Persius/hicric huggingface dataset:
CPG Sec. 525.900 Whole Plant (Unprocessed) 
Marjoram, Unground (Processed) Marjoram & 
Ground Marjoram - Adulteration by Insect & 
Rodent Filth; Mold; Mammalian Excreta 
REGULATORY ACTION GUIDANCE: 
1.  The following represents criteria for direct reference seizure *requests to the Office of 
Human and Animal Food Operations (OHAFO) in consultation with the Office of 
Enforcement and Import Operations (OEIO) and CFSAN, and for direct citation by the 
appropriate Field Office in the Human and Animal Food Program*:  
Whole Plant (Unprocessed) Marjoram 
a.  Insect Filth and Mold  
The spice contains an average of 5% or more insect infested and/or moldy pieces by weight. 
or 
b.  Mammalian Excreta  
The spice contains an average of 1 milligram or more of mammalian excreta per pound 
(mammalian excreta should be identified as to source when possible). 
c.    
2.  The following represents the criteria for recommending legal action to CFSAN/Office of 
*Compliance*/Division of Enforcement (HFS-605):  
a.  Ground Marjoram  
The ground marjoram contains an average of 1175 or more insect fragments and/or an average of 
8 or more rodent hairs per 10-gram subsample. 
b.  Unground (Processed) Marjoram  
The unground processed marjoram contains an average of 250 or more insect fragments and/or 
an average of 2 or more rodent hairs per 10-gram subsample. 
NOTE: Determination for all defects are made on a minimum of six (6) ten (10) gram 
subsamples for ground and unground processed marjoram.  See Macroanalytical Procedures Manual for number of grams of subsamples used in analyses of 
whole spices. 
REMARKS: 
Since the majority of spices are imported, determine that the lot in question has not been 
previously examined and released by FDA as an import. If the lot has been examined and 
released previously, submit all available facts to CFSAN/Office of *Compliance*/Division of 
Enforcement (HFS-605) for seizure consideration in the usual manner. 
SPECIMEN CHARGES (for all including leafy spices): 
Article (whole plant unprocessed/unground processed/ground marjoram) adulterated (when 
introduced into and while in interstate commerce) (while held for sale after shipment in interstate 
commerce) within meaning of 21 U.S.C. 342(a)(3), in that it consists wholly or in part of a filthy 
substance by reason of presence therein of (insects), (insect webbing), (insect fragments), 
(mammalian excreta), and (insect damage, marjoram), (rodent hairs); and that it consists in part 
of a decomposed substance by reason of the presence therein of (moldy, decomposed marjoram) 
(mold). 
NOTE: Only use direct citation authority when prosecution is anticipated and evidence to 
support a prosecution is included with the adulteration charge. Evidence necessary to support a 
prosecution is specified in existing regulatory procedures issuances. 
*Material between asterisks is new or revised.* 
Issued: 2/1/86 
Revised: 3/95, 5/05 
Updated: 11/29/05
CPG Sec. 525.925 Whole Plant (Unprocessed) 
Thyme, Unground (Processed) Thyme & 
Ground Thyme - Adulteration by Insect & 
Rodent Filth; Mold; Mammalian Excreta 
REGULATORY ACTION GUIDANCE: 
1.  The following represents criteria for direct reference seizure *requests to the Office of 
Human and Animal Food Operations (OHAFO) in consultation with the Office of 
Enforcement and Import Operations (OEIO) and CFSAN, and for direct citation by the 
appropriate Field Office within the Human and Animal Food Program*: 
Whole Plant (Unprocessed) Thyme 
a.  Insect Filth and Mold  
The spice contains an average of 5% or more insect infested and/or moldy pieces by weight. 
b.  Mammalian Excreta  
The spice contains an average of 1 milligram or more of mammalian excreta per pound 
(mammalian excreta should be identified as to source when possible). 
2.  The following represents the criteria for recommending legal action to CFSAN/Office of 
*Compliance*/Division of Enforcement (HFS-605): 
a.  Ground Thyme  
The ground thyme contains an average of 925 or more insect fragments and/or an average of 2 or 
more rodent hairs per 10-gram subsample. 
b.  Unground (Processed) Thyme  
The unground processed thyme contains an average of 325 or more insect fragments and/or an 
average of 2 or more rodent hairs per 25-gram subsample. 
3.  NOTE: Determinations for all defects are made on a minimum of six (6) ten-gram 
subsamples for ground and six (6) twenty-five-gram subsamples for unground thyme. 
