Criteria Used for Evaluating Nonfood Compounds

Criteria Used by the Former Compounds and Packaging Branch for Evaluating Nonfood Compounds and Proprietary Substances

General Aspects
Establishments are responsible for all safety and performance aspects of processing compounds. Processing compounds are those chemical compounds that are used in the areas of food processing, handling, and storage, and that do not otherwise require declaration on food labeling under the Code of Federal Regulations (CFR) Title 7 (part 59) or Title 9 (parts 317 and 381).

Processing compounds should be used and stored in a manner that will not result in adulterated food and that is consistent with the guidance set forth herein.

General Standards for Processing Compounds
Processing compounds should be safe and adequate for the intended purpose under conditions of use and storage.

Compounds should be identified, stored, and used in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials to prevent adulterating or deleteriously affecting meat, poultry or egg products.
Except as required for an operating process, processing compounds, e.g., cleaners, lubricants, etc., should not be used while foods or food contact packaging materials are exposed.
Product labeling from supplier should clearly identify the product and list the address of manufacturer or supplier, and purpose or use of product.
All working and storage containers of processing compounds should be clearly and individually identified with the product name or common name of the material.

Processing compounds should not create or lead to inspection interference. For example, processing compounds that mask odors, or pine oil cleaners that leave lingering odors, interfere with the ability of inspection personnel to detect pockets of insanitation.

Processing compounds should not create or lead to conditions of insanitation.

Processing compounds should not be present in plants unless required: to maintain clean and sanitary conditions; to maintain and operate the facility and equipment; or to use in the plants' operations.

Materials that are: known human carcinogens; mutagens or teratogens classified as hazardous substances; heavy metals; or hazardous compounds classified as extremely or super toxic, should not be allowed in the plants unless the plant can demonstrate that the substance will not become a component of edible product according to the levels exempted under the threshold of regulation process indicated in 21 CFR 170.39.

Standards for Specific Compounds

Cleaners
1. Labeling should include appropriate use directions.
2. Cleaners should be formulated so that rinsing will be sufficient to ensure effective removal of cleaning solution from food contact surfaces and removal of residual odors from food processing areas.
3. Cleaners should not contain undesirable microorganisms.
4. General use cleaners as supplied should not have an expected human single oral LD50 of <10mg/kg.
5. Use of special purpose cleaners classified as hazardous materials should be limited to the amount and frequency only sufficient for the required effect. Personnel protection provisions and precautions to prevent food and food contact surfaces from contamination should be specified and followed; use should be in accordance with manufacturer's labeling instructions and precautions.
6. Cleaners consisting primarily of hydrocarbon, chlorinated hydrocarbon, or other water immiscible solvents should be limited to use in non-processing areas. Treated food processing equipment and utensils should be washed and thoroughly rinsed with potable water.
7. Cleaners formulated to provide very low freezing points such as alcohol or glycol based compounds, are appropriate for use on surfaces that do not contact food in areas with subfreezing temperatures. The cleaning solution and solubilized soil should be effectively removed by wiping, wet vacuuming, or other appropriate means.
8. Boric acid and salts thereof, should be limited to 90% of a cleaner in association with strong acids, strong alkalis, soaps or synthetic detergents.
9. Use of hazardous substances containing fluorine compounds, such as hydrofluoric acid, hydrofluosilic acid, or ammonium bifluoride, to remove siliceous scale deposits or for similar cleaning purposes, should be in accordance with provisions for the special purpose cleaners classified as hazardous materials. Each use should be documented and the substance should not be stored within the plant.
Laundry Compounds
1. Labeling should include appropriate use directions.
2. Laundry compounds should be formulated so that rinsing instructions will be sufficient to prevent food contamination or inspection interference, and to ensure effective removal of laundry agents from food contact articles, e.g. carcass shrouds.
Hand Care Treatment
1. Treatments intended to remain on the hands of food handlers should be formulated in compliance with appropriate food additive regulations, 21 CFR 178.1010, or of appropriate materials that are Generally Recognized as Safe (GRAS).
2. Hand sanitizer solutions should be kept clean and maintained at a germicidal equivalency of at least 50 ppm available chlorine as hypochlorite at 20oC(68°F) for 1 minute.
3. Test kits or other means should be provided and used as frequently as necessary to ensure minimum germicidal activity is consistently provided.
4. Only liquid hand cleaners and sanitizers should be used in areas where food and food contact surfaces are exposed. Precautions should be taken to ensure hand care stations do not result in direct or indirect contamination of food or food contact surfaces with hand care substances.
5. Treatments not formulated in compliance with appropriate food additive regulations should be:
  - thoroughly removed from the hands by rinsing in clean potable water, or
  - separated from contact with food by the use of gloves that are sufficient to maintain an effective barrier to prevent migration of the nonfood substances to edible product.

