Professional Documents
Culture Documents
Canned whole kernel (whole grain) corn, including vacuum packed corn, means the canned
product property prepared from clean, sound, succulent kernels of sweet corn as defined in the
Standard of identify for Canned Corn (21 CFR 155.130) issued pursuant to the Federal Food,
Drug, and Cosmetic Act.
(a) Conventional means kernels of sweet corn that convert sugars to starch by going
through distinct stages of maturity—milk, cream, then dough stages.
(b) Supersweet (shrunken 2) means kernels (or grains) of corn that provide higher
naturally occurring sugar, and=or crisper texture (may be yellow, white or combination
of each) typical for the variety. These varieties may be slightly darker in color, and some
varieties have slightly tougher pericarp (kernel skin) than conventional sweet corn.
(a) Golden (or yellow) means kernels (or grains) of corn that are predominately golden
(or yellow) and typical for the variety.
(b) White means kernels (or grains) of corn that are predominately light cream in color and
typical for the variety.
(c) Combination yellow and white means any combination of the above varieties and color
types or a bicolored variety.
(a) Acceptable quality level (AQL) means the maximum percent of defective units or the
maximum number of defects per hundred units of product that, for the purpose of
acceptance sampling, can be considered satisfactory as a process average.
(b) Appearance.
(1) Good appearance means the sample unit has a practically uniform color typical of
the varietal of color type.
(2) Reasonably good appearance means the sample unit has a reasonably uniform
color typical of the varietal or color type.
(3) Fairly good appearance means the sample unit has a fairly uniform color typical
of the varietal or color type. Fairly good appearance limits the “Lot Grade” to
Grade B.
(c) Chaff means bits of internal and external kernel parts.
(d) Cob means tough cellulose material that the kernels of corn grow upon. A portion of cob
material means a piece of cob that may or may not be attached to kernel(s) of corn (corn
kernels are removed from cob tissue before making measurements).
(e) Cut means the degree of smoothness of the cut surface of the kernels, uniformity of
depth of cut, chaff, and the degree of freedom from adhering cob tissue.
(1) Well cut means the product is more than slightly affected by the presence of
ragged cut kernels, torn kernels, chaff, and irregular cut kernels.
(2) Reasonably well cut means the product is not materially affected by the presence
of ragged cut kernels, torn kernels and irregular cut kernels.
(3) Fairly well cut means the product is not seriously affected by the presence of
ragged cut kernels, torn kernels, chaff, and irregular cut kernels.
(f) Damaged kernel means any kernel affected by insect injury, discoloration, pathological
injury, or by other means to the extent that the appearance or eating quality is materially
affected. Seriously damaged kernel means any kernel affected by insect injury,
discoloration, pathological injury, or by other means to the extent that the appearance or
eating quality is seriously affected.
(g) Defect means any nonconformance of a unit of product from a specified requirement of a
signal quality characteristic.
(h) Extraneous vegetable material (EVM) means any harmless vegetable material, to
include, but not limited to: cob; husk; shank and stalk; or silk (any color).
(i) Flavor and odor refers to the palatability of the product. The natural flavor of the sweet
corn for the varietal type and=or the effect of added natural sweeteners, salt, or other
suitable optional ingredients (Standard of Identity 155.130) are considered in evaluating
this factor.
(1) Good flavor and odor means the product has a good characteristic flavor and odor
for the varietal type of canned sweet corn and is free from objectionable flavors and
odors. The number of sample units in a lot that have “fairly good flavor” shall not
exceed the applicable acceptance number specified in the sample plan contained in
the “Regulations Governing Inspection and Certification of Processed Fruits and
Vegetables and Related Products.”
(2) Fairly good flavor and odor means the product may be lacking in good flavor and
odor, may have a flavor typical of very mature corn, may have an overcooked
flavor or an atypical flavor caused by processing or postharvest conditions, but is
free from objectionable flavors and odors.
(j) Husk means the fibrous vegetable sheath that surrounds the ear of the corn.
(k) Pulled kernel means a kernel of corn that has been removed from the cob (with cob
tissue attached) such that the appearance or eating quality is materially affected as shown
in examples 5, 6, and 7 of the USDA Photo-Guide for Classifying “Cut” and “Pulled”
Kernels in Canned and Frozen Whole Kernel Corn.
(l) Sample unit means the amount of product specified to be used for grading. For
appearance, cut, flavor and odor, tenderness and maturity, and varietal characteristics this
includes the entire drained contents of the container. For grading EVM this includes 850
grams (30 oz drained weight); for seriously damaged kernels, damaged kernels and
pulled kernels the sample unit is 1000 kemels. The sample unit may be:
(1) The entire contents of a container;
(2) A portion of the contents of a container; or
(3) A combination of the contents of two or more containers.
(m) Shank means the tough stem that attaches the ear of corn to the stalk. Shank material
includes the tough basal portion that is attached to the husk.
(n) Silk means the silky hair-like filament of any color.
(o) Stalk means the tough woody main support stem of the corn plant.
(p) Tolerance means the percentage of defective units allowed for a specific sample size.
(q) Tenderness and maturity means tender in texture with characteristics typical of early
stage of development of the kernels for the varietal type(s).
(1) Good tenderness and maturity.
For conventional sweet corn—corn is tender with a cream texture a pericarp that
chews easily. The kernels are full and tender, typical of the milk and early cream stage of
maturity. There are three levels of quality within “good tenderness and maturity”: very
tender, tender, moderately tender.
For supersweet corn—corn is crisp and may have slightly tough pericarp, compact
internal flesh, that is associated with plump or full kernels. There are three levels of
quality within “good tenderness and maturity:” very tender and crisp; tender and crisp;
and moderately tender and crisp.
(2) Reasonably good tenderness and maturity.
For conventional sweet corn—is typical of the cream stage of maturity but lacks the
attributes for “good tenderness and maturity.” Some pericarp residue may be evident
upon chewing. There are two levels of quality within “reasonably good tenderness and
maturity”: cream stage and moderate cream stage.
Far supersweet corn—is corn that lacks tenderness and maybe moderately dry. Kernels
may have a reasonably tough pericarp and occasionally are dented. There are two levels
of quality within “reasonably good tenderness and maturity”: not crisp, not moist; and
not crisp, moderately dry, and may include occasionaldented kernels. The number of
sample units in a lot that fail to meet “reasonably good tenderness and maturity” shall
not exceed the applicable acceptance number specified in the sample plan contained in
the “Regulations Governing Inspection and Certification of Processed Fruits and
Vegetables and Related Products” (Reference 109-A-1, 52.38).
(3) Fairly tough.
For conventional sweet corn—is corn that is in the dough stage “dry and chewy.”
Kernels may be dented, but not woody. Pericarp may be tough but not very tough.
For supersweet corn—is corn that is dry, chewy corn, with tough but not very tough
pericarp. The number of sample units in a lot that fail to meet “tough” shall not exceed
the applicable acceptance number specified in the sample plan contained in the
“Regulations Governing Inspection and Certification of Processed Fruits and
Vegetables and Related Products.”
(r) Unit means a kernel of corn or a significant portion thereof.
The standard for fill of container is not incorporated in the grades of the finished product,
since fill of container, as such, is not a factor of quality for the purposes of these grades. It is
recommended that each container of canned corn be filled as full as practicable without
impairment of quality and that, except for vacuum pack, the product and packing medium
occupy not less than 90 percent of the capacity of the container. The product is considered
“Vacuum Packed” when the liquid in the container [as outlined in 21 CFR 155.130 (a)] is not
more than 20 percent of the netweight and the container is closed under conditions creating a
high vacuum.
The minimum drained weight recommendations found in the Grading Manual for Canned Whole
Kernel Corn are not incorporated in the grades of the finished product, since drained weight, as
such, is not a factor of quality for the purpose of these grades.
§52.887 GRADES
Sample units sample unit size 1 850 3 850 6 850 13 850 21 850 29 850
Units of product in grams 850 2550 5100 11,050 17,850 24,650
Extraneous vegetable material (EVM) TOL 1a AQL Acceptance numbers
Grade A
b
Cob each cc (0.061cu in) 1.41 1.25 0.80 2.05 3.85 7.85 12.35 16.85
Husk each cm2 (0.155 sq. in)b 0.57 0.47 7 17 32 64 99 133
Silk, each 2.54 cm, recorded in inches 3.5 3.2 36 96 184 384 611 835
Grade B
Cob each cc (0.061cu in)b 3.5 3.2 1.8 4.8 9.2 19.2 30.6 41.8
Husk each cm2 (0.155 sq. in)b 1.14 0.99 13 33 62 126 198 270
Silk, each 2.54 cm, recorded in inches 7.0 6.6 68 189 367 774 1235 1693
Grade C
Cob each cc (0.061cu in)b 4.94 4.6 2.45 6.75 13.0 27.3 43.4 59.5
Husk each cm2 (0.155 sq. in)b 1.71 1.5 18 48 91 187 244 402
Silk, each 2.54 cm, recorded in inches 24.5 23.8 222 642 1264 2703 4342 5976
a
Tolerance for cob is based on each 0.55 cc; for husk—each cm2; and silk—each 9cm at 11,050 grams.
b
Corn stalk and shank: If hard and tough, count as cob; if less severe, count as husk.
573
574
Table 3 AQL’s, Tolerances, and Acceptance Numbers for Other Defectsa
Sample units sample unit size 1 1000 3 1000 6 1000 13 1000 21 1000 29 1000
Units of product by count 1000 3000 6000 13,000 21,000 29,000
Defects other than EVM TOLa AQL Acceptance numbers
Grade A
Grade B
Grade C
Appendix A
Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved.
U.S. Standards for Canned Corn 575
The grade of canned corn is based on requirements for the following quality factors:
(a) Prerequisite quality factors:
(1) Varietal characteristics;
(2) Appearance;
(3) Cut;
(4) Flavor and odor; and
(5) Tenderness and maturity.
(b) Classified quality factors:
(1) Extraneous vegetable material (EVM);
(2) Seriously damaged kernels;
(3) Damaged kernels; and
(4) Pulled kernels.
§52.889 ALLOWANCES FOR DEFECTS
The sample size used to determine whether the requirements of these standards are met shall be as
specified in the sampling plans and procedures in the “Regulations Governing Inspection and
Certification of Processed Fruits and Vegetables, Processed Products Thereof, and Certain Other
Processed Food Products” (7 CFR 52.1 through 52.83).
(a) A lot of canned corn is considered as meeting the requirements for quality if:
(1) The prerequisite requirements specified in Section 52.887 are met; and
(2) None of the allowances for the individual quality factors, specified in Section
52.889 in Tables 2 and 3, as applicable are exceeded.
(b) Single sample unit. Each unofficial sample unit submitted for quality evaluation will be
treated individually and is considered as meeting the requirements for quality if:
(1) The prerequisites requirements specified in Section 52.887 are met;
(2) The acceptable quality levels (AQL’s) in Section 52.889 in Tables 2 and 3, as
applicable for the style, are not exceeded.
For the purposes of this part the following definitions shall apply:
(a) Lot. A collection of primary containers or units of the same size, type and style
manufactured or packed under similar conditions and handled as a single unit of trade.
(b) Lot size. The number of primary containers or units (pounds when in bulk) in the lot.
(c) Sample size. The total number of sample units drawn for examination from a lot.
(d) Sample unit. A container, a portion of the contents of a container, or a composite mixture of
product from small containers that is sufficient for the examination or testing as a single unit.
(e) Defective. Any sample unit shall be regarded as defective when the sample unit does not
meet the criteria set forth in the standards.
(f) Acceptance number. The maximum number of defective sample units permitted in the
sample in order to consider the lot as meeting the specified requirements. The following
acceptance numbers shall apply:
Size container
Size container
(g) Acceptable quality level (AQL). The maximum percentage of defective sample units
permitted in a lot that will be accepted approximately 95 percent of the time.
(a) Identity—(1) Product definition. Frozen peas is the food in “package” form as that term is
defined in Sec. 1.20 of this chapter, prepared from the succulent seed of the pea plant of the
species Pisum sativum L. Any suitable variety of pea may be used. It is blanched, drained,
and preserved by freezing in such a way that the range of temperature of maximum
crystallization is passed quickly. The freezing process shall not be regarded as complete
until the product temperature has reached 2 188C (08F) or lower at the thermal center, after
thermal stabilization. Such food may contain one, or any combination of two or more, of
the following safe and suitable optional ingredients:
(i) Natural and artificial flavors.
(ii) Condiments such as spices and mint leaves.
(iii) Dry nutritive carbohydrate sweeteners.
(iv) Salt.
(v) Monosodium glutamate and other glutamic acid salts.
(2) Size specifications. If size graded, frozen peas shall contain not less than 80% by
weight of peas of the size declared or of smaller sizes. The sample unit may not contain
more than 20% by weight of peas of the next two larger sizes, of which not more than
one quarter by weight of such peas may be of the larger of these two sizes, and may
contain no peas larger than the next two larger sizes, if such there be. The following
sizes and designations shall apply:
(3) Labeling. The name of the product is “peas.” The term “early,” “June,” or “early June”
shall precede or follow the name in the case of smooth-skin or substantially smooth-
skin peas, such as Alaska-type peas. Where the peas are of sweet green wrinkled
varieties, the name may include the designation “sweet,” “green,” “wrinkled,” or any
combination thereof. The label shall contain the words “frozen” or “quick frozen.” The
name of the food shall include a declaration of any flavoring that characterizes the
product as specified in Sec. 101.22 of this chapter and a declaration of any condiment
such as spices and mint leaves that characterizes the product, e.g., “Spice added.”
Where a statement of pea size is made, such statement shall indicate either the size
designation as specified in paragraph (a) (2) of this section or the applicable sieve size.
However, the optional descriptive words “petite” or “tiny” may be used in conjunction
with the product name when an average of 80% or more of the peas, will pass through
a circular opening of a diameter of 8.75mm (0.34 in.) or less for sweet green wrinkled
peas and 8.2mm (0.32 in.) for smooth-skin or substantially smooth-skin peas, such as
Alaska-type peas.
(4) Label declaration. Each of the ingredients used in the food shall be declared on the
label as required by the applicable sections of parts 101 and 130 of this chapter.
(b) Quality. (1) The standard of quality for frozen peas is as follows:
(i) Not more than 4 percent by weight blond peas, i.e., yellow or white but edible peas;
(ii) Not more than 10 percent by weight blemished peas, i.e., slightly stained or spotted
peas;
(iii) Not more than 2 percent by weight seriously blemished peas, i.e., peas that are hard,
shrivelled, spotted, discolored or otherwise blemished to an extent that the
appearance or eating quality is seriously affected.
(iv) Not more than 15 percent by weight pea fragments, i.e., portions of peas, separated
or individual cotyledons, crushed, partial or broken cotyledons and loose skins, but
excluding entire intact peas with skins detached;
(v) Not more than 0.5 percent by weight, or more than 12 sqcm (2sq in.) in area,
extraneous vegetable material, i.e., vine or leaf or pod material from the pea plant or
other such material per sample unit as defined in paragraph (b) of this section.
(vi) The sum of the pea material described in paragraphs (b) (1) (i), (ii), (iii), and (iv) of
this section shall not exceed 15 percent.
(vii) For peas that meet the organoleptic and analytical characteristics of sweet green
wrinkled varieties:
(a) The alcohol-insoluble solids may not be more than 19 percent based on the
procedure set forth in paragraph (b) (3) of this section.
(b) Not more than 15 percent by count of the peas may sink in a solution containing
16 percent salt by weight according to the brine flotation test set forth in paragraph
(b) (4) of this section;
(viii) For smooth-skin or substantially smooth-skin varieties the alcohol-insoluble solids
may not be more than 23 percent based on the procedure set forth in paragraph
(b) (3) of this section.
(ix) The quality of a lot shall be considered acceptable when the number of defectives does
not exceed the acceptance number in the sampling plans set forth in Sec. 158.3 (f).
(2) The sample unit for determining compliance with the requirements of paragraph (b)
(1) of this section other than those of paragraphs (b) (1) (vii) (a) and (b) (1) (viii) of
this section, shall be 500g (17.6 oz). For the determination of alcohol-insoluble
solids as specified in paragraph (b) (3) of this section, the container may be the
sample unit.
The pH and=or acidity of a food are generally used to determine processing requirements
and the applicability of GMP regulations for regulatory purposes. Methods and conditions for
determining the pH and acidity of foods are also summarized in 21 CFR 114.90. Methodology for
pH is generally available from pH meter and electrode manufacturers.
To assist readers in determining the product pH levels, the approximate ranges of pH values
are complied here. Considerable variation exists between varieties, conditions of growing, and
processing methods, etc. Data is presented for the edible portion of foods in their normal and
natural state, unless otherwise designated. We solicit your input to this matter. This list will be
updated when new information is available.
The references have been omitted from this appendix. Please consult the original document
for details.
Item Approximate pH
Artichokes 5.60
Artichokes, canned, acidified 4.30– 4.60
Artichokes, French, cooked 5.60– 6.00
Artichokes, Jerusalem, cooked 5.93– 6.00
Asparagus 6.00– 6.70
Buds 6.70
Stalks 6.10
Asparagus, cooked 6.03– 6.16
Asparagus, canned 5.00– 5.80
Asparagus, frozen, cooked 6.35– 6.48
Asparagus, green, canned 5.20– 5.32
Asparagus, strained 4.80– 5.09
Bamboo shoots 6.20
Bamboo shoots, preserved 3.50– 4.60
Beans 5.60– 6.50
Lima 6.50
String 5.60
Kidney 5.40– 6.00
Boston style 5.05– 5.42
Black, cooked 5.78– 6.02
Soy 6.00– 6.60
(continued )
Item Approximate pH
Item Approximate pH
Horseradish 3.56
Kale, cooked 6.36– 6.80
Ketchup 3.89– 3.92
Kohlrabi, cooked 5.72– 5.82
Leeks 5.52– 6.17
Leeks, cooked 5.49– 6.10
Lentils, cooked 6.30– 6.83
Lettuce 5.80– 6.15
Lettuce, Boston 5.89– 6.05
Lettuce, Iceberg 5.70– 6.13
Mushrooms 6.00– 6.70
Mushrooms, cooked 6.15– 6.22
Mushroom soup, cream of, canned 5.95– 6.40
Okra, cooked 5.50– 6.60
Olives, green, fermented 3.60– 4.60
Olives, ripe 6.00– 7.30
Onions, white 5.40– 5.80
Onions, red 5.30– 5.80
Onions, red 5.32– 5.52
Onions, white 5.37– 5.85
Onions, yellow 5.32– 5.60
Onions, pickled 3.70– 4.60
Onions, yellow 5.40– 5.60
Parsley 5.70– 6.03
Parsnip 5.30– 5.70
Parsnips, cooked 5.45– 5.65
Pea soup, cream of, canned 5.70
Peas, cooked 6.22– 6.88
Peas, frozen, cooked 6.40– 6.70
Peas, canned 5.70– 6.00
Peas, pureed 4.90– 5.85
Peas, strained 5.91– 6.12
Peas, dried (split green), cooked 6.45– 6.80
Peas, dried (split yellow), cooked 6.43– 6.62
Peas, chick, garbanzo 6.48– 6.80
Peppers 4.65– 5.45
Peppers, green 5.20– 5.93
Pickles, fresh pack 5.10– 5.40
Pimiento 4.40– 4.90
Persimmons 4.42– 4.70
Pimento, canned, acidified 4.40– 4.60
Potatoes 5.40– 5.90
Tubers 5.70
Sweet 5.30– 5.60
Mashed 5.10
Pumpkin 4.90– 5.50
Radishes, red 5.85– 6.05
Radishes, white 5.52– 5.69
Red pepper relish 3.10– 3.62
(continued )
Item Approximate pH
The information in this appendix has been adapted from “Analysis and Evaluation of Preventive
Control Measures for the Control and Reduction/Elimination of Microbial Hazards on Fresh and
Fresh-Cut Produce,” FDA, September 30, 2001. All references have been removed. Please consult
the original document for details.
