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.

Proposed Rules Federal Register

2481 

Vol. 77, No. 11 

Wednesday, January 18, 2012 

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: http://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: 

http://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: http://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. 


srobinson on DSK4SPTVN1PROD with PROPOSALS
2482 Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Proposed Rules 

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, 

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 

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 


srobinson on DSK4SPTVN1PROD with PROPOSALS
Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Proposed Rules 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. 

* * * * * 

§ 42.106 [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

Code Lot size ranges—number of 

containers in lot Type of plan 

Acceptable quality levels 

Origin inspection Other than origin inspection 

Sample 

size 

0.25 1.5 6.5 0.25 2.5 10.0 

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 


srobinson on DSK4SPTVN1PROD with PROPOSALS
2484 Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Proposed Rules 

BILLING CODE 3401–02–C 

5. Revise § 42.110, to read as follows: 

§ 42.110 Sampling plans for tightened 

condition of container inspection; Tables II 

and II–A. 


srobinson on DSK4SPTVN1PROD with PROPOSALSEP18JA12.000</GPH>
Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Proposed Rules 2485 

TABLE II—SINGLE SAMPLING PLANS FOR TIGHTENED CONDITION OF CONTAINER INSPECTION

Code Lot size ranges—number of 

containers in lot Type of plan 

Acceptable quality levels 

Origin inspection Other than origin inspection 

Sample 

size 

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 ................................. 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

Code 

Lot size ranges— 

number of containers in 

lot 

Type of 

plan Sample size 

Acceptable quality levels 

Origin inspection Other than origin inspection 

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 § 42.111, to read as follows: § 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

Code Lot size ranges—number of 

containers in lot Type of plan 

Acceptable quality levels 

Origin inspection Other than origin inspection 

Sample 

size 

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 ................................. 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

Code 

Lot size ranges— 

number of containers in 

lot 

Type of 

plan Sample size 

Acceptable quality levels 

Origin inspection Other than origin inspection 

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 


srobinson on DSK4SPTVN1PROD with PROPOSALS
2486 Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Proposed Rules 

TABLE III–A—DOUBLE SAMPLING PLANS FOR REDUCED CONDITION OF CONTAINER INSPECTION—Continued 

Code 

Lot size ranges— 

number of containers in 

lot 

Type of 

plan Sample size 

Acceptable quality levels 

Origin inspection Other than origin inspection 

0.25 1.5 6.5 0.25 2.5 10.0 

Ac Re Ac Re Ac Re Ac Re Ac Re Ac Re 

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

Number of sample units from last 10 lots inspected within 6 months 

Acceptable quality level 

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 § 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) 

Defects 

Categories 

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 container .............................................................................................. 1 .................... ....................

(b) Non-heat processed primary container ...................................................................................... .................... 101 ....................

(c) Other than primary container ...................................................................................................... .................... .................... 201 

Dirty, stained, or smeared container ....................................................................................................... .................... .................... 202 

Key opening metal containers (when required): 

(a) Key missing ................................................................................................................................. .................... 102 ....................

(b) Key does not fit tab ..................................................................................................................... .................... 103 ....................

(c) Tab of opening band insufficient to provide accessibility to key ................................................ .................... 104 ....................

(d) Improper scoring (band would not be removed in one continuous strip) .................................. .................... 105 ....................

Metal pop-top: 

(a) Missing or broken pull tab .......................................................................................................... .................... 106 ....................

(b) Missing or incomplete score line ................................................................................................ .................... 107 ....................

Flexible pop-top: 

(a) Poor seal (wrinkle, entrapped matter, etc.) ................................................................................ .................... 108 ....................

(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 (making opening or reapplication difficult) ........................................... .................... 111 ....................

Outside tinplate or coating (when required): 

(a) Missing or incomplete ................................................................................................................. .................... .................... 205 

(b) Blistered, flaked, sagged, or wrinkled ......................................................................................... .................... .................... 206 

(c) Scratched or scored .................................................................................................................... .................... .................... 207 

(d) Fine cracks .................................................................................................................................. .................... .................... 208 


srobinson on DSK4SPTVN1PROD with PROPOSALS
Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Proposed Rules 2487 

TABLE IV—METAL CONTAINERS (RIGID AND SEMI-RIGID)—Continued 

Defects 

Categories 

Critical Major Minor 

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 containers) .......................................................................................... .................... .................... 210 

Dent: 

(a) Materially affecting appearance but not usability ....................................................................... .................... .................... 211 

(b) Materially affecting usability ........................................................................................................ .................... 113 ....................

