Recent Posts

Phthalates

Phthalates

Phthalates, or phthalate esters, are esters of plastic. They are mainly used as plasticizers, i.e. substances added to plastics to increase their flexibility, transparency, durability, and longevity.

Heavy Metals

Heavy Metals

The World Health Organization lists Cadmium, Mercury, Arsenic and Lead as highly poisonous major public concerns.

Macronutrients

Macronutrients

What are they?
Macronutrients are dietary elements required in large amounts for growth and development. These include Protein, Fat, Fiber and Carbohydrates. Macronutrients contain Micronutrients such as Vitamins, Minerals and Amino Acids.

Pet food products list guaranteed analyses on their package labels. In theory, these are accurate, or close to accurate. However, Protein and Fat are listed in minimum quantities. For example, if Protein says it’s 25% minimum, it could be 80% and still be in compliance. Fat is listed as a maximum, and carbohydrates are not required to be listed at all on your pets food nutrient analysis.

Register or Login to see Macronutrient results

DNA Analysis & Cross-Contamination

DNA Analysis & Cross-Contamination

What is DNA Analysis?DNA Analysis is a determination of cross-contamination or missing DNA containing ingredients. DNA is found in meat proteins such as chicken, pork, beef, insects, rodents, dogs, cats, etc. DNA is also found in fruits, vegetables, grains, legumes, nuts and seeds. DNA is […]

Minerals

Minerals

Nutritional Minerals are essential nutrients that perform functions necessary for life, such as Calcium, Phosphorus, Potassium, Sodium and Magnesium.

Phytic Acid

Phytic Acid

What is it?
Phytic Acid, also known as Phytates, are commonly found in plant seeds. This is a naturally occurring chemical that works as a protective mechanism to the plant, allowing it grow and not be over-consumed by animals. While Phytic Acid has some anti-oxidant effects, it also binds to Calcium, Iron, Zinc, and other nutrients, thus preventing their absorption and in use the body. This can lead to nutritional deficiencies.

Foods that are highest in phytic acid are soy, pinto beans, navy beans, kidney beans and peanuts though other beans, seeds, nuts and grains may be high in phytates as well.

Register or Login to see Phytic Acid results

Veterinary Drug Residue

Veterinary Drug Residue

Vet Residues include hormones, antibiotics, steroids, and pentobarbital (euthanasia drugs). We test for 90 pet residues in foods.

Pathogens

Pathogens

What are Pathogens?

BPA

BPA

What is BPA?
Also known as bisphenol A, BPA is a chemical found in containers that store food and beverages. Research shows that BPA can seep into food or beverages from containers that are made with BPA. BPA has been linked to negative health effects on the brain, behavior and prostate gland. It has also been linked to high blood pressure.

Register or Login to see BPA results

B-Vitamins

B-Vitamins

B-Vitamins play an important role in metabolic reactions for energy production, red blood cell production, and regulation of mood.

Aflatoxins

Aflatoxins

Aflatoxins are poisonous, cancer-causing chemicals produced by certain molds which grow in soil, decaying vegetation, hay and grains. They have been the cause of numerous pet food recalls historically.

Vitamin D

Vitamin D

What is Vitamin D?
Vitamin D is a fat-soluble vitamin, normally sourced from sunlight, that increases intestinal absorption of calcium, magnesium and phosphate. It is responsible for multiple body functions including regulating bone density, boosting immune health and reducing the risk of cancer.

Register or Login to see Vitamin D results

Glyphosate

Glyphosate

Glyphosate is a chemical compound of Monsanto’s pesticide, Roundup. Glyphosate has been implicated in increases in cancer in humans.

FDA Compliance – Action Levels for Aflatoxin in Animals Feeds

FDA Compliance – Action Levels for Aflatoxin in Animals Feeds

FDA Compliance Policy Guide on Aflatoxin limitations in Animal Feed

FDA – Tracers in Animal Feed

FDA – Tracers in Animal Feed

CPG Sec 680.100 on reduced iron coated color additive in animal feed

BACKGROUND:
There have been inquiries about the use of reduced iron coated with color, as a “tracer” in animal feed, without declaring its presence on the label. The purpose of the “tracer” in this instance is to provide a quick method to help assure that the drug component containing the tracer is present in the Type A medicated article, and that when formulated into a finished feed, it has been uniformly mixed.

