Nuts

Sec. 570.100 Jordan Almonds - Common or Usual Name (CPG 7112.01)

BACKGROUND:

Administration Information Letter (AIL) No. 173, October 20, 1941, stated that the term "Jordan" almonds was not considered misleading solely because almonds were not of Palestinian origin. This AIL read as follows:

"We have your letter of September 28 inquiring as to the use of the term 'Jordan Almonds' on labels for sugar-coated almonds in which almonds other than 'genuine Spanish Jordan Almonds' are used.

"Upon receipt of a similar inquiry as to the present-day consumer understanding of the term 'Jordan Almonds" in connection with the confection you have in mind we undertook a little research as to the origin and evolution of the term. As far as we can determine the term 'Jordan Almonds' according to one source of information came from the French word 'jardin,' meaning 'garden,' 'hence, a cultivated almond' (Webster's New International Dictionary). Another source of information indicated that at one time the term referred to a variety of almonds originally grown along the Jordan River in Palestine characterized by long, thin, slender, rather smooth kernels in thick, heavy shells.

"The information we were able to elicit as to present-day trade and consumer understanding led us to conclude that to consumers the term may have no significance other than identification of the confection consisting of candy-coated almonds so long as the almonds used are of a certain type or shape that has been found most suitable for candy coating -- in other words, a shape similar to that of the original Jordan almond which would be a long, thin, slender, rather smooth kernel in a thick, heavy shell.

"In the light of our present information we have not been disposed to institute action against this confection labeled 'Jordan Almonds' if the almonds used are of a variety having the physical characteristics described above no matter what may be their source. Of course if it should develop that consumers are in fact being misled as to the identity of the almonds used by this term it would be necessary for us to recall this opinion and advise the trade accordingly."

POLICY:

The term "Jordan Almonds" is considered the common or usual name for candy-coated almonds. The almonds used are varieties that are long, thin, slender, rather smooth kernels.

Issued: 8/20/73
Reissued: 10/1/80, 12/2/88

Sec. 570.200 Brazil Nuts - Adulteration with Aflatoxin (CPG 7112.07)

REGULATORY ACTION GUIDANCE:

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

The entire sample of nuts (20-60 lbs.) is cracked out and the obviously inedible nuts discarded. The remaining moldy and non-moldy nuts are composited and the well-mixed sample analyzed in accordance with applicable methods of the current Official Methods of Analysis of the Association of Official Analytical Chemists, (at the time of this transmittal) Thirteenth Edition, sections 26.026-26.031 or 26.032-26.036 and 26.083.

Recommend legal action where the following analytical conditions are met:

1. Original and check analysis show aflatoxin above 20 mcg/kg

and

2. Identity of aflatoxin B1 is confirmed by chemical derivatives.

REMARKS:

The Department of Agriculture, importers of Brazil nuts, and FDA carry out a total coverage analysis program on imported Brazil nuts (former CPG 7155a.13). This program should preclude sampling by the Field Districts on an objective basis.

RECONDITIONING OF BRAZIL NUTS:

Collect sample from the lot using the same sampling scheme used for the original sample collection. Crack-out 1000 nuts drawn representatively from the sample. Discard obviously inedible nuts. Combine the moldy and non-moldy nuts into a single composite and analyze for aflatoxins. Release reconditioned lot when the aflatoxin content of the composited nuts does not exceed 5 mcgs/kg, currently the limit of detectability of the methodology. For a reconditioned lot found to contain aflatoxin above 20 mcgs/kg, the analytical conditions specified above for recommending legal action are to be met. When the aflatoxin content falls between 5 and 20 mcgs/kg, contact *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)* for further guidance.

*Material between asterisks is new or revised*

Issued: 8/1/83
Revised: 3/95

Sec. 250.Cashews, Insect Infested - Reconditioning.(CPG 7112.10)

BACKGROUND:

The *Center for Food Safety and Applied Nutrition* has established guidelines to be used to determine the adequacy of reconditioning proposals for lots of cashews that are contaminated due to insect infestation.

POLICY:

1. Segregation of the lot is permitted on a tin by tin basis, with further reconditioning required only for those tins that contain insect infestation.

2. Cracking or splitting of the cashews is required as part of the reconditioning procedure when the cashews in a tin show evidence of internal insect infestation which cannot be removed by other means.

3. All cashews in a tin must be cracked if more than 2 percent of l00 cashews cracked or split from that tin show internal insect infestation.

4. Reconditioning, as above, is permitted regardless of whether the insects have been killed by freezing or other acceptable methods.

*Material between asterisks is new or revised.*

Issued: 7/9/80
Reissued: 10/1/80
Revised: 12/2/88

Sec. 570.300 Peanut Butter - Adulteration with Filth; Grit (CPG 7112.03)

REGULATORY ACTION GUIDANCE:

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

1. Filth

a. The peanut butter contains an average of 30 or more insect fragments per 100 grams;

or

b. The peanut butter contains an average of 1 or more rodent hairs per 100 grams.

2. Grit

The peanut butter is gritty to the taste and the Water-Insoluble Inorganic Residue (W.I.I.R.) is more than 25 milligrams per 100 grams.

REMARKS:

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

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

SPECIMEN CHARGES:

The article was adulterated when introduced into, while in, and is adulterated while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 342(a)(3) in that it consists in part of a filthy substance by reason of the presence therein of insect fragments (rodent hair), or that it is unfit for food because it contains grit and is gritty to the taste.

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

*Material between asterisks is new or revised.*

Issued: 10/7/79
Revised: 12/2/88, 3/95

Sec. 570.350 Peanuts, Shelled and Unshelled - Adulteration with Filth and Reject Nuts (CPG 7112.04)

REGULATORY ACTION GUIDANCE:

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

1. Unshelled Peanuts

The unshelled peanuts contain an average of 10% or more reject peanuts (insect infested; moldy; rancid; otherwise decomposed; blanks, and shriveled) when examined by Macroanalytical Procedures Manual 10.B.(4).

2. Shelled Peanuts

a. The peanut kernels average 5% or more reject kernels (insect infested, moldy, rancid, otherwise decomposed, and dirty); when examined by Macroanalytical Procedures Manual 10.B.(5)a.

b. The shelled peanuts contain an average of 20 or more whole insects or equivalent per whole bag siftings (100 pound bag basis) when examined by Macroanalytical Procedures Manual 10.B.(5)a.

REMARKS:

For live insects refer to Compliance Policy Guide because of reject nuts must be discussed with the U.S. Department of Agriculture. *Submit the following information via EMS or FAX to CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*, and await reply before proceeding:

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

SPECIMEN CHARGE:

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

NOTES:

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

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

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

*Material between asterisks is new or revised.*

Issued: 11/7/79
Reissued: 10/1/80
Revised: 12/2/88, 3/95

Sec. 570.375 Aflatoxin in Peanuts and Peanut Products (CPG 7112.02)

BACKGROUND :

The FDA program activity involving aflatoxin in domestic peanut products is directed toward products intended for direct consumption and not raw peanut products. The USDA has a comprehensive program involving raw peanuts which can be expected to result in proper processing or destruction of any high aflatoxin raw peanuts. The USDA will provide FDA with a copy of the certificate of analysis and the name of the applicant for each lot found to exceed 25 ppb aflatoxin (formerly CPG 7155a.14).

Also, some districts have been detaining shipments of U.S. raw peanuts returned from Canada because Canadian officials had found them to contain aflatoxin in excess of the Canadian limit.

POLICY:

The FDA offers no objection to the shipment of peanuts over the 25 ppb level for aflatoxin to processors if facilities are available to remove moldy or otherwise defective nuts from the lot before incorporation into the finished product.