4.  See Macroanalytical Procedures Manual for number of grams of subsamples used in 
analyses of whole spices. 
5.  REMARKS:  6.  Since the majority of spices are imported, determine that the lot in question has not been 
previously examined and released by FDA as an import. If the lot has been examined and 
released previously, submit all available facts to CFSAN/Office of 
*Compliance*/Division of Enforcement (HFS-605) for seizure consideration in the usual 
manner. 
7.  SPECIMEN CHARGES (for all including leafy spices): 
8.  Article (whole plant unprocessed/unground processed/ground thyme) adulterated (when 
introduced into and while in interstate commerce) (while held for sale after shipment in 
interstate commerce) within meaning of 21 U.S.C. 342(a)(3), in that it consists wholly or 
in part of a filthy substance by reason of presence therein of (insects), (insect fragments), 
(insect webbing), (insect excreta), (insect damaged thyme), (mammalian excreta), and 
(rodent hairs); and that it consists in part of a decomposed substance by reason of the 
presence therein of (moldy, decomposed thyme) (mold). 
9.  NOTE: Only use direct citation authority when prosecution is anticipated and evidence to 
support a prosecution is included with the adulteration charge. Evidence necessary to 
support a prosecution is specified in existing regulatory procedures issuances. 
10. *Material between asterisks is new or revised.* 
11. Issued: 2/1/86 
Revised: 6/1/86, 3/95, 5/05 
Updated: 11/29/05
CPG Sec. 525.950 Whole Plant (Unprocessed) 
Sage, and Ground Sage - Adulteration by Insect 
and Rodent Filth; Mold; Mammalian Excreta 
REGULATORY ACTION GUIDANCE: 
1.  The following represents criteria for direct references seizure *requests to the Office of 
Human and Animal Food Operations (OHAFO) in consultation with the Office of 
Enforcement and Import Operations (OEIO) and CFSAN, and for direct citation by the 
appropriate Field Office within the Human and Animal Food Program*: 
Whole Plant (Unprocessed) Sage  
a.  Insect Filth and Mold 
The spice contains an average of 5% or more insect infested and/or mold pieces 
by weight. 
or 
b.  Mammalian Excreta 
The spice contains an average of 1 milligram or more of mammalian excreta per 
pound (mammalian excreta should be identified as to source when possible). 
 
2.  The following represents the criteria for recommending legal action to CFSAN/Office of 
*Compliance*/Division of Enforcement (HFS-605): 
Ground Sage  
The ground sage contains an average of 200 or more insect fragments and/or an average of 9 or 
more rodent hairs per 10 gram subsample. 
NOTE: Determinations for all defects are made on a minimum of six (6) ten (10) gram 
subsamples for ground sage. See Macroanalytical Procedures Manual for number of grams of 
subsamples used in analysis of whole spices. 
REMARKS: 
Since the majority of spices are imported, determine that the lot in question has not been 
previously examined and released by FDA as an import. If the lot has been examined and 
released previously, submit all available facts to CFSAN/Office of *Compliance*/Division of 
Enforcement (HFS-605) for seizure consideration in the usual manner.  SPECIMEN CHARGES (for all including leafy spices): 
Article (whole plant unprocessed/ground sage) adulterated (when introduced into and while in 
interstate commerce) (while held for sale after shipment in interstate commerce) within the 
meaning of 21 U.S.C 342(a)(3) in that it consists wholly or in part of a filthy substance by reason 
of presence therein of (insects), (insect fragments), (insect webbing), (insect excreta), (insect 
damaged sage), (mammalian excreta), and (rodent hairs); and that it consists in part of a 
decomposed substance by reason of the presence therein of (moldy, decomposed sage) (mold). 
NOTE: Only use direct citation authority when prosecution is anticipated and evidence to 
support a prosecution is included with the adulteration charge. Evidence necessary to support a 
prosecution is specified in existing regulatory procedures issuances. 