Regulations in 21 CFR 501.100(a)(3)(ii)(c) exempt from label declaration a harmless substance added to an animal food for a technical or functional effect in its processing, where it is present at insignificant levels and has no technical or functional effect in the finished animal food. A harmless inactive ingredient of a Type A medicated article is not required to be declared on the label under the drug provisions of the Federal, Food, Drug and Cosmetic Act.

Section 512 of the Act requires preclearance of all ingredients in a new animal drug Type A medicated article by means of an approved new animal drug application or supplement. *Inclusion of tracers in Type A medicated articles does not fall under 21 CFR 514.8(a)(5) (changes which may be placed in effect without the approval of a supplemental NADA). Similarly, it does not fall under 21 CFR 514.8(d)(3) (changes that should be placed into effect at the earliest possible time because they give increased assurance of identity, strength, quality and purity).*

POLICY:
A harmless substance, such as reduced iron colored with a permitted FDC color, present at insignificant levels in a medicated or non-medicated animal feed as a tracer to help assure the presence of and thorough mixing of a component, is exempt under 21 CFR 501.100(a)(3)(ii)(c) from the requirement that its presence be declared on the label of the finished feed. Such a tracer is not considered to have a technical or functional effect on the finished feed.
A harmless tracer used in a Type A medicated article to help assure the presence of and thorough mixing of a drug component is considered to be an acceptable inactive ingredient which does not have to be declared on the label of the *type A article or any product made from it.*

A tracer may be used in a new animal drug Type A medicated article only if its use is approved in a new animal drug application or supplement, *prior to implementation.*

*Material between asterisks is new or revised*

AAFCO OP, page 444, Tracers (73.400-425)
T73.400 Iron Nickel Tracer are the particles resulting from water atomization of high purity iron and nickel. The nickel content of the particles is between 35 and 51% with the remainder being iron. The particle size of the iron nickel alloy must range between 150 and 300 microns. This ingredient may be used in animal foods as a tracer for other ingredients or premixes present in a finished animal food. The inclusion level of the ingredient must not exceed 10ppm in the finished food. The label shall include a maximum nickel guarantee and a caution statement indicating the maximum permitted inclusion level. (Proposed 2017 rev.1)

Click here to see our results. Click here to donate to our cause

FDA Compliance Policy Guide – Rendered Animal Feed Ingredients

FDA Compliance Policy Guide – Rendered Animal Feed Ingredients

FDA’s Compliance Policy Guide on Rendered Animal Feed Ingredients

FDA’s Compliance Policy Guide –  Streptomycin Residues in Cattle Tissues (withdrawal)

FDA’s Compliance Policy Guide – Streptomycin Residues in Cattle Tissues (withdrawal)

FDA withdrawals Compliance Policy Guide on Streptomycin Residues in Cattle Tissues

FDA Compliance Policy Guide – Listeria monocytogenes

FDA Compliance Policy Guide – Listeria monocytogenes

This guidance document is being distributed for comment purposes only.
Contains Nonbinding Recommendations
Draft – Not for Implementation

Compliance Policy Staff
Guidance for FDA Staff
Sec. 555.320
Listeria monocytogenes
DRAFT GUIDANCE

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document, contact the Center for Food Safety and Applied Nutrition (CFSAN) at 301-436-1400.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Regulatory Affairs
February 2008

TABLE OF CONTENTS

  1. INTRODUCTION
  2. BACKGROUND
  3. POLICY
    1. Ready-to-Eat Food
    2. Ready-to-Eat Foods that Support Growth of L. monocytogenes
    3. Ready-to-Eat Foods that Do Not Support Growth of L. monocytogenes
  4. REGULATORY ACTION GUIDANCE
    1. Ready-to-Eat Foods that Support Growth of L. monocytogenes
    2. Ready-to-Eat Foods that Do Not Support Growth of L. monocytogenes
    3. Foods that are Not RTE Foods
    4. Other Considerations
  5. SPECIMEN CHARGES
    1. Domestic Seizure
    2. Import Detention

Compliance Policy Guide
Guidance for FDA Staff
Sec. 555.320
Listeria monocytogenes

This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate telephone number listed on the title page of this guidance.