Lots of raw peanuts which have been shipped to processors containing aflatoxin above 25 ppb level may be subject to appropriate action in cases where there is a lack of assurance that the finished product will comply with the current action level.

Raw peanuts, returned to the U.S. after export, should not be detained because of aflatoxin contamination. However, districts that learn of U.S. raw peanuts being returned should so inform Mr. J.S. Miller, Assistant Chief, Specialty Crops Branch, USDA/AMS, Independence Avenue, Washington, D.C. (202-447-5697) to make certain that USDA is aware of the return.

REGULATORY ACTION GUIDANCE:

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

Analyze nuts in accordance with applicable methods outlined in the current edition of the Official Methods of Analysis of the Association of the Official Analytical Chemists and supplements (at the time of this transmittal, Twelfth Edition sections 26.014-26.019 and 26.A17).

Recommend legal action where the following conditions are met:

1. Original and check analysis shows aflatoxin above 20 mcgs/kg;

and

2. Identity of aflatoxin B1 is confirmed by chemical derivative.

REMARKS:

Raw peanuts which have been sampled by USDA should not be sampled routinely on an objective basis. However, sampling and appropriate follow-up is indicated when lots of raw peanuts are reported by USDA certificate of analysis as exceeding 25 micrograms of aflatoxin per kilogram, and when such peanuts are destined for processors that do not have facilities and procedures to remove defective nuts, and there is no assurance that the finished products will be below the 20 mcgs/kg guideline.

The above guideline criteria do not preclude recommending action at lower than 20 mcgs/kg levels of aflatoxin in the finished product where there are inadequate control and sorting procedures, or deliberate attempts to dilute aflatoxin containing lots.

NOTE: The reserve sample must be of sufficient size to provide for the chick embryo test should it become necessary.

*Material between asterisks is new or revised*

Issued: 10/1/80
Revised: 3/95

Sec. 570.425 Tree Nuts - Adulteration Involving Rejects (Insect Infestation, Moldy, Rancid, otherwise Decomposed, Blanks, and Shriveled) (CPG 7112.05)

REGULATORY ACTION GUIDANCE:

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

1. Nuts in-shell and shelled nuts

The nuts contain rejects (insect infested, moldy, rancid, otherwise decomposed, blanks, and shriveled) above the following action levels:

Percentage Rejects

       Inshell    Shelled 

Almonds 05         05 
Brazils 10         05 
Cashews --         05 
Green chestnuts         15         -- 
Baked chestnuts         10         -- 
Dried chestnuts         --         05 
Filberts10         05 
Pecans  10         05 
Pistachios              10         05 
Walnuts 10         05
Lichee nuts             15         -- 
Pili nuts               15         10 

2. Mixed nuts in-shell

Separate each variety and recommend seizure of lot if the percentage of rejects for any variety is *greater than* the action level for that individual variety.

Where insect infestation is involved, the above action levels are for orchard type infestation.

Determination of reject in-shell and shelled nuts is done using the appropriate sequential sampling plans in Macroanalytical Procedures Manual 10.A.(4)a and b, and 10.A.(5)a and b.

REMARKS:

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

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

SPECIMEN CHARGES:

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

NOTES:

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

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

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

*Material between asterisks is new or revised.*

Issued: 11/07/79
Reissued: 10/1/80
Revised: 12/2/88, 3/95

Sec. 570.450 Tree Nuts - Adulteration with Filth, Involving the Presence of the Organism Escherichia coli (CPG 7112.11)

REGULATORY ACTION GUIDANCE:

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

Nut Meats

When Escherichia coli MPN of at least 0.36 per gram (IMVIC confirmed) is found in 2 or more subsamples, if less than 10samples examined, or in 20% or more of the subsamples if more than 10 subsamples examined, and no inspectional evidence is available to indicate the most probable source of the Escherichia coli.

SPECIMEN CHARGE:

The article was adulterated when introduced into, while in, and is adulterated while held for sale after shipment in interstate commerce, within the meaning of said Act 21 U.S.C. 342(a)(4) in that the food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth.

NOTES:

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

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

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

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

Nut Meats

When Escherichia coli MPN of at least 0.36 per gram (IMVIC confirmed) is found in one or more subsamples, and inspectional evidence is available which would indicate the most probable source of the Escherichia coli.

Cases referred to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)* will be reviewed to determine if a 21 U.S.C. 342(a)(3) charge can be supported.

*Material between asterisks is new or revised.*

Issued: 10/1/82
Revised: 12/2/88, 3/95

Sec. 570.500 Pistachio Nuts - Aflatoxin Adulteration (CPG 7112.08)

BACKGROUND AND POLICY:

At the request of spokesmen for the importers of pistachio nuts and with concurrence by FDA and USDA (formerly CPG 7155a.11), USDA will carry out the sampling and aflatoxin testing for imported pistachio nuts. Neither USDA nor FDA has a formal agreement with the pistachio importers and the program will be conducted on a voluntary basis. This program does not preclude sampling by the field districts on an objective basis. When sampling on an objective basis, notify USDA of pistachio nuts being detained.

Domestic and imported pistachio nuts will be analyzed for aflatoxin in accordance with the applicable methods outlined in the current edition of the Official Methods of Analysis of the Association of the Official Analytical Chemists and supplements (at the time of this transmittal, Fourteenth Edition, section 26.067 or 26.068).

NOTE: Also refer to Sec. 570.425 (CPG 7112.05), Tree Nuts - Adulteration Involving Rejects (Insect Infestation, Moldy, Rancid, Otherwise Decomposed, Blanks and Shriveled). Determination of a violation based on reject criteria set forth in Sec. 570.425 (formerly CPG 7112.05) may alleviate the necessity to conduct a chemical analysis for aflatoxin.

In-Shell Lots (Domestic and Import)

Shell and Kernel Analysis: The entire sample, shells and kernels, is ground and examined by the applicable method. Aflatoxin content will be calculated on a kernel weight basis.*

Shelled Lots (Domestic and Import)

The entire sample, including kernels which are obviously inedible, is ground and examined by the applicable method.

REGULATORY ACTION GUIDANCE:

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

Lots in Domestic Status

*Recommend legal action when:

1. Original and check analysis show aflatoxin above 20 ppb;

and

2. Identity of aflatoxin B1 is confirmed by chemical derivatives.

NOTE: When the original analysis shows 100 ppb or more of aflatoxin, the dealer may be asked to hold the lot pending check and confirmatory analysis.

Imports - Detention

Detain when the original and check analysis show aflatoxin above 20 ppb.

NOTE: The sample must be of sufficient size to provide for the confirmatory test should it become necessary.

*Material between asterisks is new or revised*

Issued: 10/1/82
Revised: 5/15/86, 3/95

Sec. 570.550 Reconditioning - Tree Nuts Contaminated with E. coli (CPG 7112.09)

BACKGROUND:

We occasionally receive requests for reconditioning of tree nuts contaminated with E. coli by gas infusion with propylene oxide. This is not an acceptable means of reconditioning products contaminated with E. coli.

Our experience in inspecting tree nut processors has led us to the conclusion that if nuts are handled properly, following good sanitation procedures, E. coli should not be present. The presence of E. coli in tree nuts is an indication that the nutmeats were processed under insanitary conditions and constitutes a violation of sections 402(a)(3) and 402(a)(4) of the act. The only way to bring such nuts into compliance E. coli and* physically remove the filth, such as by washing with water containing sufficient chlorine to prevent the multiplication of the bacteria while the nuts are wet and subject to bacterial growth.