Appendix D
L. monocytogenes Lettuce Sri Lanka NR 10/20 50 —
L. monocytogenes Lettuce United Kingdom Retail 0/151 0 Imported whole lettuce
L. monocytogenes Lettuce United States Retail 1/92 1.1 Samples obtained from two
supermarkets
587
Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved.
588
Table D-1 Continued
Salmonella Lettuce Italy Retail 82/120 68 Samples taken from five retail
outlets and sampled at monthly
intervals for 1 year
Salmonella Lettuce Netherlands Various 2/28 7.1 Salmonella tested only when
E. coli present
Salmonella Lettuce United Kingdom Retail 0/151 0 Imported whole lettuce
Salmonella Salad greens Egypt Retail/food service 2/57 3.5 —
Salmonella Salad mix Egypt Retail/food 1/159 0.6 —
(various) service
Salmonella Salad mix United States Retail and 0/63 0 Samples taken from 31 retail and
(various) food service food service facilities
Salmonella Lettuce Spain Farms, wholesale 5/80 6.3 Samples collected during the four
markets, seasons and from different
and retail sources. Possible use of
contaminated irrigation water
Shigella Lettuce Various — 1/116 1.0 Produce imported into the US.
Samples collected and
analyzed from 11 countries
Shigella Lettuce United Kingdom Retail 0/151 0 Imported whole lettuce
Shigella Salad greens Egypt Retail/food service 1/157 1.8 —
Shigella Salad mix Egypt Retail/food service 3/159 1.9 —
(various)
Vibrio cholerae Lettuce United Kingdom Retail 0/151 0 Imported whole lettuce
Yersinia Lettuce, cut Australia Retail or production 71/120 59 Cut and packaged lettuce samples
enterocolitica obtained over an 8-month period
Yersinia Prepacked United Kingdom Retail 3/3 100 Subsamples from same batch.
salads Predominantly environmental
Appendix D
strains of Y. enterocolitica
a
Country where produce samples were collected and tested.
b
Not reported.
589
Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved.
590
Table D-2 Continued
Appendix D
Pathogens: Vegetables and Vegetable Products
Table D-3 Examination of Raw Herbs or Spices for the Presence of Pathogens
Pathogen Type Countrya Place of sampling Incidence Percentage Comments
Campylobacter Parsley Canada Outdoor markets 1/177 0.6 Samples from farmers’ markets
and supermarkets and supermarkets. Positives
only from farmers’ markets
Cryptosporidium Cilantro (leaves) Costa Rica Open markets 4/80 5.0 Samples obtained from eight
open markets during the rainy
and dry season
Cryptosporidium Cilantro (roots) Costa Rica Open markets 7/80 8.7 Samples obtained from eight
open markets during the rainy
and dry season
Escherichia coli Cilantro Mexico NRb 8/41 20 —
O157:H7
E. coli O157:H7 Coriander Mexico NR 2/10 20 —
Salmonella Parsley Spain Farm, wholesale, 1/23 4.3 Samples collected all four
and retail seasons at different sources.
Possible contamination from
contaminated irrigation water
Salmonella Chili Netherlands Various 5/16 31 —
Salmonella Chili Surinam NR 5/16 31 —
Salmonella Cilantro Various Various 16/177 9.0 Produce imported into the US.
Samples collected from
6 countries
Salmonella Culantro Various Various 6/12 50 Produce imported into the US.
Samples collected from
2 countries
Salmonella Parsley Various Various 1/84 1.2 Produce imported into the US.
Samples collected from
7 countries
Shigella Cilantro Various Various 0/177 0 Produce imported into the US.
Samples collected from
6 countries
591
(continued )
Shigella Culantro Various Various 0/12 0 Produce imported into the US.
Samples collected from
7 countries
Shigella Parsley Various Various 1/84 1.2 Produce imported into the US.
Samples collected from
6 countries
Staphylococcus Parsley Lebanon NR NR 7.7 —
a
Country where produce samples were collected and tested.
b
Not reported.
Appendix D
Pathogens: Vegetables and Vegetable Products
Table D-4 Examination of Raw Vegetables Other than Lettuce and Salad Greens for the Presence of Pathogens
Pathogen Type Countrya Place of sampling Incidence Percentage Comments
593
594
Table D-4 Continued
Campylobacter Potatoes Canada Outdoor markets 1/153 0.7 Samples from farmers markets
and supermarkets and supermarkets. Positives
only from farmers markets
Campylobacter Spinach Canada Outdoor markets 2/183 1.1 Samples from farmers markets
and supermarkets and supermarkets. Positives
only from farmers markets
Campylobacter Radish Canada Outdoor markets 2/174 1.1 Samples from farmers markets
and supermarkets and supermarkets. Positives
only from farmers markets
Cryptosporidium Cabbage Costa Rica Open markets 0/80 0 Samples obtained from eight
open markets during the rainy
and dry season
Cryptosporidium Carrots Costa Rica Open markets 1/80 1.3 Samples obtained from eight
open markets during the rainy
and dry season
Cryptosporidium Cucumber Costa Rica Open markets 1/80 1.3 Samples obtained from eight
open markets during the rainy
and dry season
Cryptosporidium Radish Costa Rica Open markets 1/80 1.3 Samples obtained from eight
open markets during the rainy
and dry season
Cryptosporidium Tomato Costa Rica Open markets 1/80 1.3 Samples obtained from eight
open markets during the dry
and rainy season
E. coli O157:H7 Celery Mexico NRc 6/34 18 —
Listeria Broccoli Canada Hospital 2/35 5.7 Samples stored at 108C prior to
monocytogenes testing
Appendix D
L. monocytogenes Broccoli United States Retail 0/92 0 Samples obtained from two
supermarkets
L. monocytogenes Cabbage United States Retail 1/92 1.1 Samples obtained from two
supermarkets
Pathogens: Vegetables and Vegetable Products
L. monocytogenes Cabbage, United States Processing facility 73/1016 7.2 Samples collected between
green December 1992 and February
1993
L. monocytogenes Cabbage, United States Processing facility 10/399 2.5 Samples collected between
red December 1992 and February
1993
L. monocytogenes Carrots Canada Hospital 0/35 0 Samples stored at 108C prior to
testing
L. monocytogenes Carrots United States Retail 1/92 0 Samples obtained from two
supermarkets
L. monocytogenes Cauliflower Canada Hospital 0/39 0 Samples stored at 108C prior to
testing
L. monocytogenes Cauliflower United States Retail 0/92 0 Samples obtained from two
supermarkets
L. monocytogenes Celery Canada Retail 0/30 0 Produce grown either in the US or
in Canada
L. monocytogenes Celery Canada Hospital 0/39 0 Samples stored at 108C prior to
testing
L. monocytogenes Coleslaw Canada Hospital 1/35 2.9 Samples obtained from stored
conditions of 108C
L. monocytogenes Coleslaw Singapore NR 2/50 4.0 —
L. monocytogenes Coleslaw United Kingdom Retail 3/39 7.7 Samples taken year round from
four supermarkets
L. monocytogenes Cucumber Malaysia Restaurants 4/5 80 Samples taken from street
vendors. Samples sliced
L. monocytogenes Cucumber Pakistan Retail 1/15 6.7 —
L. monocytogenes Cucumber United States Retail 2/92 2.2 Samples obtained from two
supermarkets
L. monocytogenes Green pepper Canada Hospital 1/35 2.9 Samples stored at 108C prior to
testing
L. monocytogenes Leafy Malaysia Retail 5/22 23 Samples taken from refrigerated
vegetables supermarkets and open wet
markets
(continued )
595
596
Table D-4 Continued
L. monocytogenes Mushrooms United States Retail 10/92 11 Samples obtained from two
supermarkets
L. monocytogenes Potatoes United States Retail 21/132 16 Samples obtained from two
supermarkets
L. monocytogenes Raddiccio United States Processing 0/180 0 Samples collected between
facility December 1992 and February
1993
L. monocytogenes Radish Canada Retail 0/10 0 Produce grown either in the US or
in Canada
L. monocytogenes Radish United States Retail 19/132 14 Samples obtained from two
supermarkets
L. monocytogenes Tomato Canada Retail 0/20 0 Produce grown either in the US or
in Canada
L. monocytogenes Tomato Pakistan NR 2/15 13 —
L. monocytogenes Tomato United States Retail 0/92 0 Samples obtained from two
supermarkets
L. monocytogenes Unspecified United Kingdom Retail 5/90 5.6 Samples taken year round from
vegetables four supermarkets
Salmonella Artichoke Spain Farm, wholesale, 3/25 12 Samples collected all four
and retail seasons at different sources.
Possible contamination from
contaminated irrigation water
Salmonella Cabbage Netherlands Various 0/18 0 —
Salmonella Cabbage Spain Various 7/41 17 Samples collected all four
seasons at different sources.
Possible contamination from
contaminated irrigation water
Appendix D
Salmonella Cardoon Spain Farm, wholesale, 1/4 20 Samples collected all four
and retail seasons at different sources.
Possible contamination from
contaminated irrigation water
Pathogens: Vegetables and Vegetable Products
Salmonella Cauliflower Netherlands Various 1/13 7.7 Salmonella tested only when
E. coli present
Salmonella Cauliflower Spain Farm, wholesale, 1/23 4.3 Samples collected all four
and retail seasons at different sources.
Possible contamination from
contaminated irrigation water
Salmonella Celery Netherlands Various 0/20 0 —
Salmonella Celery Various Various 1/84 1.2 Produce imported into the US.
Samples collected from 2
countries
Salmonella Eggplant Netherlands Various 2/13 1.5 Salmonella tested only when
E. coli present
Salmonella Endive Netherlands Various 2/26 7.7 Samples either locally grown or
imported from Italy
Salmonella Fennel Italy Retail 64/89 72 Samples taken from five retail
outlets and sampled monthly
for 1 year
Salmonella Fennel Netherlands Various 0/15 0 Samples either locally grown or
imported from Italy
Salmonella Green onion Various Various 1/180 0.6 Produce imported into the US.
Samples collected from 5
countries
Salmonella Pepper Netherlands Various 0/20 0 —
Salmonella Spinach Spain Various 2/38 5.2 Samples collected all four
seasons at different sources.
Possible contamination from
contaminated irrigation water
Salmonella Zuchini Netherlands Various 0/11 0 —
Salmonella Beet Spain Various 4/52 7.7 Samples collected all four
leaves seasons at different sources.
Possible contamination from
contaminated irrigation water
(continued )
597
598
Table D-4 Continued
Salmonella Celery Spain Farm, wholesale, 2/26 7.7 Samples collected all four
and retail seasons at different sources.
Possible contamination from
contaminated irrigation water
Shigella Celery Various Various 2/84 2.4 Produce imported into the US.
Samples collected from 2
countries
Shigella Green Various Various 2/180 1.1 Produce imported into the US.
onion Samples collected from 5
countries
Staphylococcus Carrots Lebanon NR NR 14 —
Staphylococcus Radish Lebanon NR NR 6.3 —
Yersinia Watercress Brazil Retail 1/5 20 —
enterolitica
a
Country where produce samples were collected and tested.
b
Modified atmosphere packaging.
c
Not reported.
Appendix D
Pathogens: Vegetables and Vegetable Products
Table D-5 Examination of Seed Sprouts for the Presence of Pathogens
Pathogen Type Countrya Place of sampling Incidence Percentage Comments
Bacillus cereus Alfalfa United States Health food stores 13/14 92.9 Seeds sprouted in the lab using a
home sprouting kit
B. cereus Mung bean United States Health food stores 33/40 83 Seeds sprouted in the lab using a
home sprouting kit
B. cereus Mung bean United States At production 2/16 12 Ten surveys conducted over a
six-month period
B. cereus Wheat United States Health food stores 15/24 63 Seeds sprouted in the lab using a
home sprouting kit
Listeria Mung bean France At production 1/31 3.1 —
monocytogenes
L. monocytogenes Mung bean France Retail 19/102 19 —
L. monocytogenes Mung bean Malaysia Retail 6/7 86 Samples taken from refrigerated
supermarkets and open wet
markets
Salmonella Mung bean United States At production 0/13 0 Ten surveys conducted over a
six-month period
Salmonella Mung bean Sweeden NRb NR NR —
Salmonella Mung bean Thailand Open markets 30/344 8.7 Samples collected monthly for
seven months
Staphylococcus Alfalfa Canada Retail 4/18 22 Sprouts produced by a single
aureus processor. Samples obtained
from three retail outlets
S. aureus Mixed sprouts Canada Retail 5/18 28 Sprouts produced by a single
processor. Samples obtained
from three retail outlets
S. aureus Onion Canada Retail 4/18 22 Sprouts produced by a single
processor. Samples obtained
from three retail outlets
a
Country where produce samples were collected and tested.
b
599
Not reported.
600 Appendix D
Listeria Tomato 4.1 Cells suspended in Stored in sealed 10 4.5– 4.8 10d , 3.5– 4.2 CFU/g Subjectively
monocytogenes (chopped) 0.1 M phosphate bags with 3% O2 judged to be
(2 strains) buffer, 10 mL and 97% N2 or inedible after
mixed in 1000 g ambient air. 10 days due to
of tomatoes Tomatoes either deterioration
unwashed or
washed in 210 –
280 ppm chlorine
prior to chopping
L. monocytogenes Tomato 4.1 Cell suspension in Stored in sealed 21 5 8d 1.0– 3.5 CFU/g Survival slightly
(2 strains) (chopped) 0.1 M phosphate bags with 3% O2 better in chlorine
buffer, 10 mL and 97% N2 or treated samples
mixed in 1000 g ambient air.
of tomatoes Tomatoes either
unwashed or
washed in 210 –
280 ppm chlorine
prior to chopping
L. monocytogenes Tomato Nra Dip inoculation, Stored in sealed 10 3.5– 3.7 20d 3.5– 5.0 CFU/g Significant growth
(2 strains) (whole, inoculum bags with 3% O2 observed only for
cherry) suspended in and 97% N2 or Scott A
0.1 M phosphate ambient air. inoculated onto
buffer Tomatoes either chlorine treated
not washed or tomatoes stored in
washed in 210 – air. Little
280 ppm chlorine difference
between strains,
tomato
treatments, or
storage conditions
(continued )
601
Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved.
602
Table D-7 Continued
Initial
Method of Storage Temperature counts Incubation Final counts
Pathogen Produce type pH inoculation conditions (8C) (log10 CFU) time (log10 CFU) Unit Comments
L. monocytogenes Tomato NR Dip inoculation, Stored in sealed 21 3.4 – 3.6 2–8d 4.8 – 5.5 CFU/g Significant growth
(2 strains) (whole, inoculum bags with 3% O2 observed only for
cherry) suspended in and 97% N2 or Scott A
0.1 M phosphate ambient air. inoculated onto
buffer Tomatoes either chlorine treated
not washed or tomatoes stored in
washed in 210 – air. Little
280 ppm chlorine difference
between strains,
tomato
treatments, or
storage conditions
Salmonella Tomato 4.50 – 4.52 Cells suspended in Tomatoes (450 g) 4 0.4 12d , 1.0 CFU/g Not detected in 6
baildon (diced) deionized water; sealed in plastic enriched 25 g
30 mL mixed with bags. Stored for samples analyzed
2270 g of up to 12 d each day (0, 2, 5,
tomatoes 8, 12d)
S. baildon Tomato (diced) 4.50 – 4.52 Cells suspended in Tomatoes (450 g) 4 3.4 12d 1.8 CFU/g Counts reduced by
deionized water; sealed in plastic 0.40, 0.67, and
30 mL mixed with bags. Stored for 0.75 log10 CFU/g
2270 g of up to 12 d after 2, 5, and 8 d
tomatoes respectively
S. baildon Tomato (diced) 4.39 – 4.41 Cell suspended in Tomatoes (100 g) 21 0.79 72h 8.1 CFU/g Counts 5.32 and
deionized water; sealed in plastic 7.60 log10 CFU/g
20 mL mixed with bags. Stored for after 24 and 48 h,
600 g of tomatoes up to 72 h respectively
S. baildon Tomato (diced) 4.39 – 4.41 Cells suspended in Tomatoes (100 g) 30 0.79 72h 7.94 CFU/g Counts 7.30 and
deionized water; sealed in plastic 7.90 log10 CFU/g
20 mL mixed with bags. Stored for after 24 and 48 h,
600 g of tomatoes up to 72 h respectively
,7.5
Appendix D
S. montevideo Tomato 4.31 – 4.52 Spot inoculation, Tomato sliced into 25 3.4 12h CFU/slice —
(cut slices) inoculum quarters 4.4 12h ,8.0
suspended in 7.4 12h ,9.5
distilled water.
25 mL inoculated
onto each slice
603
Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved.
604
Table D-7 Continued
Initial
Method of Storage Temperature counts Incubation Final counts
Pathogen Produce type pH inoculation conditions (8C) (log10 CFU) time (log10 CFU) Unit Comments
S. montevideo Tomato, skin NR Spot inoculation, Filter discs dried at 20 5.5 7d 2.6 CFU/area —
cells suspended in room temperature 25 5.5 7d 4.1 inoculated
TSR. Sterile filter for 2 h and
discs submerged removed from
in inoculum and tomatoes.
placed on Tomatoes stored
tomatoes at 83% (208C) or
72% (258C)
relative humidity
Salmonella Tomato (cut, 4.0 – 4.40 Cell suspension in Inoculated samples 22 1.1 24 h 6.3 – 6.9 CFU/g Final pH
(3 serotypes) small pieces) saline, 0.1 mL, sealed in 30 7.2 – 8.4 CFU/g 3.90 – 4.36.
inoculated into polyethylene S. Enteriditis,
20 g of sample plastic bags S. Infantis, and
S. Typhimurium
a
Not reported.