  1. INTRODUCTION: The purpose of this Compliance Policy Guide is to provide guidance to FDA Staff on FDA’s enforcement policy for Listeria monocytogenes (L. monocytogenes) in foods. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
  2. BACKGROUND: L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility. L. monocytogenes can contaminate foods and cause a mild illness (called listerial gastroenteritis) or a severe, sometimes life-threatening, illness (called invasive listeriosis). Foods that have been implicated in outbreaks of invasive listeriosis have been foods that are ready-to-eat (RTE).RTE foods can be contaminated if ingredients in the foods are contaminated with L. monocytogenes and are not treated to destroy viable cells of this pathogen, or if L. monocytogenes is allowed to contaminate the RTE food because of improper sanitary conditions or practices. Most RTE foods do not contain detectable numbers of L. monocytogenes. For many RTE foods, contamination with L. monocytogenes can be avoided – e.g., through the application of current good manufacturing practice requirements that establish controls on ingredients, listericidal processes, segregation of foods that have been cooked from those that have not, and sanitation. Sanitation controls include effective environmental monitoring programs designed to identify and eliminate L. monocytogenes in and on surfaces and areas in the plant.In 2003, FDA and the Food Safety and Inspection Service of the United States Department of Agriculture, in consultation with the Centers for Disease Control and Prevention of the United States Department of Health and Human Services, released a quantitative assessment (the Risk Assessment) of relative risk associated with consumption of certain categories of RTE foods that had a history of contamination with L. monocytogenes, or that were implicated epidemiologically with an outbreak or a sporadic case of listeriosis. The Risk Assessment estimated that the risk of listeriosis would vary widely among these food categories.According to the Risk Assessment, foods estimated to pose the highest risk of being associated with listeriosis are RTE foods that support the growth of L. monocytogenes. Examples of RTE foods that support the growth of L. monocytogenes include:
    • Milk;
    • High fat and other dairy products (e.g., butter and cream);
    • Soft unripened cheeses (greater than 50 percent moisture) (e.g., cottage cheese and ricotta cheese);
    • Cooked crustaceans (e.g., shrimp and crab);
    • Smoked seafood (e.g., smoked finfish and mollusks);
    • Raw seafood that will be consumed as sushi or sashimi;
    • Many vegetables (such as broccoli, cabbage, and salad greens);
    • Non-acidic fruit (such as melon, watermelon, and papaya); and
    • Some deli-type salads and sandwiches (particularly those containing seafood and those prepared at retail establishments without acidification and/or the addition of antimicrobial substances).In contrast, the foods estimated to pose the lowest risk of being associated with listeriosis are foods that, because of intrinsic factors, extrinsic factors, and/or processing factors do not support the growth of L. monocytogenes. Intrinsic factors include chemical and physical factors that are normally within the structure of the food, e.g., pH and water activity. Extrinsic factors are those that refer to the environment surrounding the food, e.g., storage temperature. Processing factors include substances added to adjust the pH of food (e.g., acids) and substances that, alone or in combination with other substances, have antimicrobial properties (e.g., sorbates and benzoates). It is well established that L. monocytogenes does not grow when:
    • The pH of the food is less than or equal to 4.4;
    • The water activity of the food is less than or equal to 0.92; or
    • The food is frozen. Foods may naturally have a pH or water activity that prevents growth of L. monocytogenes or processing factors may be deliberately used to achieve those characteristics (e.g., by adding acid to deli-type salads to bring the pH to less than or equal to 4.4). At pH values above 4.4, processing factors generally are used in combination to prevent the growth of L. monocytogenes (e.g., sorbates or benzoates may be used in combination with organic acids such as acetic acid, lactic acid, and citric acid in foods such as deli-type salads). The effectiveness of a particular listeristatic control measure in preventing growth in a particular RTE food generally is determined case-by-case, for example, using the results of growth studies specific to the food matrix.Examples of RTE foods that generally are considered to not support the growth of L. monocytogenes include:
    • Fish that are preserved by techniques such as drying, pickling, and marinating;
    • Ice cream and other frozen dairy products;
    • Processed cheese (e.g., cheese foods, spreads, slices);
    • Cultured milk products (e.g., yogurt, sour cream, buttermilk);
    • Hard cheeses (less than 39 percent moisture) (e.g., cheddar, colby, and parmesan);
    • Some deli-type salads, particularly those processed to a pH less than 4.4 and those containing antimicrobial substances such as sorbic acid/sorbates or benzoic acid/benzoates under conditions of use documented to be effective in preventing the growth of L. monocytogenes;
    • Some vegetables (such as carrots); and
    • Crackers, dry breakfast cereals, and other dry foods.Fruits, vegetables, and cheeses (e.g., soft and semi-soft cheeses) not listed in this CPG may include some products that support growth as well as other products that do not support growth.