POLICY:

Killing of E. coli in tree nuts by gas infusion or other means is not acceptable as a method of reconditioning, because the E. coli is an indicator of the presence of fecal material and/or of insanitary processing conditions *which must also be remedied.*

Acceptable means of reconditioning must *address removal of the filth from the nuts as well as killing of the E. coli.*

*Material between asterisks is new or revised.*

Issued: 10/1/80
Revised: 12/9/88

Sec. 570.700 Mixed Nuts - Misbranding Involving Food Standards (CPG 7112.06)

REGULATORY ACTION GUIDANCE:

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

The average of the subsamples (see note) examined deviates from the standards with respect to one or more of the individual factors listed below; and the number of subs out of compliance, for each such deviation, equals or exceeds the number required for action (Table I on page 2).

1. The weight of any one nut ingredient is less than 2% of the total net weight found - 164.110(a).

2. The weight of a nut ingredient is more than 80% of the total net weight found - 164.110(a).

3. The weight of a nut ingredient exceeds 50% of the total net weight found and the label does not state this fact - 164.110(d).

4. The percent weight of a nut ingredient (computed on the basis of the total net weight found) exceeds the labeled declaration (e.g. 60% peanuts) - 164.110(d).

5. Fill of container is less than 85% of container volume - 164.120(c).

NOTE: A sample consists of 24 containers with a net weight declaration of 16 ounces or less; or at least 24 lbs. of mixed nuts consisting of containers bearing a net weight declaration of more than 16 ounces, where each container is considered a subsample.

TABLE 1 

Container
labeled declaration        No. of Subsamples     No. of Subsamples
(pounds)  to be examined         required for legal action

1 or <       24        17
1 1/8        23        16 
1 1/4        18        13
1 1/2        16        12
1 3/4        14        11
2            12        10
2 1/4        11        09
2 1/2        10        08
2 3/4        09        08
3            08        07
3 1/4        08        07
3 1/2        07        06

*Material between asterisks is new or revised*

Issued: 11/07/79
Reissued: 10/1/80
Revised: 12/2/88, 3/95

Sub Chapter 575

Pesticides

Sec. 575.100 Pesticide Residues in Food and Feed - Enforcement Criteria (CPG 7141.01)

BACKGROUND:

The regulation of food and feed containing pesticide residues is governed by sections 402, 408, and 409 of the Federal Food, Drug, and Cosmetic Act (FFDCA) as set forth in the following:

Tolerances for Pesticides:

Section 408 of the FFDCA authorizes the Environmental Protection Agency (EPA) to establish a tolerance for the maximum amount of a pesticide residue that may be legally present in or on a raw agricultural commodity. This section also authorizes EPA to exempt a pesticide residue in a raw agricultural commodity from the requirement of a tolerance. A tolerance or tolerance exemption is required when EPA grants registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for the use of a pesticide in food and feed production in the United States. Registration of a pesticide is not, however, a prerequisite for establishing a tolerance. For example, EPA may establish a temporary tolerance under section 408(j) to permit the experimental use of a non-registered pesticide, or EPA may establish a tolerance for a pesticide residue resulting from the use of the pesticide in food or feed production in a foreign country.

Tolerances and exemptions from tolerances established by EPA for pesticide residues in a raw agricultural commodities are listed in 40 CFR Part 180.

Food Additive Regulations for Pesticides:

A tolerance or tolerance exemption for a pesticide residue in a raw agricultural commodity also applies to the processed form of the commodity when ready to eat. (See section 402(a)(2)(C) of the FFDCA.) However, if a pesticide is to be used on a processed food or feed, or if conformity with residue present in or on a raw agricultural commodity in conformity with its tolerance under section 408 concentrates during processing to a level when ready to eat that is greater than the tolerance for the raw agricultural commodity, a food additive regulation is required. In either instance, EPA is authorized under section 409 of the FFDCA to establish a food additive regulation for the maximum amount of a pesticide residue that may be legally present in a processed food or feed.

Food additive regulations issued by EPA for pesticide residues in processed food and feed appear in 21 CFR Part 193 and in 21 CFR Part 561, respectively.

Enforcement of Tolerances and Food Additive Regulations for Pesticides:

The Food and Drug Administration (FDA) is responsible for the enforcement of pesticide tolerances and food additive regulations established by EPA. This enforcement authority is derived from section 402(a)(2)(B) and of the FFDCA. Under this section a raw agricultural commodity or a processed food or feed is deemed to be adulterated and subject to FDA enforcement action if it contains either:

- A pesticide residue at a level greater than that specified by a tolerance or food additive regulation; or

- A pesticide residue for which there is no tolerance, tolerance exemption, or food additive regulation.

There are exceptions to FDA enforcing an adulteration charge under section 402 for a pesticide residue in a food or feed that is not subject to a tolerance, tolerance exemption, or food additive regulation. The exceptions include:

- Unavoidable Pesticide Residues: Food or feed may contain a pesticide residue from sources of contamination that cannot be avoided by good agricultural or manufacturing practices, such as contamination by a pesticide that persists in the environment. In the absence of a tolerance, tolerance exemption, or food additive regulation, FDA may establish an "action level" for such unavoidable pesticide residues. An action level specifies the level below which FDA exercises its discretion not to take enforcement action. An action level established by FDA is based on EPA's recommendation, which follows the criteria of Section 406 of the FFDCA. (See 21 CFR Parts 109 and 509 for information on FDA policy and procedures for establishing action levels for unavoidable food and feed contaminants.) Food or feed found to contain an unavoidable pesticide residue at a level that is at or greater than an action level is subject to FDA enforcement action. FDA action levels currently in effect for unavoidable pesticide residues in food and feed are listed in Attachment B.

- EPA Emergency Exemptions: EPA is authorized by section 18 of FIFRA to grant an exemption from the registration requirements for the use of a non-registered pesticide under emergency conditions. (See 40 CFR Part 166.) Neither FIFRA nor the FFDCA have explicit provisions for establishing an "emergency tolerance" for a pesticide residue resulting from an emergency exemption granted-by EPA for food or feed use. Under a formal agreement between the U.S. Department of Agriculture, EPA, and FDA (50 FR 2304), however, EPA will recommend an enforcement level for residues of a pesticide granted an emergency exemption. FDA will use the recommended enforcement level to determine compliance with the FFDCA. (See FDA Field Management Directive No. 136.)

FDA will also consider taking enforcement action for violation of sections 402(a)(2)(B) or 402(a)(2)(C) in the following situations:

- A food or feed contains residues of two or more pesticides of the same chemical class and the total amount of such residues when added together exceeds the lowest numerical tolerance for residues of one of the pesticides found in that class as set forth in 40 CFR 180.3(e)(1). (Note: In applying the criteria in this regulation, the residues to be added together must be at or above the analytical limit of quantitation as specified in the Pesticide Analytical Manual (PAM), Volume I, section 143.21.).

- A processed food or feed was derived from a raw agricultural commodity that contained a pesticide residue that did not conform to an established tolerance or tolerance exemption.

- In the absence of a food additive regulation and in accordance with 21 CFR 170.19 or 21 CFR 570.19, a pesticide residue in a processed food or feed when ready to eat is greater than the tolerance prescribed for the raw agricultural commodity.

Imports:

The requirements of section 402 of the FFDCA apply equally to domestically produced and imported food and feed found to contain pesticide residues. Therefore, even though the use of a pesticide in a foreign country is not subject to EPA registration requirements under FIFRA, a pesticide residue in imported food or feed must be in conformity with a tolerance, tolerance exemption, or food additive regulation established by EPA or, if the pesticide residue is unavoidable, an action level established by FDA.

