Law Library

Sub Chapter 585

Vegetables

Sec. 585.100 Artichoke; Jerusalem Artichoke - Common or Usual Name (CPG 7114.01)

BACKGROUND:

From time to time questions arise concerning the common or usual names to be used in the labeling of two distinct articles of food, both called artichokes. One such article is thistle-like herb (Cynara scolymus), sometimes called globe artichoke, cultivated for its flower buds. This is the artichoke referred to by the standard of identity (21 CFR 155.200, *Certain other* canned vegetables). Trade Correspondence 345, December l940, in discussing the question of common or usual names, stated that the "artichoke most familiar to the consuming public is the undeveloped blossom of the leafy artichoke plant, which is commonly and usually referred to simply as 'artichoke'."

The other type of artichoke is called Jerusalem artichoke (Helianthus tuberosus) and belongs to the sunflower family. It is widely cultivated for its tuber which is used as a vegetable directly, in pickles and relishes, and as a source of inulin used in the manufacture of fructose. TC 345 stated that this should be designated as "Jerusalem artichoke."

POLICY:

To minimize confusion in the labeling of foods, the unqualified term "artichoke" should be used as the common or usual name for the flower buds of the globe artichoke (Cynara scolymus).

The term "Jerusalem artichoke" should be used as the common or usual name for the tuber (Helianthus tuberosus).

*Material between asterisks is new or revised.*

Issued: 8/20/73
Reissued: 10/1/80
Revised: 12/8/88

Sec. 585.150 Asparagus, Canned or Frozen - Adulteration with Insect Filth (CPG 7114.02)

REGULATORY ACTION GUIDANCE:

The following represents criteria for direct reference seizure to the Division of Compliance Management and Operations (HFC-210) and for direct citation by District Offices:

1. 10 Percent or more by count of spears or pieces are infested with six or more attached asparagus beetle eggs and/or sacs;

or

2. The asparagus contains an average of 40 or more thrips per 100 grams;

or

3. The asparagus contains an average of 5 or more insects (whole or equivalent) of any size per 100 grams, or insects (whole or equivalent) 3mm or longer having an average aggregate length of 7 mm or longer per 100 grams of asparagus.

SPECIMEN CHARGE:

*The article was adulterated when introduced into and while in interstate commerce, and is adulterated while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 342(a)(3) in that it consists in part of a filthy substance by reason of the presence therein of: asparagus beetle eggs or sacs or thrips or insects or insect fragments*.

NOTE: Use direct reference citation authority only when prosection is anticipated and evidence to support a prosecution is included with the adulteration charge. Evidence necessary to support a prosecution is specified in existing regulatory procedures issuances.

*Material between asterisks is new or revised.*

Issued: 11/7/79
Reissued: 10/1/80
Revised: 11/1/81, 12/8/88

Sec. 585.200 Beets, Canned - Adulteration with Rot (CPG 7114.04)

REGULATORY ACTION GUIDANCE:

The following represents criteria for direct reference seizure to the Division of Compliance Management and Operations (HFC-210) and for direct citation by District Offices:

The canned beets contain an average of 5% or more, by weight, pieces with dry rot.

SPECIMEN CHARGE:

*The article was adulterated when introduced into and while in interstate commerce, and is adulterated while held for sale after shipment in interstate commerce within the meaning of 21 U.S.C. 342(a)(3), in that it consists in part of a decomposed substance by reason of the presence therein of beets with dry rot.

NOTE: Use direct reference citation authority only when prosecution is anticipated and evidence to support a prosecution is included with the adulteration charge. Evidence necessary to support a prosecution is specified in existing regulatory procedures issuances.*

*Material between asterisks is new or revised.*

Issued: 11/7/79
Reissued: 10/1/80
Revised: 11/1/81, 12/8/88

Sec. 585.225 Black-Eyed Peas (Cow Peas, Field Peas); Dried -Adulteration with Lygus Bug Damage (CPG 7114.05)

REGULATORY ACTION GUIDANCE:

The following represents the criteria for direct reference seizure to the Division of Compliance Management and Operations (HFC-210) and for direct citation by the District Offices:

The dried black-eyed peas contain an average of 10% or more by count of class 6 damage or higher, minimum of 12 subsamples examined.

NOTE: See FDA Technical Bulletin No. 5 - Macroanalytical Procedures Manual, V-116 for classification of black-eyed peas damaged by lygus bug.

REMARKS:

If there is reason to believe the lot was graded and certified by the U.S. Department of Agriculture, submit the following information via EMS or FAX to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)* and await reply before proceeding:

Sample Number     Date of Shipment
Article Involved  Dealer
Amount of Lot     Shipper 
Codes             Analytical Conclusions

SPECIMEN CHARGE:

The article was adulterated when introduced into and while in interstate commerce, and is adulterated while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 342(a)(3) in that it consists in part of a filthy substance by reason of the presence therein of insect damaged peas.

NOTES:

1. If the evidence establishes that the article became adulterated after receipt in interstate commerce, then charge only that the article "is adulterated while held for sale after shipment in interstate commerce."

2. If the evidence does not establish where the article became adulterated and the violation is such that it could have occurred anywhere, i.e. it is not a manufacturing defect, then also charge only that the article "is adulterated while held for sale after shipment in interstate commerce."

*Material between asterisks is new or revised.*

Issued: 11/7/79
Reissued: 10/1/80
Revised: 12/8/88, 3/95

Sec. 585.260 Broccoli, Frozen - Adulteration with Insects (CPG 7114.06)

REGULATORY ACTION GUIDANCE:

The following represents criteria for direct reference seizure to the Division of Compliance Management and Operations (HFC-210) and for direct citation by District Offices:

The broccoli contains an average of 60 or more aphids, thrips or mites (or any combination of these) per 100 grams.

SPECIMEN CHARGE:

The article was adulterated when introduced into and while in interstate commerce, and is adulterated while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 342(a)(3) in that it consists in part of a filthy substance by reason of the presence therein of insects.

NOTE: Use direct reference citation authority only when prosecution is anticipated and evidence to support a prosecution is included with the adulteration charge. Evidence necessary to support a prosecution is specified in existing regulatory procedures issuances.

*Material between asterisks is new or revised.*

Issued: 10/1/80
Revised: 11/1/81, 12/8/88

Sec. 585.275 Brussels Sprouts, Frozen - Adulteration by Insects (CPG 7114.07)

REGULATORY ACTION GUIDANCE:

The following represents the criteria for direct reference seizure to the Division of Compliance Management and Operations (HFC-210) and for direct citation by the District Offices:

The brussels sprouts contain an average of 30 or more aphids and/or thrips per 100 grams.

REMARKS:

Seizures of these products must be discussed with the U.S. Department of Agriculture. Submit the following information via EMS or FAX to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)* and await reply before proceeding:

Sample Number     Date of Shipment
Article Involved  Dealer
Amount of Lot     Shipper 
Codes             Analytical Conclusions

SPECIMEN CHARGE:

The article was adulterated when introduced into and while in interstate commerce, and is adulterated while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 342(a)(3) in that it consists in part of a filthy substance by reason of the presence therein of insects.

*Materials between asterisks is new or revised.*

Issued: 11/7/79
Reissued: 10/1/80
Revised: 12/8/88, 3/95

Sec. 585.300 Corn, Sweet; Canned - Adulteration by Corn Ear Worms, Corn Borers (CPG 7114.08)

REGULATORY ACTION GUIDANCE:

The following represents the criteria for direct reference seizure to the Division of Compliance Management and Operations (HFC-210) and for direct citation by the District Offices:

Examine a minimum of 24 lbs. (24 No. 303 cans or equivalent). The corn contains two or more 3 mm or longer larvae, cast skins, larval or cast skin fragments of corn ear worm or corn borer;

and

The aggregate length of such larvae, cast skins, larval or cast skin fragments exceeds 12 mm.