Sanitizers and Disinfectants

Chemical sanitizers and other chemical antimicrobials used and left on food contact surfaces must comply with the appropriate food additive regulations.
Antimicrobials registered with the Environmental Protection Agency (EPA) must include labeling instructions stating that use is allowed in food establishments.
Chemicals used to sanitize food contact surfaces and utensils must comply with 21 CFR 178.1010.
Sanitizers should only be applied to cleaned surfaces. Sanitized food contact equipment and utensils should be air-dried or adequately drained, in accordance with 21 CFR 178.1010, sufficient to prevent food adulteration.
Chemical sanitizers should be EPA registered for sanitizing food contact surfaces or otherwise established to provide germicidal efficacy yielding a 5 log reduction of representative disease microorganisms of public health importance.
Chemical sanitization of food contact surfaces should ensure exposure times of at least 10 seconds for chlorine solutions or at least 30 seconds for other chemical sanitizer solutions, or according to EPA registered use directions for food contact surfaces.

A chlorine sanitizing solution should have a minimum temperature based on the concentration and PH(pH) of the solution as listed in the following chart; or as specified under EPA registered label use instructions.

Minimum Concentration		Minimum Temperature
MG/L (mg/L)		PH(pH) 10 or less	PH(pH) 8 or less
	⁰C (⁰F)		⁰C (⁰F)
25	49 (120)		49 (120)
50	38 (100)		24 (75)
100	13 (55)		13 (55)

Chemical germicides established as meeting efficacy requirements of EPA as both a hospital level disinfectant and a tuberculocide are appropriate for use in lieu of 180°F water to decontaminate implements provided:
- food contact surfaces are subsequently washed and rinsed,
- appropriate preventative actions are taken to protect edible products and food packaging materials, and
- labeled use directions specify minimum contact time required to meet both registered kill levels.
Antimicrobial solutions should be kept clean, and effectiveness should be maintained under conditions of intended use.
Test kits or other adequate methods sufficient to measure germicide strength should be provided and used to ensure that sanitizer solutions comply with regulatory requirements under continuing conditions of use.