CRITERIA FOR INITIATING AN ENFORCEMENT ACTION:

1. General Requirements

A district may initiate an enforcement action involving any of the violative situations described in the preceding section, provided each of the following general requirements is met:

a. The sample of food or feed was collected in accordance with instructions provided in the Inspection Operations Manual, Sample Schedule, Chart 3;

b. The portion of food or feed analyzed was in accordance with 40 CFR 180.1(j) or PAM Volume I, section 141, Column b. (Note: Generally, the portion of commodity analyzed will be on a whole commodity basis as set forth in the cited references. In some situations, however, it may be necessary to analyze the edible portion of a commodity for investigative and/or enforcement purposes. The appropriate center is responsible for advising the districts(s) regarding such situations.);

c. An original and check analysis on the amount of residue was performed, and the results obtained from each are in reasonably close agreement based on the pesticide residue, type of food or feed, analytical method, and level of residue;

d. The pesticide residue was measured and the level was calculated in accordance with the residue definition for the applicable tolerance, food additive regulation, or action level;

e. The analytical methods used for the original and check analyses are contained in the PAM, Volume I or II, or the Official Methods of Analysis of the Association of Official Analytical Chemists, or are considered by the appropriate center to be suitable for FDA enforcement purposes; and

f. The identity of the residue in either the original or check analysis sample was confirmed in accordance with PAM, Volume I, section 601.

2. Requirements for Direct Reference Seizure or Import Detention

a. Direct reference seizure for domestic food or feed, or detention of imported food or feed, without prior approval of the appropriate center is authorized provided:

1. The "General Requirements" under section A are met; and

2. The level of pesticide residue found by the original and check analyses exceeds by at least one half the amount specified by either a tolerance (or the limit specified in Attachment A if the pesticide has a zero tolerance), a food additive regulation, or an action level. (Note: Enforcement action may be recommended to the appropriate center whenever the level of pesticide residue exceeds a tolerance or food additive regulation or is below or above an action level, but not by the incremental amount specified. Also, because of the gas chromatographic patterns for chlordane and toxaphene, the above criteria do not apply to residue of these pesticides. In such cases, refer to the guidance in section C below); or

b. Direct reference seizure or detention of imports without prior center approval is also authorized for a pesticide residue finding for which there is no tolerance, tolerance exemption, or food additive regulation, provided:

1. The "General Requirements" under section A are met;

2. There is evidence or other reasons to conclude that the residue could have been avoided by good agricultural or manufacturing practices;

3. The district has had an enforcement action previously approved by the center for the same pesticide residue and the same food or feed;

4. The levels of pesticide residue found by the original and check analyses in the instant case are at or above the level of residue for the previously approved case and the same analytical methodology was used; and

5. The direct seizure referral includes the FDC number of the previous case.

3. Requirements for Recommending an Enforcement Action to a Center:

A district is authorized to submit a recommended enforcement action to the Center for Food Safety and Applied Nutrition's *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)* for a food or to the Center for Veterinary Medicine's Case Guidance Branch (HFV-236) for feed provided:

a. The "General Requirements" in section A are met;

b. The food or feed may be considered actionable under any of the violative situation described in BACKGROUND; and

c. The requirements for direct reference seizure or detention are not met.

A recommendation must be accompanied by all analytical worksheets (including chromatograms) and inspection reports. For a recommendation involving a pesticide residue for which there is no tolerance, tolerance exemption, or food additive regulation, the recommendation must also include the investigational or other evidence that supports the district's conclusion that the pesticide residue could have been avoided by good agricultural or manufacturing practices.

If a district encounters a food or feed that contains an unavoidable pesticide residue, but there is no tolerance or action level, the district should contact the appropriate center for specific guidance. In such cases, it may be necessary for FDA to request that EPA recommend an action level.

SPECIMEN CHARGES FOR DIRECT REFERENCES SEIZURE AND FOR IMPORT DETENTIONS:

For a raw agricultural commodity that contains a pesticide residue in excess of tolerance:

Domestic

The article of food was adulterated when introduced into and while in interstate commerce and is adulterated while held for sale after shipment in interstate commerce within the meaning of 21 U.S.C. 342(a)(2)(B) in that it is a raw agricultural commodity within the meaning of 21 U.S.C. 321(r) which bears an contains a pesticide chemical, namely, which is unsafe within the meaning of 21 U.S.C. 346a since the quantity of such pesticide chemical exceeds the limits of the tolerance granted for the use of such pesticide chemical in or on the article pursuant to 40 CFR 180.

Imports

The article of food is violative within the meaning of 21 U.S.C. 381(a)(3) in that it appears to be adulterated because it contains, ____ a pesticide chemical which is unsafe.

For a raw agricultural commodity that contains a pesticide residue for which there is no tolerance or tolerance exemption:

Domestic

The article of food was adulterated when introduced into and while in interstate commerce and is adulterated while held for sale after shipment in interstate commerce within the meaning of 21 U.S.C. 342(a)(2)(B) in that it is a raw agricultural commodity within the meaning of 21 U.S.C. 321(r) which bears and contains a pesticide chemical, namely, which is unsafe within the meaning of 21 U.S.C. 346a since no tolerance or exemption from a tolerance has been granted for the use of such pesticide chemical on ____.

Imports

The article of food is violative within the meaning of 21 U.S.C. 381(a)(3) in that it appears to be adulterated because it contains, ___ a pesticide chemical which is unsafe.

For a processed food or feed that contains a pesticide residue that is actionable under the situations described in the "BACKGROUND":

Domestic

The article of food was adulterated when introduced into and while in interstate commerce and is adulterated while held for sale after shipment in interstate commerce within the meaning of 21 U.S.C. 342(a)(2)(C) in that it bears and contains, a food additive, which is unsafe within the meaning of 21 U.S.C. 348 since its presence in the article is not in conformity with any regulation or exemption in effect under 21 U.S.C. 348.

Imports

The article of food is violative within the meaning of 21 U.S.C. 381(a)(3) in that it appears to be adulterated because it contains, ____ a food additive which is unsafe.

ENFORCEMENT LEVELS FOR PESTICIDES HAVING A ZERO TOLERANCE

The following table lists the level at which an enforcement action may be considered when residues of these pesticides are found in a commodity that the cited regulation specifies as having a zero tolerance. *The analytical levels are based on the level at which residues of these pesticides can be detected, quantified, and confirmed in the particular commodity.* The enforcement levels specified for raw agricultural commodities also apply to their corresponding processed commodity.

40 CFR Section   Pesticide               Commoditya       Level (ppm) 

* 

180.131          Endrin   Vegetables       0.05 
          Cottonseed       0.05 

180.139          Perthane Milk             0.2 (fat basis) 

180.169          Carbaryl Grains           0.2 

180.174          Tetradifon               Milk             0.4 (fat basis) 

180.190          Diphenylamine            Milk             b 

^a Commodities cited as broad food classes of vegetables and grains are limited to only those specific commodities listed in the regulation as having a zero tolerance.

^b No level can be prescribed at this time due to lack of analytical experience with this pesticide.

FDA ACTION LEVELS FOR UNAVOIDABLE PESTICIDE RESIDUES IN FOOD AND FEED COMMODITIES

INDEX

Pesticide

ALDRIN & DIELDRIN
BENZENE HEXACHLORIDE (BHC)
CHLORDANE
CHLORDECONE (KEPONE)
DDT, DDE, & TDE
DICOFOL (KELTHANE)
ETHYLENE DIBROMIDE (EDB)
HEPTACHLOR & HEPTACHLOR EPOXIDE
LINDANE
MIREX

None of the action levels listed here are binding on the agency, the regulated industry, or the courts. In any given case, FDA may decide to initiate an enforcement action below the action level or decide not initiate an enforcement action if the level is exceeded. A district must contact the appropriate center for a preliminary assessment regarding the use of an action level in a given case.