REMARKS:

Seizures involving these products must be discussed with the U.S. Department of Agriculture. Submit the following information via EMS or FAX to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)* and await reply before proceeding:

Sample Number     Date of Shipment
Article Involved  Dealer
Amount of Lot     Shipper 
Codes             Analytical Conclusions

SPECIMEN CHARGE:

The article was adulterated when introduced into and while in interstate commerce, and is adulterated while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 342(a)(3) since it consists in part of a filthy substance by reason of the presence therein of insects and/or insect fragments.

*Material between asterisks is new or revised.*

Issued: 11/issued: 10/1/80
Revised: 12/8/88, 3/95

Sec. 585.325 Corn on the Cob, Canned - Quantity of Contents Declaration (CPG 7114.09)

BACKGROUND:

In the past we have advised packers of canned corn on the cob that the quantity of contents declaration should be in terms of both net weight and count.

Upon the basis of information supplied by the National Canners Association, we have concluded that a net weight declaration on canned corn on the cob would not be meaningful to consumers since such declaration would include the weight of the inedible cobs and the packing medium which is customarily discarded. A drained weight declaration, which would include the weight of the inedible cobs, would not be meaningful, and might be misleading, since drained weight declarations usually indicate the quantity of edible food in packages.

POLICY:

In order to satisfy the requirement of *21 CFR 101.105(a)*, the quantity of contents declaration on canned corn on the cob should be in terms of count (number of ears). We will not object to a declaration in terms of net weight also, but this is not required. The can should, of course, be well filled to avoid deception.

*Material between asterisks is new or revised.*

Issued: 1/22/70
Revised: 8/20/73
Reissued: 10/1/80
Revised: 12/8/88

Sec. 585.350 Corn Husks (for Tamales) - Adulteration with Filth (CPG 7114.10)

REGULATORY ACTION GUIDANCE:

The following represents the criteria for direct reference seizure to the Division of Compliance Management and Operations (HFC-210) and for direct citation by the District Offices:

The corn husks contain an average of 5% or more by weight of insect-infested (including insect damaged) or moldy husks.

SPECIMEN CHARGE:

*The article was adulterated when introduced into and while in interstate commerce, and is adulterated while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 342(a)(3) in that it consists in part of a filthy substance by reason of the presence therein of insects, insect damage; and of a decomposed substance by reason of the presence therein of moldy corn husks.*

*Material between asterisks is new or revised.*

Issued: 11/21/79
Reissued: 10/1/80
Revised: 12/8/88

Sec. 585.400 Cowpeas (Black-Eyed Peas); Canned (Succulent Peas) - Adulteration by Insects (CPG 7114.11)

REGULATORY ACTION GUIDANCE:

The following represents the criteria for direct reference seizure to the Division of Compliance Management and Operations (HFC-210) and for direct citation by the District Offices:

The peas contain an average of five or more cowpea curculio larvae or the equivalent per #2 can.

REMARKS:

Seizures involving these products must be discussed with the U.S. Department of Agriculture. Submit the following information via EMS or FAX to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)* and await reply before proceeding:

Sample Number     Date of Shipment
Article Involved  Dealer
Amount of Lot     Shipper 
Codes             Analytical Conclusions

SPECIMEN CHARGE:

The article was adulterated when introduced into and while in interstate commerce, and is adulterated while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 342(a)(3) in that it consists in part of a filthy substance by reason of the presence therein of insect larvae.

*Material between asterisks is new or revised.*

Issued: 11/21/79
Reissued: 10/1/80
Revised: 12/8/88, 3/95

Sec. 585.450 Greens, Canned - Adulteration by Mildew (CPG 7114.12)

REGULATORY ACTION GUIDANCE:

The following represents criteria for direct reference seizure to the Division of Compliance Management and Operations (HFC-210) and for direct citation by District Offices:

The greens contain on average of 10 percent or more of leaves by count or weight showing mildew over 1/2" in diameter.

SPECIMEN CHARGE:

*The article was adulterated when introduced into and while in interstate commerce, and is adulterated while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 342(a)(3) in that it consists in part of a decomposed substance by reason of the presence therein of mildewed greens.

NOTE: Use direct reference citation authority only when prosecution is anticipated and evidence to support a prosecution is included with the adulteration charge. Evidence necessary to support a prosecution is specified in existing regulatory procedures issuances.*

*Material between asterisks is new or revised.*

Issued: 10/1/80
Revised: 11/1/81, 12/8/88

Sec. 585.475 Canned Green Beans and Canned Wax Beans - Misbranding Involving Food Standards (CPG 7114.03)

REGULATORY ACTION GUIDANCE:

The following represents criteria for direct reference seizure to the Division of Compliance Management and Operations (HFC-210) and for direct citation by the District Offices:

A. Length of Cut: Section 155.120(b)(1)(i). Note that this applies only to beans represented as "Cuts" and "Diagonal cuts" (Section 155.120(a)(2)(iii)(c) and (e)) and mixtures of beans (Section 155.120(a)(2)(iii)(g)).

1. More than 240 Bean Units Per 340 Grams (12 Ounces) Drained Weight

a. Each of the subsamples contains more than 25% by count of units less than 13 millimeters (0.50 inch) long;

or

b. The average of the subsamples is more than 25% by count of units less than 13 millimeters (0.50 inch) long and at least one-half the subsamples contain more than 35% units less than 13 millimeters (0.50 inch) long.

2. 240 Bean Units or Less Per 340 Grams (12 Ounces) Drained Weight

a. Each of the subsamples contains more than 60 units by count less than 13 millimeters (0.50 inch) long per 340 grams (12 ounces) drained weight;

or

b. The average of the subsamples is more than 60 units by count less than 13 millimeters (0.50 inch) long per 340 grams (12 ounces) drained weight and at least one-half the subsamples contain more than 80 units less than 13 millimeters (0.50 inch) long per 340 grams (12 ounces) drained weight.

B. Fiber - Section 155.120(b)(1)(iii)

1. The deseeded bean pods in each of the subsamples contain more than 0.15% by weight fibrous material;

or

2. The average of the subsamples is more than 0.15% by weight fibrous material in the deseeded bean pods and at least one-half the subsamples contain more than 0.20% by weight fibrous material.

C. Blemish (See NOTE 2) - 21 CFR Part 155.120(b)(1)(iv)

1. Each of the subsamples contains more than 10% by weight blemished units;

or

2. The average of the subsamples is more than 10% by weight blemished units and at least one-half the subsamples contain more than 14% by weight blemished units.

D. Unstemmed units - 21CFR Part 155.120(b)(1)(v)

1. Each of the subsamples contains more than 8 unstemmed units per 340 grams (12 ounces) drained weight;

or

2. The average of the subsamples is more than 8 unstemmed units per 340 grams (12 ounces) drained weight and at least one-half the subsamples contain more than 11 unstemmed units per 340 grams (12 ounces) drained weight.

NOTES:

1. At least 6 subsamples must be examined from each code in commingled lots. At least 12 subsamples must be examined from lots containing only one code or no code.

2. Rust-like discolorations and abnormalities other than discrete blemishes such as physical damage (insect stings, abrasions, dried discolored wounds where pods have been broken, etc.) are difficult to categorize as blemish as intended by the standards. Borderline samples containing such nondescript abnormalities should be referred to *CFSAN/Office of Field Programs/Division of HACCP/Regulatory Food Processing and Technology Branch (HFS-617* for examination.