Appendix D
Pathogens: Vegetables and Vegetable Products
Table D-8 Survival and Growth of Pathogenic Bacteria on Raw Vegetables Other than Tomatoes, Sprouts, Lettuce, and Salads
Produce Mode of Storage Temperature Initial counts Incubation Final counts
Pathogen type pH inoculation conditions (8C) (log10 CFU) time (log10 CFU) Unit Comments
Aeromonas Asparagus a
NR Dip inoculation, Samples stored in 15 4.5 4d ,8.0 CFU/g Asparagus first
hydrophila 1 min. Cells 6% CO2, 79% 4 4.5 14 d ,7.5 CFU/g became
(2 strains) suspended in N2, and 15% O2 unacceptable for
0.1 M potassium in glass jars consumption on
phosphate buffer day 6 (158C) or
day 21 (48C)
A. hydrophila Asparagus NR Dip inoculation, Samples stored in 15 4.5 4d ,8.0 CFU/g Asparagus first
(2 strains) 1 min. Cells ambient air in 4 4.5 21 d ,7.5 CFU/g became
suspended in glass jars unacceptable for
0.1 M potassium consumption on
phosphate buffer day 4 (158C) or
day 15 (48C)
A. hydrophila Broccoli NR Dip inoculation, Samples stored in 15 5.1 4d ,8.2 CFU/g Broccoli first
(2 strains) 1 min. Cells 10% CO2, 79% 4 4.0 14 d ,6.0 CFU/g became
suspended in N2, and 11% O2 unacceptable for
0.1 M potassium in glass jars consumption on
phosphate buffer day 10 (158C) or
day 21 (48C)
A. hydrophila Broccoli NR Dip inoculation, Samples stored in 15 5.1 4d ,8.2 CFU/g Broccoli first
(2 strains) 1 min. Cells ambient air in 4 4.0 14 d ,6.0 CFU/g became
suspended in glass jars unacceptable for
0.1 M potassium consumption on
phosphate buffer day 6 (158C) or
day 21 (48C)
A. hydrophila Cauliflower NR Dip inoculation, Samples stored in 15 4.0 4d ,8.5 CFU/g Cauliflower first
(2 strains) 1 min. Cells ambient air in 4 3.5 14 d ,5.9 CFU/g became
suspended in glass jars unacceptable for
0.1 M potassium consumption on
phosphate buffer day 6 (158C) or
day 21 (48C)
(continued )
605
Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved.
606
Table D-8 Continued
Produce Mode of Storage Temperature Initial counts Incubation Final counts
Pathogen type pH inoculation conditions (8C) (log10 CFU) time (log10 CFU) Unit Comments
A. hydrophila Cauliflower NR Dip inoculation, Samples stored in 15 4.0 4d ,8.5 CFU/g Cauliflower first
(2 strains) 1 min. Cells 3% CO2, 79% 4 3.5 14 d ,6.0 CFU/g became
suspended in N2, and 18% O2 unacceptable for
0.1 M potassium in glass jars consumption on
phosphate buffer day 8 (158C) or
day 21 (48C)
A. hydrophila Endive NR Cell suspension Stored in 6.5 3.2 3–7d ,7.0 CFU/g —
(1 strain) (chicory) added to moderate
samples vacuum
packaging
containers under
moderate
vacuum
A. hydrophila Endive NR Cell suspension Stored in 6.5 3.2 3d 6.5 CFU/g Populations
(1 strain) (chicory) added to moderate declined to
samples vacuum log 1.0 CFU/g
packaging by day 7
container in
ambient air
A. hydrophila Vegetable salads 6.0 Cell suspension Samples sealed 4 3.0 9d ,3.5 CFU/g Population at
(mixed injected through and stored in 15 3.0 24 h ,7.9 158C steadily
vegetables) a silicone polypropylene declined from
septum. Cells plastic film 24h to 6 d
suspended in
brain heart
infusion broth
Clostridium Broccoli 6.9 Spot inoculation, Samples loosely 21 2.0 3d NR spores/g 6/6 samples toxic.
botulinum spores prepared packaged and Spoilage
(10 strains) in broth, heat stored in sealed observed
shocked, and polyethylene
diluted in bags
distilled water
Appendix D
C. botulinum Broccoli 6.9 Spot inoculation, Samples loosely 12 2.0 9d NR spores/g 3/6 samples toxic.
(10 strains) spores prepared packaged and Gross spoilage
in broth, heat stored in sealed observed
shocked, and polyethylene
diluted in bags
distilled water
Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved.
Pathogens: Vegetables and Vegetable Products
C. botulinum Broccoli 6.9 Spot inoculation, Samples loosely 4 2.0 30 d NR spores/g 0/6 samples toxic.
(10 strains) spores prepared packaged and Gross spoilage
in broth, heat stored in sealed observed
shocked, and polyethylene
diluted in bags
distilled water
C. botulinum Butternut squash NR Spore suspension 1-inch cubes, 10 3.0 7d NR spores/g Toxin detected at
nonproteolytic (2.5 mL) added inoculated and 5 3.0 21 d 7 d (108C) or
(8 strains) to 500 g sample sealed in a 21d (58C). No
polystyrene tray change in
appearance.
Final pH 6.4
(58C), 6.7
(108C)
C. botulinum Butternut squash NR Spore suspension 1-inch cubes, 15 2.0 14 d NR spores/g Toxin detected at
proteolytic (2.5 mL) added inoculated and 25 2.0 3d 14d (158C) or
(10 strains) to 500 g sample sealed in a 3 d (258C). 158C
polystyrene tray samples dry and
moldy. Swelling
of package
observed in
258C samples.
Final pH 6.5
(158C), 6.2
(258C)
C. botulinum Cabbage NR Spore suspension Samples were 4.4 2.1 28 d 2.2 MPN No toxin detected
(12 strains) (shredded) (1 mL), heat sealed in 3-qt 12.7 2.1 28 d 2.0 spores/g in samples
shocked, pouches and 21 2.1 28 d NDb stored at 4.48C
sprayed onto stored vented or or 12.78C. Toxin
sample. Spores not vented. detected in
suspended in Vented bags nonvented
gel-phosphate were placed with samples stored
buffer space between at 218C after 7 d.
samples so that Samples judged
air could to be inedible
circulate prior to toxin
detection
C. botulinum Cabbage 6.2 Spore suspended Stored in ethylene 22 –25 0.8– 1.8 6d NR spores/g No toxin detected
(10 strains, (shredded) in water, 1 mL vinyl alcohol
5 type A heat shocked bags. Sealed in
and 5 type B) suspension MAP of 70%
607
added to sample CO2 and 30%
N2
(continued )
C. botulinum Cabbage 6.2 Spore suspended Stored in ethylene 22 – 25 2 – 2.3 4d NR spores/g 5/6 bags toxic.
(10 strains, (shredded) in water, 1 mL vinyl alcohol Cabbage
5 type A and heat shocked bags. Sealed in acceptable. Only
5 type B) suspension MAP of 70% type A grew and
added to sample CO2 and 30% produced toxin
N2
C. botulinum Cabbage 6.2 Spore suspended Stored in ethylene 22 – 25 2.9 4d NR spores/g 2/2 bags toxic.
(10 strains, (shredded) in water, 1 mL vinyl alcohol Cabbage
5 type A and heat shocked bags. Sealed in acceptable. Only
5 type B) suspension MAP of 70% type A grew and
added to sample CO2 and 30% produced toxin
N2
C. botulinum Cabbage 6.2 Spore suspended Stored in ethylene 22 – 25 1.6– 2.1 6d NR spores/g No toxin detected
(5 strains, (shredded) in water, 1 mL vinyl alcohol
type A) heat shocked bags. Sealed in
suspension MAP of 70%
added to sample CO2 and 30%
N2
C. botulinum Cabbage 6.2 Spore suspended Stored in ethylene 22 – 25 2.5– 3.0 4d NR spores/g 5/10 bags toxic at
(5 strains, (shredded) in water, 1 mL vinyl alcohol 5d 4 d, 8/10 bags
type A) heat shocked bags. Sealed in 6d toxic at 5 d, and
suspension MAP of 70% 9/10 bags toxic
added to sample CO2 and 30% at 6 d. Cabbage
N2 acceptable
C. botulinum Cabbage 6.4 Spot inoculation, Samples stored in 4 2.0 37 NR spores/g 0/6 samples were
(10 strains) (shredded) spores prepared polyethylene 12 8 toxic at end
in broth, heat bags and 21 4 of storage for
shocked, and vacuum sealed all three
diluted in temperatures.
distilled water Gross spoilage
Appendix D
observed
609
package
(continued )
C. botulinum Onion NR Spore suspension 5-mm slices, 25 3.0 6d — spores/g Toxin detected at
proteolytic (2.5 mL) added inoculated and 6 d. Swelling of
(10 strains) to 500 g sample sealed in package
polystyrene observed but no
trays change in
appearance of
onions
C. botulinum Rutabaga NR Spore suspension 1-inch cubes, 5 3.0 21 d NR spores/g No toxin detected
nonproteolytic (2.5 mL) added inoculated and 10 3.0 after 21d. No
(8 strains) to 500 g sample sealed in change in
polystyrene tray appearance
C. botulinum Rutabaga NR Spore suspension 1-inch cubes, 15 2.0 21 d NR spores/g No toxin detected
proteolytic (2.5 mL) added inoculated and 25 2.0 after 21d
(10 strains) to 500 g sample sealed in (158C). No
polystyrene tray change in
appearance. At
258C toxin
detected at 7d.
Decay evident.
Final pH 5.9
C. botulinum Stir fry vegetables NR Spore suspension Stored in plastic 5 3.0 21 d 3.0 CFU/g No toxin detected
nonproteolytic (1 mL) injected film 10 3.0 3.3 after 21d. No
(8 strains) into sealed bags change in
through gas- appearance
tight septum
C. botulinum Stir fry vegetables NR Spore suspension Stored in plastic 15 2.0 21 d 2.8 CFU/g No toxin detected
proteolytic (1 mL) injected film at 21 d. No
(10 strains) into sealed bags change in
through gas- appearance
tight septum
C. botulinum Stir fry vegetables NR Spore suspension Stored in plastic 25 2.0 11 d .4.5 CFU/g Toxin detected at
proteolytic (1 mL) injected film 11d. Soft
Appendix D
(10 strains) into sealed bags appearance.
through gas- Final pH 4.2
tight septum
611
612
Table D-8 Continued
Produce Mode of Storage Temperature Initial counts Incubation Final counts
Pathogen type pH inoculation conditions (8C) (log10 CFU) time (log10 CFU) Unit Comments
E. coli O157:H7 Cucumber 7.3 Dip inoculation, 5-mm discs, 5 2.3 3d ,1 CFU/g Samples stored at
(5 strains) (sliced) 1 min. Cells stored in air in 12 3d ,1 5 and 128C
suspended in polyolefin 21 7d 3.1 positive upon
deionized water L-bags enrichment
through day 3
and day 10,
respectively
Listeria Asparagus NR Cells injected into Stored in 2 5.0 6 – 24 d 4.5 CFU/g Approximately
monocytogenes samples hemetically 4 5.0 6 – 24 d 5.0 CFU/g 1 log increase at
(1 strain) sealed bags 8 5.0 3 – 24 d 7.0 CFU/g 2 and 48C within
12 5.0 3 – 15 d 9.0 CFU/g 3 d followed by
20 5.0 3–6d 9.0 CFU/g decrease
L. monocytogenes Asparagus NR Dip inoculation, Samples stored in 15 4.0/4.8 6d ,7.3 CFU/g Asparagus first
(2 strains) 1 min. Cells 6% CO2, 79% 4 4.2/4.8 21d ,5.8/6.5 CFU/g became
suspended in N2, and 15% O2 unacceptable for
0.1M potassium in glass jars consumption on
phosphate buffer day 6 (158C) or
day 21 (48C)
L. monocytogenes Asparagus NR Dip inoculation, Samples stored in 15 4.0/4.8 4d ,7.0 CFU/g Asparagus first
(2 strains) 1 min. Cells ambient air in 4 4.2/4.8 14d ,5.0/5.5 CFU/g became
suspended in glass jars unacceptable for
0.1M potassium consumption on
phosphate buffer day 4 (158C) or
day 14 (48C)
L. monocytogenes Broccoli NR Dip inoculation, Samples stored in 15 5.0/5.5 10d ,8.8 CFU/g Broccoli first
,4.0/4.5
Appendix D
(2 strains) 1 min. Cells 10% CO2, 79% 4 4.0 21d CFU/g became
suspended in N2, and 11% O2 unacceptable for
0.1M potassium in glass jars consumption on
phosphate buffer day 10 (158C) or
day 21 (48C)
613
Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved.
614
Table D-8 Continued
Produce Mode of Storage Temperature Initial counts Incubation Final counts
Pathogen type pH inoculation conditions (8C) (log10 CFU) time (log10 CFU) Unit Comments
L. monocytogenes Cabbage 6.32 (day 1) Cells suspended Samples stored in 25 4.0 2 d/6 – 9 d ,4.5/,1.3 CFU/g —
(1 strain) (shredded) in Butterfield’s gas
phosphate impermeable
buffer, 1 mL plastic bags and
added to sample sealed in 70%
CO2 and 30%
N2
L. monocytogenes Cabbage NR Cells suspended Samples mixed, 5 4.0 25– 64d ,8.0 CFU/g —
(1 strain) (shredded) in 0.1M drained, and
potassium adjusted to
phosphate buffer incubation
and added to temperature
sample within 3 h
L. monocytogenes Carrot NR Cell suspension, Samples 4 2.3 9d 1.0 CFU/g —
(5 strains) 1 to 1.6mLof purchased from 10 2.3 9d ,1.0
inoculum the store, stored
injected through in original
a gas-tight packaging
septum. Cells
suspended in
0.1% peptone
L. monocytogenes Carrot (shredded) — Dip inoculation, Carrots washed or 5 1.1– 2.6 24 d 3.8– 4.6 CFU/g Similar results
(2 strains) cells suspended unwashed in 15 , 1.0 7d 3.4– 5.8 obtained for
in 0.1M 200 – 250 ppm unwashed
potassium prior to carrots stored at
phosphate buffer shredding. 58C. Population
Stored in declined to
ambient air or ,1 log CFU/g
in 3% O2 and (day 7) in
97% N2 unwashed
carrots
stored at 158C
Appendix D
Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved.
Pathogens: Vegetables and Vegetable Products
L. monocytogenes Carrot (whole) — Dip inoculation, Carrots washed or 5 1.8– 2.4 18 d ,1.0 CFU/g —
(2 strains) cells suspended unwashed in 15 2.5– 3.0 7d ,1.0
in 0.1M 200 – 250 ppm.
potassium Stored in
phosphate buffer ambient air or
in 3% O2 and
97% N2
L. monocytogenes Cauliflower NR Dip inoculation, Samples stored in 15 3.4/4.0 8d ,6.8/7.1 CFU/g Cauliflower first
(2 strains) 1 min. Cells 3% CO2, 79% 4 2.8/3.0 21 d ,3.0/3.6 CFU/g became
suspended in N2, and 18% O2 unacceptable for
0.1 M potassium in glass jars consumption on
phosphate buffer day 8 (158C) or
day 21 (48C)
L. monocytogenes Cauliflower NR Dip inoculation, Samples stored in 15 3.4/4.0 8d ,6.2/6.8 CFU/g Cauliflower first
(2 strains) 1 min. Cells ambient air in 4 2.8/3.0 14 d ,2.3/3.6 CFU/g became
suspended in glass jars unacceptable for
0.1 M potassium consumption on
phosphate buffer day 6 (158C) or
day 14 (48C)
L. monocytogenes Coleslaw 6.6 Cell suspension, Samples 4 2.5 9d ,4.0 CFU/g —
(5 strains) 1 to 1.6mL of purchased from 10 2.5 ,5.0
inoculum the store. Stored
injected through in original
a gas-tight packaging
septum. Cells
suspended in
0.1% peptone
L. monocytogenes Endive (chicory) NR Cell suspension Stored in 6.5 3.3 7d ,2.5 CFU/g —
(1 strain) added to moderate
samples vacuum
packaging
containers under
moderate
vacuum
L. monocytogenes Endive (chicory) NR Cell suspension Stored in 6.5 3.3 7d ,5.2 CFU/g —
(1 strain) added to moderate
samples vacuum
packaging
container in
ambient air
(continued )
615
Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved.
616
Table D-8 Continued
Produce Mode of Storage Temperature Initial counts Incubation Final counts
Pathogen type pH inoculation conditions (8C) (log10 CFU) time (log10 CFU) Unit Comments
Appendix D
Stored in
modified
atmosphere
of 10% CO2,
10% O2
617
Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved.
618
Table D-8 Continued
Produce Mode of Storage Temperature Initial counts Incubation Final counts
Pathogen type pH inoculation conditions (8C) (log10 CFU) time (log10 CFU) Unit Comments
S. Typhi Jicama (cubes) 5.97 Spot inoculation, 12cm2 cubes, 25 –27 3.2 6h 4.7 CFU/cube —
cells suspended inoculated and
in saline. 1 drop stored in
(Pasteur pipette) covered glass
inoculated per trays
cube
Shigella Jicama (cubes) 5.97 Spot inoculation, 12cm2 cubes, 25 –27 1.5 6h 2.2 CFU/cm2 —
dysenteriae cells suspended inoculated and
(1 strain) in saline. 1 drop stored in
(Pasteur pipette) covered glass
inoculated per trays
cube
S. flexneri Carrot salad NR Cells suspended Samples stored in 5 ,6.7 11 d ,2.5 CFU/g —
(1 strain) in water and 50mL
added to sample polypropylene
centrifuge tubes
S. flexneri Green pepper NR Cells suspended Samples stored in 4 6.7 12 d 4.3 CFU/g —
(1 strain) (chopped) in water and 50mL
added directly to polypropylene
sample centrifuge tubes
S. flexneri Coleslaw NR Cells suspended Samples stored in 4 ,5.1 16 d ,4.3 CFU/g —
(1 strain) in water, added 50mL
directly to polypropylene
sample centrifuge tubes
Appendix D
S. flexneri Cabbage NR Cells suspended Samples stored in 4 6.5 26 d 3.1 CFU/g —
(1 strain) (chopped) in water, added 50mL
directly to polypropylene
sample centrifuge tubes
619
Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved.
620
Table D-8 Continued
Produce Mode of Storage Temperature Initial counts Incubation Final counts
Pathogen type pH inoculation conditions (8C) (log10 CFU) time (log10 CFU) Unit Comments
S. sonnei Parsley (chopped) — Dip inoculation, Stored in 9-liter 4 6.48/3.49 2d ,9.2/,6.3 CFU/g The pathogen
(3 strains) cells suspended plastic pans 21 grew to 9.2 and
in 0.05 M 6.3 log CFU/g
potassium within 2 d at
phosphate- 218C, followed
buffered saline. by a decline.