Buckle: 

(a) Not involving end seam .............................................................................................................. .................... .................... 212 

(b) Extending into the end seam ...................................................................................................... .................... 114 ....................

Collapsed container ................................................................................................................................. .................... 115 ....................

Paneled side materially affecting appearance but not usability .............................................................. .................... .................... 213 

Solder missing when required ................................................................................................................. .................... 116 ....................

Cable cut exposing seam ........................................................................................................................ .................... 117 ....................

Improper side seam ................................................................................................................................. .................... 118 ....................

Swell, springer, or flipper (not applicable to gas or pressure packed product or frozen products) ....... 2 .................... ....................

Leaker or blown container ....................................................................................................................... 3 .................... ....................

Frozen products only: 

(a) Bulging ends 3⁄16-inch to 1⁄4-inch beyond lip .............................................................................. .................... .................... 214 

(b) Bulging ends more than 1⁄4-inch beyond lip ............................................................................... .................... 119 ....................

Metal drums: leaking filling seal (bung) swell 1 ................................................................................ 4 120 ....................

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) 

Defects 

Categories 

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: ............................ 1 .................... ....................

Dirty, stained, or smeared container ....................................................................................................... .................... .................... 201 

Easy open closure: 

(a) Pull tab: ....................................................................................................................................... .................... .................... ....................

1. Missing or broken pull tab ..................................................................................................... .................... 101 ....................

2. Missing or incomplete score line .......................................................................................... .................... 102 ....................

(b) Membrane top: ............................................................................................................................ .................... .................... ....................

1. Poor seal (wrinkle, entrapped matter, etc.) .......................................................................... .................... 103 ....................

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 missing ........................................................................................................ .................... 107 ....................

2. Plastic overcap warped (making opening or reapplication difficult) ..................................... .................... 108 ....................

Outside tinplate or coating on ends (when required): 

(a) Missing or incomplete ................................................................................................................. .................... .................... 202 

(b) Blistered, flaked, sagged, or wrinkled ......................................................................................... .................... .................... 203 

(c) Scratched or scored .................................................................................................................... .................... .................... 204 

(d) Fine cracks .................................................................................................................................. .................... .................... 205 

Collapsed container ................................................................................................................................. .................... 109 ....................

Paneled side materially affecting appearance but not usability .............................................................. .................... .................... 206 

Leaker ...................................................................................................................................................... 2 .................... ....................

Wet or damp: 

(a) Materially affecting appearance but not usability ....................................................................... .................... .................... 207 

(b) Materially affecting usability ........................................................................................................ .................... 110 ....................

Crushed or torn area: 

1. Materially affecting appearance but not usability ......................................................................... .................... .................... 208 

2. Materially affecting usability ......................................................................................................... .................... 111 ....................


srobinson on DSK4SPTVN1PROD with PROPOSALS
2488 Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Proposed Rules 

TABLE VI—GLASS CONTAINERS (BOTTLES, JARS) 

Defects 

Categories 

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 container ....................................................................................................... .................... .................... 201 

Chip in glass ............................................................................................................................................ .................... .................... 202 

Stone (unmelted material) in glass .......................................................................................................... .................... .................... 203 

Pits in surface of glass ............................................................................................................................ .................... .................... 204 

Sagging surface ....................................................................................................................................... .................... .................... 205 

Bead (bubble within glass): ..................................................................................................................... .................... .................... ....................

(a) 1⁄8-inch to 3⁄16-inch in diameter ................................................................................................... .................... .................... 206 

(b) Exceeding 1⁄8-inch in diameter .................................................................................................... .................... 102 ....................

Checked ................................................................................................................................................... .................... 103 ....................

Thin spot in glass .................................................................................................................................... .................... 104 ....................

Blister (structural defect) .......................................................................................................................... .................... 105 ....................

Bird swing (glass appendage inside container) ...................................................................................... 2 .................... ....................