REMARKS:

Seizures involving these products must be discussed with the U.S. Department of Agriculture. Submit the following information to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)* via EMS or FAX and await reply before proceeding:

Sample Number     Date of Shipment
Article Involved  Dealer
Amount of Lot     Shipper 
Codes             Analytical Conclusions

SPECIMEN CHARGES:

1. Length of Cut

The article was misbranded when introduced into and while in interstate commerce, and is misbranded while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 343(h)(1), in that it purports to be and is represented as canned cut green beans, a food for which a standard of quality has been prescribed by regulation (21 CFR 155.120(b)) promulgated pursuant to 21 U.S.C. 341, and its quality falls below such standard, since section 155.120(b)(1)(i) of such standard provides that in canned green beans of standard quality not more than 60 units per 340 grams (12 ounces) drained weight are less than 13 millimeters (0.50 inch) long; whereas the article contains more than 60 units per 340 grams (12 ounces) drained weight less than 13 millimeters (0.50 inch) long; and its label fails to bear, in such manner and form as such regulations specify, a statement that it falls below such standard.

2. Excess Fiber

The article was misbranded when introduced into and while in interstate commerce, and is misbranded while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 343(h)(1), in that it purports to be and is represented as canned cut green beans, a food for which a standard of quality has been prescribed by regulation (21 CFR 155.120(b)) promulgated pursuant to 21 U.S.C. 341, and its quality falls below such standard, since Part 155.120(b)(1)(iii) of such standard provides that in canned green beans of standard quality the deseeded pods contain not more than 0.15 percent by weight of fibrous material; whereas, the deseeded pods of the article contain more than 0.15 percent by weight of fibrous material, and its label fails to bear, in such manner and form as such regulations specify, a statement that it falls below such standard.

3. Blemish

The article was misbranded when introduced into and while in interstate commerce, and is misbranded while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 343(h)(1), in that it purports to be and is represented as canned cut green beans, a food for which a standard of quality has been prescribed by regulation (21 CFR 155.120(b)) promulgated pursuant to 21 U.S.C. 341, and its quality falls below such standard, since section 155.120(b)(1)(iv) of such standard provides that in canned green beans of standard quality there are not more than 10 percent by weight of blemished units; whereas, there are more than 10 percent by weight of blemished units in the article; and its label fails to bear, in such manner and form as such regulations specify, a statement that it falls below such standard.

4. Unstemmed Units

The article was misbranded when introduced into and while in interstate commerce, and is misbranded while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 343(h)(1), in that it purports to be and is represented as canned cut green beans, a food for which a standard of quality has been prescribed by regulation (21 CFR 155.120(b)) promulgated pursuant to 21 U.S.C. 341, and its quality falls below such standard, since Part 155.120(b)(1)(v) of such standard provides that in canned green beans of standard quality there are not more than 8 unstemmed units per 340 grams (12 ounces) of drained weight; whereas, the article contains more than 8 unstemmed units per 340 grams (12 ounces) of drained weight; and its label fails to bear, in such manner and form as such regulations specify, a statement that it falls below such standard.

*Material between asterisks is new or revised.*

Issued: 4/15/80
Reissued: 10/1/80
Revised: 12/8/88, 3/95

Sec. 585.500 Mushrooms, Canned or Dried (Freeze-Dried or Dehydrated) - Adulteration Involving Maggots, Mites, Decomposition (CPG 7114.13)

REGULATORY ACTION GUIDANCE:

The following represents the criteria for recommending legal action to the *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*:

Analyze for maggots or mites by AOAC 44.115-44.116, 14th edition or subsequent current revision. Analyze for decomposition by Macronalytical Procedures Manual V-100. Actionable if examination of minimum of six 100 g portions of drained canned mushrooms and proportionate amounts of liquid (contents of each can analyzed separately), or a minimum of six 15 g portions of dried mushrooms, from one code in lot shows one or more of the following:

1. Maggots -- An average of 20 or more maggots of any size per 100 g of drained mushrooms and the proportionate liquid, or an average of 20 or more maggots of any size per 15 g of dried mushrooms;

or

An average of 5 or more maggots that are 2 mm or longer per 100 g portion of drained mushrooms and the proportionate liquid, or an average of 5 or more maggots that are 2 mm or longer per 15 g of dried mushrooms.

or

2. Mites -- An average of 75 or more mites per 100 g of drained mushrooms and the proportionate liquid, or an average of 75 or more mites per 15 g of dried mushrooms.

or

3. Decomposition -- An average of 10% or more decomposed mushrooms by weight.

*Material between asterisks is new or revised*

Issued: 11/21/79
Reissued: 10/1/80
Revised: 12/8/88, 3/95

Sec. 585.525 Mushroom Mycelium - Fitness for Food; Labeling (CPG 7114.14)

BACKGROUND:

The Food and Drug Administration sometimes receives inquiries about the use of mushroom mycelium produced by submerged culture propagation in various media. Mushroom mycelium is considered suitable for food use when grown in acceptable media.

However, mushroom mycelium has an identity different from mushrooms, and food products in which it is used should be labeled to clearly indicate that they contain mushroom mycelium.

POLICY:

Mushroom mycelium grown in acceptable media is regarded as suitable for food use. Any food in which mushroom mycelium is used should be labeled to state that fact. Labeling should not suggest or imply that the food contains mushrooms. For example, a soup in which mushroom mycelium is an ingredient should not be labeled or sold as "mushroom soup" since that name by long consumer understanding and usage is preempted by soup containing real mushrooms.

Issued: 10/20/76
Reissued: 10/1/80, 12/8/88

Sec. 585.575 Peas and Beans; Dried - Adulteration Involving Storage Insect Damage, Rocks (CPG 7114.15)

REGULATORY ACTION GUIDANCE:

The following represents the criteria for direct reference seizure to the Division of Compliance Management and Operations (HFC-210) and for direct citation by the District Offices:

Examine a minimum of 12 subsamples. The dried peas or dried beans contain an average of 5% or more by count insect infested and/or insect damaged (storage insects) peas or beans.

REMARKS:

If there is reason to believe the lot was graded and certified by the U.S. Department of Agriculture, submit the following information via EMS or FAX to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)* and await reply before proceeding:

Sample Number     Date of Shipment
Article Involved  Dealer
Amount of Lot     Shipper 
Codes             Analytical Conclusions

SPECIMEN CHARGE:

The article was adulterated when introduced into and while in interstate commerce, and is adulterated while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 342(a)(3) in that it consists in part of a filthy substance by reason of the presence therein of insects and/or insect damaged beans.

NOTES:

1. If the evidence establishes that the article became adulterated after receipt in interstate commerce, then charge only that the article "is adulterated while held for sale after shipment in interstate commerce."

2. If the evidence does not establish where the article became adulterated and the violation is such that it could have occurred anywhere, i.e. it is not a manufacturing defect, then also charge only that the article "is adulterated while held for sale after shipment in interstate commerce."

Other Criteria:

The following represents the criteria for recommending legal action to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*:

Refer for seizure action, accompanied by exhibits, all samples from lots in consumer-size packages which contain sharp and jagged rocks even if the amount of these rocks is below the limit in the USDA grade.

*Material between asterisks is new or revised.*

Issued: 11/21/79
Reissued: 10/1/80
Revised: 12/8/88, 3/95

Sec. 585.600 Peas and Carrots, Labeling of Canned Mixture (CPG 7114.16)

BACKGROUND:

The Food and Drug Administration, since 1940, has consistently held that a mixture of canned peas and carrots is not a standardized article. Trade Correspondence (TC) 263 stated that such a mixture may be appropriately designated as "peas and carrots" or "carrots and peas" and that it is not necessary in such a mixture to state on the label the optional pea ingredient or the optional form of carrots.

In 1956, in response to an inquiry about a canned item consisting of Blair process peas and frozen diced carrots, we stated that "the name 'Peas and Carrots' should be followed by a complete ingredient statement" and "the fact that the carrots have been frozen is a material one which should be revealed." This opinion then evolved into the more recent policy that all labels for mixtures of canned peas and carrots should bear a complete ingredient statement.

Both TC 263 and recent policy are inconsistent with regulations *21 CFR 155.170(a)* and the following policy is designed to resolve this inconsistency.

