ADMINISTRATIVE CODE

TITLE 77: PUBLIC HEALTH
CHAPTER I: DEPARTMENT OF PUBLIC HEALTH
SUBCHAPTER m: FOOD, DRUGS AND COSMETICS
PART 725 SALVAGE WAREHOUSES AND STORES FOR FOODS, ALCOHOLIC LIQUORS, DRUGS, MEDICAL DEVICES AND COSMETICS CODE

Section 725.10 Scope

Section 725.15 Incorporated Materials

Section 725.20 Definitions

Section 725.30 License Requirement

Section 725.40 Contamination Protection, Handling and Movement of Distressed Merchandise

Section 725.41 Segregration of Merchandise

Section 725.42 Transporting of Distressed Merchandise

Section 725.43 Handling of Non-Human Food, Drug or Medical Device Distressed Articles

Section 725.44 Cross-Contamination Protection

Section 725.50 Reconditioning and Labeling of Distressed Merchandise

Section 725.51 Relabeling

Section 725.60 Distribution of Non-Salvageable Merchandise

Section 725.70 Returned Drug Products

Section 725.71 Drug Product Salvaging

Section 725.80 Records Required

Section 725.10 Scope

The Illinois Department of Public Health hereby finds and declares that uniform Statewide salvage rules are needed to regulate all food, alcoholic liquors, drugs, medical devices and cosmetics salvage processing plants and distributors conducting business within the State, to provide for uniformity of inspections of such establishments, and to protect the health of consumers by preventing the sale or distribution of foods, alcoholic liquors, drugs, medical devices and cosmetics which may have become adulterated or misbranded, until such time as that portion of such items as can be reconditioned or reclaimed for sale and distribution has been placed in a condition which satisfies all requirements of the Salvage Warehouse and Salvage Warehouse Store Act (Ill. Rev. Stat. 1987, ch. 114, pars. 400 et seq.) and all referenced regulations and standards cited in Section 725.15.

Section 725.15 Incorporated Materials

The following materials are incorporated or referenced in this Part:

a) Federal Laws and Rules

1) The Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.);

2) The Federal Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.);

3) 21 CFR 105 (1988);

4) 21 CFR 110 (1988);

5) 21 CFR 211 (1988);

b) State Laws and Rules

1) The Illinois Food, Drug and Cosmetic Act (Ill. Rev. Stat. 1987, ch. 56½, pars 501 et seq.);

2) AN ACT to prevent the preparation, manufacture, packing, storing, or distributing of food intended for sale, or sale of food, under insanitary, unhealthful or unclean conditions or surroundings, to create a sanitary inspection, to declare that such conditions shall constitute a nuisance, and to provide for the enforcement thereof. (Ill. Rev. Stat. 1987, ch. 56½, pars. 67 et seq.);

3) The Environmental Protection Act (Ill. Rev. Stat. 1987, ch. 111½, pars. 1001 et seq.);

4) Water Pollution (35 Ill. Adm. Code: Subtitle C);

5) Waste Disposal (35 Ill. Adm. Code: Subtitle G);

6) The Illinois Food, Drug and Cosmetic Act (77 Ill. Adm. Code 720);

7) The Manufacturing, Processing, Packing or Holding of Food (77 Ill. Adm. Code 730);

8) Food Service Sanitation (77 Ill. Adm. Code 750);

9) Sanitation of Retail Food Stores (77 Ill. Adm. Code 760);

10) The Illinois Liquor Control Commission (11 Ill. Adm. Code 100).

c) Codes and Standards

1) Classification of Visible Can Defects (Exterior), Association of Official Analytical Chemists, 1111 North 19^th Street, Suite 210, Arlington, Virginia, 22209, (703) 522-3032, 1984, with the exception of the interpretation of rusted can defects

2) Guidelines for Evaluation and Disposition of Damaged Canned Food Containers, National Food Processors Association, 1401 New York Avenue, N.W., Washington, D.C., 20005, (202) 639-5900, Bulletin 38-L, Second Edition, 1979, with the exception of the interpretation of rusted can defects.

3) A Pocket Guide to Can Defects, Association of Food and Drug Officials, P.O. Box 3245, York, Pennsylvania, 17402, (717) 757-2888, 1987, with the exception of rusted can defects.

d) All incorporations by reference of federal regulations and the standards of nationally recognized organizations refer to the regulations and standards on the date specified and do not include any additions or deletion subsequent to the date specified.

e) Copies of these materials shall be on file and available for inspection by the public at the Department's Central Office (535 West Jefferson, Springfield, Illinois 62761).