1200 g sample Inoculated
inoculated and chopped parsley
dried. Chopped stored at 48C
after drying declined
throughout a
14 day storage
period
S. sonnei Parsley (whole — Dip inoculation, Stored in 9-liter 21 3.23/6.19 7 d/7 d ,3.0/,6.5 CFU/g An increase of ,1
(3 strains) leaves) cells suspended plastic pans log within 1 day
in 0.05 M at 218C,
potassium followed by a
phosphate- decline in
buffered saline. population after
1200 g sample 2 d. Inoculated
inoculated and parsley stored at
dried. 48C declined
throughout the
14 day storage
period
S. sonnei Cabbage 6.8 Dip inoculation, Stored under 24 ^ 2 3.2 1 d/7 d 7.0/ , 2 0.52 MPN/g —
(1 strain) (shredded) cells suspended vacuum in gas- 0 –6 3.5 7d 3.5
in Butterfield’s impermeable
phosphate buffer bags
S. sonnei Cabbage 6.8 Dip inoculation, Stored in 24 ^ 2 3.4 1 d/7 d 7.0/3.7 MPN/g —
(1 strain) (shredded) cells suspended modified 0 –6 2.6 7d 2.5
in Butterfield’s atmosphere
Appendix D
phosphate buffer (30% N2, 70%
CO2) in gas-
impermeable
bags
Clostridium Lettuce 6.2 Spot inoculation, Samples stored in 4 2.0 50 d NR NR At 48C, 0/6 toxic.
botulinum (intact) spores prepared in polyethylene bags 12 13 d At 128C, 0/6
(10 strains) broth, heat and vacuum 21 6d toxic. At 218C,
shocked, and sealed 2/6 toxic. Gross
diluted in distilled spoilage observed
water when toxin
detected
C. botulinum Mixed NRa Spore suspension, Samples in original 5 3.0 21 d 3.7 spores/g No toxin at 5 or
nonproteolytic salad 1 mL injected package 10 21 d 3.7 108C. Toxin
(8 strains) through gas-tight 15 14 d .4.5 detected at 14 d
septum 25 4d .4.4 (158C) and 4 d
(258C). Moderate
browning at time
of toxin detection.
Final pH 5.3– 5.9
C. botulinum Mixed NR Spore suspension, Samples in original 15 1.0 21 d NR spores/g No toxin at 158C.
proteolytic salad 1 mL injected package 15 2.0 21 d NR Extensively decay
(10 strains) through gas-tight 25 7d .4.5 observed when
septum toxin detected
(7d at 248C)
C. botulinum Romaine NR Spore suspension Samples sealed in 4.4 2.0 28 d 2.0 MPN No toxin detected
(12 strains) lettuce (1 mL), heat 3-qt pouches and 12.7 2.0 28 d 2.1 spores/g in samples stored
(shredded) shocked, sprayed stored vented or 21 2.0 28 d NDb at 4.48C or
onto sample. not vented. 12.78C. Toxin
Spores suspended Vented bags detected in
in gel-phosphate placed with space nonvented
buffer between samples samples stored at
so that air could 218C after 14 d
circulate and in vented
samples after 21d.
Samples were
judged to be
inedible prior to
toxin detection
(continued )
621
Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved.
622
Table D-9 Continued
Mode of Temperature Initial counts Incubation Final counts
Pathogen Produce type pH inoculation Storage conditions (8C) (log10 CFU) time (log10 CFU) Unit Comments
C. botulinum Romaine NR Spore suspension, Samples in original 5 3.0 21 d NR spores/g Toxin not detected.
nonproteolytic lettuce 1 mL injected package 10 No change in
(8 strains) through gas-tight appearance
septum
C. botulinum Romaine NR Spore suspension, Samples packaged 15 1.0 21 d NR spores/g Toxin not detected
proteolytic lettuce 1 mL injected in film 15 2.0 21 d NR at 158C. No
(10 strains) through gas-tight 25 9d .4.5 change in
septum appearance.
Extensive decay
observed when
toxin detected
at 258C
Escherichia coli Lettuce ,7.4 Dip inoculation, Stored in 5 5.3 14 d 3.1 CFU/g —
O157:H7 (shredded) 1 min. Cells polyolefin L-bags 12 3 d/14 d 7.0/8.0
suspended in consisting 3% O2 21 3 d/7 d 8.5/8.7
deionized water and 97% N2
E. coli Lettuce ,7.4 Dip inoculation, Stored in air in 5 5.3 14 d 4.2 CFU/g —
O157:H7 (shredded) 1 min. Cells polyolefin L-bags 12 3 d/14 d 6.8/7.5
suspended in 21 3 d/7 d 8.5/8.8
deionized water
E. coli Iceberg NR Dip inoculation Stored in plastic 5 3.4 18 d 2.9 CFU/g Counts on heated
O157:H7 lettuce (1 min) in 0.1 M bags for up to 18d lettuce were
(shredded) phosphate buffer similar to counts
(pH 7.0) on unheated
suspension before lettuce.
mild heat
treatment (508C,
90 s)
E. coli Iceberg NR Dip inoculation Stored in plastic 15 3.4 7d 7.6 CFU/g Counts on heated
O157:H7 lettuce (1 min) in 0.1 M bags for up to 7 d lettuce were
Appendix D
(shredded) phosphate buffer significantly
(pH 7.0) higher than
suspension before counts on
mild heat unheated lettuce
treatment (508C, stored for 4
90 s) and 7 d
623
Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved.
624
Table D-9 Continued
Mode of Temperature Initial counts Incubation Final counts
Pathogen Produce type pH inoculation Storage conditions (8C) (log10 CFU) time (log10 CFU) Unit Comments
L. monocytogenes Lettuce, NR Dip inoculation, Produce not 5 4.6 15d 5.4 CFU/g —
(2 strains) whole 1 min. Cells washed and stored 10 4.7 10d 6.8
leaves suspended in in Cryvovac
0.1 M phosphate L-bags in 3% O2
buffer and 97% N2
L. monocytogenes Lettuce, NR Dip inoculation, Produce washed in 5 4.3 15d 4.9 CFU/g —
(2 strains) whole 1 min. Cells 200 – 250 ppm 10 4.7 10d 6.8
leaves suspended in chlorine and
0.1 M phosphate stored in
buffer Cryvovac L-bags
in 3% O2 and
97% N2
L. monocytogenes Lamb’s NR Dip inoculation, Samples drained 10 4.1 7d 4.0 CFU/g —
(1 strain) lettuce 10 min. Cells on absorbent
suspended in paper, sealed, and
sterile distilled stored in
water polypropylene
pouches
Appendix D
L. monocytogenes Iceberg — Dip inoculation, Stored in sealed 4 ,4.1 4 ,4.4 CFU/g —
lettuce 30 s. Cells plastic bags
(pieces) suspended in
trypticase soy
broth
a
Not reported.
b
Not determined.
625
626
Table D-10 Survival of Pathogenic Viruses on Raw Produce
Produce Storage Temperature Initial counts Incubation Final counts
Pathogen type Mode of inoculation conditions (8C) (log10 CFU) time (log10 CFU) Unit Comments
Coxsackie Carrot, 0.05 mL spot Samples left 4 ,2.6 1d ,1.6 PFU/sample Presence of moisture
virus B5 whole inoculated onto uncovered 5d ,0.6 improved survival. Survival
sample. Virus significantly better in closed
suspended in water containers with high
humidity. Presence of feces
improval survival
Coxsackie Carrot, 0.05 mL spot Samples were left 4 ,2.6 1d ,1.7 PFU/sample Presence of moisture
virus B5 whole inoculated onto uncovered 5d ,1.2 improved survival. Survival
sample. Virus significantly better in closed
suspended in dilute containers with high
feces (1%) humidity. Presence of feces
improved survival
Coxsackie Carrot, Spot inoculation, Samples left 4 ,2.6 1d ,1.9 PFU/sample Presence of moisture
virus B5 whole 0.05mL inoculated uncovered 5d ,1.4 improved survival. Survival
onto sample. Virus significantly better in closed
suspended in containers with high
undiluted feces humidity. Presence of feces
improved survival
Coxsackie Celery 0.05 mL spot Sample enclosed 4 ,2.6 8d ,2.6 PFU/sample Presence of moisture
virus B5 inoculated onto in polyethylene improved survival. Survival
sample. Virus bags which significantly better in closed
suspended in water contained a dish containers with high
or dilute feces (1%) of water to humidity. Presence of feces
maintain improved survival
humidity
Coxsackie Celery 0.05 mL spot Samples left 4 ,2.6 1d ,2.0 PFU/sample Presence of moisture
virus B5 inoculated onto uncovered improved survival. Survival
sample. Virus significantly better in closed
suspended in water containers with high
or dilute feces (1%) humidity. Presence of feces
improved survival
Coxsackie Lettuce, Spot inoculation, Lettuce discs 4 2.0 7d ,1.9 — —
Appendix D
virus B5 pieces 0.1mL inoculated stored in capped
onto each 16-mm storage flasks
disc. Virus grown in with no moisture
hep-2 cells, diluted
in phosphate
buffered saline
627
Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved.
628
Table D-10 Continued
Produce Storage Temperature Initial counts Incubation Final counts
Pathogen type Mode of inoculation conditions (8C) (log10 CFU) time (log10 CFU) Unit Comments
Enteroviruses Tomato, Virus suspended in Samples kept in 3.1 Unknown 15d — TCD50/mL 1 to 2.5 log decrease observed
(5 strains) whole saline, 1 mL 150 – 200 mL
inoculated per 100 g beakers
sample
Hepatitis A virus Lettuce Inoculum contained Samples held in 4 7.3 12d 6.9 PFU/mL —
(strain hM 175) (pieces) 5% fetal bovine loosely covered 22 7.3 12d 3.3
serum petri dishes to
allow air flow
Hepatitis A virus Lettuce Inoculum contained Samples held 4 7.3 12d 7.1 PFU/mL —
(strain hM 175) (pieces) 5% fetal bovine inside heat 22 7.3 12d 6.1
serum sealed plastic
bag
Hepatitis A virus Lettuce Inoculum contained Samples held in 4 7.3 12d 7.2 PFU/mL —
(strain hM 175) (pieces) 5% fetal bovine heat sealed 22 7.3 12d 6.9
serum plastic bags
containing 70%
CO2 and 30%
N2
Rotavirus SA-11 Carrot, 0.1mL spot Samples stored in 4 4.5 25d ,1.2 PFU/mL —
pieces inoculated onto uncovered 25 4.5 15d ,1.0
sample. Virus containers
grown on MA-
104 cells. Virus
suspended in Tris-
buffered saline
Rotavirus SA-11 Carrot, Immersion Samples stored in 4 3.0 4d ,1.0 PFU/mL —
pieces inoculation, 200 mL uncovered 25 2.8 2d ,1.0
Appendix D
of 105 PFU/mL. containers
Virus grown on
MA-104 cells.
Virus suspended in
Tris-buffered saline
629
630
Table D-11 Survival and Growth of Pathogenic Organism on Sprout Seeds or Raw Sprouts
Produce Mode of Storage Temperature Initial counts Incubation Final counts
Pathogen type inoculation conditions (8C) (log10 CFU) time (log10 CFU) Unit Comments
Aeromonas Sprouts, Diluted suspension Stored in rigid 6.5 5.0 5d ,6.8 CFU/g Sprouts obtained
hydrophila mung bean inoculated onto plastic containers, from local retail
sprouts 400 mB market
A. hydrophila Sprouts, Diluted suspension Stored in rigid 6.5 5.0 7d ,9.2 CFU/g Sprouts obtained
mung bean inoculated onto plastic containers from local retail
sprouts market
Escherichia coli Seeds, Dip inoculation, Inoculated seeds 5 3 54 weeks ,0.3 CFU/g Counts decreased to
O157:H7 alfalfa 1min. Cells dried (5.1–6.2% 1.5 log10 CFU/g
(5 strains) suspended in moisture) before within 38 weeks.
deionized water storage in sealed Detected by
containers enrichment at
54 weeks
E. coli O157:H7 Seeds, Dip inoculation, Inoculated seeds 25 3 54 weeks ,0.3 — Counts decreased to
(5 strains) alfalfa 1min. Cells dried (5.1–6.2% 0.74 and ,0.3
suspended in moisture) before log10 CFU/g after 8
deionized water storage in sealed and 12 weeks,
containers respectively.
Detected by
enrichment after
38 weeks but not
54 weeks
E. coli O157:H7 Seeds, Dip inoculation, Inoculated seeds 37 3 54 weeks ,0.3 — Counts decreased to
(5 strains) alfalfa 1min. Cells dried (5.1–6.2% ,0.3 log10 CFU/g
suspended in moisture) before within 8 weeks.
deionized water storage in sealed Detected by
containers enrichment after
38 weeks but not
54 weeks
Appendix D
E. coli O157:H7 Sprouts, Dip inoculation of Counts monitored 25 NR 5d 7.1–8.0 CFU/g Seeds treated with
(5 strains) alfalfa seeds, 1min. Cells during sprout disinfectants before
suspended in production in glass sprouting
Butterfield’s jars
phosphate buffer
631
Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved.
632
Table D-11 Continued
Produce Mode of Storage Temperature Initial counts Incubation Final counts
Pathogen type inoculation conditions (8C) (log10 CFU) time (log10 CFU) Unit Comments
S. Typhi Sprouts, Dip inoculation of Counts monitored 22 2.5 6d 3.7 CFU/g Counts increased to
alfalfa seeds, 10min. Cells during sprout ca. 6.1 log10 CFU/g
suspended in 0.1% production in within 1d, then
peptone covered trays decreased
through 6 d
S. Typhi Sprouts, Dip inoculation of Stored in closed 4 –7 4.8 15d 4.5 CFU/g Decreases have no
alfalfa seeds, 10min. Cells trays practical
suspended in 0.1% significance to
peptone. Sprouts safety
produced at 228C
for 7d
S. Typhi Sprouts, Seeds germinated Counts monitored 22 3.4 8d 2.4 CFU/g Counts decreased by
alfalfa for 24h, then during sprout ca. 1 log10,
inoculated with production in suggesting inability
cells suspended in covered trays to compete with
0.1% peptone aerobic
microorganisms,
which were present
Appendix D
at 7.5 log10 CFU/g
when sprouts were
inoculated with
S. Typhi
633
APPENDIX E
Reference Tables for Modified Atmosphere
Packaging (MAP) and Controlled Atmosphere
Systems (CAS)
The information in this appendix has been adapted from “Analysis and Evaluation of Preventive
Control Measures for the Control and Reduction=Elimination of Microbial Hazards on Fresh and
Fresh-Cut Produce,” FDA, September 30, 2001. All references have been removed. Please consult
the original document for details.
System Description
Table E-2a Polymers, Film Types, and Permeability Available for Packaging of MAP Produce
Water vapor
transmission,
g=m2=day=atm
(388C and
Permeability (cm3=m2 . d . atm for 25 m film at 258C)
90% relative
Film Oxygen Nitrogen Carbon dioxide humidity)
Table E-2b
Pectin 57.5 — — 87
Chitosan 91.4 — 1,553 93
Wheat (gluten) 190=250 — 4,750=7,100 91=94.5
Na caseinate 77 — 462 77
Gluten-DATEM 153 — 1,705 94.5
Gluten-beeswax 133 — 1,282 91
Na casenate=Myvacet 83 — 154 48
MC=MPMC=fatty acids 46.6 — 180 52
MC and beeswax 4 — 27 42
Gluten-DATEM and beeswax ,3 — 15 56
Gluten-Beeswax and beeswax ,3 — 13 56
Methylcellulose-palmitic acid 78.8 — — 100
Zein 0.36b — 2.67b 0.116c
Cozeen 0.89b — 5.25b 0.407c
Polyethylene 8.3b — 26.1b —
Polypropylene 0.55b — — 0.00065c
Sucrose polyester 2.10b — — 0.00042c
Table E-2c
Smart Films
Antimicrobial films
(i) Edible
Chlorinated phenoxy compound with biocide incorporated into the polymer layer
(that is, nisin, lysozyme)
Chlorine dioxide with biocide incorporated into polymer layer
Edible films with sorbic acid, sodium benzoate, benzoic acid, and potassium sorbate
Pine-based volatiles added to edible film
Horseradish extract added to edible film
(ii) Nonedible films=products
Propyl paraben dispersed in a polymer emulsion (Permax 801 or Carboset)
LDPE with Imazalil
LDPE with grapefruit seed extract
Gas, as produced by sachets or other materials to produce sodium metabisulfite to obtain
the production of sulfite
Table E-3 Commercially Available Modified Atmosphere Packaging Systems for Small and Large
Quantities of Vegetables
Pallet Package System Pallet box wrapped in heavy gauge polyethylene, Various perishables
with a silicone membrane window to allow gas
exchange regulation and a calibrated hole for
pressure regulation.
Marcellin System For room storage: regulates the atmospheric Various perishables
composition via a parallel series of rectangular
bags of silicone rubber; can be installed in or out
of storage area and maintains a fairly consistent
atmosphere.
Atmolysair System System of gas diffusion panels enclosed in an Cabbage in Canada,
airtight container, having two separate airflow other perishables
paths and a control panel, allowing the potential
for automation.
Tom-Ah-Toes Long, narrow box overwrapped with gas Tomatoes
(Natural Pak permeable film; contains a sachet containing
Produce) calcium chloride and activated lime to
absorb CO2.
FreshSpanTM Consists of a breathable plastic membrane in the Fresh-cut
(SunBlush liner of the walls of a corrugated paperboard asparagus,
Technologies Inc.) FreshSpanTM box, which can be hermetically broccoli,
sealed. cauliflower
MaptekFreshTM Maptek FreshTM is a postharvest biotechnology Fresh-cut produce
(SunBlush where specific features and conditions are
Technologies Inc.) applied for each type of product to stabilize the
produce and place it in a state of hibernation.
FreshflexTM Curwood provides a variety of films for produce Produce
(Curwood) packaging and can add a variety of features to
the package such as antifog, EZ Peelw, Peel-
Reseal, Integra Tearw, and Magic Cutw
MAPAXw (AGA, This system incorporates the optimal atmosphere Fresh-cut produce,
Sweden) by testing, to choose the exact gas mixture and lettuce,
the best film for each product considering mushrooms,
respiration rate, temperature, packaging film, prepeeled
pack volume, fill weight, and light. potatoes
FreshHold (Hercules Polypropylene label with calcium carbonate Broccoli,
Chemical Co.) embedded in it. asparagus,
cauliflower
Cryovac (W.R. Grace 0.75, 1.25, 2.5 mm thick bag made of several Cut lettuce,
and Co.) layers of polyethylene related polymers. broccoli,
cauliflower,
spinach, peeled
potatoes, and
other vegetables
Propafilm CR and CK Polypropylene-based films. Fresh-cut lettuce
(Imperial Chemical and other
Industries PLC) vegetables
(continued )
P-Plus films Spark perforated films which result in nonuniform Brussels sprouts,
(Courtaulds perforations throughout the film to facilitate gas lettuce, broccoli,
Packaging) exchange. fresh
mushrooms, and
bean sprouts
T-grade (CVP Systems) Films are coextruded bilayer films in 1.0, 1.25, 1.5,
and 1.75 mm thickness.
Clysar EHC, EH, ECL, Biaxially oriented, heat shrinkable polyethylene or
LLP (DuPont) polyolefin films.