POLICY:

No specific standard of identity has been established for a canned mixture of carrots and peas. However, the food is considered to be a mixture of the standardized ingredients if (1) prepared from the fresh succulent vegetables in accordance with the methods prescribed by the standards for peas 21 CFR *155.170(a)* and carrots 21 CFR *155.200* and (2) it contains only water and the optional ingredients permitted by the standards; provided that if the food contains the optional ingredient butter, it is present in a quantity of not less than three percent of the finished food. A food meeting the above conditions may be designated by an appropriate statement of identity that includes the optional form of the carrot ingredient unless such optional form designation may be omitted in accordance with the regulations of 21 CFR *101.3(c)*. The optional pea ingredient need not be included as part of the statement of identity.

The ingredients should be designated on the label in accordance with 21 CFR *101.4(a)* by statements naming the optional pea ingredient, the optional form of the carrot ingredient, and supplemented by statements showing the optional ingredients which are present. If ingredients not permitted by the standards of identity are used, the article must bear an appropriate statement of identity and a full listing of all ingredients.

*Material between asterisks is new or revised.*

Issued: 7/25/69
Reissued: 12/3/73
Revised: 10/1/80, 12/8/88

Sec. 585.625 Canned Peas - Label Designation of Sizes (CPG 7114.17)

BACKGROUND:

In 1918 Food Inspection Decision No. 173, issued by the Bureau of Chemistry, U.S. Department of Agriculture, designated pea sizes on the basis of raw peas that would pass through screens of specified mesh sizes. These same size designations are still being used except that in practice today the size is determined on the basis of the canned peas. Since 1923 we have maintained the position that the size designation "petit pois" is inapplicable to peas larger than the No. 1 sieve size. The question of label designations of pea sizes was re-examined in 1940 (Trade Correspondence - 321) and our position was stated as follows:

"It is accordingly our view that the only label designation of pea size entirely without objection is a facsimile of the size actually present in the can. However, we will not raise objection, for the present, to statements in terms of sieve size, such as 'No. 2 sieve size,' etc., since there is reasonable agreement and fairly widespread understanding as to the meaning of these terms. Where the canner elects to use size terms which are such on their face e.g. 'Petit Pois,' 'Small,' 'Medium Small,' and the like, we believe that they should be accompanied by a statement of sieve size (or of average pea diameter in thirty-seconds of an inch). Other terms which have no clear size connotation to the consumer, and which may even give an entirely false impression as to variety or quality or both, are regarded as misbranding in the light of Sections 403(a) and 20l(n) of the Federal Food, Drug, and Cosmetic Act. We have already advised correspondents that 'Telephone' is in this category, and the same would be true of such terms as 'Midgets', 'Sifted,' 'Melting,' 'Gems,' etc."

"In our opinion, if the extreme sizes of peas are removed from the run by grading, the remainder could not properly be labeled as 'Ungraded.' For the present, and without prejudice to the possibility of a change in viewpoint should the expression be misinterpreted, we would offer no objection to the statement 'Nos. 3, 4, and 5 Sieve Sizes' or to the expression 'Mixed Sizes.'"

Concerning use of the term "midget," FDA field stations were advised in 1948 (Administration Information Letter No. 25) that inserting the word "midget" in the name prescribed by the standard of identity would conflict with the standard. We also expressed doubt concerning use of the term at some other place on the label unless such term was used on the smallest sieve size of canned peas and unless the term was accompanied by a drawing showing the actual size of the peas in the can.

The U.S. Department of Agriculture has promulgated standards for grades of canned peas wherein size designations for peas are given. These size designations are "applicable to peas in canned peas" and size is determined on the basis of the diameter of the circular opening(s) through which the peas will pass or will not pass without force or pressure.

POLICY:

*Size designations in the labeling of canned peas are determined on the basis of the circular openings through which the canned peas will pass as given by the following table taken from the USDA grade standard:*

       Diameter of Circular 
     Openings in Inches 
    Will Not Pass     Will Pass
Peas Size Designation Through      Through
Size l (Tiny)              -----         09/32 
Size 2 (Small)             09/32         l0/32 
Size 3 (Medium Small)      10/32         11/32 
Size 4 (Medium)            ll/32         l2/32 
Size 5 (Large)             l2/32         l3/32 
Size 6 (Large)             l3/32         l4/32 
Size 7 (Large)             l4/32         ----- 

The terms "petit pois," "petit peas," "midget," as well as "tiny" should not be used to describe peas other than size 1-peas that pass through 9/32 inch circular openings. In order to avoid consumer misunderstanding, the Food and Drug Administration recommends that these and other descriptive size terms, given in parenthesis in the above table, be accompanied by a facsimile of the size actually present in the can and/or a label designation in terms of numerical sizes given in the above table.

Size designations should not be inserted in the name of the food or used in lieu of words and statements required to appear on the label by the standard of identity and standard of quality 21 CFR *155.170(a) and 155.170(b)*.

*Material between asterisks is new or revised.*

Issued: 8/24/70
Reissued: 8/23/73
Revised: 10/1/80, 12/8/88

Sec. 585.650 Canned Pimentos and Red Sweet Peppers - Seeds Should be Removed (CPG 7114.18)

BACKGROUND:

Seeds are not mentioned in the standard of identity for canned pimentos or red sweet peppers (21 CFR 155.200). The standard states, "The vegetable ingredient in each such canned vegetable is obtained by proper preparation from the succulent vegetable". The findings of fact on which the standard is based provide for exclusion of "inedible, undesirable and unsuitable portions."

POLICY:

The seeds of pimentos and sweet red peppers are considered undesirable and unsuitable portions which should be removed in accord with good manufacturing practices.

Issued: 10/20/76
Reissued: 10/1/80, 12/8/88

Sec. 585.675 Popcorn - Adulteration with Rodent Filth and Field Corn (CPG 7114.19)

REGULATORY ACTION GUIDANCE:

The following represents the criteria for direct reference seizure to *Chief Counsel* through the Division of Compliance Management and Operations (HFC-210) and for direct citation by District Offices:

If upon examination of 10/225 gm subs or 6/10 oz. consumer size packages one of the following conditions is met:

1. One or more rodent excreta pellets are found in one or more subs and one or more rodent hairs are found in a least two other subs.

or

2. Examination shows two or more rodent hairs/lb., and rodent hair are found in 50% or more of the subs.

or

3. Examination shows 20 or more gnawed kernels/lb., and rodent hair are found in 50% or more of the subs.

or

4. Examination shows 5% or more by weight of field corn.

SPECIMEN CHARGE:

The article was adulterated when introduced into and while in interstate commerce, and is adulterated while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 342(a)(3) in that it consists in part of a filthy substance by reason of the presence therein of rodent excreta pellets, rodent hair, and by reason of being rodent gnawed.

If the adulteration is due to the presence of field corn, cite, "within the meaning of 21 U.S.C. 342(b)(2) in that field corn has been substituted in part for popcorn."

NOTES:

1. If the evidence establishes that the article became adulterated after receipt in interstate commerce, then charge only that the article "is adulterated while held for sale after shipment in interstate commerce."

2. If the evidence does not establish where the article became adulterated and the violation is such that it could have occurred anywhere, i.e. it is not a manufacturing defect, then also charge only that the article "is adulterated while held for sale after shipment in interstate commerce."

3. Use direct reference citation authority only when prosecution is anticipated and evidence to support a prosecution is included with the adulteration charge. Evidence to support a prosecution is specified in existing regulatory procedures issuances.

*Material between asterisks is new or revised.*

Issued: 10/1/80
Revised: 7/1/83, 12/8/88, 8/96

Sec. 585.700 Potato Chips - Adulteration with Rot (CPG 7114.20)

REGULATORY ACTION GUIDANCE:

The following represents the criteria for direct reference seizure to the Division of Compliance Management and Operations (HFC-210) and for direct citation by the District Offices:

The potato chips contain an average of six percent or more rot by weight.

