Skip page top navigationFDA Logo--links to FDA home page Logo of and Link to start page of Office of Regulatory Affairs, U.S. Food and Drug Administration U.S. Food and Drug Administration Office of Regulatory Affairs HHS Logo and link to Department of Health and Human Services website

FDA Home Page | Federal-State | Import Program | Compliance | Inspection | Science | ORA Search

Updated: 2005-11-29

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:

  1. 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
      1. Each of the subsamples contains more than 25% by count of units less than 13 millimeters (0.50 inch) long;


        2. or

      2. 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
      1. 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;


        2. or

      2. 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.
  2. 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;


      2. 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.
  3. 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;


      2. 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.
  4. 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;


      2. 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 *Compliance/Division of Field Programs/Low Acid and Acidified Foods Team (HFS-605)* 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 *Compliance/Division of Enforcement (HFS-605) by e-mail* or FAX and await reply before proceeding:

Sample NumberDate of Shipment
Article InvolvedDealer
Amount of LotShipper
CodesAnalytical 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, 5/2005