Section 725.20 Definitions

The definitions and interpretations contained in Section 201 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.), 21 CFR 105, the Illinois Food, Drug and Cosmetic Act (Ill. Rev. Stat. 1987, ch. 56½, pars. 501 et seq.), and Section 401 of the Salvage Warehouse and Salvage Warehouse Store Act are applicable to such items when used in this Part. The following definitions shall also apply:

"ACT" shall mean the Salvage Warehouse and Salvage Warehouse Store Act (Ill. Rev. Stat. 1987, ch. 114, pars. 400 et seq.).

"Adequate" shall mean that which is needed to accomplish the intended purpose in keeping with good public health practice. Good public health practices are those practices and standards which reduce the opportunity for microorganisms to gain entrance and multiply in foods, drugs, medical devices, cosmetics or alcoholic liquors. This would also include such practices and standards which assure that such items remain sound, undamaged, clean, free from adulteration and contamination, and otherwise suitable for human use.

"Adulterated" shall mean the containing of any poisonous or deleterious substance which may render an item injurious to health; or if an item consists in whole or in part of any filthy, putrid or decomposed substance; or if an item has been produced, prepared, packed or held under unsanitary conditions; or any other meaning ascribed under the Illinois Food, Drug and Cosmetic Act. (Section 10 of the Illinois Food, Drug and Cosmetic Act)

"Contaminated" shall mean bearing or containing any poisonous or deleterious substance which may render an item injurious to health.

"Cross-contaminated" shall mean the contamination of food or equipment with a contaminated raw food or non-food item.

"Department" shall mean the Department of Public Health. (Section 2 of the Illinois Food, Drug and Cosmetic Act)

"Distressed Merchandise" shall mean any food, drug, cosmetic, medical device or alcoholic liquor which has had the label lost or which has been subjected to possible damage due to accident, fire, smoke, storm, flood, adverse weather, train or truck wreck, or to any other similar cause, or which may have been rendered unsafe or unsuitable for human consumption or use pursuant to this Part.

"Flipper" shall mean a can with a bulged or swelled end which, when depressed, will force the opposite end of the can to bulge or swell.

"Leaker" shall mean a can or other container which shows evidence of leakage of its contents.

"Misbranded" shall mean labeled or having labeling which is false or misleading in any particular; or any other meaning ascribed under the Illinois Food, Drug and Cosmetic Act. (Section 11 of the Illinois Food, Drug and Cosmetic Act)

"Non-Salvageable Merchandise" shall mean "distressed merchandise," as defined in this Section which cannot be reconditioned such as foods, alcoholic liquors, drugs, medical devices and cosmetics contaminated and/or adulterated by pesticides, chemicals, or filth; potentially hazardous foods (frozen or those requiring refrigeration) which have been exposed to a temperature above 45º F (7.2º C) for a period exceeding 4 hours; foods, alcoholic liquors, drugs, medical devices and cosmetics found unfit for salvage on examination; foods, alcoholic liquors, drugs, medical devices and cosmetics packaged in paper or other porous materials which have been subject to contamination; and foods, alcoholic liquors, drugs, medical devices or cosmetics found to have pitted rust upon examination. Drug products or infant formulas containing expiration dates or beyond use dates which have expired shall be considered non-salvageable merchandise.

"Perishable" shall mean that there exists a significant risk of spoilage or deterioration when a product has not been refrigerated.

"Personnel" shall mean any person employed at a salvage processing plant or distributor who does or may in any manner handle or come in contact with the handling, storing, transporting, or selling and distributing of salvageable or salvaged merchandise.

"Pitted Rust" shall mean any rust that has penetrated the surface of the container to such a depth that it cannot be removed with a wiping cloth only. Containers with rust that cannot be removed with a wiping cloth only are non-salvageable merchandise.

"Potentially Hazardous Food" shall mean any food or food ingredient, natural or synthetic, in a form capable of supporting the rapid and progressive growth of infectious or toxigenic microorganisms or the slower growth of Clostridium botulinum as stated in 77 Ill. Adm. Code 750.20.

"Reconditioning" shall mean any sanitary process or procedure by which distressed merchandise can be made available for consumption or use by the public pursuant to this Part.

"Salvage Distributor" shall mean a person who engages in the business of selling, ditribution or otherwise trafficking in any distressed or salvaged merchandise.

"Salvage Processing Plant" shall mean an establishment engaged in the business of reconditioning or by other means salvaging distressed merchandise and which sells or distributes or holds for sale salvaged merchandise for human consumption or use.

"Salvageable Merchandise" shall mean any damaged or distressed item or product from a manufacturer closeout, or distressed merchandise which can be reconditioned pursuant to this Part or is not adulterated, contaminated or misbranded.