Unless otherwise a specified, an action level listed for:

1. a raw agricultural commodity (other than grains) may also apply to the corresponding processed food intended for human consumption;

2. grains may also apply to both raw and processed grains intended for human or animal consumption;

3. fish may also apply to shellfish and processed fish intended for human consumption; and

4. processed animal feed may include mixed feeds and feed ingredients.

ALDRIN AND DIELDRIN

The following action levels are for residues of the above pesticides individually or in combination. In adding amounts of aldrin and dieldrin do not count aldrin or dieldrin found at a level below 0.01 ppm for nonfatty foods, 0.1 ppm for fish and 0.1 (fat basis) for milk.

Commodity a      Action Level (ppm) 
Alfalfa          0.03 
Animal feed, processed           0.03 
Artichokes       0.05 
Asparagus        0.03 
Bananas          0.02 
Beets (garden and sugar)         0.1 
Beet tops (garden and sugar)     0.05 
Broccoli         0.03 
Brussels sprouts 0.03 
Bulb vegetables  0.1 
Cabbage          0.03 
Carrots          0.1 
Cauliflower      0.03 
Cereal grains (except buckwheat, millet, 
teosinte, and wild rice)         0.02 
Celerey          0.03 
Clover           0.03 
Collards         0.05 
Cowpea hay       0.03 
Cucumbers        0.1 
Eggplant         0.05 
Eggs             0.03 
Endive (escarole)0.05 
Fats and oils (animal feed)      0.3 
Figs             0.05 
Fish (edible portion)            0.3
Forage, fodder, and straw of cereal 
grains (except those of buckwheat, 
millet, teosinte, and wild rice) 0.3 
Grapefruit       0.02 
Hay              0.03 
Horseradish      0.1 
Kale             0.05 
Kohlrabi         0.05 
Legume vegetables (except guar, 
jackbeans, lablab beans, and lentils)            0.05 
Lemons           0.02 
Lespedeza        0.03
Lettuce          0.03 
Limes            0.02 
Mangoes          0.03 
Melons           0.1 
Milk (fat basis) 0.03
Mustard greens   0.05 
Oranges          0.02 
Parsnips         0.1 
Pea              0.03 
Peaches          0.02 
Peanuts          0.05 
Peanut hay       0.03 
Peppers          0.05 
Pimentos         0.05 
Pineapple        0.03 
Pome Fruits (except crabapples and loquats)      0.03 
Potatoes         0.1 
Radishes         0.1 
Radish tops      0.03 
Rutabagas        0.1 
Salsify roots    0.1 
Salsify tops     0.05 
Small fruits and berries         0.05 
Soybean hay      0.03 
Spinach          0.05 
Squash           0.1 
Stone fruits (except Chickasaw, 
Damson, and Japanese plums, 
and peaches)     0.03 
Sugarbeet pulp (animal feed)     0.1 
Sweet potatoes   0.1 
Swiss chard      0.05 
Tangerines       0.02 
Tomatoes         0.05 
Turnips          0.1 
Turnip tops      0.05 

a Action levels for crop groups cover all commodities specified in 40 CFR 108.34(f), except where an exception is noted.

BENZENE HEXACHLORIDE (BHC)

The following action levels 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 0.02 ppm in milk and rabbits, and 0.01 ppm for all other commodities listed. Do not count beta BHC at a level below 0.05 ppm for milk and rabbits, and 0.02 ppm for all other commodities listed.

Commodity a        Action Level (ppm) 

Alfalfa               0.03
Animal feed, processed0.05
Apples0.05
Asparagus             0.05
Avocados              0.05
Beans 0.05
Brassica (cole) leafy vegetables (except 
broccoli raab, rape greens)           0.05
Celery0.05
Carrots               0.3 
Cereal grains (except Balsam pears,   0.05
Chinese waxgourds, gherkins, gourds) 
Citrus Fruits         0.05
Cocoa Beans           0.5
Cucurbit vegetables (except Balsam,   0.05
  pears, Chinese waxgrounds, gherkins,
  gourds)
Eggplant              0.05 
Eggs  0.05
Endive0.05
Figs  0.05
Frog legs (edible portion)            0.3 
Guavas0.05
Hay   0.03
Horseradish           0.1
Kale  0.05
Legume vegatables (exceptguar,
 jackbeans, lablab beans, and lentils)0.05
Lemons0.05
Lespedeza             0.03
Lettuce               0.03 
Limes 0.05
Mangoes               0.05
Milk (fat basis)      0.03 
Okra  0.05
Onions0.05
Paprika               1.0 
Pears 0.05
Peas  0.05
Pecans0.05
Peppers               0.05
Pineapples            0.05
Quices0.05
Rabbits (fat basis)b  0.3 
Root and tuber vegetables
 (except carrots)     0.05
Small fruits and berries              0.05
Spinach               0.05
Swiss chard           0.05
Stone fruits (except Chickasaw, 
Damson, and Japanese plums)           0.05
Tomatoes              0.05
Turnip greens         0.05

^a Action levels for crop groups cover all commodities specified in 40 CFR 180.34(f), except where an exception is noted.

^b For rabbits that contain insufficient fat to conduct an analysis on a fat basis, analyze the rabbits on a whole product basis (edible portion) and use 0.1 ppm, the limit of determination, as the action level.

CHLORDANE

The following action levels are for residues of chlordane, including cis and trans chlordane, cis and trans nonachlor, oxychlordane, alpha, beta, and gamma chlordane and chlordane. Levels of individual components must be quantitated at 0.02 ppm or above and confirmed in order to be added into the "chlordane" total value. See analytical note below.

Commodity a         Action Level (ppm) 

Animal fat, rendered0.3 
Animal feed, processed              0.1 
Asparagus           0.1 
Bananas             0.1 
Beans               0.1 
Beets (with or without tops)        0.1 
Beets greens        0.1 
Brassica (cole) leafy vegetables (except
broccoli,raab, Chinese mustard 
cabbage, and rape greens)           0.1 
Carrots             0.1 
Celery              0.1 
Citrus fruits       0.1 
Corn0.1 
Cucumbers           0.1 
Eggplant            0.1 
Fish (edible portion)               0.3 
Lettuce             0.1 
Melons              0.1 
Okra0.1 
Onions              0.1 
Papayas             0.1 
Parsnips            0.1 
Peanuts             0.1 
Peas0.1 
Peppers             0.1 
Pineapple           0.1 
Pome fruits (except crabapples 
  and loquats)      0.1 
Potatoes            0.1 
Radishes            0.1 
Radish tops         0.1 
Rutabagas (with or without tops)    0.1 
Rutabaga tops       0.1 
Small fruits and berries 
 (except cranberries, 
 currants, elderberries,
 gooseberries, and 
olallie berries)    0.1 
Spinach             0.1 
Squash              0.1 
Stone fruits (except, Chickasaw, Damson, 
and Japanese plums) 0.1 
Sweet potatoes      0.1 
Swiss chard         0.1 
Tomatoes            0.1 
Turnips (with or without tops)      0.1 
Turnip greens       0.1 

a Action levels for crop groups cover all commodities specified in 40 CFR 180.34(f), unless
an exception is noted. 
Analytical Note: 

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 chlordane and chlordane), 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.

CHLORDECONE a

Commodity     Action Level (ppm) 

Crabmeat       0.4 

Fish           0.3 

^a The trade name for chlordecone is Kepone.

DDT, TDE, and DDE

The following action levels are for residues of the above pesticides of the above pesticides individually or in combination. However, in adding amounts of DDT, TDE, and DDE do not count any of the three found below 0.02 ppm for non-fatty food and 0.2 ppm for fish, eggs, and grains.