*Material between asterisks is new or revised.* 
Issued: 2/1/86 
Revised: 3/95, 5/05 
Updated: 11/29/05
CPG Sec. 527.100 Butter - Adulteration 
Involving Insufficient Fat Content 
REGULATORY ACTION GUIDANCE: 
The following represents criteria for direct reference seizure *requests to the Office of Human 
and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and 
Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office 
within the Human and Animal Food Program*: 
1.  The average of the fat determinations, by both original and check analysis, on the number 
of subdivisions shown in the following table is below 79.85%; 
or 
2.  The number of individual fat determinations by both original and check analysis meets or 
exceeds the figures in the right hand column of the following table: 
No. Subs  No. Determinations Below 
   Lot Sizes 
Examined  79.85% 
Print Butter 
35cs or less  5  2 
 
Over 35cs  8  3 
35 cs or less  12  4 
No Churn Mark Present 
Over 35cs  20  7 
Bulk Butter (Tub or Cube) 
1 - 2 units  
All  1 
  
Each Churn Mark 
Present 
3 units  2  1 
Over 3 units  3  1 
No Churn Mark Present 1 - 5 units  All  1  No. Subs  No. Determinations Below 
   Lot Sizes 
Examined  79.85% 
6 - 14  5  2 
15 - 24 units  7  3 
25 - 150 units 8  3 
Over 150 
14  4 
units 
*REMARKS: (For Seizures Only) 
If there is reason to believe that a lot was packed under the supervision of, or certified by the 
U.S. Department of Agriculture, submit the following information *by e-mail* to CFSAN, 
Office of *Compliance*/Division of Enforcement (HFS-605) and await reply before proceeding: 
Sample Number 
Date of Shipment 
Article Involved 
Dealer 
Amount of Lot 
Shipper 
Codes 
Analytical Conclusions 
  
SPECIMEN CHARGE: 
Article adulterated when introduced into and while in interstate commerce, within the meaning 
of 21 U.S.C. 342(b)(2) [Sec. 402(b)(2) of the Food, Drug, and Cosmetic Act], in that a product 
containing less than 80% by weight of milk fat has been substituted for butter, a product which 
should contain not less than 80% of milk fat as provided by the Act of March 4, 1923 (21 U.S.C. 
321a). 
*Material between asterisks is new or revised.*  Issued: 10/1/80 
Revised: 8/96, 5/05 
Updated: 11/29/05
CPG Sec. 527.225 Cheese - Misbranding Due to 
Moisture and Fat 
REGULATORY ACTION GUIDANCE: 
The following represent criteria for direct reference seizure *requests to the Office of Human and 
Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and Import 
Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office within the 
Human and Animal Food Program*: 
A.  Cheddar, washed curd, colby, granular, swiss, gruyere, brick, samsoe, muenster, edam, 
gouda, monterey, high-moisture jack, asiago, cook, sap sago, gammelost, hard, semi-soft 
part-skim, pasteurized process, pasteurized blended and cold pack cheese (with nothing 
added), and mozzarella, represented as standardized cheese.  
1.  For High Moisture  
a.  If the average moisture of the vat, or lot if no vat numbers present, is at 
least 2 percentage points above the limit of the standard: or 
b.  If no vat numbers present, moisture of two subdivisions is at least 4 
percentage points above the limit of the standard, or moisture of one 
subdivision is at least 5 percentage points above the limit of the standard. 
2.  For Insufficient Fat Content  
a.  If the average fat of the vat, or lot if no vat numbers present, is at least 1.5 
percentage points less than the limit of the standard: or 
b.  If no vat numbers present, the fat of two subdivisions is at least 2.5 
percentage points less than the limit of the standard, or the fat of one 
subdivision is at least 3.5 percentage points less than the limit of the 
standard. 
NOTE: Duplicate moisture determinations should check within 0.2% and check analysis within 
0.3%. Duplicate fat determinations on dry basis should check within 0.5% and check analysis 
within 0.6% 
B.  Cottage Cheese, Dry Curd Cottage Cheese, and Low Fat Cottage Cheese represented as 
standardized.  
1.  For High Moisture   a.  Cottage Cheese and Dry Curd Cottage Cheese. The average moisture is 
81.0% or more. 
b.  Low Fat Cottage Cheese. The average moisture is 83.5% or more. 
2.  For Insufficient Fat Content The average fat is 3.6% or less. 
NOTE: Duplicate moisture determinations should check within 0.2% and check analysis within 
0.3%. Duplicate fat determinations and check analysis should check within 0.2%. 
SPECIMEN CHARGE (example for cheddar cheese): 
Article misbranded when introduced into and while in interstate commerce within meaning of 
*21 U.S.C. 343(g)(1),* in that it purports to be and is represented as cheddar cheese, a food for 
which a definition and standard of identity has been prescribed by Regulation (21 CFR 133.113) 
promulgated pursuant to 21 U.S.C. 341, and it fails to conform to such definition and standard, 
since *133.113(a)(1)* of such definition and standard requires that cheddar cheese contain not 
more than 39 percent of moisture, and that its solids contain not less than 50 percent of milk fat; 
whereas the article contains more than 39 percent of moisture and the solids of the article contain 
less than 50 percent of milk fat. 
