Appendices L Through N

Appendix L.  Applicable Regulations, Standards of Identity for Milk and Milk Products and the Federal Food, Drug, and Cosmetic Act

21 CFR PART 101 - FOOD LABELING
21 CFR PART 108 - EMERGENCY PERMIT CONTROL
21 CFR PART 110 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD
21 CFR PART 113 - THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS
21 CFR PART 130.10 - Requirements for foods named by use of a nutrient content claim and a standardized term
21 CFR 131.3 Definitions - Cream, Pasteurized and Ultra-pasteurized
21 CFR 131.110 Milk
21 CFR 131.111 Acidified Milk
21 CFR 131.112 Cultured Milk
21 CFR 131.150 Heavy Cream
21 CFR 131.155 Light Cream
21 CFR 131.157 Light Whipping Cream
21 CFR 131.160 Sour Cream
21 CFR 131.162 Acidified Sour Cream
21 CFR 131.170 Eggnog
21 CFR 131.180 Half-and-Half
21 CFR 131.200 Yogurt
21 CFR 131.203 Lowfat Yogurt
21 CFR 131.206 Nonfat Yogurt
21 CFR 133.128 Cottage Cheese
21 CFR 133.129 Dry Curd Cottage Cheese

Federal Food, Drug, and Cosmetic Act, as amended Sec. 402. [342| Adulterated Food
Federal Food, Drug, and Cosmetic Act, as amended Sec. 403. [343| Misbranded Food

Appendix M.  Reports and Records

The following forms are available at:
http://www.fda.gov/opacom/morechoices/fdaforms/cfsan.html

FORM FDA 2359        Milk Plant Inspection Report

FORM FDA 2359a      Dairy Farm Inspection Report

FORM FDA 2359b     Milk Plant Equipment Test Report

FORM FDA 2359c      Single-Service Manufacturing Plant Inspection Report

FORM FDA 2399       Milk Sample Collector Evaluation Form

FORM FDA 2399a      Milk Tank Truck, Hauler Report and Sampler Evaluation Form

FORM FDA 2399b     Milk Tank Truck Inspection Form

Appendix N. Drug Residue Testing and Farm Surveillance

I. INDUSTRY RESPONSIBILITIES

1. Monitoring and Surveillance

   Industry shall screen all bulk milk pickup tankers for Beta lactam drug residues.  Additionally, other drug residues shall be screened for by employing a random sampling program on bulk milk pickup tankers.  The random bulk milk pickup tanker sampling program shall represent and include, during any consecutive six (6) months, at least four (4) samples collected in at least four (4) separate months, except when three (3) months show a month containing two (2) sampling dates separated by at least twenty (20) days. Samples collected under this random sampling program shall be analyzed as specified by FDA. (See M-a-75).

   Bulk milk pickup tanker testing shall be completed prior to processing the milk.  Industry samplers shall be evaluated according to the requirements specified in Section 6 - The Examination of Milk and Milk Products of this Ordinance.  Bulk milk pickup tanker samples found to be positive for drug residues shall be retained as determined necessary by the Regulatory Agency.  Industry shall also record all sample results and retain such records for a period of six (6) months.

2. Reporting and Farm Traceback

   When a bulk milk pickup tanker is found to be positive for drug residues, the Regulatory Agency shall be immediately notified of the results and the ultimate disposition of the raw milk.

   The producer samples from the bulk milk pickup tanker, found to be positive for drug residues, shall be individually tested to determine the farm of origin.  The samples shall be tested as directed by the Regulatory Agency.

   Further pickups of the violative individual producer's milk shall be immediately discontinued, until such time, that subsequent tests are no longer positive for drug residues. 

II. REGULATORY AGENCY RESPONSIBILITIES

1. Monitoring and Surveillance

   Regulatory Agencies shall monitor industry surveillance activities by making unannounced, on-site inspections to collect samples from bulk milk pickup tankers and to review industry records of the sampling program.  Alternately, the Regulatory Agency or Laboratory Evaluation Officer may take known samples with them on the audit visit and observe the industry analyst test the samples.  Receiving locations that choose to certify all receiving analysts, certified under the provisions of the NCIMS Laboratory Certification Program, are exempt from the sample collection requirements of this Section. 

