5E-3.003. Inspection; Sampling; Analysis; Reporting Rejected Feed and Feedstuff; Reduced Sampling Requirements; Laboratory Certification/Exemption Requirements and Fees

(1) Definitions.

(a) The term “lot” means an identifiable quantity of commercial feed of the same brand and analysis which is offered for sale, sold or distributed within the state. Bulk feed and bagged feed, even though the same brand and analysis, in the same shipment, shall be considered separate lots.

(b) The term “core” means the quantity of feed contained in the designated sampling tool when the stream is cut a sufficient number of times to yield approximately one quart or when a single insertion and withdrawal of a probe is made from bagged or bulk feed.

(c) The term “product type” means mixed poultry feed, dairy cow feed, beef cattle feed, horse feed, swine feed, or other feed.

(d) The term “Mixed Feed” means a product which is a mixture of nutritional ingredients intended or represented for use as a substantial source of nutrients in an animal diet, which may or may not be limited to the sole ration of the animal.

(e) The term “Ingredient” means each of the constituent materials used to make a commercial feed.

(f) The term “Other Feed” is inclusive of all other commercial feed products intended for consumption by species of animals not previously stipulated.

(g) The term “Grain or Grain Products” includes Barley, Maize – (Corn Products), Grain Sorghum, Oats, Rice, Rye, Triticale, and Wheat.

(h) The term “Other Feed Ingredients” is inclusive of all ingredients other than Cottonseed Products, Peanut Products, and ingredients identified as “Grain or Grain Products”.

(i) The term “Treats” includes products identified as Snacks, Chews, Biscuits, Cookies, or Bones that are intended for intermittent or supplemental feeding only and which are not intended or represented to serve as the primary source of nutrients in an animal diet.

(j) The term “Mineral or Vitamin Supplement” means all mixtures that contain mineral or vitamin ingredients generally regarded as dietary factors essential for the normal nutrition of animals and that are sold or represented for the primary purpose of supplying these minerals or vitamins as additions to rations in which these same mineral or vitamin factors may be deficient.

(k) The term “expiration date” means the month and year as determined by the manufacturer, packer, or distributor on the basis of tests or other information showing that the product, until that date, under the conditions of handling, storage, preparation, and use per label directions, will contain not less than the quantity of each ingredient as set forth on its label.

(l) The term “Hemp” is defined in Section 581.217(3)(d), F.S.

(m) The term “Hemp extract” is defined in Section 581.217(3)(e), F.S. Hemp extract does not include any material, compound, mixture or preparation that contains any quantity of Synthetic Cannabinoids as defined in Section 893.03(1)(c)190., F.S.

(n) The term “pet food” means any commercial feed prepared and distributed for consumption by dogs or cats.

(o) The term “pet treats” means any treat as defined in paragraph 5E-3.003(1)(i), F.A.C., prepared and distributed for consumption by dogs or cats.

(p) The term “specialty pet” means any animal normally maintained in a household, including, rodents, ornamental birds, ornamental fish, reptiles and amphibians, ferrets, hedgehogs, marsupials, and rabbits not raised for food or fur.

(q) The term “specialty pet food” means any commercial feed prepared and distributed for consumption by specialty pets.

(r) The term “specialty pet treats” means any treat as defined in paragraph 5E-3.003(1)(i), F.A.C., prepared and distributed for consumption by specialty pets.

(s) The term “total delta-9-tetrahydrocannabinol concentration” means [delta-9-tetrahydrocannabinol] + (0.877 x [tetrahydrocannabinolic acid)].

(2) Inspection.

(a) All commercial feed and feedstuff distributed for use in Florida is subject to inspection by the Department of Agriculture and Consumer Services or its authorized agent at any public or business premises, manufacturing or mixing establishment, and in any vehicle of transport during regular business hours in order to have access to such feeds and records relating to their manufacture, transportation and sale.