Commodity a            Action Level (ppm) 

Animal feed, processed  0.5
Artichokes              0.5 
Asparagus               0.5 
Avocados0.2 
Beets (roots and tops)  0.2 
Brassica (cole) leafy vegetables
(except broccoli, raab, Chinese
mustard cabbage, and rape greens)       0.5 
Carrots 3 
Cereal grains (except buckwheat,
fresh sweetcorn, millet, popcorn,        
teosinte, and wild rice)0.5 
Celery  0.5 
Citrus fruits           0.1 
Cocoa beans             1 
Corn, fresh sweet       0.1 
Cottonseed              0.1 
Cucumbers               0.1 
Eggplant0.1 
Eggs    0.5
Endive (escarole)       0.5 
Fish (edible portion)   5
Grapes  0.05 
Guavas  0.2 
Hay     0.5 
Hops    0.1 
Legume vegetables (except guar,
jackbeans, lablab beans, and lentils    0.2 
Lettuce 0.5 
Mangoes 0.2 
Melons  0.1 
Milk (fat basis)        1.25
Mushrooms               0.5 
Okra    0.2 
Onions (dry bulb)       0.2 
Papayas 0.2 
Parsnips (roots and tops)               0.2 
Peanuts 0.2 
Peppermint hay          0.5 
Peppermint oil          1 
Peppers 0.1 
Pineapples              0.2 
Pome fruits (except crabapples and 
loquats)0.1 
Potatoes1 
Radishes (roots and tops)               0.2 
Rutabagas (roots and tops)              0.2 
Small fruits and berries (except 
 elderberries, grapes, and 
 olallie berries)       0.1 
Soybean oil (crude)     1 
Spearmint hay           0.5 
Spearmint oil           1 
Spinach 0.5 
Squash  0.1 
Stone fruits (except Chickasaw,          
Damson, and Japanese plums)             0.2 
Sweet potatoes          1 
Swiss chard             0.5 
Tomatoes0.05 
Tomato pomace           0.5 
Turnips (roots and t    0.2 

^a Action levels for crop groups cover all commodities specified in 40 CFR 180.34(f), except where an exception is noted.

DICOFOL ^a

Commodity               Action Level (ppm) 

Animal feed, processed               0.5 

^a The trade name for dicofol is Kelthane.

ETHYLENE DIBROMIDE (EDB)

Commodity               Action Level (ppb) 

Grain Products 

Intermediate (milled) grain products         150 
(must be cooked prior to consumption) 
Examples: flour, cake mix, pancake mix, 
corn meal, grits, quick grits, oatmeal, 
instant oatmeal, hominy, brown and 
serve rolls, frozen bread dough 
Ready-to-eat (cooked) products               30 
(require no cooking prior to consumption) 
Examples: bread, cakes, pancakes, corn 
bread, hushpuppies, cooked grits, cooked 
oatmeal, cooked hominy, crispy rice 
cereal, wheat flakes cereals, puffed 
oats, corn oil 
Honey 
Ready-to-eat 
(will not undergo further processing         30 

prior to consumption) 

HEPTACHLOR AND HEPTACHLOR EXPOXIDE

The figures below are for residues of the above pesticide and its metabolite individually or in combination. However, do not count heptachlor or heptachlor epoxide found at a level below 0.1 ppm for fish, 0.05 ppm (fat basis) for milk, and 0.01 ppm for nonfatty foods.

Commodity a         Action Levels (ppm) 

Animal feed, processed0.01
Artichokes            0.01 
Asparagus             0.01 
Brassica (cole) leafy vegetables      0.01 
Bulb vegetables       0.01 
Cereal grains         0.01 
Citrus fruits         0.01 
Cottonseed            0.02 
Cucurbit vegetables   0.02 
Eggs  0.01 
Figs  0.01 
Fish (edible portion) 0.3 
Fruiting vegetables   0.01 
Grass forage, fodder, and hay         0.01 
Leafy vegetables (except Brassica)    0.01 
Legume vegetables     0.01 
Milk (fat basis)      0.3
Non-grass animal feeds0.01 
Peanuts               0.01 
Pineapple             0.02 
Pome fruits           0.01 
Rabbit (fat basis)*b  0.2 
Root and tuber vegetables             0.01 
Salsify tops          0.01 
Small fruits and berries              0.01 
Stone fruits          0.01 
Sugarcane             0.01 

a Action levels for crop groups cover all commodities specified in 40 CFR 10.34(f). 

^b For rabbits that contain insufficient fat to conduct an analysis on a fat basis, analyze the rabbits on a whole product basis (edible portion) and, assuming 10 percent fat content, use 0.02 ppm as the action level.

LINDANE

Commodity       Action Level (ppm) 

Animal feed, processed          0.1 
Artichokes      0.5 
Barley          0.1 
Beans           0.5 
Citrus fruits a0.5 
Cocoa beans, whole raw bean     0.5 
Corn, fresh sweet               0.5 
Corn            0.1 
Eggs            0.5 
Endive          0.5 
Figs            0.5 
Hay             0.1 
Milk (fat basis)0.3
Oats            0.1 
Peas            0.5 
Rice            0.1 
Root vegetables a,b              0.5 
Rye             0.1 
Small fruits a,b 0.5 
Sorghum (milo)  0.1 
Turnip greens   0.5 
Wheat           0.1 

a Refer to 40 CFR 180.34(f) for commodities covered by this food group. 
b Other than those commodities specified in 40 CFR 180.133. 

MIREX

Commodity        Action Level (ppm) 

Fish (edible portion)             0.1 

Material between asterisks is new or revised.*

Issued: 9/15/86
Revised:4/1/87, 8/25/89, 3/95

Sub Chapter 578

Processed Grains

Sec. 578.100 Starches - Common or Usual Names (CPG 7104.01)

BACKGROUND:

No standards of identity have been promulgated for food starches.

The United States Pharmacopeia XVII contains a monograph on starch which includes this definition: "Starch consists of the granules separated from the mature grain of Zea Mays, Linne (Fam. Gramineae)". This is followed by a description of the starch granules, and by purity specifications.

In the past the Food and Drug Administration has taken the position that starch meeting the U.S.P. specification is considered acceptable for food use.

Modified food starches are subject to the Food Additives Amendment and regulations have been promulgated for "food starch - modified."

POLICY:

In the absence of a standard of identity, starch meeting the specification of the United States Pharmacopeia is acceptable for food use.

For purposes of labeling in accordance with Section 403(i) of the Federal Food, Drug, and Cosmetic Act, and Section 4(a)(1) of the Fair Packaging and Labeling Act, the term "starch" is considered the common or usual name for starch made from corn; alternatively, the name "cornstarch" may be used.

Starches from other sources should be designated by some non-misleading term that indicates the source of such starch, for example, "potato starch," "wheat starch," or "tapioca starch."

The term "arrowroot" is the common or usual name for starch obtained from Maranta arundinacea L.

If the word arrowroot is used to designate similar starches obtained from other plant sources it should be qualified by some term indicating the source.

A regulation has been promulgated to prescribe safe conditions of use for "food starch-modified" (21 CFR 172.892). This regulation requires that the label shall bear the name of the additive "food starch-modified." This name should be used to designate this additive on labels of fabricated foods in which it is used as an ingredient.