Insecticides, Rodenticides and similar Pesticides
1. Pest control programs and treatments should be recorded with details sufficient to document compliance and provide trace back capability in the event of accidental contamination's.
2. Pesticides registered with EPA must be applied in accordance with the specific instructions for food establishments.
3. Restricted-use pesticides should be used only under the control of certified applicators (as defined in 7 USC 136(e)).
4. Dry bait rodenticides should be secured in tamper-resistant bait stations.
5. Dry bait rodenticides, except those in which the inert ingredients consist mainly of whole or cracked grain, or flour or meal pressed into cakes or pellets that do not have characteristics of food products, should be colored a distinct blue or green to distinguish the pesticide from edible substances.
6. Powdered or granular insecticides should be colored a distinct blue or green to distinguish the pesticide from edible substances.
7. Residual insecticides should be limited to crack and crevice treatments in food processing areas. Treated cracks and crevices should be sealed after treatment.
8. Pesticidal tracking materials should not be used.
9. Nonpesticidal tracking materials should have a distinct blue or green color.
10. To minimize risks of food contamination and personnel hazard, pesticides should be applied and stored in a manner such that:
  - Pesticides are not applied during establishment production hours.
  - All containers used to store, dilute, dispense, or transport pesticides are clearly labeled.
  - Re-use of containers for other purposes is prevented by destruction of the container or other means sufficient to render the containers unfit for reuse.
  - Specific safeguards are employed to protect food and food contact materials, including employee clothing, from direct and indirect contamination by pesticide residues.
  - Treated areas are sufficiently ventilated and equipment, utensils and other food contact surfaces are thoroughly washed after pesticide application.
Water Treatments
1. Processing additives are appropriate for use provided that the quantities of these compounds are controlled, monitored, and limited to the amount sufficient for the purpose of such use.
2. Processing additives for potable water treatments should be composed of appropriate substances that are prior sanctioned or GRAS, and limited to the following:
  - In potable water phosphate should not exceed 10ppm, silicate should not exceed 10ppm, and chlorine should not exceed 5ppm.
  - In other processing applications, chlorine should not exceed 50ppm in carcass wash and 20ppm on trimmed or reprocessed poultry carcasses.
3. Boiler water treatments where the steam may
  contact food and food contact surfaces must be formulated with substances found in 21 CFR, 173.310.
4. Ion-exchange resins used for water purification must be formulated in compliance with 21 CFR, 173.25.
5. Compounds containing the sodium or potassium salts of nitrate, sulfite, bisulfite, or metabisulfite should be decharacterized so their effect on the heme pigments in meat products is prevented. Decharacterization may be achieved by the addition of colorant such as lignosulfonate to prevent mishandling or by other means such as creation of a basic environment to prevent the formation of acid species of these additives.
6. Nitrite-, borate-, and nitrate-containing treatments for nonprocessing water should be clearly colored a definite blue or green to prevent misuse as a meat preservative.
7. Additives used in water in which fruits and vegetables are washed must be formulated in compliance with 21 CFR 173.315 and 21 CFR 173.340(a)(2).
8. Additives used in water for preflushing of animal casings must be GRAS as listed in 21 CFR 182 and 184.
Shell Egg Compounds
1. Compounds used to treat shell eggs, including cleaners, destainers, defoamers, and sanitizers, must be composed of appropriately regulated food additives, prior sanctioned substances, or GRAS substances, or exempted from regulation for this use under the threshold of regulation process in 21 CFR 170.39.
2. Compounds used to treat shell eggs must not bear or contain any poisonous or deleterious substances that may render the egg or egg product injurious to health [Sec 4(a)(1) and Sec 6(a) Egg Products Inspection Act (EPIA)], [Sec 203(h) and (i) Agricultural Marketing Act (AMA)] or unfit for human food [Sec 4(a)(2)(A) and Sec 203(h) and (i) AMA].
3. Substances to clean, destain, dry or sanitize shell eggs must be used in accordance with regulatory specifications, 7 CFR Parts 56 and 59. Temperatures should be recorded to document compliance.
4. Sanitizers must include use directions in EPA registered labeling that states specific instructions for treatment of shell eggs.
Lubricants
1. Should be limited to the amount necessary to achieve the technical effect.
2. Use on food contact surfaces requires appropriate food additive status, i.e., formulated from an edible oil, mineral oil complying with 21 CFR 172.878, or GRAS substance.
3. Where incidental food contact may occur, lubricants must comply with food additive regulations pertaining to incidental food contact, 21 CFR 178.3570.
4. Lubricants should be applied to food contact equipment that requires lubrication in a manner that does not contaminate food contact surface.
Anti-Slip Compounds
1. Limited to portion of floors to correct temporary hazardous conditions.
2. Should not promote microbial growth or attract or harbor pests.
3. Should be an inert material that will not cause dusting or tracking under the intended conditions of use.
4. Should be formulated so that any contact with food and food contact surfaces results only in surface contamination that is easily identified and removable.


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