Laminated boxes Cartons with films laminated within the cardboard Broccoli and other
(Georgia Pacific, or coated on the inside of the cardboard liner. perishables
Weyerhaeuser and Reduces moisture loss and potentiates air flow.
Tamfresh Ltd.)
Film Convertors The converters (companies) buy resin or film and Variable=product
adapt it to attractive specifications. Converters specific
are often more flexible with respect to specific
applications of the requested film.
Edible filmsa
Intelligent systems
Activated Earth Films Typically polyethylene bags with powdered clay Variable
material made of powdered aluminum silicates,
incorporated into the film matrix. Possibly
reduces ethylene concentration by facilitating its
diffusion out of the bag.
Temperature Films increase their gas permeabilities in response Specific for each
Responsive Films to temperature increases as well as increases in product
(Landec Labs) respiration. Stabilizes the modified atmosphere
so it remains the same under various
temperatures.
CO2 Scavengers Sachet type product which is placed directly in the Vegetables
FreshLock package and absorbs both carbon dioxide and
(Mitsubishi Gas oxygen.
Chemical Co.),
Verifrais (Codimer
Tournessi,
Gujan-Mestras)
Ethylene absorbents Sachet type product which is placed directly in the Vegetables
Ethysorb (StayFresh package and absorbs ethylene. They are
Ltd), Ageless C composed of a variety of products such as
(Mitsubishi Gas aluminum oxide, potassium permanganate,
Chemical activated carbon, and silicon dioxide.
Company),
Freshkeep
(Kurarey), Acepack
(nippon Greener),
Peakfresh (Klerk
Plastic Industrie,
Chantler Packaging
Inc.)
Appendix E
Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved.
Reference Tables for MAP and CAS 643
General films
Lipid-based coatings
Casein, collagen, corn Obtained from aqueous Biodegradable More permeable to water
zein, gelatin, soy or ethanolic solution Reduces moisture loss vapor than lipid
protein, wheat Adds nutritional value barriers
gluten, gelatin, WPIb Does not require support
matrix
Wheat (gluten) Obtained from aqueous Effective oxygen barrier Vapor barrier ability
solution at low relative limited
humidity High gluten content may
High gluten content also be a disadvantage
Increased puncture for those intolerant to
strength and gluten
extensibility
Polysaccharide barriers
Pectin Generally made from Can retard water loss Not adequate moisture
Most effective on low-methoxyl from food barriers
low-moisture pectin, calcium Can improve handling Low oxygen
products chloride (cross- and appearance of permeability
linker), a plasticizer, foods
and sometimes
organic acids
Chitosan Methylation of the Natural preservative, At 100% RH,
Nutri-Save chitosan polymer inhibits growth of permeability to CO2
(NovaChem), results in increased fungi and O2 due to
used for whole resistance to CO2 Impermeable to gases at diffusion with water
apples and pears Permeability use of 70% RHc
chitosan with lipids
may solve moisture
barrier problems
Derivatives of cellulose Used mainly for Good film formers due to Not good barriers to
Tal pro-long composite coatings linear structure of movement of water;
(Courtaulds comprised of the polymer backbone however, the film can
Group) sodium salt of O2 is limited in entering retain a moisture layer
Semperfresh carboxymethyl the fruit more than which will delay
(Surface cellulose (CMC) as CO2 is from escaping; moisture loss from the
Systems Intl., Ltd.) the film former, with limiting buildup of fruit by being the first
sucrose fatty acid harmful CO2 and layer of moisture lost
ester as the maintenance of
emulsifiers reduced O2
Carrageenan coatings Extracted from several Can reduce moisture Not yet approved by the
Successfully used on species of red loss, oxidation or FDA for food coatings
cut grapefruit seaweeds and used in disintegration of the
halves Bryan food systems as a gel product
1972)
Not yet approved by
FDA for coatings
a
See glossary for definition of molding techniques.
b
Wheat protein isolate.
c
Relative humidity.
Polysaccharide coatings
I. Cellulose
Carboxymethyl cellulose
II. Chitin=Chitosan
Fresh cucumbers, bell peppers Postharvest decay control
Protein Coatings
I. Corn Zein
Zein
Appendix E
Green beana Air 5,500 – 7,500 20,000 – 24,000 — — P & NP, 100 21 7 No toxin Gross spoilage
Green beana Air 16,544 35,175 — — P & NP, 100 21 7 No toxin Gross spoilage
Romaine UK 40 — 1.37 25.2 P, 100=g 25 9 Extensive decay
lettuced
647
APPENDIX F
FDA Food Defect Action Levels for Vegetables
and Vegetable Products
I. INTRODUCTION
Title 21, Code of Federal Regulations, Part 110.110 allows the Food and Drug Administration
(FDA) to establish maximum levels of natural or unavoidable defects in foods for human use that
present no health hazard. These “Food Defect Action Levels” listed in this booklet are set on this
premise—that they pose no inherent hazard to health.
Poor manufacturing practices may result in enforcement action without regard to the action
level. Likewise, the mixing or blending of food with a defect at or above the current defect action
level with another lot of the same or another food is not permitted. That practice renders the final
food unlawful regardless of the defect level of the finished food.
The FDA set these action levels because it is economically impractical to grow, harvest, or
process raw products that are totally free of nonhazardous, naturally occurring, unavoidable
defects. Products harmful to consumers are subject to regulatory action whether or not they
exceed the action levels.
It is incorrect to assume that because the FDA has an established defect action level for a
food commodity, the food manufacturer need only stay just below that level. The defect levels do
not represent an average of the defects that occur in any of the products—the averages are actually
much lower. The levels represent limits at which FDA will regard the food product as “adulterated”
and subject to enforcement action under Section 402(a)(3) of the Food, Drug, and Cosmetics Act.
As technology improves, the FDA may review and change defect action levels on this list.
Also, products may be added to the list. The FDA publishes these revisions as Notices in the Federal
Register. It is the responsibility of the user of this booklet to stay current with any changes to this list.
If there is no defect action level for a product, or when findings show levels or types of defects that
do not appear to fit the action level criteria, FDA evaluates the samples and decides on a case-by-
case basis. In this procedure, FDA’s technical and regulatory experts in filth and extraneous
materials use a variety of criteria, often in combination, in determining the significance and
regulatory impact of the findings.
Source: The Food Defect Action Levels: Levels of Natural or Unavoidable Defects in Food That Present No
Health Hazards for Humans, FDA May 1995; revised March 1997; revised May 1998.
The criteria considered are based on the reported findings (e.g., lengths of hairs, sizes of insect
fragments, distribution of filth in the sample, and combinations of filth types found). Moreover,
FDA interprets the findings considering available scientific information (e.g., ecology of animal
species represented) and the knowledge of how a product is grown, harvested, and processed.
It is FDA’s position that pesticides are not the alternative to preventing food defects. The use of
chemical substances to control insects, rodents, and other natural contaminants has little if any
impact on natural and unavoidable defects in foods. The primary use of pesticides in the field is to
protect food plants from being ravaged by destructive plant pests (leaf feeders, stem borers, etc.).
A secondary use of pesticides is for cosmetic purposes—to prevent some food products
from becoming so severely damaged by pests that they become unfit to eat.
This edition of The Food Defect Action Level includes the source of each defect and the
significance of it (i.e., how the defect affects the food). Food processors may find this information
helpful as a quality control tool in their operation.
Vegetable and vegetable products are listed alphabetically. Each listing indicates the analytical
methodology (Defect Method) used, as well as the parameters for the defect (Defect Action Level).
AOAC refers to the Association of Official Analytical Chemists. The reference number
following AOAC refers to its official method of analysis.
The glossary describes terms used throughout this booklet.
V. GLOSSARY
contributed by insects, rodents, and birds; decomposed material; and miscellaneous matter such
as sand, soil, glass, rust, or other foreign substances.
FOREIGN MATTER Includes objectionable matter such as sticks, stones, burlap bagging,
cigarette butts. Also includes the valueless parts of the raw plant material, such as stems.
GUMMY A resinous glaze on an almond kernel that is induced by an insect injury or
mechanical damage.
HARVEST Occurs during the harvesting process.
HISTAMINE A chemical compound formed by the bacterial decomposition of seafood.
INDOLE A chemical compound formed by the bacterial decomposition of seafood.
INFECTION A condition due to the growth of an organism in a host (e.g., rot or decay,
visible mold mycelia).
INFESTATION The presence of any live or dead life cycle stages of insects in a host product
(e.g., weevils in pecans, fly eggs and maggots in tomato products); or evidence of their presence
(i.e., excreta, cast skins, chewed product residues, urine, etc.); or the establishment of an active
breeding population, (e.g., rodents in a grain silo).
MILDEW Refers to downy mildew, which is a fungus infection that causes yellow-brown
spots on the leaves of edible greens in the mustard family.
MOLD COUNT Refers to the results of the Howard mold count method, which is reported
as the percentage of positive microscopic fields that have been scored as either positive or negative
based on the presence or absence of a minimum amount of mold hyphae. Performed only on
comminuted fruits and vegetables, and some ground spices. The source of the mold hyphae is
rotten raw material that is processed along with sound raw material but is no longer visible due to
the comminution process.
MOLDY Evidenced by the presence of mold (mold hyphae and=or spore forming structures)
that are visible to the unaided eye. Microscopic examination may be used to confirm the presence
of characteristic hyphal filaments and fruiting structures.
POSTHARVEST Occurs after harvest, for example,
Field holding of the harvested crop prior to transit
Farm storage of harvested crop
During transit by truck, ship, rail, etc.
At the processing facility, awaiting processing, or proper storage.
PREHARVEST Occurs while product is in the field, during growth, or awaiting harvest.
PROCESSING Occurs while in the processing facility, in storage, or during processing.
RANCID A condition where a product has a disagreable odor or taste of decomposed oils or
fat. For example, rancid nuts frequently are soft, with a yellow, dark, or oily appearance, a bitter
taste, and a stale odor.
ROT Plant tissue that is visibly decomposed, usually discolored with disagreeable odors and
taste. The plant tissue has been invaded and is being digested by microorganisms. Although rot
can also be caused by bacteria and yeasts, these organisms are secondary invaders. Molds are the
primary organisms of decomposition, and the presence of mold hyphae in the tissue is used to
confirm rot.
SHRIVELED A condition where the nut kernel is shrunken and not fully developed,
commonly a result of climatic stress or infection by certain molds.
SIGNIFICANCE OF DEFECT Refers to the real or potential impact on the consumer due
to the presence of a particular defect. A listed defect can have more than one significance to the
consumer (e.g., the mold defect of whole cassia has an aesthetic significance, whereas the mold
defect of green coffee beans has a potential health hazard significance due to the threat of mold
toxins produced by the mold species known to infect coffee beans).
SOUR In fruits, consists of the bacterial breakdown of the product and the formation of lactic
acid and subsequent sour taste.
WATER INSOLUBLE INORGANIC MATTER A contaminant of the finished product
that consists of fine grit that originates from the sand, dirt, and stones that contaminate the raw
agricultural product at the time of harvest.
WHOLE OR EQUIVALNET INSECT A whole insect, separate head, or body portions
with head attached.
WORTHLESS Any condition where the product has been affected by organisms or the
environment so that it has no food value.
CINNAMON, GROUND Insect filth (AOAC Average of 400 or more insect fragments per
968.38b) 50 grams
Rodent filth (AOAC Average of 11 or more rodent hairs per
968.38b) 50 grams
DEFECT SOURCE: Insect fragments—postharvest and=or processing insect infestation. Rodent
hair—postharvest and=or processing contamination with animal hair or excreta
SIGNIFICANCE: Aesthetic
DEFECT SOURCE: Insects and insect fragments—preharvest and=or postharvest and=or processing insect
infestation. Rodent hair and excreta fragments—postharvest and=or processing contamination with
animal hair or excreta
SIGNIFICANCE: Aesthetic
FENNEL SEED Insects (MPM-V32) 20% or more of subsamples contain insects
Mammalian excreta 20% or more of subsamples contain
(MPM-V32) mammalian excreta
OR
average of more than 3 mg of mammalian
excreta per pound
DEFECT SOURCE: Insects—preharvest and=or postharvest insect infestation. Excreta—postharvest
and=or processing animal contamination
SIGNIFICANCE: Aesthetic
GINGER, WHOLE Insect filth and=or mold Average of 3% or more pieces by weight are
(MPM-V32) insect infested and=or moldy
Mammalian excreta Average of 3 mg or more of mammalian
(MPM-V32) excreta per pound
DEFECT SOURCE: Insect infestation—postharvest and=or processing. Mold—postharvest and=or
processing infection. Mammalian excreta—postharvest and=or processing animal contamination
SIGNIFICANCE: Aesthetic; potential health hazard—may contain mycotoxin producing fungi
GREENS, CANNED Mildew (AOAC 967.23) Average of 10% or more of leaves, by count or
weight, showing mildew over 1=200 in
diameter
DEFECT SOURCE: Preharvest infection
SIGNIFICANCE: Aesthetic
MACE Insect filth and=or moldAverage of 3% or more pieces by weight are
(MPM-V32) insect infested and=or moldy
Mammalian excreta Average of 3 mg or more of mammalian
(MPM-V32) excreta per pound
Foreign matter (MPM-V32)
Average of 1.5% or more of foreign matter
through a 20-mesh sieve
DEFECT SOURCE: Insect infestation—preharvest and=or postharvest and=or processing.
Mold—preharvest and=or postharvest infection. Mammalian excreta—postharvest and=or processing
animal contamination. Foreign matter—postharvest contamination
SIGNIFICANCE: Aesthetic
MARJORAM, WHOLE Insect filth and=or mold Average of 5% or more pieces by weight are
PLANT, (MPM-V32) insect infested or moldy
UNPROCESSED Mammalian excreta Average of 1 mg or more mammalian excreta
(MPM-V32) per pound
DEFECT SOURCE: Insect infestation—preharvest and=or postharvest and=or processing.
Mold—postharvest and=or processing infection. Mammalian excreta—postharvest and=or processing
animal contamination
SIGNIFICANCE: Aesthetic
MARJORAM, Insect filth (AOAC 975.49) Average of 1175 or more insect fragments
GROUND per 10 grams
Rodent filth (AOAC 975.49) Average of 8 or more rodent hairs per
10 grams
DEFECT SOURCE: Insect fragments—preharvest and=or postharvest and=or processing insect infestation.
Rodent hair—postharvest and=or processing contamination with animal hair or excreta
SIGNIFICANCE: Aesthetic
Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved.
(continued )
656 Appendix F
PEAS, COWPEAS, Insect larvae (MPM-V104) Average of 5 or more cowpea curculio larvae
BLACK-EYED PEAS or the equivalent per No. 2 can
(SUCCULENT),
CANNED
DEFECT SOURCE: Preharvest and=or postharvest insect infestation
SIGNIFICANCE: Aesthetic
PEAS AND BEANS, Insect filth (MPM-V104)
Average of 5% or more by count insect
DRIED infested and=or insect damaged
by storage insects in a minimum of
12 subsamples
DEFECT SOURCE: Preharvest and=or postharvest and=or processing infestation
SIGNIFICANCE: Aesthetic
PEPPER, WHOLE Insect filth and=or Average of 1% or more pieces by weight are
(BLACK & WHITE) insect-mold (MPM-V39) infested and=or moldy
Mammalian excreta Average of 1 mg or more mammalian excreta
(MPM-V39) per pound
Foreign matter Average of 1% or more pickings and siftings
(MPM-V39) by weight
DEFECT SOURCE: Insect infested—postharvest and=or processing infestation. Moldy—postharvest
and=or processing infection. Mammalian excreta—postharvest and=or processing animal contamination.
Foreign material—postharvest contamination
SIGNIFICANCE: Aesthetic; potential health hazard—mammalian excreta may contain salmonella
PEPPER, GROUND Insect filth (AOAC 972.40)
Average of 475 or more insect fragments per
50 grams
Rodent filth (AOAC 972.40) Average of 2 or more rodent hairs per 50 grams
DEFECT SOURCE: Insect fragments—postharvest and=or processing insect infestation. Rodent
hair—postharvest and=or processing contamination with animal hair or excreta
SIGNIFICANCE: Aesthetic
POTATO CHIPS Rot (MPM-V113)Average of 6% or more pieces by weight
contain rot
DEFECT SOURCE: Preharvest and=or postharvest infection
SIGNIFICANCE: Aesthetic
SAGE, WHOLE Insect filth (MPM-V32)
Average of 5% or more pieces by weight are
PLANT, insect infested
UNPROCESSED Mammalian excreta Average of 1 mg or more per pound after
(MPM-V32) processing
DEFECT SOURCE: Insect infested—preharvest and=or postharvest and=or processing infestation.
Mammalian excreta—postharvest and=or processing animal contamination
SIGNIFICANCE: Aesthetic
SAGE, GROUND Insect filth (AOAC 985.38)
Average of 200 or more insect fragments per
10 grams
Rodent filth (AOAC 985.38) Average of 9 or more rodent hairs per 10 grams
DEFECT SOURCE: Insect fragments—preharvest and=or postharvest and=or processing infestation.
Rodent hair—post harvest and=or processing contamination with animal hair or excreta
SIGNIFICANCE: Aesthetic
SAUERKRAUT Insects (AOAC 955.45) Average of more than 50 thrips per 100 grams
DEFECT SOURCE: Preharvest insect infestation
SIGNIFICANCE: Aesthetic
SPICES, LEAFY, Insect filth and=or mold Average of 5% or more pieces by weight are
OTHER THAN BAY (MPM-V32) insect infested and=or moldy
LEAVES Mammalian excreta Average of 1 mg or more of mammalian
(MPM-V32) excreta per pound after processing
DEFECT SOURCE: Insect infested—preharvest and=or postharvest and=or processing infestation.
Mold—preharvest and=or postharvest and=or processing infection. Mammalian excreta—postharvest
and=or processing animal contamination
SIGNIFICANCE: Aesthetic
SPINACH, CANNED Insects and mites Average of 50 or more aphids, thrips, and=or
OR FROZEN (AOAC 974.33) mites per 100 grams
OR
2 or more 3 mm or longer larvae and=or larval
fragments or spinach worms (caterpillars)
whose aggregate length exceeds 12mm are
present in 24 pounds
OR
Leaf miners of any size average 8 or more per
100 grams or leaf miners 3 mm or longer
average 4 or more per 100 grams
DEFECT SOURCE: Preharvest infestation
SIGNIFICANCE: Aesthetic
THYME, WHOLE Insect filth (MPM-V32)
Average of 5% or more pieces by weight are
PLANT, insect infested and=or moldy
UNPROCESSED Mammalian excreta Average of 1 mg or more mammalian excreta
(MPM-V32) per pound after processing
DEFECT SOURCE: Insect infested—preharvest and=or postharvest and=or processing infestation.
Mold—preharvest and=or postharvest and=or processing infection. Mammalian excreta—postharvest
and=or processing animal contamination
SIGNIFICANCE: Aesthetic
THYME, GROUND Insect filth (AOAC 975.49)
Average of 925 or more insect fragments per
10 grams
Rodent filth (AOAC 975.49) Average of 2 or more rodent hairs per 10 grams
DEFECT SOURCE: Insect fragments—preharvest and=or postharvest and=or processing infestation.
