001-12,000........ Single............. 168 1 2 5 6 16 17 1 2 7 8 23 24
CC........... 12,001-36,000....... Single............. 315 2 3 8 9 28 29 2 3 13 14 41 42
CD........... Over 36,000......... Single............. 500 3 4 12 13 42 43 3 4 18 19 62 63
CE........... .................... Single............. 800 4 5 18 19 64 65 4 5 27 28 95 96
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ac = Acceptance number.
Re = Rejection number.
BILLING CODE 3410-02-P
[[Page 2484]]
[GRAPHIC] [TIFF OMITTED] TP18JA12.000
BILLING CODE 3401-02-C
5. Revise Sec. 42.110, to read as follows:
Sec. 42.110 Sampling plans for tightened condition of container
inspection; Tables II and II-A.
[[Page 2485]]
Table II--Single Sampling Plans for Tightened Condition of Container Inspection
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acceptable quality levels
-----------------------------------------------------------------------------------------------
Lot size ranges-- Origin inspection Other than origin inspection
Code number of Type of plan -----------------------------------------------------------------------------------------------
containers in lot 0.25 1.5 6.5 0.25 2.5 10.0
Sample ------------------------------------------------------------------------------------
size Ac Re Ac Re Ac Re Ac Re Ac Re Ac Re
--------------------------------------------------------------------------------------------------------------------------------------------------------
CB........... 6,000 or less....... Single............. 168 0 1 4 5 11 12 0 1 5 6 16 17
CC........... 6,001-12,000........ Single............. 315 1 2 6 7 19 20 1 2 8 9 28 29
CD........... 12,001-36,000....... Single............. 500 2 3 9 10 28 29 2 3 12 13 42 43
CE........... Over 36,000......... Single............. 800 3 4 13 14 42 43 3 4 18 19 64 65
CF........... .................... Single............. 1,250 4 5 19 20 63 64 4 5 26 27 96 97
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table II-A--Double Sampling Plans for Tightened Condition of Container Inspection
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acceptable quality levels
------------------------------------------------------------------------------------
Lot size ranges-- Origin inspection Other than origin inspection
Code number of Type of plan Sample size ------------------------------------------------------------------------------------
containers in lot 0.25 1.5 6.5 0.25 2.5 10.0
------------------------------------------------------------------------------------
Ac Re Ac Re Ac Re Ac Re Ac Re Ac Re
--------------------------------------------------------------------------------------------------------------------------------------------------------
CB........ 6,000 or less.... Double........... 1st--120......... (*) (*) 2 5 6 10 (*) (*) 2 6 10 14
2d--60...........
�����������
Total--180....... (*) (*) 4 5 12 13 (*) (*) 5 6 17 18
--------------------------------------------------------------------------------------------------------------------------------------------------------
CC........ 6,001-12,000..... Double........... 1st--168......... 0 2 1 5 7 13 0 2 2 7 12 18
2d--180..........
�����������
Total--348....... 1 2 7 8 21 22 1 2 9 10 31 32
--------------------------------------------------------------------------------------------------------------------------------------------------------
CD........ 12,001-36,000.... Double........... 1st--228......... 0 3 2 7 8 17 0 3 3 9 15 24
2d--288..........
�����������
Total--516....... 2 3 9 10 29 30 2 3 12 13 43 44
--------------------------------------------------------------------------------------------------------------------------------------------------------
CE........ Over 36,000...... Double........... 1st--456......... 0 4 5 10 21 28 0 4 8 13 32 41
2d--408..........
�����������
Total--864....... 3 4 14 15 44 45 3 4 19 20 69 70
--------------------------------------------------------------------------------------------------------------------------------------------------------
(*) = Reject on one or more defects.
6. Revise Sec. 42.111, to read as follows:
Sec. 42.111 Sampling plans for reduced condition of container
inspection, Tables III and III-A; and limit number for reduced
inspection, Table III-B.