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 cap and glass ...................................................................................... .................... 108 ....................

(c) Ends overlap by less than 1⁄2-inch .............................................................................................. .................... 109 ....................

(d) Loose or deteriorating ................................................................................................................. .................... 110 ....................

Missing or torn outer safety seal ............................................................................................................. .................... 111 ....................

Inner safety seal—missing, torn, poor seal ............................................................................................. .................... 112 ....................

TABLE VII—PLASTIC CONTAINERS (RIGID AND SEMI-RIGID, BOTTLES, JARS, TUBS, TRAYS, PAILS, ETC.) 

Defects 

Categories 

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 container ....................................................................................................... .................... .................... 201 

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-inch in diameter ................................................................................................... .................... .................... 206 

(b) Exceeding 1⁄8-inch in diameter .................................................................................................... .................... 102 

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-threaded or loose ...................................................................................... 3 .................... ....................

Security seals: 

(a) Closure ring missing ................................................................................................................... .................... 106 ....................

(b) Missing or torn outer safety seal ................................................................................................ .................... 107 ....................

(c) Inner safety seal—missing, torn, or poor seal ............................................................................ .................... 108 ....................

(d) Sealing tape or cello band (when required): 

1. Improperly placed .................................................................................................................. .................... .................... 209 

2. Not covering juncture of cap and plastic .............................................................................. .................... 109 ....................

3. Ends overlap by less than 1⁄2-inch ........................................................................................ .................... 110 ....................


srobinson on DSK4SPTVN1PROD with PROPOSALS
Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Proposed Rules 2489 

TABLE VII—PLASTIC CONTAINERS (RIGID AND SEMI-RIGID, BOTTLES, JARS, TUBS, TRAYS, PAILS, ETC.)—Continued 

Defects 

Categories 

Critical Major Minor 

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] 

Defects 

Categories 

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 container ...................................................................................................... .................... .................... 201 

Dirty, stained, or smeared container ....................................................................................................... .................... .................... 202 

Wet or damp (excluding ice packs): 

(a) Materially affecting appearance but not usability ....................................................................... .................... .................... 203 

(b) Materially affecting usability ........................................................................................................ .................... 102 ....................

Moldy area ............................................................................................................................................... 2 .................... ....................

Crushed or torn area: 

(a) Materially affecting appearance but not usability ....................................................................... .................... .................... 204 

(b) Materially affecting usability ........................................................................................................ .................... 103 ....................

Separation of lamination (corrugated fiberboard): 

(a) Materially affecting appearance but not usability ....................................................................... .................... .................... 205 

(b) Materially affecting usability ........................................................................................................ .................... 104 ....................

Product sifting or leaking ......................................................................................................................... .................... 105 ....................

Nails or staples (when required): 

(a) Not as required, insufficient number or improperly positioned ................................................... .................... .................... 206 

(b) Nails or staples protruding .......................................................................................................... .................... 106 ....................

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 container ...................................................................................................... .................... .................... 207 

Flap: 

(a) Projects beyond edge of container more than 1/4-inch ............................................................. .................... .................... 208 

(b) Does not meet properly, allowing space of more than 1/4-inch ................................................ .................... .................... 209 

Sealing tape or strapping (when required): 

(a) Missing. ....................................................................................................................................... .................... 108 ....................

(b) Improperly placed or applied ...................................................................................................... .................... .................... 210 

Missing component (straw, etc.) .............................................................................................................. .................... .................... 211 

Aseptic containers: 

Missing re-sealable cap or tab ................................................................................................................ .................... 109 ....................

Inner or outer safety seal—missing, torn, poor seal ............................................................................... 3 .................... ....................

Thermostabilized polymeric trays: 

Tray body: 

(a) Swollen container ........................................................................................................................ 4 .................... ....................

(b) Tear, crack, hole, abrasion through more than one layer of multi-layer laminate for the tray .. 5 .................... ....................

(c) Presence of delamination in multi-layered laminate ................................................................... .................... .................... 212 

(d) Presence of any permanent deformation, such that deformed area is discolored or roughened in texture .............................................................................................................................. .................... .................... 213 

Lid material: 

(a) Closure seal not continuous along tray flange surface .............................................................. 6 .................... ....................