  3. POLICY: FDA will review the available evidence on a case-by-case basis to determine if a food is a RTE food that supports growth or a RTE food that does not support growth.
    1. Ready-to-Eat Food “Ready-to-eat food” (RTE food) means a food that is customarily consumed without cooking by the consumer, or that reasonably appears to be suitable for consumption without cooking by the consumer. A food may be considered to be suitable for consumption without cooking by the consumer, and thus a RTE food, even though cooking instructions are provided on the label. For examples, fresh and frozen crabmeat and individually quick frozen (IQF) peas and corn may be RTE foods. Some consumers eat such products without cooking, because they appear to be ready-to-eat.
    2. Ready-to-Eat Foods that Support Growth of L. monocytogenes Generally, we intend to consider that a RTE food will support the growth of L. monocytogenes if it does not meet the characteristics of a RTE food that does not support growth, as indicated in section III.C.FDA may regard a RTE food that supports growth of L. monocytogenes to be adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act; the FD&C Act) (21 U.S.C. 342(a)(1)) when L. monocytogenes is present in the food based on the detection method indicated in section IV.A.
    3. Ready-to-Eat Foods that Do Not Support Growth of L. monocytogenes A RTE food does not support the growth of L. monocytogenes if the food:
      • Has a pH that is less than or equal to 4.4; or
      • Is customarily held and consumed in a frozen state; or
      • Has a water activity that is less than 0.92; or
      • Is processed using an effective listeristatic control measure (e.g., an antimicrobial substance or a combination of factors such as pH, water activity, and antimicrobial substances).
        FDA may regard a RTE food that does not support the growth of L. monocytogenes to be adulterated within the meaning of section 402(a)(1) of the Act (21 U.S.C. 342(a)(1)) when L. monocytogenes is present at or above 100 colony forming units per gram of food (cfu/g)
  4. REGULATORY ACTION GUIDANCE:
    1. Ready-to-Eat Foods that Support Growth of L. monocytogenes The following represents criteria for recommending legal action to CFSAN/Office of Compliance/Division of Enforcement (HFS-605):
      • L. monocytogenes is detected in one or more subsamples of a RTE food that supports the growth of L. monocytogenes.Use Bacteriological Analytical Manual Online, Chapter 10 – “Listeria monocytogenes,” “Detection and Enumeration of Listeria monocytogenes in Foods” as the method for detecting and confirming presence of L. monocytogenes (available at http://www.cfsan.fda.gov/~ebam/bam-10.html).
    2. Ready-to-Eat Foods that Do Not Support Growth of L. monocytogenes Consult with CFSAN/Office of Compliance/Division of Enforcement (HFS-605) before recommending legal action for RTE foods that do not support the growth of L. monocytogenes. Use ISO 11290-2:1998(E) “Microbiology of food and animal feeding stuffs – Horizontal method for the detection and enumeration of Listeria monocytogenes – Part 2: Enumeration method” as the method for enumerating L. monocytogenes. (ISO 11290-2:1998/Amd. 1:2004(E) “Microbiology of food and animal feeding stuffs – Horizontal method for the detection and enumeration of Listeria monocytogenes – Part 2: Enumeration method AMENDMENT 1: Modification of the enumeration medium” amends ISO 11290-2:1998(E). The amendment uses ALOA agar instead of PALCAM agar. If ALOA agar is not commercially available in the United States, use PALCAM according to ISO 11290-2:1998(E)). ISO methods are available from the International Organization for Standardization at http://www.iso.org/iso/en/ISOOnline.frontpage.Use rapid biochemical test kits according to the Bacteriological Analytical Manual Online, Chapter 10 – “Detection and Enumeration of Listeria monocytogenes in Foods” Section E-11 (available at http://www.cfsan.fda.gov/~ebam/bam-10.html), instead of ISO 11290-2:1998(E) Section 9.5, for confirmation of L. monocytogenes isolates.
    3. Foods that are Not RTE Foods Consult with CFSAN/Office of Compliance/Division of Enforcement (HFS-605) when L. monocytogenes is present in a food that is not a RTE food.
    4. Other Considerations The criteria in this guidance do not establish an acceptable level of L. monocytogenes in food. FDA may choose to take legal action against adulterated food that does not meet the criteria for recommending legal action to CFSAN.Further, the criteria in this guidance do not excuse violations of the requirement in section 402(a)(4) of the Act (21 U.S.C. 342(a)(4)) that food may not be prepared, packed, or held under insanitary conditions or the requirements in FDA’s good manufacturing practices regulation (21 CFR part 110). As set out in 21 CFR 110.80, food manufacturers must take “[a]ll reasonable precautions … to ensure that production procedures do not contribute contamination from any source.”
  5. SPECIMEN CHARGES:
    1. Domestic Seizure 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 the Act, 21 U.S.C. 342(a)(1), in that it bears and contains a poisonous or deleterious substance, namely Listeria monocytogenes, which may render it injurious to health.
    2. Import Detention The article of food is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it appears to be adulterated within the meaning of section 402(a)(1) of the FD&C Act in that it bears and contains a poisonous or deleterious substance, Listeria monocytogenes, which may render it injurious to health.
Click here to see our results. Click here to donate to our cause 
FDA Compliance Policy Guide – Labeling and Marketing of Dog and Cat Food Diets Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases

FDA Compliance Policy Guide – Labeling and Marketing of Dog and Cat Food Diets Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases

FDA Compliance Policy Guide on Prescription Feeds intended to Diagnose, Cure, Mitigate, Treat or Prevent Diseases

FDA Compliance Policy Guide – Salmonella in Food for Animals

FDA Compliance Policy Guide – Salmonella in Food for Animals

FDA Compliance Policy Guide on Salmonella in Pet Food

FDA Compliance – Pesticide Residues in Food and Feed

FDA Compliance – Pesticide Residues in Food and Feed

CPG Sec. 575.100 Pesticide Residues in Food and Feed
CPG 7141.01, 2008
CPG 555.700 Revocation of Tolerances of Cancelled Pesticides, Withdrawal 2008

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 ENFORCE
4. 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;
5. 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
6. The identity of the residue in either the original or check analysis sample was confirmed in accordance with PAM, Volume I, section 601.

B. Requirements for Direct Reference Seizure or Import Detention:
1. 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:
a. The “General Requirements” under section A are met; and
b. 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

2. 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: a. The “General Requirements” under section A are met;
b. There is evidence or other reasons to conclude that the residue could have been avoided by good agricultural or manufacturing practices;
c. The program field office has had an enforcement action previously approved by the center for the same pesticide residue and the same food or feed;
d. 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
e. The direct seizure referral includes the FDC number of the previous case.

C. Requirements for Recommending an Enforcement Action to a Center:
The field office 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 Division of Compliance (HFV-230) for feed provided: 1. The “General Requirements” in section A are met;
2. The food or feed may be considered actionable under any of the violative situation described in BACKGROUND; and
3. 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 program field office’s conclusion that the pesticide residue could have been avoided by good agricultural or manufacturing practices. If the field office encounters a food or feed that contains an unavoidable pesticide residue, but there is no tolerance or action level, the field office 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 and 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 Commodity (see note “a”) Le 180.131 Endrin Vegetables0.05 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 (see note “b”) Note “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. Note “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:

Pesticides Covered 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 to initiate an enforcement action if the level is exceeded. The field office 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 (see note “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,0.02 teosinte, and wild rice)
Celery 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 0.3
grains (except those of buckwheat, millet, teosinte, and wild rice)
Grapefruit 0.02
Hay 0.03
Horseradish 0.1
Kale 0.05
Kohlrabi 0.05
Legume vegetables (except guar, 0.05 Jack beans, lablab beans, and lentils)
Lemons 0.02
Lespedeza 0.03
Lettuce 0.03
Limes 0.02
Mangoes 0.03
Melons 0.1
Milk (fat basis) 0.3
Mustard green 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 0.03 and loquats)
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, 0.3 Damson, and Japanese plums, and peaches)
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 Note “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 Hays 0.05 Lettuce 0.05 Mangoes 0.05 Milk (fat basis) 0.3 Okra 0.05 Onions 0.05 Paprika 1.0 Pears 0.05 Peas 0.05 Pecans 0.05 Peppers 0.05 Pineapples 0.05 Quices 0.05 Rabbits (fat basis)b 0.3 Root and tuber vegetables 0.05 (except carrots) Small fruits and berries 0.05 Spinach 0.05 Swiss chard 0.05 Stone fruits (except Chickasaw, 0.05 Damson, and Japanese plums) Tomatoes 0.05 Turnip greens 0.05