Table III--Single Sampling Plans for Reduced Condition of Container Inspection
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acceptable quality levels
-----------------------------------------------------------------------------------------------
Lot size ranges-- Origin inspection Other than origin inspection
Code number of Type of plan -----------------------------------------------------------------------------------------------
containers in 0.25 1.5 6.5 0.25 2.5 10.0
lot Sample ------------------------------------------------------------------------------------
size Ac Re Ac Re Ac Re Ac Re Ac Re Ac Re
----------------------------------------------------------------------------------------------------------------------------------------------
CAA....... 6,000 or less... Single.......... 29 1 2 1 2 4 5 1 2 2 3 5 6
CA........ 6,001-36,000.... Single.......... 84 1 2 3 4 9 10 1 2 4 5 13 14
CB........ Over 36,000..... Single.......... 168 1 2 5 6 16 17 1 2 7 8 23 24
CC........ Single.......... 315 2 3 8 9 28 29 2 3 13 14 41 42
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table III-A--Double Sampling Plans for Reduced Condition of Container Inspection
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acceptable quality levels
------------------------------------------------------------------------------------
Lot size ranges-- Origin inspection Other than origin inspection
Code number of Type of plan Sample size ------------------------------------------------------------------------------------
containers in lot 0.25 1.5 6.5 0.25 2.5 10.0
------------------------------------------------------------------------------------
Ac Re Ac Re Ac Re Ac Re Ac Re Ac Re
--------------------------------------------------------------------------------------------------------------------------------------------------------
CAA....... 6,000 or less.... Double........... 1st--18 0 2 0 2 1 4 0 2 0 3 2 5
2d--18.
-------------------------------------------------------------------------------------------------------
Totals--36 1 2 1 2 5 6 1 2 2 3 6 7
--------------------------------------------------------------------------------------------------------------------------------------------------------
CA........ 6,001-36,000..... Double........... 1st--36, 0 2 0 4 2 7 0 2 0 4 3 9
[[Page 2486]]
2d--60.
-------------------------------------------------------------------------------------------------------
Total........96 1 2 3 4 10 11 1 2 4 5 15 16
--------------------------------------------------------------------------------------------------------------------------------------------------------
CB........ Over 36,000...... Double........... 1st--120 0 2 2 6 10 14 0 2 3 7 14 19
2d--60.
-------------------------------------------------------------------------------------------------------
Total--180 1 2 5 6 17 18 1 2 8 9 25 26
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table III--B--Limit Numbers for Reduced Inspection
----------------------------------------------------------------------------------------------------------------
Acceptable quality level
Number of sample units from last 10 lots inspected within 6 months --------------------------------------------
0.25 1.5 2.5 6.5 10.0
----------------------------------------------------------------------------------------------------------------
320-499............................................................ (*) 1 4 14 24
500-799............................................................ (*) 3 7 25 40
800-1,249.......................................................... 0 7 14 42 68
1,250-1,999........................................................ 0 13 24 69 110
2,000-3,149........................................................ 2 22 40 115 181
3,150-4,999........................................................ 4 38 67 186 293
5,000-7,999........................................................ 7 63 110 302 472
8,000-12,499....................................................... 14 105 181 491 765
12,500-19,999...................................................... 24 169 290 777 1207
----------------------------------------------------------------------------------------------------------------
* Denotes that the number of sample units from the last 10 inspection lots is not sufficient for reduced
inspection for this AQL. In this instance more than 10 inspection lots may be used for the calculations if;
the inspection lots used are the most recent ones in sequence within the last 6 months, they have all been on
normal inspection, and none has been rejected on original inspection.
7. Section Sec. 42.112, is revised to read as follows:
Sec. 42.112 Defects of containers: Tables IV, V, VI, VII, VIII, IX,
and X.
Table IV--Metal Containers (Rigid and Semi-Rigid)
------------------------------------------------------------------------
Categories
Defects --------------------------------------
Critical Major Minor
------------------------------------------------------------------------
Type or size of container or
component parts not as specified None permitted.
--------------------------------------
Closure incomplete, not located
correctly or not sealed,
crimped, or fitted properly:
(a) Heat processed primary 1 ........... ...........
container...................
(b) Non-heat processed ........... 101 ...........
primary container...........
(c) Other than primary ........... ........... 201
container...................
Dirty, stained, or smeared ........... ........... 202
container.......................
Key opening metal containers
(when required):
(a) Key missing............. ........... 102 ...........
(b) Key does not fit tab.... ........... 103 ...........
(c) Tab of opening band ........... 104 ...........
insufficient to provide
accessibility to key........
(d) Improper scoring (band ........... 105 ...........
would not be removed in one
continuous strip)...........