Issued: 10/1/80

Sec. 578.200 Corn Meal - Adulteration by Insect and Rodent Filth (CPG 7104.02)

REGULATORY ACTION GUIDANCE:

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

1. Insects - The corn meal contains an average of 1 or more whole insects or equivalent/50 gms. (0.5 or more whole insects or equivalent/25 gms.);

or

2. Insect fragments - The corn meal contains an average of 25 or more insect fragments/25 gms.;

or

3. Rodent hair - The corn meal contains an average of 1 or more rodent hairs/25 gms.;

or

4. Rodent excreta - The corn meal contains an average of 1 or more rodent excreta fragments/50 gms.

SPECIMEN CHARGE:

*The article was adulterated (when introduced into) (while in) (while held for sale after shipment in interstate commerce within meaning of 21 U.S.C. 342(a)(3), in that it consists in part of a filthy substance by reason of the presence therein of insects, insect fragments, rodent hairs, and rodent excreta fragments, as applicable.

NOTES:

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

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

*Material between asterisks is new or revised.*

Issued: 10/11/79
Revised: 10/1/80, 6/6/88

Sec. 578.300 Wheat - Adulteration by Insect and Rodent Filth (CPG 7104.03)

REGULATORY ACTION GUIDANCE:

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

1. Insect filth - The wheat contains an average of 32 or more insect damaged kernels per 100 gms;

or

2. Rodent excreta - The wheat contains an average of 9 mg or more rodent excreta pellets and/or fragments of rodent excreta pellets per kg;

or

3. Plugging - There is clear-cut evidence of uneven loading or plugging, and wheat from any identifiable portion of the load meets the above criteria for insect damaged kernels or rodent excreta pellets.

SPECIMEN CHARGE:

*The article was adulterated (when introduced into) (while in) (while held for sale after shipment in) interstate commerce within the meaning of 21 U.S.C. 342(a)(3), in that it consists in part of a filthy substance by reason of the presence therein of insect damaged wheat kernels, insects, insect fragments, rodent hairs, and rodent excreta fragments, as applicable.

NOTES:

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

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

*Material between asterisks is new or revised.*

Issued: 10/11/79
Revised: 10/1/80, 6/6/88

Sec. 578.350 Wheat for Human Consumption - Reconditioning (CPG 7104.04)

REGULATORY ACTION GUIDANCE:

1. Insect Infested Wheat

Reconditioning will be considered adequate when macroscopic examination of representative samples reveals an average of no more than 0.4% insect damaged kernels.

2. Rodent Excreta Pellet Contaminated Wheat

Reconditioning will be considered adequate when all the following conditions are met:

a. Not more than one pellet is found upon examination of 20 representative pints.

b. The wheat has been scoured to the extent that examination of representative samples reveals that 50% or more of the kernels show removal of the surface seed coat layers down to the cross cell layer (removal of approximately 20% of the kernel) and practically all the beard is gone.

c. Examination of representative samples shows no Salmonella organisms to be present; evidence proves the wheat has been heat treated in such a manner as to insure killing any Salmonella organisms present.

Issued: 10/1/80

Sec. 578.400 Treated Grain Seed - Mercury Residue (CPG 7104.05)

REGULATORY ACTION GUIDANCE:

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

The wheat contains an average of 10 or more pink kernels per 500 grams, and the mercury residue on the pink kernels exceeds one part per million.

SPECIMEN CHARGE:

Article adulterated when introduced into and while in interstate commerce, within meaning of 21 U.S.C. 342(a)(2)(B), in that it is a raw agricultural commodity and contains a pesticide chemical, namely, a mercurial compound, which is unsafe within meaning of 21 U.S.C. 346a(a), since no tolerance and no exemption from the requirement of a tolerance for such pesticide chemical on wheat has been prescribed by regulations promulgated pursuant to 21 U.S.C. 346a(b).

Issued: 10/1/80

Sec. 578.450 Wheat Flour - Adulteration with Insect Fragments and Rodent Hairs (CPG 7104.06)

REGULATORY ACTION GUIDANCE:

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

Examination of six 50 gram subsamples shows:

*

1. Insect fragments - an average of 75 or more insect fragments per 50 grams;*

or

2. Rodent Hairs - an average of 1.0 or more rodent hair per 50 grams.

*NOTE: These criteria do not apply to flour prepared from durum and/or red durum wheats.*

SPECIMEN CHARGE:

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

NOTES:

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

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

*Material between asterisks is new or revised.*

Issued: 10/1/80
Revised: 12/31/87

Sec. 578.500 Dimethylnitrosamine in Barley Malt (CPG 7104.07)

BACKGROUND:

In 1978, German researchers reported finding low levels of dimethylnitrosamine (DMNA) in beer. Subsequent studies provided evidence that the DMNA found in beer was derived from the barley malt used for making beer and other malt beverages.

Barley malt is produced by moistening barley with water, allowing it to germinate, and then drying (kilning) the barley to reduce the moisture content to about 4%. DMNA may be formed during the drying process as a result of a reaction between amines, which are naturally present in the barley, and a nitrosating agent, such as nitrogen oxides (NOx), which may be present in the air or may be formed during combustion of the fuel used for firing.

The addition of sulfur when direct fire is used for drying has been shown to reduce DMNA formation. Studies also have indicated that the use of indirect fire during kilning generally results in nondetectable levels of DMNA. This finding may be correlated with the fact that, during indirect firing, the combustion products do not come in contact with the amines as they would when an open flame or direct fire is used. However, the use of indirect fire does not always ensure elimination of DMNA in the malt. Evidence indicates that even when indirect fire is used, DMNA may be derived from the ambient air. This problem has been reported by malt producers who use indirect fire and are located in industrial areas.

A survey of all known malt producers in the U.S. was conducted in 1980. Data from the survey provided evidence that within the technology available to the industry at the time of the survey, barley malt containing less than or equal to 10 ppb DMNA could be produced. Therefore, DMNA in barley malt at levels greater than 10 ppb is considered avoidable contamination under section 406 of the Federal Food, Drug, and Cosmetic Act. The action level of 10 ppb DMNA in barley malt applies to all barley malt produced after October 1, 1980.

REGULATORY ACTION GUIDANCE:

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

Actionable if a composite of 10 subsamples of finished product barley malt contains greater than 10 ppb dimethylnitrosamine and the presence of dimethylnitrosamine is confirmed by mass spectrometry.

NOTE: Refer to IOM sample schedules for "Pesticides Sampling" (Chart 3) and "Wheat Carload Sampling" (Chapter 4) for sampling instructions.

See Sec. 510.600 (for CPG 7101.07) for action level for DMNA in malt beverages.

*Material between asterisks is new or revised.*

Issued: 6/1/76
Revised: 10/1/80, 6/6/88, 3/95

Sec. 578.600 Unapproved Additives for Exported Grains (CPG 7104.08)

BACKGROUND:

It has come to our attention that gentian violet has been added to grains shipped to certain countries that require coloring (or decharacterizing such as crushing or grinding) of imported feed grains. Gentian violet is not permitted as a color in food or feed in the United States. Studies at the National Center for Toxicological Research have shown gentian violet to be a carcinogen for laboratory animals.

USDA's Federal Grain Inspection Service issued guidelines to its field offices, advising them to contact FDA field offices when they learn that an exporter wants to add food or color additives to grain.

POLICY:

Because of our concern about the lack of safety of gentian violet as well as other unapproved additives for use on grains, we will insist on evidence from the exporter that the conditions of section 801(d) of the FD&C Act are met. Evidence that the product is not in conflict with laws of the foreign country [section 801(d)(1)(B)] must be in writing from the appropriate foreign government regulatory agency or their embassy in the United States. Contact the Division of Compliance (HFV-230), Center for Veterinary Medicine, for guidance regarding grain intended for animal use or Center for Food Safety and Applied Nutrition *(HFS-605)*, for guidance regarding grain for human food if there is a question regarding the safety of the substance being added to the grain.* If the Center(s) believes that additional information regarding hazards should be provided to the foreign government, or that exportation is hazardous to the public health and safety, it will consult with the Office of Regulatory Affairs.