*Material between asterisks is new or revised.* 
Issued: 10/1/80 
Revised: 3/95, 8/96, 5/05 
Updated: 11/29/05
CPG Sec. 535.100 Oleomargarine - 
Misbranding Due to Insufficient Fat 
REGULATORY ACTION GUIDANCE: 
The following represents the criteria for direct reference seizure *requests to the Office of 
Human and Animal Food Operations (OHAFO) in consultation with the Office of 
Enforcement and Import Operations (OEIO) and CFSAN, and for direct citation by the 
appropriate Field Office within the Human and Animal Food Program*: 
The average fat content by both original and check analysis is below 79.85%. 
REMARKS: (For Seizures Only) 
If there is reason to believe that a lot was packed under the supervision of or certified by 
the U. S. Department of Agriculture, submit the following information *by e-mail* or 
FAX to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) and await 
reply before proceeding: 
Sample Number 
Article Involved 
Amount of Lot 
Codes 
Date of Shipment 
Dealer 
Shipper 
Analytical Conclusions 
  
SPECIMEN CHARGE: 
The article was misbranded when introduced into, while in, and is misbranded while held 
for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 
343(g)(1) in that it purports to be and is represented as oleomargarine, a food for which a 
definition and standard of identity has been prescribed by regulation (21 CFR 166.110) 
promulgated pursuant to 21 U.S.C. 341 and it fails to conform to such definition and 
standard, in that Section 166.110(a) of such definition and standard provides, among 
other things, that oleomargarine contain not less than 80 percent fat as determined by the 
method prescribed in such definition and standard, whereas, the article contains less than 
80 percent fat.  *Material between asterisks is new or revised.* 
Issued: 11/7/79 
Revised: 10/1/80, 11/22/88, 3/95, 8/96, 5/05 
Updated: 11/29/0
CPG Sec. 537.100 Eggs and Egg Products - 
Frozen - Adulteration Involving Decomposition 
REGULATORY ACTION GUIDANCE: 
The following represents criteria for direct reference seizure *requests to the Office of Human 
and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and 
Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office 
within the Human and Animal Food Program*: 
1.  If examination of the frozen eggs or frozen egg products by a qualified egg examiner 
shows two or more cans contain decomposed eggs; 
  
and 
  
2.  At least two subsamples, but all subsamples if more than two are examined, from cans 
classed as decomposed have direct microscopic counts of 5,000,000 or more bacterial 
cells per gram when analyzed by AOAC 940.37, 15 Ed. 
REMARKS: 
If all cans in the lot are examined, recommend seizure only of the cans found to contain 
decomposed eggs. 
If there is reason to believe that the lot of egg products was packed under the supervision of or 
certified by the U.S. Department of Agriculture, submit the following information *by e-mail* or 
FAX to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) and await reply 
before proceeding: 
Sample Number 
Article Involved 
Amount of Lot 
Codes 
Date of Shipment 
Dealer 
Shipper 
Analytical Conclusions 
   SPECIMEN CHARGE: 
Article adulterated when introduced into and while in interstate commerce, within the meaning 
of 21 U.S.C. 342(a)(3) in that it consists wholly or in part of a decomposed substance by reason 
of presence therein of decomposed eggs. 
*Material between asterisks is new or revised.* 
Issued: 10/1/80 
Revised: 3/95, 8/96, 5/2005 
Updated: 11/29/2005
CPG Sec. 540.590 Fish - Fresh and Frozen, as 
Listed - Adulteration by Parasites 
REGULATORY ACTION GUIDANCE: 
The following represents criteria for direct reference seizure recommendations to the Office of 
Human and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement 
and Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field 
Office within the Human and Animal Food Program*: 
Parasite findings meet or exceed the following tolerances: 
1.  Tullibees, Ciscoes, Inconnus, Chubs and White Fish 
50 cysts per 100 pounds (whole fish or fillets), provided that 20% of the fish examined 
are infested. 
2.  Blue Fin and Other Fresh Water Herring  
a.  Fish averaging one pound or less: 
60 cysts per 100 fish, provided that 20% of the fish examined are infested. 
b.  Fish averaging over one pound: 
60 cysts per 100 pounds of fish, provided that 20% of the fish examined are 
infested. 
3.  Rose Fish (Red Fish and Ocean Perch): 
3 percent of the fillets examined contain one or more copepods accompanied by pus 
pockets. 