   A review shall include, but not be limited to, the following:

   1. Is the program an appropriate routine monitoring program for the detection of drug residues?  Is the program utilizing appropriate test methods?

   2. Is each producer's milk represented in a testing program for drug residues and tested at the frequency prescribed in I. A. for drug residues?

   3. Is the program assuring timely notification to the appropriate Regulatory Agency of positive results, the ultimate disposition of the bulk milk pickup tanker milk, and of the trace-back to the farm of origin?  Is the farm pickup suspended until subsequent testing establishes the milk is no longer positive for drug residues?

   The Regulatory Agency shall also perform routine sampling and testing for drug residues determined to be necessary as outlined in Section 6 and M-a-75.

2. Enforcement

   If testing reveals milk positive for drug residues, the milk shall be disposed of in a manner that removes it from the human or animal food chain, except where acceptably reconditioned under FDA Compliance Policy Guide (CPG 7126.20). The Regulatory Agency shall determine the producer(s) responsible for the violation.

   Suspension: Any time milk is found to test as a confirmed positive for a drug residue, the Regulatory Agency shall immediately suspend the producer's Grade "A" permit or equally effective measures shall be taken to prevent the sale of milk containing drug residues.

   Penalties: Future pick-ups are prohibited until subsequent testing reveals the milk is free of drug residue.  The penalty shall be for the value of all milk on the contaminated load plus any costs associated with the disposition of the contaminated load.  The Regulatory Agency may accept certification from the violative producer's milk marketing cooperative or purchaser of milk as satisfying the penalty requirements.

   Reinstatement: The Grade "A" producer's permit may be reinstated, or other action taken, to allow the sale of milk for human food, when a representative sample taken from the producer's milk, prior to commingling with any other milk, is no longer positive for drug residue.

   Follow-Up:  Whenever a drug residue test is positive, an investigation shall be made to determine the cause.  The farm inspection is completed by the Regulatory Agency or its agent to determine the cause of the residue and actions taken to prevent future violations including:

   1. On-farm changes in procedures necessary to prevent future occurrences as recommended by the Regulatory Agency.

   2. Discussion and education on the Drug Residue Avoidance Control measures outlined in Appendix C. of this Ordinance.

   Permit Revocation:  After a third violation in a twelve (12) month period, the Regulatory Agency shall initiate administrative procedures pursuant to the revocation of the producer's Grade "A" permit under the authority of Section 3 - Permits of this Ordinance, due to repeated violations.

III. ESTABLISHED TOLERANCES AND/OR SAFE LEVELS OF DRUG RESIDUES

"Safe levels" are used by FDA as guides for prosecutorial discretion.  They do not legalize residues found in milk that are below the safe level.  In short, FDA uses the "safe levels" as prosecutional guidelines and in full consistency with CNI v. Young stating, in direct and unequivocal language, that the "safe levels" are not binding.  They do not dictate any result; they do not limit the Agency's discretion in any way; and they do not protect milk producers, or milk from court enforcement action.

"Safe levels" are not and cannot be transformed into tolerances that are established for animal drugs under Section 512 (b) of the FFD&CAas amended.  "Safe levels" do not:

1. Bind the courts, the public, including milk producers, or the Agency, including individual FDA employees; and

2. Do not have the "force of law" of tolerances, or of binding rules.

Notification, changes or additions of "safe levels" will be transmitted via Memoranda of Information (M-I's).

IV.  Approved Methods

AOAC First Action and AOAC Final Action methods are accepted in accordance with Section 6 of this Ordinance.  Drug residue detection methods shall be evaluated at the safe level or tolerance.  Regulatory action based on each test kit method may be delayed until the evaluation is completed and the method is found to be acceptable to FDA and complies with the provisions of Section 6 of this Ordinance.

One (1) year after test(s) have been evaluated by FDA and accepted by the NCIMS for a particular drug or drug family, other unevaluated tests are not acceptable for screening milk.  The acceptance of evaluated tests does not mandate any additional screening by industry with the evaluated method.