(b) Foldover wrinkle in seal area extends into the closure seal such that the closure seal is reduced to less than 1/8-inch .......................................................................................................... 7 .................... ....................

(c) Any impression or design on the seal surfaces which conceals or impairs visual detection of 

seal defects ................................................................................................................................... .................... 110 ....................

(d) Areas of ‘‘wave-like’’ striations or wrinkles along the seal area that spans the entire width of 

seal ................................................................................................................................................ .................... .................... 214 

(e) Abrasion of lid material: 

1. Within 1⁄16-inch of food product edge of seal such that barrier layer is exposed ................ 8 .................... ....................

2. Greater than 1⁄16-inch from food product edge of seal that barrier layer is exposed .......... .................... .................... 215 

(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 1⁄16- 

inch of defect free seal width at the outside edge ....................................................................... 9 .................... ....................

(g) Presence of any seal defect or anomaly (for example, entrapped moisture, gases, etc.) within 1⁄16-inch of food product edge of seal ...................................................................................... .................... 111 ....................


srobinson on DSK4SPTVN1PROD with PROPOSALS
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] 

Defects 

Categories 

Critical Major Minor 

(h) Closure seal width less than 1⁄8-inch ................................................................................................. .................... .................... 216 

TABLE IX—FLEXIBLE CONTAINERS (PLASTIC, CELLOPHANE, PAPER, TEXTILE, LAMINATED MULTI-LAYER POUCH, BAG, ETC.) 

Defects 

Categories 

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 container .............................................................................................. 1 .................... ....................

(b) Non-heat processed primary container ...................................................................................... .................... 101 ....................

(c) Other than primary container ...................................................................................................... .................... .................... 201 

Dirty, stained, or smeared container ....................................................................................................... .................... .................... 202 

Unmelted gels in plastic .......................................................................................................................... .................... .................... 203 

Torn or cut container or abrasion (non-leaker): 

(a) Materially affecting appearance but not usability ....................................................................... .................... .................... 204 

(b) Materially affecting usability ........................................................................................................ .................... 102 ....................

Moldy area ............................................................................................................................................... 2 .................... ....................

Individual packages sticking together or to shipping case (tear when separated) ................................. .................... 103 ....................

Not fully covering product ........................................................................................................................ .................... 104 ....................

Wet or damp (excluding ice packs): 

(a) Materially affecting appearance but not usability ....................................................................... .................... .................... 205 

(b) Materially affecting usability Over wrap (when required): .......................................................... .................... 105 ....................

(a) Missing ........................................................................................................................................ .................... 106 ....................

(b) Loose, not sealed, or closed ...................................................................................................... .................... .................... 206 

(c) Improperly applied ....................................................................................................................... .................... .................... 207 

Sealing tape, strapping, or adhesives (when required): .................... .................... ....................

(a) Missing ........................................................................................................................................ .................... 107 ....................

(b) Improperly placed, applied, torn, or wrinkled ............................................................................. .................... .................... 208 

Tape over bottom and top closures (when required): 

(a) Not covering stitching ................................................................................................................. .................... 108 ....................

(b) Torn (exposing stitching) ............................................................................................................ .................... 109 ....................

(c) Wrinkled (exposing stitching) ...................................................................................................... .................... 110 ....................

(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, entrapped matter, etc.) reducing intact seal to less than 1⁄16-inch ............. 4 .................... ....................

(b) Short pull tab (materially affecting usability) ............................................................................... .................... .................... 212 

(c) Missing pull tab ........................................................................................................................... .................... 113 ....................

(d) Torn pull tab (materially affecting usability) ................................................................................ .................... .................... 213 

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 containers) ............................................................................................. .................... .................... 216 

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—missing, torn, poor seal ............................................................................... 6 .................... ....................

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 across seal area or reduces seal less than 1⁄16-inch ........................ 7 .................... ....................

(b) Does not extend through all plies and effective seal to is 1⁄16-inch or greater .......................... .................... .................... 219 

Incomplete seal (thermostabilized pouches) ........................................................................................... 8 .................... ....................