Metal pop-top:
(a) Missing or broken pull ........... 106 ...........
tab.........................
(b) Missing or incomplete ........... 107 ...........
score line..................
Flexible pop-top:
(a) Poor seal (wrinkle, ........... 108 ...........
entrapped matter, etc.).....
(b) Short pull tab.......... ........... ........... 203
(c) Missing pull tab........ ........... 109 ...........
(d) Torn pull tab........... ........... ........... 204
Open top with plastic overcap
(when required):
(a) Plastic overcap missing. ........... 110 ...........
(b) Plastic overcap warped ........... 111 ...........
(making opening or
reapplication difficult)....
Outside tinplate or coating (when
required):
(a) Missing or incomplete... ........... ........... 205
(b) Blistered, flaked, ........... ........... 206
sagged, or wrinkled.........
(c) Scratched or scored..... ........... ........... 207
(d) Fine cracks............. ........... ........... 208
[[Page 2487]]
Rust (rust stain confined to the
top or bottom double seam or
rust that can be removed with a
soft cloth is not scored a
defect):
(a) Rust stain.............. ........... ........... 209
(b) Pitted rust............. ........... 112 ...........
Wet cans (excluding refrigerated ........... ........... 210
containers).....................
Dent:
(a) Materially affecting ........... ........... 211
appearance but not usability
(b) Materially affecting ........... 113 ...........
usability...................
Buckle:
(a) Not involving end seam.. ........... ........... 212
(b) Extending into the end ........... 114 ...........
seam........................
Collapsed container.............. ........... 115 ...........
Paneled side materially affecting ........... ........... 213
appearance but not usability....
Solder missing when required..... ........... 116 ...........
Cable cut exposing seam.......... ........... 117 ...........
Improper side seam............... ........... 118 ...........
Swell, springer, or flipper (not 2 ........... ...........
applicable to gas or pressure
packed product or frozen
products).......................
Leaker or blown container........ 3 ........... ...........
Frozen products only:
(a) Bulging ends \3/16\-inch ........... ........... 214
to \1/4\-inch beyond lip....
(b) Bulging ends more than ........... 119 ...........
\1/4\-inch beyond lip.......
Metal drums: leaking filling 4 120 ...........
seal (bung) swell \1\.......
------------------------------------------------------------------------
\1\ Defect classification depends on the severity of the defect.
Table V--Composite Containers (Fiberboard Body With Metal Lids or Metal
Bottoms, Plastic or Foil Top With Cap)
------------------------------------------------------------------------
Categories
Defects --------------------------------------
Critical Major Minor
------------------------------------------------------------------------
Type or size of container or
component parts not as specified None permitted.
--------------------------------------
Closure incomplete, not located 1 ........... ...........
correctly or not sealed,
crimped, or fitted properly:....
Dirty, stained, or smeared ........... ........... 201
container.......................
Easy open closure:
(a) Pull tab:................ ........... ........... ...........
1. Missing or broken pull ........... 101 ...........
tab.....................
2. Missing or incomplete ........... 102 ...........
score line..............
(b) Membrane top:............ ........... ........... ...........
1. Poor seal (wrinkle, ........... 103 ...........
entrapped matter, etc.).
2. Short pull tab........ ........... 104 ...........
3. Missing pull tab...... ........... 105 ...........
4. Torn pull tab......... ........... 106 ...........
(c) Open top with plastic ........... ........... ...........
overcap (when required):....
1. Plastic overcap ........... 107 ...........
missing.................
2. Plastic overcap warped ........... 108 ...........
(making opening or
reapplication difficult)
Outside tinplate or coating on
ends (when required):
(a) Missing or incomplete.... ........... ........... 202
(b) Blistered, flaked, ........... ........... 203
sagged, or wrinkled.........
(c) Scratched or scored...... ........... ........... 204
(d) Fine cracks.............. ........... ........... 205
Collapsed container.............. ........... 109 ...........
Paneled side materially affecting ........... ........... 206
appearance but not usability....
Leaker........................... 2 ........... ...........
Wet or damp:
(a) Materially affecting ........... ........... 207
appearance but not usability
(b) Materially affecting ........... 110 ...........
usability...................
Crushed or torn area:
1. Materially affecting ........... ........... 208
appearance but not usability
2. Materially affecting ........... 111 ...........
usability...................