"Salvaged Merchandise" shall mean distressed merchandise which has been reconditioned pursuant to this Part.

"Springer" shall mean a can with a bulged or swelled end which, after depression, returns voluntarily to its bulged or swelled condition.

"Surface Rust" shall mean rust that can removed with a wiping cloth only.

"Swell" shall mean a can which exhibits a bulged end.

"Vehicles" shall mean any truck, car, bus, or other means by which distressed, salvageable or salvaged merchandise is transported from one location to another.

(Source: Amended at 14 Ill. Reg. 864, effective January 1, 1990)

Section 725.30 License Requirement

A separate license shall be required for each location of a salvage distributor and salvage processing plant. Licenses will be issued in accordance with Section 2 of the Act.

Section 725.40 Contamination Protection, Handling and Movement of Distressed Merchandise

All salvageable and salvaged merchandise, while being stored or procesed at a salvage processing plant, or during transportation, shall be protected from contamination or adulteration. All foods and drugs shall be kept at such temperature as will protect against spoilage or deterioration. All potentially hazardous foods shall be maintained at a temperature of 45°F (7.2°C) or below. Frozen foods shall be maintained at temperatures which ensure that the foods remain frozen solid. Poisonous and toxic materials shall be identified and handled under such conditions as will not contaminate other salvageable or salvaged merchandise, or constitute a hazard to personnel.

Section 725.41 Segregration of Merchandise

All salvageable merchandise shall be promptly sorted and segregated from non-salvageable merchandise to prevent further contamination of merchandise to be salvaged or offered for sale or distribution.

Section 725.42 Transporting of Distressed Merchandise

Merchandise distressed within Illinois shall be moved under Department seal from the site of a fire, flood, sewer backup, wreck or other cause as expeditiously as possible so as not to become putrid, rodent or insect harborages, or otherwise a menace to public health. All distressed and salvageable merchandise of a perishable nature shall, prior to reconditioning, be transported only in vehicles provided with adequate refrigeration. No interstate movement of distressed or salvageable merchandise shall be made without the prior approval of the Department and the responsible State agency in the State to receive the merchandise.

Section 725.43 Handling of Non-Human Food, Drug or Medical Device Distressed Articles

If distressed articles other than human food, drugs or medical devices are salvaged, they shall be handled in rooms or solid partitioned areas separate from those in which foods, drugs or medical devices are reconditioned.

Section 725.44 Cross-Contamination Protection

Precautions shall be taken to prevent cross-contamination (animal feed to human food, etc.) among the various types of merchandise which are salvageable or salvaged. Precautionary measures which may prevent cross-contamination include, but are not limited to, segregration of items by location, and not storing non-human foods, toxins or other food items directly above or contiguous to human foods, drugs, cosmetics, medical devices or alcoholic beverages.

(Source: Amended at 14 Ill. Reg. 864, effective January 1, 1990)

Section 725.50 Reconditioning and Labeling of Distressed Merchandise

a) All salvageable merchandise shall be reconditioned prior to sale or distribution except for such sale or distribution to a person holding a valid license pursuant to Section 725.30 to engaged in a salvage operation or transportation of such salvageable merchandise in accordance with Section 725.42.

b) All metal cans of items offered for sale or distribution shall be free from pitted rust and free from dents on the rim, end double seams and/or side seams in accordance with Section 725.50(d). Containers which are leakers, springers, flippers, and swells shall be deemed unfit for sale or distribution. Containers, including metal and glass containers with cork press caps, screw caps, pull rings or other types of openings which have been in contact with water, liquid foam, soot, smoke or other deleterious substances, as a result of fire fighting efforts, flood, sewer backups or similar mishaps, shall be deemed unfit for sale or distribution (i.e., non-salvageable merchandise as defined in Section 725.20 of this Part).

c) All metal containers, other than those mentioned in subsection (b) above, the integrity of which has not been compromised and would not be compromised by reconditioning, and which have been in contact with water, liquid foam, soot, smoke or other deleterious substances as a result of fire fighting efforts, flood, sewer backup or other reasons shall, after thorough cleaning, be subjected to sanitizing rinse of a concentration of 100 ppm available chloringe, or an equivalent santizer listed in 21 CFR 178.1010, for minimum period of one minute. All metal containers shall be thoroughly dried to inhibit rust formation after sanitization.

d) In addition to the requirements of Section 725.50(b) and 725.50(c) of this Part, the reconditioning of metal cans shall be regulated in accordance with the provisions of "Classification of Visible Can Defects (Exterior)," published by the Association of Official Analytical Chemists, 1984, with the exception of its explanations of rusted can defects, and "Guidelines for Evaluation and Disposition of Damaged Canned Food Containers," published by the National Food Processors Association, 1979, with the exception of Chapter J as it relates to rusted can defects, and "A Pocket Guide to Can Defects," published by the Association of Food and Drug Officials, 1987, with the exception of rusted can defects as stated on page 19.