*Material between asterisks is new or revised*

Issued: 2/1/84
Revised: 6/6/88, 3/95

Sub Chapter 580

Storage

Sec. 580.100 Food Storage & Warehousing - Adulteration - Filth (Domestic and Import) (CPG 7103.01)

REGULATORY ACTION GUIDANCE - DOMESTIC:

The following represents criteria for direct reference seizure to *Chief Counsel* through Division of Compliance Management and Operations (HFC-210) and for direct citation by district offices of foods for human consumption if the foods are not reconditioned by sampling, when one of the following conditions is met:

NOTE: Refer to Sec. 690.600 (for CPG 7126.38) for guidance regarding rodent contamination of pet food. All animal food cases involving insect, rodent or bird 402(a)(3), or 402(a)(4) contamination should be referred to Division of Compliance, CVM (HFV-236) for concurrence.

A. Rodent Contamination

1. The storage facility is rodent infested and:

a. Three or more of the bags in the lot are rodent gnawed;

or

b. At least five of the bags in the lot bear either rodent urine stains at least 1/4 inch in diameter, or two or more rodent pellets;

or

c. The food in at least one container in the lot contains rodent-gnawed material, or rodent excreta or urine.

2. Whether or not the warehouse is rodent infested,

a. At least three bags bear rodent urine stains of at least 1/4 inch diameter which penetrate to the product even though the product cannot be demonstrated to have been contaminated;

or

b. At least two bags are rodent gnawed and at least five bags bear either rodent urine stains at least 1/4 inch in diameter, with or without penetration to the product, or two or more rodent pellets;

or

c. The food in at least one bag in the lot contains rodent-gnawed material or rodent excreta or rodent urine, and at least five bags bear either rodent urine stains at least 1/4 inch in diameter or two or more rodent pellets.

B. Insect Contamination

NOTE: The criteria involving dead insects only should not be used to seize any food if the food will undergo further processing which will effectively remove all the dead insects present (For example: cocoa beans).

1. The product contains:

a. One live insect in each of two or more immediate containers; or, one dead insect in each of three or more immediate containers; or, three live or dead insects in one immediate container;

plus

b. Similar live or dead insect infestation present on, or in the immediate proximity of, the lot to clearly support a charge under Section 402(a)(4).

or

2. The product contains one or more live insects in each of three or more immediate containers.

or

3. The product contains two or more dead whole insects in at least five of the immediate containers. NOTE: This situation may follow fumigation and vacuuming of the exteriors of the bags of a lot.

or

4. The product is in cloth or burlap bags and two or more live or dead insects are present on at least five of the containers.

NOTE: Some live insects must be present. Product need not be shown to have become contaminated.

C. Bird Contamination

If product is in permeable containers (paper, cloth, burlap, etc.),

and

1. The product contains bird excreta in one or more containers, and the insanitary storage conditions clearly support a charge under Section 402(a)(4);

or

2. Bird excreta is present on the exteriors of at least five of the containers, and the product contains bird excreta in one;

or

3. At least 30% of the number of the bags examined, but at least five bags, are contaminated with bird excreta; and at least three of the bags bear excreta stains which penetrate to the product, even though the product cannot be demonstrated by chemical analysis to have been contaminated.

NOTE: Bird excreta must in all instances be confirmed by positive test for uric acid.

REMARKS:

When the evidence clearly shows contamination after receipt in interstate commerce, and a 342(a)(4) charge is made, insert the following sentence at the end of the "Examination shows ..." paragraph:

"The evidence does not show article was adulterated when introduced into interstate commerce." If there is doubt whether the adulteration occurred before or after shipment, omit this sentence but still charge that the article was adulterated while held for sale after shipment in interstate commerce. If the evidence shows that rodents have gnawed through all layers of some of the bags and into the food, charge 342(a)(3), as shown in the attached specimen charge. If the gnawing is not shown to be all the way through the bags, then show in the Examination paragraph that the article is held in rodent-gnawed bags and charge under 342(a)(4) only. Likewise, if rodent urine, rodent excreta pellets, bird excreta or insects are observed in the food itself, charge 342(a)(3). If they are observed on the outsides of the bags but cannot be found in the food, show in the Examination paragraph that the article is held in bags contaminated with rodent urine, rodent pellets or bird excreta, or in insect-infested bags, and charge under 342(a)(4) only.

SPECIMEN CHARGE:

Article adulterated while held for sale after shipment in interstate commerce, within the meaning of 21 U.S.C., as follows:

-342(a)(3) in that it consists in part of a filthy substance by reason of the presence therein of rodent urine and rodent excreta pellets; and

-342(a)(4) in that it has been held under insanitary conditions whereby it may have become contaminated with filth.

or

Article adulterated while held for sale after shipment in interstate commerce, within the meaning of 21 U.S.C. 342(a)(4) in that it has been held under insanitary conditions whereby it may have become contaminated with filth.

CRITERIA FOR PROSECUTION:

NOTE: This authority is delegated to the District Director or in his absence to the authorized Acting Director and may not be re-delegated.

1. The inspection or inspections on which the prosecution recommendation is based shows substantial insect, rodent or bird infestation of the warehouse;

and

2. Samples of lots from at least two different interstate shippers are found to contain insects, bird excreta, rodent gnawed food, rodent excreta, or rodent urine in the food itself. This does not mean one insect infested lot and one rodent infested lot. If the area is rodent infested there must be two rodent infested lots; if bird infested, two bird infested lots; or if insect infested, two insect infested lots. On insect infested lots, there must be insects of the same species in both lots;

and

3. At least one responsible individual is included in the prosecution recommendation;

and

4. There is substantial evidence to show that each individual included in the prosecution commendation has authority to prevent or correct violative conditions found;

and

5. There is a background showing prior notification of the firm and all individuals included in the prosecution recommendation for similar insanitary conditions prior to the last inspection on which the prosecution is based.

REMARKS:

If the firm or any individual included in the prosecution recommendation has been previously prosecuted for violation of the Federal Food, Drug, and Cosmetic Act, a second offense must be charged (by indictment) if the case is referred directly to General Counsel. If the district thinks a second offense should not be charged the case should not be referred to General Counsel but should be forwarded to CFSAN/Office of Field Programs/Division of Enforcement (HFS-605) in the usual manner.

There will, of course, be cases which do not meet the above criteria but which will warrant prosecution. In such cases, if the district thinks prosecution is warranted, forward all information to CFSAN/Office of Field Programs/Division of Enforcement (HFS-605) by the usual procedure for recommending prosecution.

REGULATORY ACTION GUIDANCE - IMPORT:

Detain import foods on the basis of the domestic criteria in this guideline only when associated with insanitary storage conditions on the dock, except for live insects.

NOTE: Mites, aphids, psocids, and thrips must be reported separately from usual storage insect contamination and are not applicable to this CPG.

Live Insect Contamination

Detain whether or not the present storage facility is insect infested if the product contains:

1. One live insect in each of two or more immediate containers;

or

2. Three live insects in one immediate container.

NOTE: Where there are insanitary storage conditions on the dock or live infestationm in or on the product, disregard any existing DAL or other guidelines level for the product. When field insect filth (other than live insects) is found in a product, use the defect action levels (DALs) to determine whether or not to detain the shipment. If there is no applicable DAL for the specific product in question or the evidence suggests stored product insect filth, facsimile worksheets to CFSAN/Office of Field Programs/Division of Enforcement (HFS-605) to determine if detention action should be taken.

*Material between asterisks is new or revised*

Issued: 10/1/80
Revised: 7/1/83, 3/1/86, 3/95, 8/96