REMARKS: 
If there is reason to believe that a lot was packed under the supervision of or certified by the 
National Marine Fisheries Service National Oceanic and Atmospheric Administration, US 
Department of Commerce, *e-mail* or FAX the following information to CFSAN/Office of 
*Compliance*/Division of Enforcement (HFS-605) and await reply before proceeding: 
Sample Number 
Article Involved 
Amount of Lot 
Codes  Date of Shipment 
Dealer 
Shipper 
Analytical Conclusions  
SPECIMEN CHARGE: 
The article was adulterated when introduced into and while in interstate commerce and is 
adulterated while held for sale after shipment in interstate commerce within meaning of 21 
U.S.C. 342(a)(3), in that it consists wholly or in part of a filthy substance by reason of presence 
therein of parasitic cysts. 
*Material between asterisks is new or revised.* 
Issued: 10/1/80 
Revised: 10/30/89, 3/95, 5/2005 
Updated: 11/29/2005
CPG Sec. 545.300 Foods, Rail Car Sanitation  
Adulteration 
BACKGROUND: 
One of the field offices learned during an industry workshop that rail companies were not 
adequately cleaning cars being spotted for use in transporting foods. The rail companies told the 
food shippers that the shippers would have to clean the cars or else the railroads would not 
furnish any cars. 
General Counsel has previously reviewed the problem of developing evidence for prosecution 
concerning rail car sanitation and is of the opinion that Section 703 of the act was not intended to 
exempt carriers from liability in cases where the carrier's own acts cause the adulteration or 
misbranding of articles in interstate commerce. 
General Counsel offered the following comments which we quote: 
"...it does appear logical that Congress, in order to provide the protection of the public intended 
by the Act, did exempt interstate carriers from the consequences of merely receiving, carrying, 
holding, or delivering articles which were already adulterated or misbranded when delivered to 
them, a state of affairs that the carrier in most instances could not ascertain, but it has not 
intended to grant a complete exemption from liability for actually causing the adulteration or 
misbranding of articles while in their custody." 
POLICY: 
The Food and Drug Administration has the responsibility for initiating regulatory action, if a 
carrier has caused a product under our jurisdiction to become adulterated or misbranded. The 
adulteration may be caused by a failure to properly clean vehicles prior to delivering the vehicle 
to food, drug, or cosmetic shippers. The adulteration may consist of filth or of poisonous 
substances such as pesticide chemicals. 
REGULATORY ACTION GUIDANCE: 
The following represents the criteria for recommending legal action to CFSAN/Office of 
*Compliance*/Division of Enforcement (HFS-605): 
1.  There is definite proof that the carrier was responsible for the act of adulteration (filth, 
pesticide contamination). This should, of course, be based on a thorough inspection of the 
vehicle with appropriate collection of samples, exhibits, photos, etc.  
and  2.  Immediate inspection of the shipper firm shows that the adulteration of the goods in the 
suspect vehicle could only come from the vehicle used for transportation. 
In any case where pesticides or other poisonous chemicals are involved you may wish to 
coordinate your investigation with local representatives of the Department of Transportation as 
penalties for furnishing unfit vehicles contaminated with "Class B Poisons" are also possible 
under the laws that department enforces even when no provable adulteration occurs. 
*Material between asterisks is new or revised.* 
Issued: 10/1/80 
Revised: 6/27/88, 3/95, 5/2005 
Updated: 11/29/2005
CPG Sec. 545.600 Cinnamon-Flavored 
Toothpicks 
REGULATORY ACTION GUIDANCE: 
The following represents criteria for direct reference seizure *requests to the Office of Human 
and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and 
Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office 
within the Human and Animal Food Program*: 
If the toothpicks contain an average of 18% or more by weight of cinnamaldehyde. 
REMARKS: 
If the toothpicks contain between 13% and 18% by weight of cinnamaldehyde, refer to 
CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) with all available injury 
information. 
SPECIMEN CHARGE: 
Article adulterated when introduced into and while in interstate commerce, within meaning of 21 
U.S.C. 361(a), in that it contains an added poisonous or deleterious substance, namely, 
cinnamaldehyde, which may render it injurious to users under customary or usual conditions of 
use. 
NOTE: Only use direct reference citation authority when prosecution is anticipated and evidence 
to support a prosecution is included with the adulteration charge. Evidence to support a 
prosecution is specified in existing regulatory procedures issuances. 
*Material between asterisks is new or revised.* 
Issued: 1/1/73 
Revised: 10/1/80, 7/1/83, 9/1/86, 3/95, 5/2005 
Updated: 11/29/05