------------------------------------------------------------------------
[[Page 2488]]
Table VI--Glass Containers (Bottles, Jars)
------------------------------------------------------------------------
Categories
Defects --------------------------------------
Critical Major Minor
------------------------------------------------------------------------
Type or size of container or
component parts not as specified None permitted.
--------------------------------------
Closure not sealed, crimped, or
fitted properly:
(a) Heat processed........... 1 ........... ...........
(b) Non-heat processed....... ........... 101 ...........
Dirty, stained, or smeared ........... ........... 201
container.......................
Chip in glass.................... ........... ........... 202
Stone (unmelted material) in ........... ........... 203
glass...........................
Pits in surface of glass......... ........... ........... 204
Sagging surface.................. ........... ........... 205
Bead (bubble within glass):...... ........... ........... ...........
(a) \1/8\-inch to \3/16\-inch ........... ........... 206
in diameter.................
(b) Exceeding \1/8\-inch in ........... 102 ...........
diameter....................
Checked.......................... ........... 103 ...........
Thin spot in glass............... ........... 104 ...........
Blister (structural defect)...... ........... 105 ...........
Bird swing (glass appendage 2 ........... ...........
inside container)...............
Broken or leaking container...... 3 ........... ...........
Cap (nonheat processed):
(a) Cross-threaded........... ........... ........... 207
(b) Loose but not leaking.... ........... ........... 208
(c) Pitted rust.............. ........... 106 ...........
Cap (heat processed):
(a) Cross-threaded or loose.. 4 ........... ...........
(b) Pitted rust.............. ........... 107 ...........
Sealing tape or cello band (when
required):
(a) Improperly placed........ ........... ........... 209
(b) Not covering juncture of ........... 108 ...........
cap and glass...............
(c) Ends overlap by less than ........... 109 ...........
\1/2\-inch..................
(d) Loose or deteriorating... ........... 110 ...........
Missing or torn outer safety seal ........... 111 ...........
Inner safety seal--missing, torn, ........... 112 ...........
poor seal.......................
------------------------------------------------------------------------
Table VII--Plastic Containers (Rigid and Semi-Rigid, Bottles, Jars,
Tubs, Trays, Pails, etc.)
------------------------------------------------------------------------
Categories
Defects --------------------------------------
Critical Major Minor
------------------------------------------------------------------------
Type or size of container or
component parts not as specified None permitted.
--------------------------------------
Closure not sealed, crimped, or
fitted properly:
(a) Heat processed.......... 1 ........... ...........
(b) Non-heat processed...... ........... 101 ...........
Dirty, stained, or smeared ........... ........... 201
container.......................
Chip in plastic.................. ........... ........... 202
Un-melted gels in plastic........ ........... ........... 203
Pits in surface of plastic....... ........... ........... 204
Sagging surface.................. ........... ........... 205
Air bubble within plastic:
(a) \1/8\-inch to \1/16\- ........... ........... 206
inch in diameter............
(b) Exceeding \1/8\-inch in ........... 102
diameter....................
Checked.......................... ........... 103
Thin spot in plastic............. ........... 104
Blister (structural defect)...... ........... 105
Broken or leaking container...... 2 ........... ...........
Cap (non-heat processed):
(a) Cross-threaded.......... ........... ........... 207
(b) Loose but not leaking... ........... ........... 208
Cap (heat processed), cross- 3 ........... ...........
threaded or loose...............
Security seals:
(a) Closure ring missing.... ........... 106 ...........
(b) Missing or torn outer ........... 107 ...........
safety seal.................
(c) Inner safety seal-- ........... 108 ...........
missing, torn, or poor seal.
(d) Sealing tape or cello
band (when required):
1. Improperly placed..... ........... ........... 209
2. Not covering juncture ........... 109 ...........
of cap and plastic......
3. Ends overlap by less ........... 110 ...........
than \1/2\-inch.........
[[Page 2489]]
4. Loose or deteriorating ........... 111 ...........
Closure not sealed, crimped, or
fitted properly.................
------------------------------------------------------------------------
Table VIII--Rigid and Semi-Rigid Containers--Corrugated or Solid
Fiberboard, Chipboard, Wood, Aseptic, Polymeric Trays, etc.