SPECIMEN CHARGE:

*The article was adulterated when introduced into and while in interstate commerce, and is adulterated while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 342(a)(3) in that it consists in part of a decomposed substance by reason of the presence therein of decomposed potato chips.

NOTE: Use direct reference citation authority only when prosecution is anticipated and evidence to support a prosecution is included with the adulteration charge. Evidence to support a prosecution is specified in existing regulatory procedure issuances.*

*Material between asterisks is new or revised.*

Issued: 11/ 7/79
Reissued: 10/1/80
Revised: 12/8/88

Sec. 585.710 Potato Chips, Ingredients - Labeling (CPG 7114.21)

BACKGROUND:

For many years the name "potato chips" has been applied to thin slices of potatoes fried in deep fat.

*In the past,* firms have marketed articles they wish to identify as "potato chips" although these are not made by the traditional process of frying thin slices of potatoes in deep fat. These are made from dehydrated potatoes, with or without added carbohydrates from other sources, plus other ingredients commonly used in preparation of potato chips. Complaints were received both from individual manufacturers of potato chips and their trade association concerning the labeling of these new articles as "potato chips."

*The common or usual name regulation describing these products is codified at 21 CFR 102.41.*

Ingredients commonly used in preparing traditional potato chips, in addition to the potato ingredients, include shortening used as a frying medium; salt and sometimes other seasonings; antioxidants; preservatives such as ascorbic acid, sodium phosphate, sodium bisulfite; emulsifiers; and sufficient added dextrose to control browning of the chips.

POLICY:

The name "potato chips" may be used without qualification to describe the article made by frying thin slices of potato in deep fat.

The words "potato chips" will not be considered misleading in labeling an article whose composition differs from that of traditional potato chips only in having been processed from dried potatoes *provided that the food conforms to 21 CFR 102.41.*

The words "potato chips" will be considered misleading in labeling articles made from dried potatoes with significant amounts of added rice flour, corn starch, or other carbohydrates from sources other than potatoes, or which contain other ingredients not normally used in traditional potato chips.

*Material between asterisks is new or revised.*

Issued: 7/8/69
Reissued: 10/1/80
Revised: 12/8/88

Sec. 585.725 "Pumpkin" - Labeling Articles Made from Certain Varieties of Squash (CPG 7114.22)

BACKGROUND:

Canned "pumpkin" has for many years been packed from field pumpkin (Cucurbita pepo) or certain varieties of firm-shelled, golden-fleshed, sweet squash (Cucurbita maxima), or mixtures of these. Pumpkin and squash are sometimes mixed intentionally to obtain the consistency most acceptable to users.

Since l938, we have consistently advised canners that we would not initiate regulatory action solely because of their using the designation "pumpkin" or "canned pumpkin" on labels for articles prepared from golden-fleshed, sweet squash, or mixtures of such squash with field pumpkins. In the absence of any evidence that this designation misleads or deceives consumers we see no reason to change this policy.

POLICY:

In the labeling of articles prepared from golden-fleshed, sweet squash or mixtures of such squash and field pumpkin, we will consider the designation "pumpkin" to be in essential compliance with the "common or usual name" requirements of sections 403(i)(l) and 403(i)(2) of the Federal Food, Drug, and Cosmetic Act, and the "specifying of identity" required by section 1453(a)(1) of the Fair Packaging and Labeling Act.

Issued: 6/20/69
Revised: 8/20/73
Reissued: 10/1/80, 12/8/88

Sec. 585.750 Sauerkraut - Definition; Adulteration by Thrips (CPG 7114.23)

BACKGROUND:

Food Inspection Decision (F.I.D.) 196, issued August 1925, defined sauerkraut. Since that time the definition, essentially unchanged through the revision that appeared in Service and Regulatory Announcements (S.R.A.) F.D. No. 2, Rev. 5, November 1936, has been used as a guide for officials in enforcing the Food and Drug Act of 1906 and the Federal Food, Drug, and Cosmetic Act of 1938. The definition follows:

Sauerkraut: The product, of characteristic acid flavor, obtained by the full fermentation, chiefly lactic, of properly prepared and shredded cabbage in the presence of not less than 2 percent nor more than 3 percent of salt. It contains, upon completion of the fermentation, not less than 1.5 percent of acid, expressed as lactic acid. Sauerkraut which has been rebrined in the process of canning or repacking, contains not less than 1 percent of acid, expressed as lactic acid.

Shortly after enactment of the 1938 Act, sauerkraut was among the foods exempted from label declaration of ingredients requirement for labeling of nonstandardized foods. The exemption was based on the expectation that standards would soon be established. However, standards for this product were not established and on September 17, 1959, the exemption was terminated.

POLICY:

In the absence of a standard of identity, the term "sauerkraut' is considered the common or usual name for a product obtained by the lactic acid fermentation of cabbage in the presence of salt. Products which have not been fermented, but owe their acidity to added vinegar, acetic acid or other acidifiers are not entitled to the name sauerkraut. Ingredients of sauerkraut must be listed on the label by their common or usual name in descending order of predominance.

REGULATORY ACTION GUIDANCE:

Adulteration by Thrips

The following represents criteria for recommending legal action to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*:

The sauerkraut exceeds an average of 50 thrips per 100 grams.

*Material between asterisks is new or revised*

Issued: 8/24/70
Revised: 8/23/73
Reissued: 10/1/80
Revised: 8/15/82
Reissued: 12/8/88
Revised: 3/95

Sec. 585.775 Spinach, Canned or Frozen - Adulteration Involving Insects, Decomposition (CPG 7114.24)

REGULATORY ACTION GUIDANCE:

The following represents the criteria for direct reference seizure to the Division of Compliance Management and Operations (HFC-210) and for direct citation by the District Offices:

1. Aphids, Thrips, or Mites

Aphids, thrips, or mites singly or in combination, average 50 or more per 100 grams.

or

2. Spinach Worms (Caterpillars)

Two or more 3 mm or longer larvae and/or larval fragments of spinach worms (caterpillars), whose aggregate length exceeds 12 mm, are present in 24 pounds.

or

3. Leaf Miners (Larvae and Pupae)

a. Leaf miners of any size average eight or more per 100 grams;

or

b. Leaf miners, 3 mm or longer, average four or more per 100 grams.

or

4. Decomposition

An average of 10% or more of leaves by count or weight show one or more areas of at least 1/2" diameter affected by mildew or other type of decomposition.

REMARKS: involving these products must be discussed with the U.S. Department of Agriculture. Submit the following information via EMS or FAX to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)* and await reply before proceeding.

Sample Number     Date of Shipment
Article Involved  Dealer
Amount of Lot     Shipper 
Codes             Analytical Conclusions

SPECIMEN CHARGE:

The article was adulterated when introduced into and while in interstate commerce, and is adulterated while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 342(a)(3) in that it consists in part of a filthy substance by reason of the presence therein of insects; and of a decomposed substance by reason of presence therein of decomposed spinach.

NOTE: Use direct reference citation authority only when prosecution is anticipated and evidence to support a prosecution is included with the adulteration charge. Evidence to support a prosecution is specified in existing regulatory procedures issuances.

*Material between asterisks is new or revised.*

Issued: 11/21/79
Reissued: 10/1/80
Revised: 12/8/88, 3/95

Sec. 585.800 Squash Seeds - Labeling as Pumpkin Seeds (CPG 7114.25)

BACKGROUND:

See Sec. 585.725 (for CPG 7114.22) - "Pumpkin" is an acceptable designation for labeling articles made from certain varieties of squash.

Packers of canned pumpkin that use pumpkin and/or squash in their "canned pumpkin" may further process the seeds obtained therefrom for food use, or in some cases may sell the seeds to another processor. This practice would naturally lead to our being asked, as we were recently, whether squash seeds, when offered as food, may be labeled and sold as "pumpkin seeds." Horticulturists in the U. S. Department of Agriculture advise us that horticulturally, the difference between the seeds of squash (Cucurbita maxima) and pumpkin (Cucurbita pepo) is slight - there is no difference in the outward appearance - and any other difference is detectable only by an expert.