Rodent hair—postharvest and=or processing contamination with animal hair or excreta
SIGNIFICANCE: Aesthetic
THYME, UNGROUND, Insect filth (AOAC 975.49)
Average of 325 insect fragments or more per
PROCESSED 10 grams
Rodent filth (AOAC 975.49) Average of 2 rodent hairs or more
per 10 grams
DEFECT SOURCE: Insect fragments—preharvest and=or postharvest and=or processing insect
infestations. Rodent hair—postharvest and=or processing contamination with animal hair or excreta
SIGNIFICANCE: Aesthetic
TOMATOES, CANNED Drosophila fly (AOAC Average of 10 or more fly eggs per 500 grams
955.46)
(continued )
OR
5 or more fly eggs and 1 or more maggots per
500 grams
OR
2 or more maggots per 500 grams
DEFECT SOURCE: Preharvest and=or postharvest and=or processing insect infestation
SIGNIFICANCE: Aesthetic
TOMATOES, CANNED, Mold (AOAC 945.90) Average mold count in 6 subsamples is 15% or
WITH (OR) more and the counts of all of the subsamples
WITHOUT JUICE are more than 12%
(BASED ON
DRAINED JUICE)
DEFECT SOURCE: Preharvest and=or postharvest and=or processing infection
SIGNIFICANCE: Aesthetic
TOMATOES, CANNED, Mold (AOAC 945.90) Average mold count in 6 subsamples is 29% or
PACKED IN more and the counts of all of the subsamples
TOMATO PUREE are more than 25%
(BASED ON
DRAINED LIQUID)
DEFECT SOURCE: Preharvest and=or postharvest and=or processing infection
SIGNIFICANCE: Aesthetic
TOMATO JUICE Drosophila fly Average of 10 or more fly eggs per
(AOAC 955.46) 100 grams
OR
5 or more fly eggs and 1 or more maggots per
100 grams
OR
2 or more maggots per 100 grams, in a
minimum of 12 subsamples
Mold (AOAC 965.41) Average mold count in 6 subsamples is 24% or
more and the counts of all of the subsamples
are more than 20%
DEFECT SOURCE: Fly eggs and maggots—preharvest and=or postharvest and=or processing insect
infestation. Mold—preharvest and=or postharvest and=or processing infection
SIGNIFICANCE: Aesthetic
TOMATO PASTE, Drosophila flyAverage of 30 or more fly
PIZZA, AND OTHER (AOAC 955.46)eggs per 100 grams
SAUCES OR
15 or more fly eggs and 1 or more
maggots per 100 grams
OR
2 or more maggots per 100 grams in a
minimum of 12 subsamples
DEFECT SOURCE: Preharvest and=or postharvest and=or processing insect infestation
SIGNIFICANCE: Aesthetic
This appendix lists action levels established by the Food and Drug Administration (FDA) for
poisonous or deleterious substances in human food and animal feed. Action levels for poisonous
or deleterious substances are established by the FDA to control levels of contaminants in human
food and animal feed.
Action levels and tolerances are established based on the unavoidability of the poisonous or
deleterious substances and do not represent permissible levels of contaminantion where it is
avoidable. The blending of a food or feed containing a substance in excess of an action level or
tolerance with another food or feed is not permitted, and the final product resulting from blending
is unlawful, regardless of the level of the contaminant.
Action levels and tolerances represent limits at or above which FDA will take legal action to
remove products from the market. Where no established action level or tolerance exists, FDA may
take legal action against the product at the minimal detectable level of the contaminant.
The action levels are established and revised according to criteria specified in Title 21, Code
of Federal Regulations, Parts 109 and 509 and are revoked when a regulation establishing a
tolerance for the same substance and use becomes effective.
This appendix is arranged by substance, listing the applicable human and animal feed
products.
This list is current as of August, 2000. Notices will be published in the Federal Register as
new action levels are established or as existing action levels are revised or revoked. It is the
responsibility of the user of the list to keep up to date on changes in the action levels.
Only vegetable and vegetable products are included in this appendix.
The reference CPG refers to FDA’s Compliance Policy Guide.
Source: Adapted from “Action Levels for Poisonous or Deleterious Substances in Human Food and Animal
Feed,” U. S. Food and Drug Administration Industry Activities Staff Booklet, August 2000.
The figures listed are for residues of total BHC. However, in adding amounts of individual isomers, do not count alpha,
gamma, or delta BHC at a level below 0.02ppm in milk and rabbits, and 0.01ppm for all other commodities listed. Do not
count beta BHC at a level below 0.05ppm for milk and rabbits, and 0.02ppm for all other commodities listed.
a
Action levels for crop groups cover all commodities specified in 40 CFR 180.34(f), unless an exception is noted.
Chlordane
Chlordane (continued)
The listed action levels are for residues of chlordane, including cis- and trans-chlordane, cis- and trans-nonachlor,
oxychlordane, alpha-, beta-, and gamma-chlordene, and chlordene. Levels of individual components must be quantitated at
0.02ppm or above and confirmed in order to be added into the “chlordane” total value.
The GLC pattern of the residue determines which reference standard(s) will be used for quantitation. If the residue
pattern matches that of technical chlordane, quantitate against a technical chlordane reference standard. If the residue
consists of identifiable individual components (i.e., cis- and trans-chlordane, cis- and trans-nonachlor, oxychlordane,
alpha-, beta-, and gamma-chlordene, and chlordene), quantitate individual components against their respective standards.
Sum individual values to obtain the total “chlordane” level. Do not include levels of heptachlor epoxide in the summation.
2. Applicable Documents
a. CPG 7114.02 Defect Action Levels
b. 21 CFR 155.200 Standard of Identity
3. Defects
Asparagus beetles are major pests of asparagus. There are two species, the asparagus beetle
[Crioceris asparagi (L.)] and the spotted asparagus beetle [Crioceris duodecimpunctata (L.)].
The asparagus beetles emerge in the spring about the time asparagus shoots appear. The young
tips are damaged by beetle feeding and egg laying. The eggs are normally dark in color and
attached singly on end by a secretion which forms a hardened base between the egg and the spear
or shoot. The base may remain after the egg sac has been removed. After the egg has hatched, the
egg sac may remain attached and appear as a dark spot on the spear.
Larvae of the armyworm [Pseudaletia unipuncta (Haworth)] have been found on imported
frozen asparagus. The larvae range in size from 2 to 3 mm in length and have been reported to
reach a maximum length of 35 mm.
Thrips have also been reported to be a pest of asparagus.
c. Report Report total number and breakdown of whole insects and equivalent for each
container or subsample and the average of the subsamples. Report also the number of thrips in
100 g asparagus from each container or subsample examined. Also report the average of the
subsamples.
2. Applicable Documents
a. CPG 7114.07 Defect Action Level
3. Defects
The major defects associated with brussels sprouts are contamination by insects such as aphids
and thrips.
2. Applicable Documents
a. CPG 7109.20 Horseradish-Definition
3. Defects
A few manufacturers have occasionally prepared imitation horseradish products from cheaper
substitutes without declaring such on the label. Parsnip and turnip roots have been encountered
most frequently as substitutes for the genuine horseradish root. The microscope offers a ready
means for detecting such adulterants, based on diagnostic histological characteristics which
distinguish horseradish root tissues from substitute materials.
(iii) Turnip—Turnip cells are large, thin-walled, and isodiametric. They are devoid of
starch. The cells appear in cobweblike groups.
b. Microscopic Examination Mount a small portion of the subsample in water and
examine microscopically for foreign starch. Place about 5 g of the subsample in a 50 mL test tube,
add 5mL I-KI solution, and shake until thoroughly mixed. Let soak for 5min to stain the
horseradish starch thoroughly. Place in a No. 60 sieve and rinse with a stream of water to remove
excessive I-KI solution. Transfer the stained material to a petri dish, cover with a small amount of
water, and examine with a widefield binocular microscope. Horseradish tissues are stained a deep
blue. Parsnip roots may stain either a light or dark blue since the amount of starch present will vary
depending on whether roots used were dug in the spring or fall. Turnip and other starch-free roots
will stain yellow. If a considerable number of yellow-stained fragments are present, one may
suspect the addition of turnip or parsnip to the product. Make microscopic mounts in acidified
chloral hydrate– glycerol solution of several fragments and check identity from the diagnostic
characteristics listed in (4)a above. Estimate the approximate percent of foreign tissues present by
determining identity of 25 or more pieces of tissue selected at random. More accurate estimates of
amounts of foreign tissues present may be made by comparing the subsample material with
authentic mixtures containing known percentages of each ingredient in the mixture.
c. Report State the presence and approximate percent (by weight) of tissues other than
horseradish found.
REFERENCES
Ballard, Chas. W., and F. J. Pokorny. “Histological Study of Horseradish Root and Some Common
Adulterants.” J. Am. Pharm. Assoc. 28:376– 381, June 1939.
Winton, A. L., and K. B. Winton. “Vegetables, Legumes and Fruits.” Structure and Composition of Foods,
Vol. 2, pp. 72– 75, John Wiley and Sons Inc., New York, 1935.
2. Applicable Documents
3. Defects
Bacterial spot of lettuce is caused by Xanthomonas vitians, a bacterium which forms raised, pale-
yellow colonies on nutrient dextrose agar. Infestation takes place through stomata during periods
of high humidity, dew, and rain. The disease is characterized by circular or irregular translucent
water-soaked leaf lesions which become dark brown with age. If the infection is severe it may
render the crop unmarketable.
Bacterial soft rot, often called “slime,” is the most serious market disease of lettuce. The
common causative agents are Pseudomonas spp. and Erwinia spp. In the early stages of infection
the tissue appears to be water-soaked and may develop a russet or brown color. As the decay
progresses the lettuce becomes soft and slimy. Under dry conditions, decayed areas of the outer
leaves may become papery in texture.
Aphids and other insects such as leaf miners also may infest lettuce.
REFERENCE
U.S. Department of Agriculture Handbook No. 155, Washington, DC, April 1959.
2. Applicable Documents
a. CPG 7114.13 Defect Action Levels
3. Defects
a. Insect Infestation and Damage Two insects commonly infest mushrooms. The
mushroom fly larva (Lycoriella spp.) is a black-headed maggot which tunnels through the stem
and cap of the mushroom. The larvae of the Cecidomyiid or cecid fly, which feed primarily around
the mushroom gills, are pointed at both ends, and reach a length of 3 mm. Less commonly,
maggots of the phorid fly have also been found in canned mushrooms. In addition, several species
of mites also attack mushrooms. Of these, the mold mite (Tyrophagus putrescentiae (Schrank)) is
the most serious pest.
b. Mold and Other Microbial Deterioration Several species of bacteria and fungi
produce discolored rot areas on the mushrooms. These areas appear as dark brown or black spots,
streaks, blotches, or pits. Verticillium mold infection can be recognized by the gray bloom which
develops in the centers of the older spots or pits as a result of the growth of conidiophores. The
mold Trichoderma is a much less common cause of spotting and pitting. Typically, Verticellium
grows close to the surface of the mushroom, while Trichoderma penetrates more deeply into the
tissues, often causing large portions of the mushroom to become discolored and rotten.
isopropanol, add 50mL HCl, and boil 10min with gentle magnetic stirring. Transfer the trap flask
to a cool magnetic stirrer, add 40mL light mineral oil, and stir at maximum speed (without visible
or audible splashing) for 3min. Fill with water and trap off into a beaker. Stir 30 mL light mineral
oil into the flask and perform second trapping after 10 min. Filter combined trappings from beaker
and examine microscopically. Retain the trap flask contents for further analysis as in (6) below.
b. Report Report, using the applicable categories in AOAC 970.66B(i).
3. Defects
Several toxic and potentially lethal species of fungi have been found as contaminants in imported
products. Among these are
Verpa Bohemica (false morels)
Gyromitra spp. (false morels)
Helvella spp.
REFERENCES
G. Method for Peas and Beans (Canned, Frozen, and Dried) (V-104)
1. Scope
This method covers procedures for the preparation and visual examination of canned, frozen, and
dried peas and beans for mold and insect damage. Legumes or pulses (family Leguminosae) are
grown for their edible seeds. While many varieties of legumes are referred to as beans and peas,
there is at least one variety of legumes, lentils, which is not. Types of peas and beans covered by
this method include but are not limited to
Beans of the genus Phaseolus, such as French, “string,” “snap,” or kidney beans (Phaseolus
vulgaris L.); the lima or butter bean (P. lunatus L.);* and the scarlet runner bean (P.
coccineus L.)
Beans of the genus Vigna such as mung beans [Vigna radiata (L.) Wilczek], the species
from which bean sprouts are produced; the adzuki bean [Vigna angularis (Willd.)
Ohwi and Ohashi], similar but with larger seeds than the mung bean, and which is red,
cream, lilac, or mottled in color
The large podded or broad bean (Vicia faba L.) also called “lupini bean”
Soybeans and soya seeds [Glycine max (L.) Merr.] used in such products as processed
soybeans, processed soybean oil, soy flours, fermented soy products, soy mills, bean
cake, and tofu
The true pea (Pisum sativum L.)
Cowpeas, black-eyed peas, crowder peas, field peas, and southern peas [Vigna unguiculata
(L.) Walp. subsp. unguiculata]
Yard-long bean (Vigna unguiculata subsp. sesquipedalis (L.) Verdc.)
Pigeon pea (Cajanus cajan (L.) Huth)
Chick pea, garbanzo, or Bengal gram (Cicer arietenum L.), which are rounded seeds with a
characteristic “beak” resembling the head of a baby chicken
Lentil (Lens culinaris Medik.)
*White seeded types are usually grown because colored seeds often have a relatively high cyanogenic
glycoside level, which can be dangerous.
2. Applicable Documents
a. CPG7114.05 Lygus bug damage in dried cowpeas
b. CPG7114.11 Cowpea curculio in canned cowpeas
c. CPG7114.15 Insect damage and rocks in dried peas and beans
3. Defects
a. Insect Damage in Canned and Frozen Peas and Beans Peas and beans may become
infested by various types of insects, their eggs, and larvae. Such infestation may be found in the
finished product.
Pea weevil infestation [Bruchus pisorum (L.)], by far the most commonly encountered
defect in peas, occurs in the fields prior to harvesting. Adult weevils lay their eggs on the tiny
pods, and after hatching, the larvae perforate the skins and enter the peas. Infestation is evidenced
by the presence of small round holes on the peas. These holes are usually accompanied by
discolorations around the openings. The larvae may be found under the skin embedded in the
cotyledon.
The bean weevil [Acanthoscelides obtectus (Say)] may infest beans in the field, although it
is also a serious pest of dry beans in storage. The larvae attack the seeds of several varieties of
beans (including kidney beans, limas, and cowpeas) in the field and in storage. It also attacks faba
beans, peas, lentils, and others in storage only.
Cowpea curculio [Chalcodermus aeneus (Boheman)] is a common defect in field peas and
black-eyed peas. Some variety of crowder peas and the California black-eye are more susceptible
than other varieties. The greatest damage from this insect is done by the larvae feeding on the seed
within the green pods. Shelled peas with curculio damage have small dark spots present, which
may or may not contain an egg or larva. These small dark spots are commonly called “weevil
stings.” The curculio is legless and C-shaped. Its body is pale yellow and the head is brown. The
larva is less than 1=4-in. in length when full grown.
b. Weevil and Moth Damage in Dried Peas and Beans There are five major insect
species that attack dried peas and beans. They are the bean weevil (Acanthoscelides obtectus
(Say)), the cowpea weevil (Callosobruchus maculatus (Fabricius)), the Indianmeal moth (Plodia
interpunctella (HØbner)), the tobacco moth (Ephestia elutella (HØbner)), and the almond moth
(Cadra cautella (Walker)).
The bean weevil and the cowpea weevil are the most destructive. They attack beans and
peas while they are in the field, where they may become heavily infested before they are taken to
the warehouse. These species will breed continuously in the dry seeds if stored in a warn place.
The insect eggs of the bean weevil are smooth and white, and are laid singly or in clusters among
or near the beans. The eggs hatch into tiny white larvae, which eat their way into the beans. The
entrance holes are small and easily overlooked. In warm weather, the larvae develop rapidly
within the beans and soon reach the pupal, or resting, stage from which the adults are formed. The
adults then chew a round opening through the seed coat and emerge. The bean weevil is capable of
developing in all varieties of common beans and cowpeas. The life cycle of the cowpea weevil is
similar to that of the bean weevil, except that the eggs are glued to the pods or exposed seeds. The
hatching larvae chew from the egg through the seed coat and into the seed.
The damage caused by the three species of moths that attack dry peas and beans results
chiefly from the webbing and frass that is deposited among the beans and peas while the larvae are
feeding. The larvae can feed only on beans and peas that are split or have cracked seed coats.
c. Lygus and Aphid Damage in Dried Peas and Beans In the field, peas and beans may
also be damaged by sucking insects. The lygus bug (Lygus spp.) and the aphid may damage
legumes by the insertion of the proboscis into the growing seed to inject a digestive juice and to
suck out plant substances such as protein. This results in an area of dead tissue which appears as a
brown spot or in some cases a chalky pit surrounded by brown scar tissue. In some instances the
damage does not penetrate the cotyledons; however, in other instances there is extensive inner
damage while only a small amount of damage can be detected on the exterior. [See
http:==www.cfsan.fda.gov=,dms for figure showing the type of interior damage done to black-
eyed peas by the lygus bug and aphid. The illustrations have been arranged to show increasingly
greater aphid and lygus bug type of damage.]
d. Mold Damage in Dried Peas and Beans Dried beans with no visible external damage
and an apparently intact integument (seed coat) may have extensive internal mold and require
splitting of the cotyledons to detect.
b. Visual Examination and Classification of Rejects Examine the internal surface of the
seed coat for the presence of mold hyphae. In cases of extensive invasion, hyphae and fruiting
bodies may be present between the cotyledons, and the cotyledons may be discolored.
Suspected hyphae and fruiting bodies may be confirmed by removing them with forceps,
mounting in glycerol – alcohol (1 þ 1 v=v) solution, and examining with the compound
microscope at 100 –200 . The characteristics of mold hyphae used in the Howard mold count
method should be applied in confirming mold hyphae (AOAC Fig. 984.29B). Classify any pea or
bean in which 1=4 or more of the internal surface of the cotyledons is affected by mold as mold
damaged.
c. Report Report percent by number of mold-damaged peas or beans.
2. Applicable Documents
3. Defects
Cucumbers may be contaminated by insects which enter the crop in the field. The pickleworm
[Diaphania nitidalis (Stoll)], which is an internal feeder in cucumbers, may not be eliminated
during the processing steps unless the pickle stock is adequately sorted or trimmed. Cucumbers
may contain excessive grit, sand, or soil when delivered for processing. These contaminants may
not be entirely removed by washing unless special care is taken.