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

Note “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 (see Note “A”) Action Level (ppm)
Animal fat, rendered 0.3
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 0.1 (except broccoli, raab, Chinese mustard cabbage, and rape greens)
Carrots 0.1
Celery 0.1
Citrus fruits 0.1
Corn 0.1
Cucumbers 0.1
Eggplant 0.1
Fish (edible portion) 0.3
Lettuce 0.1
Melons 0.1
Okra 0.1
Onions 0.1
Papayas 0.1
Parsnips 0.1
Peanuts 0.1
Peas 0.1
Peppers 0.1
Pineapple 0.1
Pome fruits (except crabapples 0.1 and loquats)
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 0.1 cranberries, currants, elderberries, gooseberries, and olallie berries)
Spinach 0.1
Squash 0.1
Stone fruits (except, Chickasaw, 0.1 Damson, and Japanese plums)
Sweet potatoes 0.1
Swiss chard 0.1
Tomatoes 0.1
Turnips (with or without tops) 0.1
Turnip greens 0.1
Note 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 (see Note “a”) Commodity Action Level (ppm) Crabmeat 0.4 Fish 0.3 Note “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.

Commoditya Action Level (ppm)
Animal feed, processed 0.5
Artichokes 0.5
Asparagus 0.5
Avocados 0.2
Beets (roots and tops) 0.2
Brassica (cole) leafy vegetables 0.5 (except broccoli, raab, Chinese mustard cabbage, and rage greens)
Carrots 3
Cereal grains (except buckwheat, fresh 0.5 sweetcorn, millet, popcorn, teosinte, and wild rice)
Celery 0.5
Citrus fruits 0.1
Cocoa beans 1
Corn, fresh sweet 0.1
Cottonseed 0.1
Cucumbers 0.1
Eggplant 0.1
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, 0.2 Jack beans, lablab beans, and lentils 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 0.1 loquats)
Potatoes 1
Radishes (roots and tops) 0.2
Rutabagas (roots and tops) 0.2
Small fruits and berries (except 0.1 elderberries, grapes, and olallie berries)
Soybean oil (crude) 1
Spearmint hay 0.5
Spearmint oil 1
Spinach 0.5
Squash 0.1
Stone fruits (except Chickasaw, 0.2 Damson, and Japanese plums)
Sweet potatoes 1
Swiss chard 0.5
Tomatoes 0.05
Tomato pomace 0.5
Turnips (roots and tops) 0.2
Note “a”: Action levels for crop groups cover all commodities specified in 40 CFR 180.34(f), except where an exception is noted. DICOFOL (see note “a”) Commodity Action Level (ppm) Animal feed, processed 0.5 Note “a”: The trade name for dicofol is Kelthane. ETHYLENE DIBROMIDE (EDB) Commodity Action Level (ppb) Grain Products Intermediate (milled) grain products150 (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 30 (will not undergo further processing prior to consumption) HEPTACHLOR AND HEPTACHLOR EPOXIDE 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 (See Note “A” below) Action Levels (ppm) Animal feed, processed 0.03 Artichokes 0.05 Asparagus 0.05 Beans, except snap beans 0.05 Citrus fruits 0.05 Cucumbers 0.05 Eggs 0.05 Eggplant 0.03 Figs 0.05 Fish (edible portion) 0.3 Hay 0.03 Leafy vegetables 0.05 Melons 0.05 Okra 0.05 Pears 0.05 Pimentos 0.05 Pumpkins 0.05 Quinces 0.05 Rice 0.03 Small fruits a,b 0.05 Stone fruits a,b 0.05 Squash 0.05 Note A: Refer to 40 CFR 180.34(f) for commodities covered by this food group. Note B: Other than those commodities specified in 40 CFR 180.104 and 180.319. LINDANE

Commodity Action Level (ppm)
Animal feed, processed 0.1
Artichokes 0.5
Barley 0.1
Beans 0.5
Citrus fruits (see Note “A”) 0.5
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 (see Notes “A” and “B”) 0.5
Rye 0.1
Small fruits (see Notes “A” and “B”) 0.5
Sorghum (milo) 0.1
Turnip greens 0.5
Wheat 0.1
Note A: Refer to 40 CFR 180.34(f) for commodities covered by this food group. Note 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.*

Click here to see our results. Click here to donate to our cause

FDA Compliance Policy Guide on Rendered Animal Feed Ingredients

FDA Compliance Policy Guide on Rendered Animal Feed Ingredients

CPG Sec. 675.400 Rendered Animal Feed Ingredients This guidance document represents the agency’s current thinking on rendered animal feed ingredients. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative […]

FDA Compliance – Damaged Grains

FDA Compliance – Damaged Grains

FDA Compliance Policy Guide on Moisture Damaged Grains in Animal Feed