The U. S. Dispensatory, 25th Edition, states, "Much confusion exists in the usage of the terms 'pumpkin' and 'squash,' these terms having been applied almost indiscriminately to varieties of several species of Cucurbita." It also points out that the British Pharmacopeia of 1914, recognized as "pumpkin seeds," the species Cucurbita maxima which is usually considered as squash in this country.

POLICY:

The designation of "pumpkin seed" will not be considered misleading when used in the labeling of (1) squash seeds which are practically indistinguishable from pumpkin seeds, or (2) mixtures of such squash seeds with seeds of the pie or field pumpkin.

Issued: 6/20/69
Reissued: 8/23/73, 10/1/80, 12/8/88

Sec. 585.825 Sweet Potatoes - Dyeing of Yellow and Red Varieties (CPG 7114.26)

BACKGROUND:

Between 1940 and 1948 growers and shippers began to use artificially colored waxes on sweet potatoes and white potatoes. The Food and Drug Administration received many complaints from consumers who objected to the use of artificial colors, either because the practice was deceptive, or because the water soluble colors created a problem in their kitchens. In reply to these complaints and those received from State officials, the Food and Drug Administration replied that we could take action only if the colors used were poisonous or deleterious, the artificial color was not declared, or the colors served to conceal damage or inferiority or make the potatoes appear better or of greater value than they are.

About 1961, The Sweet Potato Council of the United States became concerned about declining sales of sweet potatoes and concluded that this was in part due to the dissatisfaction of housewives who purchased the red dyed potatoes thinking they were getting a variety of sweet potato with naturally red skins. Therefore, in 1965, the Council asked Congress to enact legislation to outlaw the practice of dyeing sweet potatoes red if the practice could not be outlawed under the Federal Food, Drug, and Cosmetic Act.

Those FDA districts in whose territories sweet potatoes were grown commercially were asked to investigate the allegations that the use of artificial red color concealed damage or inferiority, and made the sweet potatoes appear better or of greater value than they are.

Their findings did not support a conclusion that the red dye concealed damage, but indicated that most users of sweet potatoes prefer the natural red varieties to the natural yellow varieties, and substantiated the claims made by industry representatives that red color is added to yellow varieties to make the unwary purchaser believe he is getting the preferred red variety.

The Commissioner of Food and Drugs published a proposal to consider yellow varieties of sweet potatoes adulterated under Section 402(b) if artificially colored red. Most comments on this proposal were favorable. Some interested persons recommended that the policy be expanded to all varieties of sweet potatoes and to white (Irish) potatoes.

The Commissioner concluded that the available information would not support an expansion of the proposed policy to cover all sweet and white potatoes. In the Federal Register of June 21, 1968, a Statement of General Policy or Interpretation *(21 CFR 100.120)* was published to the effect that yellow varieties of sweet potatoes colored with red dye are adulterated within the meaning of Section 402(b) of the Federal Food, Drug, and Cosmetic Act. We have been asked to clarify our policy as to (1) the meaning of "yellow varieties of sweet potatoes," and (2) regarding use of red color on sweet potatoes with naturally red skins.

POLICY:

The expression "yellow varieties of sweet potatoes" is intended to include all sweet potatoes other than those having a naturally red outer skin. This includes those sweet potatoes whose skins might be described as white, orange, rust, gold, or any color other than naturally red. Regulatory action will not be initiated against sweet potatoes with naturally red skins which are dyed red unless: (l) the color additive (including adjuvants), is unsafe or is not used in accord with regulations to establish safe conditions of use; or (2) it can be demonstrated that the added color conceals damage or inferiority; or (3) the article fails to bear labeling stating the presence of artificial coloring.

*Material between asterisks is new or revised.*

Issued: 6/20/69
Reissued: 10/1/80
Revised: 12/8/88

Sec. 585.850 Sweet Potatoes - Sirup Pack (CPG 7114.27)

BACKGROUND:

Because confusion has arisen about the application of the provisions of 21 CFR 155.200 to canned sweet potatoes packed in sirup, it has become necessary to clarify our policy about the labeling of such articles. In 1968, some canners of sweet potatoes were advised that the standard of identity for canned sweet potatoes makes no provision for a sirup pack, and therefore, labels of canned sweet potatoes in sirup should bear a listing of ingredients in accord with Section 403(i)(2) of the Federal Food, Drug, and Cosmetic Act and *21 CFR 101.4*. At the request of interested canners and the National Canners Association we have reviewed the history of and past statements concerning sweet potatoes packed in sirup.

The standard of identity for canned sweet potatoes, as promulgated February 28, 1940, and at present, does not specifically provide for the original standard sanctioned water as a packing medium and sugar and dextrose as seasoning ingredients without requiring label declaration of these ingredients. The standard has since been amended to provide for additional nutritive sweeteners as seasonings. However, it now requires label declaration of the optional ingredients.

Although at the time the standard was promulgated it was generally known that sweet potatoes were being packed in sirup, the findings of fact, conclusion, and final order (resulting from a hearing) were silent concerning this practice. Following publication of the order no attempt was made to prohibit labeling of sweet potatoes as being packed in sirup provided such statements were not false or misleading. Recognizing the fact that sweet potatoes were being packed in sirup, FDA stated on September 5, 1940, (Trade Correspondence No. 325) that it had not had occasion to make any determination of just where seasoning leaves off and sirup begins in canned vegetables.

Again, in a letter to a packer dated January 1, 1960, we acknowledged the practice of labeling sweet potatoes as packed "in sirup". This letter states that "if a packer elects to make any label declaration about the packing medium, such declaration should not be false or misleading in any particular". Further, this same letter suggested that the USDA Standards for Grades of Canned Sweet Potatoes, promulgateed in 1954, be used as a guide in determining label statements of sirup designations and the Brix measurements thereof.

We considered the possibility of establishing separate standards of identity for canned sweet potatoes, including standards for solid pack, vacuum pack, and sirup pack. However, we lack data needed as a basis for establishing such standards, and we do not anticipate being able to make the investigations needed to obtain such data in the near future. Until the standards of identity for canned sweet potatoes are updated or further announcement is made, our policy concerning canned sweet potatoes in sirup will be as follows:

POLICY:

No regulatory action will be initiated on the basis of canned sweet potatoes, other than mashed, bearing a label designation such as "packed in sirup" or "in sirup" when in fact the packing medium is one made by using water and any one or more of the optional sweeteners provided for as seasoning ingredients by *21 CFR 155.200 (c)(3)*.

The density of the sirup need not be declared, but if a specific designation such as "light sirup", "heavy sirup", or "extra heavy sirup" is used in the labeling such sirup should meet the "cut-out" Brix measurement as given in the following table:

Designation          BRIX MEASUREMENT
Extra Heavy Sirup    30o or more 
Heavy Sirup          25o or more, but less than 30o 
Light Sirup          18o or more, but less than 25o 
In Water             Packed in Water 

The standard of identity *(21 CFR 155.200)* provides for use of water without label declaration. The standard now requires the declaration of the sweetening ingredients. Therefore, label declaration of the sirup ingredients by common or usual name is now required.

*Material between asterisks is new or revised.*

Issued: 12/3/73
Reissued: 4/16/79, 10/1/80
Revised: 12/8/88

Sec. 585.875 Tomatoes - Canned - Misbranding Involving Food Standards (Peel) (CPG 7114.28)

REGULATORY ACTION GUIDANCE:

The following represents the criteria for direct reference seizure to the Division of Compliance Management and Operations HFC-210 and for direct citation by the District Offices:

1. Examination of a minimum of 24 cans from the lot, or 24 cans from any one code in the lot, shows an average of 1.75 or more square inches of peel per pound and over one-third of the cans examined exceed one square inch of peel per pound;

or

2. Examination of a minimum of 48 cans from the lot, or 48 cans from any one code in the lot, shows an average of 1.25 or more square inches of peel per pound and over one-third of the cans examined exceed one square inch of peel per pound.