Cucumbers and other vegetables are frequently pickled in open tanks; use of this method
may allow insects and other animal filth to get into the finished product tank unless care is
exercised to prevent contamination. Outdoor salt tanks may accumulate large numbers of various
types of flying insects in the surface brine. Insects and other debris may also be found below the
surface, due to periodic addition and circulation of brine. Indoor sweetening tanks are particularly
attractive to drosophilids which breed on any exposed product and on the inner sides of the tanks
above the level of the liquid.
Moldy cucumbers or other vegetables are sometimes used in pickled and chopped vegetable
relishes. The moldy condition of the cucumbers or vegetables is concealed in the product by
grinding or chopping.
b. Organoleptic Examination Count and examine contents of each jar separately. Cut
pickles other than gherkins and midgets into approximately three equal cross sections. Score
grittiness of each pickle according to the number of thirds showing grittiness and report as in (4)d.
In scoring the grittiness of each section, do not include grittiness that is slight and unobjectionable
to the taste. Do not section midget and gherkin size pickles but record these as whole units.
c. Analysis for Grit, Sand, and Soil in Brine Filter brine onto paper and examine residue
microscopically for presence of sand or soil particles. If appreciable amount is present, ash the
filter paper and record weight of ash in mg per unit size jar.
d. Report Tabulate results as follows:
Subsample no.
1 2 etc. Totals
2. Applicable Documents
3. Defects
Pimientos in jars or cans may have decayed portions resulting from the growth of mold. These
moldy areas are found more frequently on the inner surfaces of the pimiento than on the outer.
They are distinguished by a brown or black discoloration. Dark-colored areas due to charring
during the fire flaming process for removal of the skin may also be present, but they are easily
distinguished from areas containing mold.
2. Applicable Documents
a. CPG 7114.20 Defect Action Level for Rot
3. Defects
Many of the rots encountered in potatoes are of bacterial origin, with molds occurring as
secondary rotting agents. In a number of instances, therefore, molds may not be detected in the
finished rotten chip, even though the chip shows an apparently discolored, decayed area. The
finding of mold in the decayed area is a definite proof of the existence of rot.
1 2 3 4 etc.
Subsample size Wt
No.
Rotten chips Wt
No.
% by wt.
Remarks:
2. Applicable Documents
a. CPG 7114.10 Defect Action Level
3. Defects
The most commonly encountered type of insect contamination is that of the corn earworm. Corn
husks may contain excreta, webbing, and fragments of this insect. Spiders, spider droppings,
earwigs, beetles, psocids, aphids, thrips, and mites also have been found. Occasionally corn husks
are heavily mildew-stained near the tips. Other mold is usually negligible.
c. Report Tabulate percent (by weight) of corn husks in each reject category and total
percent rejects.
2. Applicable Documents
3. Defects
Garlic is susceptible to insect and mite infestation, and to several types of decomposition,
including bulb rot (caused by Aspergillus alliaceus), blue mold rot (Penicillium spp.), and white
rot (Sclerotia cepivorum).
A nonparasitic disease known as “waxy breakdown” may be due to heat, sunscald, or
physiological breakdown. In the early stages, small, sunken, light-yellow areas are seen in the flesh
of the clove. As breakdown progresses, these areas become deep yellow or amber throughout. The
clove is usually somewhat sticky or waxy to the touch but not soft, as is the case of tissue affected
by parasitic fungi. Waxy breakdown is classified in the “otherwise unfit” category.
REFERENCE
Market Diseases of Asparagus, Onions, Beans, Peas, Carrots, Celery, and Related Vegetables. Agriculture
Handbook No. 303, Market Quality Research Division, USDA=ARS, Sept. 1966.
(g) Juices that have not been specifically processed to prevent, reduce, or eliminate the
presence of pathogens.
(1) For purposes of this paragraph (g), “juice” means the aqueous liquid expressed
or extracted from one or more fruits or vegetables, purees of the edible portions
of one or more fruits or vegetables, or any concentrate of such liquid or puree.
(2) The label of:
(i) Any juice that has not been processed in the manner described in paragraph
(g) (7) of this section; or
(ii) Any beverage containing juice where neither the juice ingredient nor the
beverage has been processed in the manner described in paragraph (g) (7)
of this section, shall bear the following warning statement:
(3) The warning statement required by this paragraph (g) shall not apply to juice that
is not for distribution to retail consumers in the form shipped and that is for use
solely in the manufacture of other foods or that is to be processed, labeled, or
repacked at a site other than originally processed, provided that for juice that has
not been processed in the manner described in paragraph (g) (7) of this section,
the lack of such processing is disclosed in documents accompanying the juice, in
accordance with the practice of the trade.
(d) Critical control point means a point, step, or procedure in a food process at which a
control measure can be applied and at which control is essential to reduce an identified
food hazard to an acceptable level.
(e) Critical limit means the maximum or minimum value to which a physical, biological,
or chemical parameter must be controlled at a critical control point to prevent,
eliminate, or reduce to an acceptable level the occurrence of the identified food
hazard.
(f ) Culled means separation of damaged fruit from undamaged fruit. For processors of
citrus juices using treatments to fruit surfaces to comply with Sec. 120.24, culled
means undamaged, tree-picked fruit that is U.S. Department of Agriculture choice or
higher quality.
(g) Food hazard means any biological, chemical, or physical agent that is reasonably
likely to cause illness or injury in the absence of its control.
(h) Importer means either the U.S. owner or consignee at the time of entry of a food
product into the United States, or the U.S. agent or representative of the foreign owner
or consignee at the time of entry into the United States. The importer is responsible for
ensuring that goods being offered for entry into the United States are in compliance
with all applicable laws. For the purposes of this definition, the importer is ordinarily
not the custom house broker, the freight forwarder, the carrier, or the steamship
representative.
(i) Monitor means to conduct a planned sequence of observations or measurements to
assess whether a process, point, or procedure is under control and to produce an
accurate record for use in verification.
(j) (1) Processing means activities that are directly related to the production of juice
products.
(2) For purposes of this part, processing does not include:
(i) Harvesting, picking, or transporting raw agricultural ingredients of juice
products, without otherwise engaging in processing; and
(ii) The operation of a retail establishment.
(k) Processor means any person engaged in commercial, custom, or institutional
processing of juice products, either in the United States or in a foreign country,
including any person engaged in the processing of juice products that are intended for
use in market or consumer tests.
(l) Retail establishment is an operation that provides juice directly to the consumers and
does not include an establishment that sells or distributes juice to other business
entities as well as directly to consumers. “Provides” includes storing, preparing,
packaging, serving, and vending.
(m) Shall is used to state mandatory requirements.
(n) Shelf-stable product means a product that is hermetically sealed and, when stored at
room temperature, should not demonstrate any microbial growth.
(o) Should is used to state recommended or advisory procedures or to identify
recommended equipment.
(p) Validation means that element of verification focused on collecting and evaluating
scientific and technical information to determine whether the HACCP plan, when
properly implemented, will effectively control the identified food hazards.
(q ) Verification means those activities, other than monitoring, that establish the validity of
the HACCP plan and that the system is operating according to the plan.
addressed in the HACCP plan. A food hazard that is reasonably likely to occur is
one for which a prudent processor would establish controls because experience,
illness data, scientific reports, or other information provide a basis to conclude
that there is a reasonable possibility that, in the absence of those controls, the
food hazard will occur in the particular type of product being processed. This
evaluation shall include an assessment of the severity of the illness or injury if the
food hazard occurs;
(3) Identification of the control measures that the processor can apply to control the
food hazards identified as reasonably likely to occur in paragraph (a) (2) of this
section;
(4) Review of the current process to determine whether modifications are necessary;
and
(5) Identification of critical control points.
(b) The hazard analysis shall include food hazards that can be introduced both within and
outside the processing plant environment, including food hazards that can occur
before, during, and after harvest. The hazard analysis shall be developed by an
individual or individuals who have been trained in accordance with Sec. 120.13 and
shall be subject to the recordkeeping requirements of Sec. 120.12.
(c) In evaluating what food hazards are reasonably likely to occur, consideration should
be given, at a minimum, to the following:
(1) Microbiological contamination;
(2) Parasites;
(3) Chemical contamination;
(4) Unlawful pesticides residues;
(5) Decomposition in food where a food hazard has been associated with
decomposition;
(6) Natural toxins;
(7) Unapproved use of food or color additives;
(8) Presence of undeclared ingredients that may be allergens; and
(9) Physical hazards.
(d) Processors should evaluate product ingredients, processing procedures, packaging,
storage, and intended use; facility and equipment function and design; and plant
sanitation, including employee hygiene, to determine the potential effect of each on
the safety of the finished food for the intended consumer.
(e) HACCP plans for juice need not address the food hazards associated with
microorganisms and microbial toxins that are controlled by the requirements of part
113 or part 114 of this chapter. A HACCP plan for such juice shall address any other
food hazards that are reasonably likely to occur.
Sec. 120.8 Hazard Analysis and Critical Control Point (HACCP) Plan
(a) HACCP plan. Each processor shall have and implement a written HACCP plan
whenever a hazard analysis reveals one or more food hazards that are reasonably likely
to occur during processing, as described in Sec. 120.7. The HACCP plan shall be
developed by an individual or individuals who have been trained in accordance with
Sec. 120.13 and shall be subject to the recordkeeping requirements of Sec. 120.12.
A HACCP plan shall be specific to:
(1) Each location where juice is processed by that processor; and
(2)
Each type of juice processed by the processor. The plan may group types of juice
products together, or group types of production methods together, if the food
hazards, critical control points, critical limits, and procedures required to be
identified and performed by paragraph (b) of this section are essentially identical,
provided that any required features of the plan that are unique to a specific
product or method are clearly delineated in the plan and are observed in practice.
(b) The contents of the HACCP plan. The HACCP plan shall, at a minimum:
(1) List all food hazards that are reasonably likely to occur as identified in
accordance with Sec. 120.7, and that thus must be controlled for each type of
product;
(2) List the critical control points for each of the identified food hazards that is
reasonably likely to occur, including as appropriate:
(i) Critical control points designed to control food hazards that are reasonably
likely to occur and could be introduced inside the processing plant
environment; and
(ii) Critical control points designed to control food hazards introduced outside
the processing plant environment, including food hazards that occur before,
during, and after harvest;
(3) List the critical limits that shall be met at each of the critical control points;
(4) List the procedures, and the frequency with which they are to be performed, that
will be used to monitor each of the critical control points to ensure compliance
with the critical limits;
(5) Include any corrective action plans that have been developed in accordance with
Sec. 120.10(a), and that are to be followed in response to deviations from critical
limits at critical control points;
(6) List the validation and verification procedures, and the frequency with which
they are to be performed, that the processor will use in accordance with Sec.
120.11; and
(7) Provide for a recordkeeping system that documents the monitoring of the critical
control points in accordance with Sec. 120.12. The records shall contain the
actual values and observations obtained during monitoring.
(c) Sanitation. Sanitation controls may be included in the HACCP plan. However, to the
extent that they are monitored in accordance with Sec. 120.6, they are not required to
be included in the HACCP plan.
(a) Processors may develop written corrective action plans, which become part of their
HACCP plans in accordance with Sec. 120.8(b) (5), by which processors predetermine
the corrective actions that they will take whenever there is a deviation from a critical
limit. A corrective action plan that is appropriate for a particular deviation is one that
describes the steps to be taken and assigns responsibility for taking those steps, to
ensure that:
(1) No product enters commerce that is either injurious to health or is otherwise
adulterated as a result of the deviation; and
(2) The cause of the deviation is corrected.
(b) When a deviation from a critical limit occurs, and the processor does not have a
corrective action plan that is appropriate for that deviation, the processor shall:
(1) Segregate and hold the affected product, at least until the requirements of
paragraphs (b) (2) and (b) (3) of this section are met;
(2) Perform or obtain a review to determine the acceptability of the affected product
for distribution. The review shall be performed by an individual or individuals
who have adequate training or experience to perform such review;
(3) Take corrective action, when necessary, with respect to the affected product to
ensure that no product enters commerce that is either injurious to health or is
otherwise adulterated as a result of the deviation;
(4) Take corrective action, when necessary, to correct the cause of the deviation; and
(5) Perform or obtain timely verification in accordance with Sec. 120.11, by an
individual or individuals who have been trained in accordance with Sec. 120.13,
to determine whether modification of the HACCP plan is required to reduce the
risk of recurrence of the deviation, and to modify the HACCP plan as necessary.
(c) All corrective actions taken in accordance with this section shall be fully documented
in records that are subject to verification in accordance with Sec. 120.11(a) (1) (iv) (B)
and the recordkeeping requirements of Sec. 120.12.
(B)
The taking of corrective actions. The purpose of this review shall be,
at a minimum, to ensure that the records are complete and to verify
that appropriate corrective actions were taken in accordance with
Sec. 120.10. This review shall occur within 1 week (7 days) of the
day that the records are made; and
(C) The calibrating of any process monitoring instruments used at
critical control points and the performance of any periodic end-
product or in-process testing that is part of the processor’s
verification activities. The purpose of these reviews shall be, at a
minimum, to ensure that the records are complete and that these
activities occurred in accordance with the processor’s written
procedures. These reviews shall occur within a reasonable time after
the records are made; and
(v) The following of procedures in Sec. 120.10 whenever any verification
procedure, including the review of consumer complaints, establishes the
need to take a corrective action; and
(vi) Additional process verification if required by Sec. 120.25.
(2) Records that document the calibration of process monitoring instruments, in
accordance with paragraph (a) (1) (iv) (B) of this section, and the performance of
any periodic end-product and in-process testing, in accordance with paragraph
(a) (1) (iv) (C) of this section, are subject to the recordkeeping requirements of
Sec. 120.12.
(b) Validation of the HACCP plan. Each processor shall validate that the HACCP plan is
adequate to control food hazards that are reasonably likely to occur; this validation
shall occur at least once within 12 months after implementation and at least annually
thereafter or whenever any changes in the process occur that could affect the hazard
analysis or alter the HACCP plan in any way. Such changes may include changes in
the following: Raw materials or source of raw materials; product formulation;
processing methods or systems, including computers and their software; packaging;
finished product distribution systems; or the intended use or consumers of the finished
product. The validation shall be performed by an individual or individuals who have
been trained in accordance with Sec. 120.13 and shall be subject to the recordkeeping
requirements of Sec. 120.12. The HACCP plan shall be modified immediately
whenever a validation reveals that the plan is no longer adequate to fully meet the
requirements of this part.
(c) Validation of the hazard analysis. Whenever a juice processor has no HACCP plan
because a hazard analysis has revealed no food hazards that are reasonably likely to
occur, the processor shall reassess the adequacy of that hazard analysis whenever there
are any changes in the process that could reasonably affect whether a food hazard
exists. Such changes may include changes in the following: Raw materials or source of
raw materials; product formulation; processing methods or systems, including
computers and their software; packaging; finished product distribution systems; or the
intended use or intended consumers of the finished product. The validation of the
hazard analysis shall be performed by an individual or individuals who have been
trained in accordance with Sec. 120.13, and, records documenting the validation shall
be subject to the recordkeeping requirements of Sec. 120.12.
request for official review. Electronic records are considered to be onsite if they
are accessible from an onsite location and comply with paragraph (g) of this
section.
(3) If the processing facility is closed for a prolonged period between seasonal
packs, the records may be transferred to some other reasonably accessible
location at the end of the seasonal pack but shall be immediately returned to the
processing facility for official review upon request.
(e) Official review. All records required by this part shall be available for review and
copying at reasonable times.
(f ) Public disclosure.
(1) All records required by this part are not available for public disclosure unless
they have been previously disclosed to the public, as defined in Sec. 20.81 of this
chapter, or unless they relate to a product or ingredient that has been abandoned
and no longer represents a trade secret or confidential commercial or financial
information as defined in Sec. 20.61 of this chapter.
(2) Records required to be maintained by this part are subject to disclosure to the
extent that they are otherwise publicly available, or that disclosure could not
reasonably be expected to cause a competitive hardship, such as generic type
HACCP plans that reflect standard industry practices.
(g) Records maintained on computers. The maintenance of computerized records, in
accordance with part 11 of this chapter, is acceptable. Sec. 120.13 Training.
(a) Only an individual who has met the requirements of paragraph (b) of this section
shall be responsible for the following functions:
(1) Developing the hazard analysis, including delineating control measures, as
required by Sec. 120.7.
(2) Developing a Hazard Analysis and Critical Control Point (HACCP) plan
that is appropriate for a specific processor, in order to meet the
requirements of Sec. 120.8;
(3) Verifying and modifying the HACCP plan in accordance with the
corrective action procedures specified in Sec. 120.10(b) (5) and the
validation activities specified in Sec. 120.11(b) and (c); and Sec. 120.7;
(4) Performing the record review required by Sec. 120.11(a) (1) (iv).
(b) The individual performing the functions listed in paragraph (a) of this section
shall have successfully completed training in the application of HACCP
principles to juice processing at least equivalent to that received under
standardized curriculum recognized as adequate by the Food and Drug
Administration, or shall be otherwise qualified through job experience to
perform these functions. Job experience may qualify an individual to perform
these functions if such experience has provided knowledge at least equivalent to
that provided through the standardized curriculum. The trained individual need
not be an employee of the processor.
(1)
Obtain the juice from a country that has an active memorandum of understanding
(MOU) or similar agreement with the Food and Drug Administration, that covers
the food and documents the equivalency or compliance of the inspection system
of the foreign country with the U.S. system, accurately reflects the relationship
between the signing parties, and is functioning and enforceable in its entirety; or
(2) Have and implement written procedures for ensuring that the juice that such
importer receives for import into the United States was processed in accordance
with the requirements of this part. The procedures shall provide, at a minimum:
(i) Product specifications that are designed to ensure that the juice is not
adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act
because it may be injurious to health or because it may have been processed
under insanitary conditions; and
(ii) Affirmative steps to ensure that the products being offered for entry were
processed under controls that meet the requirements of this part. These
steps may include any of the following:
(A) Obtaining from the foreign processor the Hazard Analysis and
Critical Control Point (HACCP) plan and prerequisite program of the
standard operating procedure records required by this part that relate
to the specific lot of food being offered for import;
(B) Obtaining either a continuing or lot specific certificate from an
appropriate foreign government inspection authority or competent
third party certifying that the imported food has been processed in
accordance with the requirements of this part;
(C) Regularly inspecting the foreign processor’s facilities to ensure that
the imported food is being processed in accordance with the
requirements of this part;
(D) Maintaining on file a copy, in English, of the foreign processor’s
hazard analysis and HACCP plan, and a written guarantee from the
foreign processor that the imported food is processed in accordance
with the requirements of this part;
(E) Periodically testing the imported food, and maintaining on file a copy,
in English, of a written guarantee from the foreign processor that the
imported food is processed in accordance with the requirements of
this part; or
(F) Other such verification measures as appropriate that provide an
equivalent level of assurance of compliance with the requirements of
this part.
(b) Competent third party. An importer may hire a competent third party to assist with or
perform any or all of the verification activities specified in paragraph (a) (2) of this
section, including writing the importer’s verification procedures on the importer’s
behalf.