[Excluding metal, glass, and plastic]
------------------------------------------------------------------------
Categories
Defects --------------------------------------
Critical Major Minor
------------------------------------------------------------------------
Type or size of container or
component parts not as specified None permitted.
--------------------------------------
Component part missing........... ........... 101 ...........
Closure not sealed, crimped, or
fitted properly:
(a) Primary container........ 1
(b) Other than primary ........... ........... 201
container...................
Dirty, stained, or smeared ........... ........... 202
container.......................
Wet or damp (excluding ice
packs):
(a) Materially affecting ........... ........... 203
appearance but not usability
(b) Materially affecting ........... 102 ...........
usability...................
Moldy area....................... 2 ........... ...........
Crushed or torn area:
(a) Materially affecting ........... ........... 204
appearance but not usability
(b) Materially affecting ........... 103 ...........
usability...................
Separation of lamination
(corrugated fiberboard):
(a) Materially affecting ........... ........... 205
appearance but not usability
(b) Materially affecting ........... 104 ...........
usability...................
Product sifting or leaking....... ........... 105 ...........
Nails or staples (when required):
(a) Not as required, ........... ........... 206
insufficient number or
improperly positioned.......
(b) Nails or staples ........... 106 ...........
protruding..................
Glue or adhesive (when required);
not holding properly, not
covering area specified, or not
covering sufficient area to hold
properly:
(a) Primary container....... ........... 107 ...........
(b) Other than primary ........... ........... 207
container...................
Flap:
(a) Projects beyond edge of ........... ........... 208
container more than 1/4-inch
(b) Does not meet properly, ........... ........... 209
allowing space of more than
1/4-inch....................
Sealing tape or strapping (when
required):
(a) Missing................. ........... 108 ...........
(b) Improperly placed or ........... ........... 210
applied.....................
Missing component (straw, etc.).. ........... ........... 211
Aseptic containers:
Missing re-sealable cap or tab... ........... 109 ...........
Inner or outer safety seal-- 3 ........... ...........
missing, torn, poor seal........
Thermostabilized polymeric trays:
Tray body:
(a) Swollen container....... 4 ........... ...........
(b) Tear, crack, hole, 5 ........... ...........
abrasion through more than
one layer of multi-layer
laminate for the tray.......
(c) Presence of delamination ........... ........... 212
in multi-layered laminate...
(d) Presence of any ........... ........... 213
permanent deformation, such
that deformed area is
discolored or roughened in
texture.....................
Lid material:
(a) Closure seal not 6 ........... ...........
continuous along tray flange
surface.....................
(b) Foldover wrinkle in seal 7 ........... ...........
area extends into the
closure seal such that the
closure seal is reduced to
less than 1/8-inch..........
(c) Any impression or design ........... 110 ...........
on the seal surfaces which
conceals or impairs visual
detection of seal defects...
(d) Areas of ``wave-like'' ........... ........... 214
striations or wrinkles along
the seal area that spans the
entire width of seal........
(e) Abrasion of lid
material:
1. Within \1/16\-inch of 8 ........... ...........
food product edge of
seal such that barrier
layer is exposed........
2. Greater than \1/16\- ........... ........... 215
inch from food product
edge of seal that
barrier layer is exposed
(f) Presence of entrapped 9 ........... ...........
matter within \1/16\-inch of
the food product edge of
seal or entrapped moisture
or vapor with \1/16\-inch of
the food product edge of
seal that results in less
than \1/16\-inch of defect
free seal width at the
outside edge................
(g) Presence of any seal ........... 111 ...........
defect or anomaly (for
example, entrapped moisture,
gases, etc.) within \1/16\-
inch of food product edge of
seal........................
[[Page 2490]]
(h) Closure seal width less than ........... ........... 216
\1/8\-inch......................
------------------------------------------------------------------------
Table IX--Flexible Containers (Plastic, Cellophane, Paper, Textile,
Laminated Multi-Layer Pouch, Bag, etc.)
------------------------------------------------------------------------
Categories
Defects --------------------------------------
Critical Major Minor
------------------------------------------------------------------------
Type or size of container or
component parts not as specified None permitted.
--------------------------------------
Closure not sealed, crimped, ........... ........... ...........
stitched, or fitted properly:
(a) Heat processed primary 1 ........... ...........
container...................