REMARKS:

Seizures involving this product must be discussed with the U.S. Department of Agriculture. Submit the following information via EMS or FAX to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)* and await reply before proceeding:

Sample Number     Date of Shipment
Article Involved  Dealer
Amount of Lot     Shipper 
Codes             Analytical Conclusions

Analytical Conclusions

SPECIMEN CHARGE:

The article was misbranded when introduced into and while in interstate commerce, and is misbranded while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 343(h)(1), in that it purports to be and is represented as canned tomatoes, a food for which a standard of quality has been prescribed by regulation (21 CFR, 155.190) promulgated pursuant to 21 U.S.C. 341, and its quality falls below such standard since section 155.190(b)(1) (iii) of such standard provides that tomato peel per pound of canned tomatoes in the container of standard quality canned tomatoes cover an area of not more than 1.06 square inches, whereas, the article contains tomato peel per pound of canned tomatoes in the container which covers an area of more than 1.06 square inches, and its label fails to bear, in such manner and form as such regulations specify, a statement that it falls below such standard.

*Material between asterisks is new or revised.*

Issued: 11/21/79
Reissued: 10/1/80
Revised: 12/8/88, 3/95

Sec. 585.890 Tomato Products - Adulteration with Drosophila Fly Eggs and Maggots (CPG 7114.29)

REGULATORY ACTION GUIDANCE

The following represents the criteria for direct reference seizure to the Division of Compliance Management and Operations (HFC-210) and for direct citation by the District Offices:

The average (minimum 12 subsamples) of any code, or of the lot if no code is present, is at least the following:

1. Canned Tomatoes

10 or more fly eggs per 500 grams or 5 or more fly eggs and 1 or more maggot per 500 grams, or 2 or more maggots per 500 grams.

2. Tomato Juice

10 or more fly eggs per 100 grams or 5 or more fly eggs and 1 or more maggot per 100 grams, or 2 or more maggots per 100 grams.

3. Tomato Puree

20 or more fly eggs per 100 grams or 10 or more fly eggs and 1 or more maggot per 100 grams, or 2 or more maggots per 100 grams.

4. Paste, Pizza and Other Sauces

30 or more fly eggs per 100 grams, or 15 or more fly eggs and 1 or more maggot per 100 grams, or 2 or more maggots per 100 grams.

NOTE: Drosophila maggots 2 mm, or less in length shall be considered equivalent to fly eggs, for the purpose of this guide.

REMARKS:

Seizures involving these products must be discussed with the U.S. Department of Agriculture. Submit the following information via EMS or FAX to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)* and await reply before proceeding:

Sample Number     Date of Shipment
Article Involved  Dealer
Amount of Lot     Shipper 
Codes             Analytical Conclusions

SPECIMEN CHARGE:

The article was adulterated when introduced into and while in interstate commerce, and is adulterated while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 342(a)(3), in that it consists in part of a filthy substance by reason of the presence therein of fly eggs and maggots.

NOTE: Use direct reference citation authority only when prosecution is anticipated and evidence to support a prosecution is included with the adulteration charge. Evidence necessary to support a prosecution is specified in existing regulatory procedures issuances.

*Material between asterisks is new or revised.*

Issued: 1/1/73
Reissued: 11/21/79
Revised: 10/1/80
Reissued: 12/1/82
Revised: 12/8/88, 3/95

Sec. 585.900 Tomato Products - Adulteration with Mold (CPG 7114.30)

REGULATORY ACTION GUIDANCE:

All mold counts are to be confirmed by a qualified analyst before consideration for regulatory action.

A. The following represents the criteria for direct reference seizure to *Chief Counsel* through Division of Compliance Management and Operations (HFC-210) and for direct citation by the District Offices if any of the following mold count criteria are met or exceeded by any code, or by the lot if no code is present:

Article              Six Subsamples examined
Tomato juice             Average 24% or above & all subs above 20%. 
Tomato Paste or          Average 45% of above, & all subs
puree (refractive        40%.
index as indicated
AOAC Methods of 
Analysis
Tomato sauce             Ditto
(Undiluted) 
Canned tomatoes          Average above 15% and all subs 
with or without          above 12% Based on examination of
added tomato             juice packing medium drained from canned tomatoes 
Canned tomatoes          Average above 29% & all subs above
packed in tomato         25%. Based on examination of
puree juice              packing medium drained from canned
tomatoes
Pizza sauce              Average above 34% & all subs
(based on 6%             above 30%
total tomato
solid after pulping)
Tomato soup &            Average 45% or above & all
tomato products          subs above 40%.

REMARKS:

Seizures involving these products must be discussed with the U.S. Department of Agriculture because some lots may have been graded by them. Teletype the following information to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)* and await reply before processing:

Sample Number      Issued of Shipment 
Article Involved   Dealer 
Amount of Lot      Shipper 
Codes              Analytical Conclusions 

SPECIMEN CHARGE:

Article adulterated when introduced into and while in interstate commerce, within meaning of 21 U.S.C. 342(a)(3), in that it consists wholly or in part of a decomposed substance by reason of presence therein of decomposed tomato material.

II. The following represents the criteria for recommending legal action to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*:

Six Subsamples

Article      Examined
Tomato catsup               Average 55% or above 
Tomato powder               Average of 45% or 
(except spray dried)        above & all subs above 40%.)
Tomato powder               Average 67% or above 
(spray dried) 

Note: Tomato Powder - check to determine if it has been spray dried. (See attachment).

Attachment to Sec. 585.900 (CPG 7114.30):

Tomato Powder

Tomato powder is produced by dehydrating concentrated tomato pulp. In preparing the powder for mold counting the moisture content is disregarded and a dilution of water is made to give a mixture with approximately the tomato solids content of the standardized preparation for mold count of tomato puree or paste, namely, 8.5 percent.

Identification of powder as spray-dried product:

Mold counts of spray-dried tomato powder show significantly higher counts than the paste from which it is made due to breakage of mold hyphae aggregates. Use following procedure to determine whether powder represents a spray-dried product.

To determine microscopically whether the product has been produced by spray-drying, suitable mount a small portion on a microscope slide in mineral oil or other non-aqueous mounting medium and examine microscopically at 100-200X. Spray-dried particles are translucent and contain air bubbles and numerous small granules within the particles. The shape of the particles ranges from spherical to elongate to irregular with rounded outlines and essentially no sharp angles. In the rehydrated powder, practically no intact tomato cells are evident. Drum-dried or similarly processed powder or flakes are characterized by irregular-shaped particles with angular outline and practically no embedded air bubbles.

Examine spray-dried tomato powder of HMC by AOAC 44.211. 14th ed.

*Material between asterisks is new or revised*

Issued: 10/1/80
Revised: 3/1/82, 7/1/83, 9/1/84, 1/16/85, 3/95, 8/96

Sub Chapter 587

Colors

Sec. 587.100 Label Declaration of Artificial Color (CPG 7127.01)

BACKGROUND:

*On 8/1/85 this CPG issued without the term "color added" as a permissible label declaration under Section 403(k) when a color is added to a food. This is in accord with the literal requirement of Section 403(k). However, it has come to our attention that food manufacturers have, in good faith, been complying with the previous long standing declaration of policy in permitting the term "color added" to declare the presence of an artificial color. Since it would not serve any useful purpose to change policy at this time, we are reissuing the 8/1/85 edition of this CPG, with appropriate revisions.*

Section 403(k) of the FD&C Act states that if a food contains an artificial color it should bear labeling "stating that fact."