(c) Records. The importer shall maintain records, in English, that document the
performance and results of the affirmative steps specified in paragraph (a) (2) (ii) of
this section. These records shall be subject to the applicable provisions of Sec. 120.12.
(d) Determination of compliance. The importer shall provide evidence that all juice
offered for entry into the United States has been processed under conditions that
comply with this part. If assurances do not exist that an imported juice has been
(a) One 20 milliliter (mL) sample (consisting of two 10mL subsamples) for each 1,000
gallons of juice produced shall be sampled each production day. If less than 1,000
gallons of juice is produced per day, the sample must be taken for each 1,000 gallons
produced but not less than once every 5 working days that the facility is producing that
juice. Each subsample shall be taken by randomly selecting a package of juice ready
for distribution to consumers.
(b) If the facility is producing more than one type of juice covered by this section,
processors shall take subsamples according to paragraph (a) of this section for each of
the covered juice products produced.
(c) Processors shall analyze each subsample for the presence of E. coli by the method
entitled “Analysis for Escherichia coli in Citrus Juices—Modification of AOAC
Official Method 992.30” or another method that is at least equivalent to this method in
terms of accuracy, precision, and sensitivity in detecting E. coli. This method is
designed to detect the presence or absence of E. coli in a 20mL sample of juice
(consisting of two 10 mL subsamples). The method is as follows:
(1) Sample size. Total—20 mL of juice; perform analysis using two 10mL aliquots.
(2) Media. Universal Preenrichment Broth (Difco, Detroit, MI), EC Broth (various
manufacturers).
(3) Method. ColiComplete (AOAC Official Method 992.30—modified).
(4) Procedure. Perform the following procedure two times:
(i) Aseptically inoculate 10mL of juice into 90mL of Universal Preen-
richment Broth (Difco) and incubate at 35 deg C for 18 to 24 hours.
(ii) Next day, transfer 1mL of preenriched sample into 10mL of EC Broth,
without durham gas vials. After inoculation, aseptically add a
ColiComplete SSD disc into each tube.
(iii) Incubate at 44.5 deg C for 18 to 24 hours.
(iv) Examine the tubes under longwave ultraviolet light (366 nm). Fluorescent
tubes indicate presence of E. coli.
(v) MUG positive and negative controls should be used as reference in
interpreting fluorescence reactions. Use an E. coli for positive control and
2 negative controls—a MUG negative strain and an uninoculated tube
media.
(d) If either 10mL subsample is positive for E. coli, the 20mL sample is recorded as
positive and the processor shall:
(1) Review monitoring records for the control measures to attain the 5-log reduction
standard and correct those conditions and practices that are not met. In addition,
the processor may choose to test the sample for the presence of pathogens of
concern.
(2) If the review of monitoring records or the additional testing indicates that the
5-log reduction standard was not achieved (e.g., a sample is found to be positive
for the presence of a pathogen or a deviation in the process or its delivery is
identified), the processor shall take corrective action as set forth in Sec. 120.10.
(e) If two samples in a series of seven tests are positive for E. coli, the control measures to
attain the 5-log reduction standard shall be deemed to be inadequate and the processor
shall immediately:
(1) Until corrective actions are completed, use an alternative process or processes
that achieve the 5-log reduction after the juice has been expressed;
(2) Perform a review of the monitoring records for control measures to attain the 5-
log reduction standard. The review shall be sufficiently extensive to determine
that there are no trends toward loss of control;
(i) If the conditions and practices are not being met, correct those that do not
conform to the HACCP plan; or
(ii) If the conditions and practices are being met, the processor shall validate
the HACCP plan in relation to the 5-log reduction standard; and
(3) Take corrective action as set forth in Sec. 120.10. Corrective actions shall include
ensuring no product enters commerce that is injurious to health as set forth in
Sec. 120.10(a) (1).
(a) Strength and redness of color means at least as much red as obtained by comparison of
the prepared product, with the blended color produced by spinning a combination of
the following concentric Munsell color discs of equal diameter, or the color equivalent
of such discs:
Disc 1—Red (5R 2.6=13) (glossy finish)
Disc 2—Yellow (2.5 YR 5=12) (glossy finish)
Disc 3—Black (N1) (glossy finish)
Disc 4—Grey (N4) (mat finish)
Such comparison is to be made in full diffused daylight or under a diffused light
source of approximately 2,691 lux (250 footcandles) and having a spectral quality
approximating that of daylight under a moderately overcast sky, with a correlated color
temperature of 7,500 degrees Kelvin kplus-minusl 200 degrees. With the light source
directly over the disc and product, observation is made at an angle of 45 degrees from a
distance of about 24 inches from the product. Electronic color meters may be used as
an alternate means of determining the color of tomato juice. Such meters shall be
calibrated to indicate that the color of the product is as red or more red than that
produced by spinning the Munsell color discs in the combination as set out above.
(b) Tomato soluble solids means the sucrose value as determined by the method
prescribed in “Official Methods of Analysis of the Association of Official Analytical
Chemists,” 13th ed., 1980, sections 32.014 to 32.016 and 52.012, under the headings
“Soluble Solids in Tomato Products Official Final Action” and “Refractive Indices (n)
of Sucrose Solutions at 20 deg.,” which is incorporated by reference. Copies are
available from the Association of Official Analytical Chemists International, 481
North Frederick Ave., Suite 500, Gaithersburg, MD 20877-2504, or available for
inspection at the Office of the Federal Register, 800 North Capitol Street, NW, Suite
700, Washington, DC. If no salt has been added, the sucrose value obtained from the
referenced tables shall be considered the percent of tomato soluble solids. If salt has
been added, either intentionally or through the application of the acidified break,
determine the percent of such added sodium chloride as specified in paragraph (c) of
this section. Subtract the percentage so found from the percentage of tomato soluble
solids found (sucrose value from the refractive index tables) and multiply the
difference by 1.016. The resultant value is considered the percent of “tomato soluble
solids.”
(c) Salt means sodium chloride, determined as chloride and calculated as percent sodium
chloride, by the method prescribed in “Official Methods of Analysis of the Association
of Official Analytical Chemists,” 13th ed., 1980, sections 32.025 to 32.030, under the
heading “Method III (Potentiometric Method),” which is incorporated by reference.
(d) Compliance means the following: Unless otherwise provided in a standard, a lot of
canned vegetable juice shall be deemed in compliance for the following factors, to be
determined by the sampling and acceptance procedure as provided in paragraph (e) of
this section, namely:
(1) Quality. The quality of a lot shall be considered acceptable when the number of
defectives does not exceed the acceptance number (c) in the sampling plans.
(2) Fill of container. A lot shall be deemed to be in compliance for fill of container
when the number of defectives does not exceed the acceptance number (c) in the
sampling plans.
(e) Sampling and acceptance procedure means the following:
(1) Definitions
(i) Lot. A collection of primary containers or units of the same size, type, and
style manufactured or packed under similar conditions and handled as a
single unit of trade.
(ii) Lot size. The number of primary containers or units in the lot.
(iii) Sample size (n). The total number of sample units drawn for examination
from a lot.
(iv) Sample unit. A container, a portion of the contents of a container, or a
composite mixture of product from small containers that is sufficient for
the examination or testing as a single unit. For fill of container, the sample
unit shall be the entire contents of the container.
(v) Defective. Any sample unit shall be regarded as defective when the
sample unit does not meet the criteria set forth in the standards.
(vi) Acceptance number (c). The maximum number of defective sample units
permitted in the sample in order to consider the lot as meeting the
specified requirements.
(vii) Acceptable quality level (AQL). The maximum percent of defective
sample units permitted in a lot that will be accepted approximately 95
percent of the time.
(2) Sampling plans:
Size of container
4,800 or less 13 2
4,801 to 24,000 21 3
24,001 to 48,000 29 4
48,001 to 84,000 48 6
(continued )
Continued
Size of container
84,001 to 144,000 84 9
144,001 to 240,000 126 13
Over 240,000 200 19
Net weight greater than 1 kg (2.2lb) but not more than 4.5kg (10 lb)
2,400 or less 13 2
2,401 to 15,000 21 3
15,001 to 24,000 29 4
24,001 to 42,000 48 6
42,001 to 72,000 84 9
72,001 to 120,000 126 13
Over 120,000 200 19
600 or less 13 2
601 to 2,000 21 3
2,001 to 7,200 29 4
7,201 to 15,000 48 6
15,001 to 24,000 84 9
24,001 to 42,000 126 13
Over 42,000 200 19
(a) Identity
(1) Definition. Tomato juice is the food intended for direct consumption, obtained
from the unfermented liquid extracted from mature tomatoes of the red or
reddish varieties of Lycopersicum esculentum P. Mill, with or without scalding
followed by draining. In the extraction of such liquid, heat may be applied by any
method which does not add water thereto. Such juice is strained free from peel,
seeds, and other coarse or hard substances, but contains finely divided insoluble
solids from the flesh of the tomato in accordance with current good
manufacturing practice. Such juice may be homogenized, may be seasoned
with salt, and may be acidified with any safe and suitable organic acid. The juice
may have been concentrated and later reconstituted with water and=or tomato
juice to a tomato soluble solids content of not less than 5.0 percent by weight as
determined by the method prescribed in Sec. 156.3(b). The food is preserved by
heat sterilization (canning), refrigeration, or freezing. When sealed in a container
to be held at ambient temperatures, it is so processed by heat, before or after
sealing, as to prevent spoilage.
(2)
Labeling.
(i) The name of the food is:
(a) “Tomato juice” if it is prepared from unconcentrated undiluted liquid
extracted from mature tomatoes of reddish varieties.
(b) “Tomato juice from concentrate” if the finished juice has been
prepared from concentrated tomato juice as specified in paragraph (a)
(1) of this section or if the finished juice is a mixture of tomato juice
and tomato juice from concentrate.
(ii) Label declaration. Each of the ingredients used in the food shall be declared
on the label as required by the applicable sections of parts 101 and 130 of
this chapter.
(b) Quality.
(1) The standard of quality for tomato juice is as follows:
(i) The strength and redness of color is not less than the composite color
produced by spinning the Munsell color discs in the following
combination: 53 percent of the area of Disc 1; 28 percent of the area of
Disc 2; and 19 percent of the area of either Disc 3 or Disc 4; or 91=2 percent
of the area of Disc 3 and 91=2 percent of the area of Disc 4, whichever
most nearly matches the appearance of the tomato juice.
(ii) Not more than two defects for peel and blemishes, either singly or in
combination, in addition to three defects for seeds or pieces of seeds,
defined as follows, per 500 milliliters (16.9 fluid ounces):
(a) Pieces of peel 3.2 millimeters (0.125 inch) or greater in length.
(b) Blemishes such as dark brown or black particles (specks) greater than
1.6 millimeters (0.0625 inch) in length.
(c) Seeds or pieces of seeds 3.2 millimeters (0.125 inch) or greater in
length.
(2) Methodology.
(i) Determine strength and redness of color as specified in Sec. 156.3(a).
(ii) Examine a total of 500 milliliters for peel, blemishes, and seeds. Divide the
500-milliliter sample into two 250-milliliter aliquots and pour each aliquot
onto separate 30.5 45.7 centimeters (12 18 inches) white grading
trays. Remove defects and evaluate for color and size as defined in
paragraph (b) (1) (ii) of this section.
(3) Determine compliance as specified in Sec. 156.3(d).
(4) If the quality of the tomato juice falls below the standard prescribed in paragraph
(b) (1) and (3) of this section, the label shall bear the general statement of
substandard quality specified in Sec. 130.14(a) of this chapter, in the manner and
form therein specified, but in lieu of such general statement of substandard
quality when the quality of the tomato juice falls below the standard in one or
more respects, the label may bear the alternative statement, “Below Standard in
Quality—,” the blank to be filled in with the words specified after the
corresponding paragraph (s) under paragraph (b) (1) of this section which such
tomato juice fails to meet, as follows:
(i) “Poor color.”
(ii) (a) “Excessive pieces of peel.”
(b) “Excessive blemishes.”
(c) “Excessive seeds” or “excessive pieces of seed.”
(c) Fill of container.
(1) The standard of fill of container for tomato juice, as determined by the general
method for fill of container prescribed in Sec. 130.12(b) of this chapter, is not
less than 90 percent of the total capacity, except when the food is frozen.
(2) Determine compliance as specified in Sec. 156.3(d).
(3) If the tomato juice falls below the standard of fill prescribed in paragraph (c) (1)
and (2) of this section, the label shall bear the general statement of substandard
fill specified in Sec. 130.14(b) of this chapter, in the manner and form therein
prescribed.
APPENDIX J
Vegetables, Vegetable Products, and
Disease Outbreaks
The information in this appendix has been adapted from “Analysis and Evaluation of Preventive
Control Measures for the Control and Reduction=Elimination of Microbial Hazards on Fresh and
Fresh-Cut Produce,” FDA, September 30, 2001. All references have been removed. Please consult
original document for details.
Appendix J
contaminated by
an infected food
handler.
705
Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved.
706
Table J-1 Continued
Type of
lettuce or No. of Isolated from
Pathogen Year Location Produce source Venue salad No. of cases deaths produce Comments
Appendix J
distributor.
Contamination
suspected to have
occurred before
distribution.
a
NR, not reported.
707
708
Table J-2 Examples of Reported Outbreaks of Foodborne Disease Associated with Raw Vegetables Other than Seed Sprouts, and Lettuce or Salads
Produce No. of No. Isolated from
Pathogen Year Location source Venue Type of produce cases of deaths produce Comments
a
Clostridium 1987 Florida NR Home Cabbage 4 0 Yes Performed toxin and
botulinum salad spores were found
(type A) in coleslaw dressing
which contained
cabbage and carrot
pieces. Possible
growth of C.
botulinum in the
cabbage.
C. botulinum 1989 New York NR Home Chopped 3 0 Yes Product was made
(type A) garlic in oil from chopped
garlic, ice water,
and olive oil
sometime between
1985 and 1987.
Chemical or acid
additives not used.
“Keep refrigerated”
in small print. Jar
was stored at room
temperature for
approximately
3 months prior to
opening.
Refrigerated after
opening. Same
processor as 1988
outbreak.
Appendix J
Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved.
Vegetables, Vegetable Products, and Disease
C. botulinum 1985 British US Restaurants Chopped 37 0 Yes The product was made
(type B) Columbia, garlic in oil from dehydrated
Canada and rehydrated and
soybean oil.
Chemical or acid
additives not used.
“Keep refrigerated”
in small print. Jar
was stored at room
temperature at the
restaurant.
Cryptosporidium 1997 Washington US Restaurants Green onions 54 0 No Green onions were not
parvum (inconclusive washed before
association) delivery to the
restaurant and not
washed before
serving to
customers. Possible
contamination by a
food handler.
Cyclospora 1997 Multistate, US US Retail=Catered Basil . 308 0 Yes Suspected fresh basil.
cayatenansis events Mode of
contamination
unknown.
Escherichia coli 1993 Rhode Island, US Airline, hotel Shredded 47,121 0 NR Possible
(enterotoxigenic) New Hampshire carrots contamination of
carrots used in
salads. Carrots used
came from same
state.
E. coli O157:H7 1998 Indianapolis NR Restaurant Coleslaw 33 0 Yes —
E. coli O157:H7 1998 Wisconsin NR Catered event Fruit salad 47 (3 HUS) 0 No —
Giardia lamblia 1989 US NR NR Lettuce, 21 NR NR —
tomatoes,
onions
(continued )
709
Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved.
710
Table J-2 Continued
Produce No. of No. Isolated from
Pathogen Year Location source Venue Type of produce cases of deaths produce Comments
Hepatitis A 1971 Tennessee Tennessee Home Raw watercress 129 0 No Watercress harvested
from small streams
near farm.
Specimen cultures
revealed gross
contamination with
fecal organisms.
Several abandoned
septic tanks were
seen near the
stream.
Hepatitis A 1994 Arkansas NR NR Diced tomatoes 92 0 NR Suspected
contamination by
food handler.
Listeria 1979 Boston NR Hospitals Raw tomatoes, 20 5 NR Multiple hospitals
monocytogenes lettuce and involved. Tuna fish,
celery suspected chicken salad, and
cheese sandwiches
epidemiologically
linked to listeriosis.
All served with
tomatoes, raw
vegetables such as
celery and lettuce.
L. monocytogenes 1981 Nova Nova Various Vegetable mix for 41 17 Yes Cabbage was grown
Scotia, Scotia, coleslaw on farm where two
Canada Canada sheep had died of
listeriosis. Raw and
composed manure
was used to fertilize
the fields. Cold
Appendix J
storage may have
allowed for Listeria
growth.
711
Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved.
712
Table J-2 Continued
Produce No. of No. Isolated from
Pathogen Year Location source Venue Type of produce cases of deaths produce Comments
Appendix J
parsley was often
chopped and left at
room temperature
for several hours
prior to serving.
a
NR, not reported.
713
714
Table J-3 Examples of Reported Outbreaks of Food-borne Disease Associated with Raw Vegetables Due to Contamination During Final Preparation
Appendix J
contamination
by a food
handler.
715
(continued )
Appendix J
Vegetables, Vegetable Products, and Disease
Table J-4 Examples of Reported Outbreaks of Foodborne Disease Associated with Seed Sprouts
Isolated from
Pathogen Year Location Seed source Type of sprout No. of cases No. of deaths sprouts=seeds Comments
Bacillus cereus 1973 Texas Uganda (soy), Soy, mustard, and 4 0 Yes=yes Sprouted from a home
Holland (cress), and cress seed sprouting kit.
Denmark (mustard)
Escherichia coli 1996 Japan NRa Radish 6561 (101 with 2 No=no Contamination route
O157:H7 HUSb), 160 unknown.
secondary cases
E. coli O157:H7 1997 Japan NR Radish 126 0 Yes=no The pathogen was
isolated from
leftover sprouts in
the refrigerator but
not the seeds from
the same seed lots.
E. coli O157:H7 1997 Michigan and Virginia NR Alfalfa 108 0 NR=NR Sprouts were sprouted
from same seed lot
in both states.
E. coli O157:NM 1998 California California and Nevada Clover=alfalfa 8 0 Yes=no Sprouts were traced to
a single sprouter.
Contaminated
seeds suspected
(same sprouter as
1997 – 1998
S. Senftenberg
outbreak).
Salmonella 1994 Sweden and Finland Australia Alfalfa 595 0 Yes=no Contaminated seeds
Bovismorbificans came from the same
seed lot and
importer.
(continued )
717
Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved.
718
Table J-4 Continued
Isolated from
Pathogen Year Location Seed source Type of sprout No. of cases No. of deaths sprouts=seeds Comments
Appendix J
Washington lot and distributed
to various growers
in California,
Florida, and
Washington. No
cases in Florida.
719
Copyright 2004 by Marcel Dekker, Inc. All Rights Reserved.
720
Table J-4 Continued
Isolated from
Pathogen Year Location Seed source Type of sprout No. of cases No. of deaths sprouts=seeds Comments
Appendix J
NR, not reported.
b
Hemolytic uremic syndrome.