(b) Non-heat processed ........... 101 ...........
primary container...........
(c) Other than primary ........... ........... 201
container...................
Dirty, stained, or smeared ........... ........... 202
container.......................
Unmelted gels in plastic......... ........... ........... 203
Torn or cut container or abrasion ........... ........... ...........
(non-leaker):
(a) Materially affecting ........... ........... 204
appearance but not usability
(b) Materially affecting ........... 102 ...........
usability...................
Moldy area....................... 2 ........... ...........
Individual packages sticking ........... 103 ...........
together or to shipping case
(tear when separated)...........
Not fully covering product....... ........... 104 ...........
Wet or damp (excluding ice ........... ........... ...........
packs):
(a) Materially affecting ........... ........... 205
appearance but not usability
(b) Materially affecting ........... 105 ...........
usability Over wrap (when
required):..................
(a) Missing.................. ........... 106 ...........
(b) Loose, not sealed, or ........... ........... 206
closed......................
(c) Improperly applied....... ........... ........... 207
Sealing tape, strapping, or ........... ........... ...........
adhesives (when required):
(a) Missing.................. ........... 107 ...........
(b) Improperly placed, ........... ........... 208
applied, torn, or wrinkled..
Tape over bottom and top closures ........... ........... ...........
(when required):
(a) Not covering stitching... ........... 108 ...........
(b) Torn (exposing stitching) ........... 109 ...........
(c) Wrinkled (exposing ........... 110 ...........
stitching)..................
(d) Not adhering to bag: ........... ........... ...........
1. Exposing stitching.... ........... 111 ...........
2. Not exposing stitching ........... ........... 209
(e) Improper placement....... ........... ........... 210
Product sifting or leaking: ........... ........... ...........
(a) Non-heat processed....... ........... 112 ...........
(b) Heat processed........... 3 ........... ...........
Flexible pop-top: ........... ........... ...........
(a) Poor seal (wrinkle, 4 ........... ...........
entrapped matter, etc.)
reducing intact seal to less
than \1/16\-inch............
(b) Short pull tab ........... ........... 212
(materially affecting
usability)..................
(c) Missing pull tab......... ........... 113 ...........
(d) Torn pull tab (materially ........... ........... 213
affecting usability)........
Missing component (straw, etc.).. ........... ........... 214
Two part container (poly ........... ........... ...........
lined box or bag in box):
(a) Outer case torn.......... ........... ........... 215
(b) Poly liner: ........... ........... ...........
1. Missing............... 5 ........... ...........
2. Improper closure...... ........... 114 ...........
Missing ``zip lock'' (re-sealable ........... ........... 216
containers).....................
Loss of vacuum (in vacuum-packed) ........... 115 ...........
Pre-formed containers: ........... ........... ...........
(a) Dented or crushed area... ........... ........... 217
(b) Deformed container....... ........... ........... 218
Missing re-sealable cap.......... ........... 116 ...........
Inner or outer safety seal-- 6 ........... ...........
missing, torn, poor seal........
Air bubble in plastic............ ........... 117 ...........
Thermostabilized products ........... ........... ...........
(includes but not limited to
tubes, pouches, etc.):
Foldover wrinkle in seal area ........... ........... ...........
(thermostabilized pouches):
(a) Extends through all plies 7 ........... ...........
across seal area or reduces
seal less than \1/16\-inch..
(b) Does not extend through ........... ........... 219
all plies and effective seal
to is \1/16\-inch or greater
Incomplete seal (thermostabilized 8 ........... ...........
pouches)........................
Non-bonding seal 9 ........... ...........
(thermostabilized pouches)......
[[Page 2491]]
Laminate separation in body of ........... ........... ...........
pouch or in seal within \1/16\-
inch of food product edge:
(a) If food contact layer is 10 ........... ...........
exposed.....................
(b) If food contact surface ........... 118 ...........
is exposed after
manipulation or laminate
separation expands after
manipulation................
(c) If lamination separation ........... ........... 220
is limited to isolated spots
that do not propagate with
manipulation or is outer ply
separation in seal within \1/
16\-inch of food product
edge of seal................
Flex cracks (cracks in foil layer ........... ........... 221
only)...........................
Swollen container................ 11 ........... ...........