Section 725.51 Relabeling

All salvageable merchandise shall be labeled, at a minimum, with the word "salvaged" and shall indicate on the label the date of salvaging. All salvaged merchandise is to be provided with labels meeting the requirements of the Illinois Food, Drug and Cosmetic Act, the Federal Food, Drug, and Cosmetic Act, the Federal Food, Drug, and Cosmetic Act, Federal Fair Packaging and Labeling Act, and regulations promulgated under such Acts. Where original labels are removed from containers which are to be resold or redistributed, the replacement labels must show as the distributor, the name and address of the salvage processing plant, as well as the date of reconditioning for sale or distribution. No person, firm or corporation shall keep or permit to remain in any salvage warehouse or salvage warehouse store any article of food, drug, medical device or cosmetic which has been held in a salvage warehouse within the State for a longer period than the reasonable shelf life of the item, but in no event, for a period longer than 12 months, except with the written approval of the Director. (Section 406 of the Act)

Section 725.60 Distribution of Non-Salvageable Merchandise

Non-salvageable merchandise shall not be sold or distributed as food, alcoholic liquors, drugs, medical devices or cosmetics, but shall be disposed of in a landfill operated in compliance with the requirements of the Environmental Protection Act, 35 Ill. Adm. Code: Subtitle G, or a waste water treatment plant operated in compliance with the requirements of 35 Ill. Adm. Code: Subtitle C, and any additional local requirements on disposal.

Section 725.70 Returned Drug Products

Returned drug products shall be identified as such. If the conditions under which returned drug products have been held, stored, or shipped before or during their return, of if the condition of the drug products, its container, carton, or labeling, as a result of storage or shipping casts doubt on the safety, identity, strength, quality or purity of the drug product, the returned product shall be destroyed unless examination, testing, or other investigations prove the drug product meets appropriate standards of safety, identity, strength, quality, or purity as stated in 21 CFR 211. A drug product may be reprocessed provided the subsequent drug product meets appropriate standards, specifications, and characteristics as stated in 21 CFR 211. Records of return drug products shall be maintained and shall include the name and label potency of the drug product dosage form, lot number (or control number or batch number), reason for the return, quantity returned, date of disposition, and ultimate disposition of the returned drug product as stated in 21 CFR 211. Procedures for the holding, testing, and reprocessing of returned drug products shall be in writing and shall be followed.

(Source: Amended at 14 Ill. Reg. 864, effective January 1, 1990)

Section 725.71 Drug Product Salvaging

Drug products that have been subjected to improper storage conditions including extremes in temperature, humidity, smoke, fumes, pressure, age, or radiation due to natural disasters, fires, accidents, or equipment failures shall not be salvaged and returned to the marketplace pursuant to this Part. Improper storage conditions include, but are not limited to, variations in temperature extremes, moisture permeation or conditions of high humidity, potential exposure of the product to the environment, insanitary storage conditions, or infestation with insects or vermin. Whenever there is a question whether drug products have been subjected to such conditions, salvaging operations may be conducted only if there is evidence from laboratory tests and assays (including animal feeding studies where applicable) that the drug products meet all applicable standards of identity, strength, quality, and purity and evidence from inspection of the premises that the drug products and their associated packaging were not subjected to improper storage conditions as a result of the disaster or accident (21 CFR 211.208). Organoleptic examinations shall be acceptable only as supplemental evidence that drug products meet appropriate standards of identity, strength, quality, and purity. Appropriate standards would include the specific portion of the products' monograph in the official compendia as stated in the Food, Drug and Cosmetic Act, the statutory or regulatory standard of identity, if existing, or a particular product, and the manufacturer's internal standards of product quality. Records including name, lot number, and disposition shall be maintained for drug products subject to this Section.

(Source: Amended at 14 Ill. Reg. 864, effective January 1, 1990)

Section 725.80 Records Required

Whenever articles of damaged foods, alcoholic liquors, drugs, medical devices or cosmetics from fires, floods, storms, train wrecks, manufacturer closeouts, or damaged from any other source whatsoever are received in a salvage warehouse or salvage warehouse store for damaged foods, alcoholic liquors, drugs, medical devices or cosmetics, a record shall be made identifying the articles of food, alcoholic liquors, drugs, medical devices or cosmetics, source of receipt, receipt date, wholesale distribution, and disposition date at the wholesale level.