Section 403(i)(2) of the FD&C Act permits a color to be listed on a food label as such without naming specifically the color used.

21 CFR 74.705(d)(2) states that all foods, including butter, cheese, and ice cream that contain FD&C Yellow No. 5 shall specifically declare the presence of this color additive in the list of ingredients.

Questions have arisen concerning the use of the terms "Food Color Added," *"color added,"* "artificial color," and "natural color" on a label to indicate the presence of artificial color.

POLICY:

For the purpose of the label declaration in accordance with Section 403(k) of the Act, the terms "Artificially Colored," "Artificial Color Added," *"color added,"* or an equally informative statement should be used which clearly indicates the addition of a color to a food, except where regulations require specific declaration of the color by common or usual name. FDA *also* will not insist upon the use of the word "artificial" with the declaration of color as an ingredient *when* the declaration identifies the color by specific common or usual name and by function. Thus, terms such as "colored with _____" or "_____ (color)" (the blank being filled with the specific color name such as annatto, beet powder, beta carotene, etc.) is considered satisfactory.

The use of the words *"food color added," "natural color," or similar words containing the term "food" or* "natural" may be erroneously interpreted to mean the color is a naturally occurring constituent in the food. Since all added colors result in an artificially colored food, we would object to the declaration of any added color as *"food" or* "natural."

*Material between asterisks is new or revised.*

Issued: 9/23/76
Revised: 8/16/78, 10/1/80, 8/1/85, 7/1/86

Sec. 587.200 Uncertified or Delisted Colors in Foods for Export - (e.g., FD&C Red #2) (CPG 7127.02)

BACKGROUND:

The provisional listing and certification of FD&C Red #2 (amaranth) was terminated in Federal Register announcements of February 10 and February 13, 1976. Since that time there have been several inquiries received by FDA concerning the use of FD&C Red #2 in food products for export.

The status of adulterated or misbranded food products for export is found in Section *801(e)* of the Federal Food, Drug, and Cosmetic Act.

POLICY:

Colors such as FD&C Red No. 2, which have been delisted, can be used in lots of food specifically manufactured for export to a country in which its use is legal, provided all the requirements of Section *801(e)* of the Act are followed and provided further, that a control system is followed which insures that there is no possibility of diversion by mistake or otherwise to domestic channels, of the food containing the color. Proper control can be achieved by following the procedure set forth below:

1. Prior to start of production and for each lot produced, a separate order, letter from the purchaser, and letter from an official of the country must be obtained.

The order from the purchaser must state the exact amount desired by the foreign purchaser and must state on the order or be accompanied by a letter from the purchaser stating that he desires that FD&C Red No. 2 or other specific color be used in the lot and that he is aware of its illegality in the United States. The letter from a responsible official of the country to which the lot is to be shipped shall state that the use of the color is legal in his country. Since the law and regulations of countries are subject to change, a continuing order or letter will not be satisfactory.

2. The stock of the color to be used for export production must be kept locked up at all times, except when actually being used. Complete records must be kept accounting for all use.

3. During all stages of production, manufacture, processing and packing the lot must be kept segregated from all other production and must be clearly marked that it is "for export only."

The outside of each shipping package of the lot must be labeled show it is for export.

4. All records pertaining to such lots, including orders and letters, must be kept for at least three years and made available to any Food and Drug Administration inspector upon oral or written request.

*NOTE: This policy only applies to uncertified or delisted colors that have been manufactured in this country, or entered legally into this country prior to being uncertified or delisted, and are intended to be used in foods solely for export.*

*Material between asterisks is new or revised.*

Issued: 9/23/76
Revised: 10/1/80, 8/31/89, 3/95

Sec. 587.300 Color Additives (CPG 7127.03)

BACKGROUND:

The status of color additives cannot always be definitely determined by reference to color additive regulations. Thus, a color additive may not appear on either the permanent or provisional lists and yet be legal because the order terminating the listing of the color additive allowed a grace period in which the color additive could continue to be used. In addition, although a color additive may no longer be permitted for a particular use, there may be extenuating circumstances which, when taken into consideration, would not warrant our taking regulatory action against a firm found to be using a non-permitted color additive.

REGULATORY ACTION GUIDANCE:

Before recommending regulatory action, where it appears that a color additive is being used illegally, the district should check with either *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)* as to the status of the color additive and of the products in which it has been used. The district should not advise or suggest recall of any product containing what appears to be a non-permitted color additive without consulting *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*.

When violations in the color additive area are confirmed, the District may forward to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)* a recommendation, accompanied by all the facts, for recall or other appropriate regulatory action.

*Material between asterisks is new or revised.*

Issued: 10/1/80
Revised: 8/31/89, 3/95

Sub Chapter 590

Cosmetics

Sec. 590.300 Direct Reference Authority for Pseudomonas Contamination of Cosmetics Used In The Eye Area (CPG 7128.03)

REGULATORY ACTION GUIDANCE:

The following represents criteria for deciding when direct reference seizure to *Chief Counsel* through Division of Compliance Management and Operations (HFC-210) is appropriate:

Any cosmetic product intended for use in the eye area which contains Pseudomonas aeruginosa.

REMARKS:

Direct reference seizure recommendations should be accompanied by complete labeling and worksheets. Positive identification using the method found in Chapter 25 of the Bacteriological Analytical Manual (BAM) is necessary to support the charge. Speciate Pseudomonas isolates using biochemical tests (BAM, Chapter 25) or appropriate commercial identification kits.

SPECIMEN CHARGE:

The article (was adulterated when introduced into and while in interstate commerce) (is adulterated while held for sale after shipment in interstate commerce) within the meaning of the Act, 21 U.S.C. 361(a), in that it contains a poisonous or deleterious substance, Pseudomonas aeruginosa, which may render it injurious to users under such conditions of use as are customary or usual.

Issued: 4/10/91
Revised: 8/96

Sec. 590.400 Natural Bristle Brushes (i.e., Hair Brushes, Shaving Brushes) - Nit Contamination (CPG 7128.04)

REGULATORY ACTION GUIDANCE:

The following represents criteria for direct reference seizure to *Chief Counsel* through Division of Compliance Management and Operations (HFC-210) and for direct citation by District Offices:

If there is an average contamination exceeding 0.15% infested bristles. Average based on examination of minimum of six brushes per sample.

REMARKS:

The tolerance for release of reconditioned lots is zero.

SPECIMEN CHARGE:

Article adulterated (when introduced into and while in interstate commerce) (while held for sale after introduction into interstate commerce) within the meaning of 21 U.S.C. 361(b), in that it consists in part of a filthy substance by reason of the presence thereon of nits.

NOTE: Only use direct reference citation authority when prosecution is anticipated and evidence to support a prosecution is included with the adulteration charge. Evidence to support a prosecution is specified in existing regulatory procedures issuances.

Issued: 1/1/73
Revised: 10/1/80, 7/1/83, 9/1/86, 8/96

Sec. 590.500 Packaging Technologies and Tamper-Resistant Packaging Requirements for Cosmetic Products (CPG 7128.06)

REFERENCE:

Tamper-resistant packaging requirements for certain cosmetic products are located in 21 CFR 700.25.

See Compliance Policy Guide Section 450.500 (formerly CPG 7132a.17) (Tamper-Resistant Packaging Requirements for Over-the-Counter Human Drug Products) for some background and a list of packaging technologies that are capable of meeting the requirements for a tamper-resistant package.

Issued: 4/27/88

Sec. 590.600 Wigs (CPG 7128.05)

POLICY:

Although we have expressed the belief that wigs for use on humans are subject to the cosmetic provisions of the Federal Food, Drug, and Cosmetic Act, it is the present position of FDA that we will not assert jurisdiction over wigs.

Our position on wigs, of course, will be promptly reconsidered if evidence of hazard to the user is encountered.

Issued: 9/10/76
Revised: 10/1/80, 9/1/86



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