Blister (in seal) reducing intact 12 ........... ...........
seal to less than \1/16\-inch...
Compressed seal (overheated to 13 ........... ...........
bubble or expose inner layer)
reducing intact seal to less
than \1/16\-inch................
Stringy seal (excessive plastic ........... ........... 222
threads showing at edge of seal
area)...........................
Contaminated seal (entrapped 14 ........... ...........
matter) reducing intact seal to
less than \1/16\-inch...........
Seal creep (product in pouch 15 ........... ...........
``creeping'' into seal) reducing
intact seal to less than \1/16\
inch............................
Misaligned or crooked seal 16 ........... ...........
reducing intact seal to less
than \1/16\-inch................
Seal formed greater than 1-inch ........... ........... 223
from edge of pouch (unclosed
edge flaps).....................
Waffling (embossing on surface ........... ........... 224
from retort racks; not scorable
unless severe)..................
Poor or missing tear notch (when ........... ........... 225
required).......................
------------------------------------------------------------------------
Table X--Unitizing (Plastic or Other Type of Casing/Unitizing)
------------------------------------------------------------------------
Categories
Defects -------------------------
Major Minor
------------------------------------------------------------------------
Not specified method.......................... 101 ...........
Missing tray (when required).................. 102 ...........
Missing shrink wrap (when required)........... 103 ...........
Loose or improperly applied wrap.............. ........... 201
Torn or mutilated............................. ........... 202
Off-center wrap (does not overlap both ends).. ........... 203
------------------------------------------------------------------------
8. Section 42.113 is revised to read as follows:
Sec. 42.113 Defects of label, marking, or code.
Table XI--Label, Marking, or Code
------------------------------------------------------------------------
Categories
Defects -------------------------
Major Minor
------------------------------------------------------------------------
Not specified method.......................... 101 ...........
Missing (when required)....................... 102 ...........
Loose or improperly applied................... ........... 201
Torn or mutilated............................. ........... 202
Torn or scratched, obliterating any markings 103 ...........
on the label.................................
Text illegible or incomplete.................. ........... 203
Incorrect..................................... 104 ...........
In wrong location............................. ........... 204
------------------------------------------------------------------------
9. Add Sec. 42.114 to read as follows:
Sec. 42.114 Procedures for Evaluating Interior Container Defects.
(a) Sections 42.101 through 42.136 of this part provide procedures
for determining lot conformance with the U.S. Standards for Condition
of Food Containers. This determination is based on the examination of
the external characteristics of the food containers.
(b) As an option, if a user of the inspection service requests to
have the interior characteristics of containers examined, and apply
these results in the determination of lot acceptability, the defects
listed in Table XII of this section may be used.
(c) The determination of lot acceptability based on internal
container defects shall be independent of the determination of lot
acceptability for U.S. Standards for Condition of Food Containers. A
user of the inspection service may choose to require inspection for
internal can defects as well as inspection for U.S. Standards for
Condition of Food Containers.
(d) If a user of the inspection service requests an examination for
internal container defects in addition to an official USDA/USDC
inspection for product quality and/or U.S. grade, the containers opened
by the official inspection service for inspection of product quality
and/or U.S. grade will be used for examination of interior container
defects. The minimum sample size for evaluation of interior container
[[Page 2492]]
defects will be 13 containers. As a result, additional containers will
be required if the inspection for quality or U.S. grade calls for fewer
than 13 containers. Table XIII of this section provides acceptance
numbers for internal container defects for selected sample sizes.
Table XII--Interior Container Defects
------------------------------------------------------------------------
Categories
Defects -------------------------
Major Minor
------------------------------------------------------------------------
De-tinning in metal container materially 101 ...........
affecting usability..........................
De-tinning in metal container not materially ........... 201
affecting usability..........................
Black spots in metal container................ ........... 202
Enamel missing (when required) in metal 102 ...........
container....................................
Enamel breakdown in metal container material 103 ...........
affecting usability..........................
Enamel cracked in metal container material not ........... 203
affecting usability..........................
Interior of container damaged materially 104 ...........
affecting usability..........................
Interior of container damaged not materially ........... 204
affecting usability..........................
Other anomaly (ies) of the interior of the 105 ...........
container (metal, plastic, paper, rigid,
etc.) that materially affects usability......
Other anomaly (ies