Non-bonding seal (thermostabilized pouches) ........................................................................................ 9 .................... ....................


srobinson on DSK4SPTVN1PROD with PROPOSALS
Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Proposed Rules 2491 

TABLE IX—FLEXIBLE CONTAINERS (PLASTIC, CELLOPHANE, PAPER, TEXTILE, LAMINATED MULTI-LAYER POUCH, BAG, 

ETC.)—Continued 

Defects 

Categories 

Critical Major Minor 

Laminate separation in body of pouch or in seal within 1⁄16-inch of food product edge: 

(a) If food contact layer is exposed .................................................................................................. 10 .................... ....................

(b) If food contact surface is exposed after manipulation or laminate separation expands after 

manipulation .................................................................................................................................. .................... 118 ....................

(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 ............................... .................... .................... 220 

Flex cracks (cracks in foil layer only) ...................................................................................................... .................... .................... 221 

Swollen container .................................................................................................................................... 11 .................... ....................

Blister (in seal) reducing intact seal to less than 1⁄16-inch ...................................................................... 12 .................... ....................

Compressed seal (overheated to bubble or expose inner layer) reducing intact seal to less than 1⁄16- 

inch ....................................................................................................................................................... 13 .................... ....................

Stringy seal (excessive plastic threads showing at edge of seal area) .................................................. .................... .................... 222 

Contaminated seal (entrapped matter) reducing intact seal to less than 1⁄16-inch ................................. 14 .................... ....................

Seal creep (product in pouch ‘‘creeping’’ into seal) reducing intact seal to less than 1⁄16 inch ............. 15 .................... ....................

Misaligned or crooked seal reducing intact seal to less than 1⁄16-inch ................................................... 16 .................... ....................

Seal formed greater than 1-inch from edge of pouch (unclosed edge flaps) ......................................... .................... .................... 223 

Waffling (embossing on surface from retort racks; not scorable unless severe) ................................... .................... .................... 224 

Poor or missing tear notch (when required) ............................................................................................ .................... .................... 225 

TABLE X—UNITIZING (PLASTIC OR OTHER TYPE OF CASING/UNITIZING) 

Defects 

Categories 

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: 

§ 42.113 Defects of label, marking, or 

code. 

TABLE XI—LABEL, MARKING, OR CODE

Defects 

Categories 

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 on the label .............................................................................................. 103 ....................

Text illegible or incomplete .............................................................................................................................................. .................... 203 

Incorrect ........................................................................................................................................................................... 104 ....................

In wrong location ............................................................................................................................................................. .................... 204 

9. Add § 42.114 to read as follows: 

§ 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 


srobinson on DSK4SPTVN1PROD with PROPOSALS
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

Defects 

Categories 

Major Minor 

De-tinning in metal container materially affecting usability ............................................................................................. 101 ....................

De-tinning in metal container not materially affecting usability ....................................................................................... .................... 201 

Black spots in metal container ........................................................................................................................................ .................... 202 

Enamel missing (when required) in metal container ....................................................................................................... 102 ....................

Enamel breakdown in metal container material affecting usability ................................................................................. 103 ....................

Enamel cracked in metal container material not affecting usability ................................................................................ .................... 203 

Interior of container damaged materially affecting usability ............................................................................................ 104 ....................

Interior of container damaged not materially affecting usability ...................................................................................... .................... 204 

Other anomaly (ies) of the interior of the container (metal, plastic, paper, rigid, etc.) that materially affects usability 105 ....................

Other anomaly (ies) of the interior of the container (metal, plastic, paper, rigid, etc.) that materially affects appearance but not usability ................................................................................................................................................... .................... 205 

TABLE XIII—ACCEPTANCE NUMBERS

FOR INTERNAL CONTAINER DEFECTS

Sample size 

(n = number of 

containers) 

Major Total 

Interior 

defects 

Interior 

defects 

Ac Re Ac Re 

n—13 ................ 0 1 2 3 

n—21 ................ 1 2 3 4 

n—29 ................ 1 2 4 5 

n—38 ................ 2 3 5 6 

n—48 ................ 2 3 6 7 

n—60 ................ 2 3 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. 

ACTION: Notice of petition. 

SUMMARY: 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 

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 http:// 

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 

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 


srobinson on DSK4SPTVN1PROD with PROPOSALS