(b) Samples shall be collected by the methods and procedures set forth by statute or established and published in the Feed Inspector’s Manual published by the Association of American Feed Control Officials Incorporated (2nd Edition 5/1/00). The Feed Inspector’s Manual published by the Association of American Feed Control Officials Incorporated, (2nd Edition 5/1/00) is incorporated by reference. Copies may be obtained from AAFCO Assistant Secretary-Treasurer, P. O. Box 478, Oxford, IN 47971.

(3) Sample and Analytical Documentation.

(a) All samples obtained and analyzed by the department or by approved certified commercial laboratories, approved Hazard Analysis Critical Control Point Programs and approved quality assurance/quality control programs shall be properly identified by the sampler’s initials and assigned a sample number (13 digit number consisting of the: date, registrant number, sequential number of samples collected on that date for the identified registrant:)

_______	_______	_______	___________	___________
month	day	year	registrant #	sequential #

and be accompanied by the completed Feed Collection/Analysis Reports (Forms Numbered DACS-13403, 13404, 13405, 13406 or 13407, Rev. 6/01) and any other available pertinent documentation.

(b) Feed Collection/Analysis Reports (Forms DACS-13403, 13404, 13405, 13406 and 13407, Rev. 6/01) are hereby incorporated by reference. Copies may be obtained from Florida Department of Agriculture and Consumer Services, Bureau of Feed, Seed and Fertilizer Laboratories, 3125 Conner Boulevard, Building 7, Tallahassee, FL 32399-1650.

(c) The Feed Collection/Analysis Report Forms shall be properly completed.

(d) Positive drugs and mycotoxin results must be reported within 48 hours of completion of analyses to the department.

(4) Sampling Requirements, Frequency and Analysis Requirements. The sampling period shall run concurrently with the registration period. Samples of commercial feed and feedstuffs shall be submitted quarterly, to laboratories certified by the Department, corresponding to the tonnage reported to the Department. A minimum of one sample shall be submitted by the end of the first quarter of each year. The sampling period ends June 1st of each year. The sampling frequency and analysis requirements to be used by feed registrants are listed below. If the department finds that circumstances exist which threaten the health of commercial livestock or the public, the department shall require additional feed sample analyses.

(a) Ingredients.

1. Nutrients – No analyses required.

2. Mycotoxins.

a. Aflatoxins.

(I) Grain and Grain Products – One sample per 5,000 tons distributed shall have a quantitative analysis performed;

(II) Cottonseed Products – One sample per 2500 tons shall have a quantitative analysis performed;

(III) Peanut Products – One sample per 500 tons shall have a quantitative analysis performed;

(IV) There will be a minimum of one quantitative analysis performed per year per distributor on the above ingredient types;

(V) No aflatoxin analysis is required on ingredients not listed above.

b. Fumonisin.

(I) Maize – (Corn Products) – One sample per 5,000 tons distributed shall have a quantitative analysis performed;

(II) No fumonisin analysis is required on ingredients not listed above.

c. Vomitoxin.

(I) Grain and grain products (excluding Maize – Corn Products) – One sample per 25,000 tons shall have a quantitative analysis performed;

(II) There will be a minimum of one quantitative analysis performed per year per distributor for grain and grain products (excluding Maize – Corn Products);

(III) No vomitoxin analysis is required on ingredients not listed above.

3. Drugs –

a. The FDA requirements as provided in 21 C.F.R. parts 225, 226 (4/1/01) shall be considered adequate for the purposes of this testing requirement.

b. 21 C.F.R. pts. 225, 226 (4/1/01) are hereby incorporated by reference. Copies may be obtained from the Superintendent of Documents, U.S. Government Printing Office, 732 N. Capitol Street, N. W., Mail Stop SDE, Washington, D.C. 20401.

(b) Mixed Feeds.

1. Nutrients.

a. Protein, fat and fiber analysis shall be performed at a frequency of one per every 750 cumulative tons for all types of feed distributed. If the distributors deficiency rate is 5% or less the sampling frequency shall be reduced to one per every 2000 tons; If the distributors deficiency rate is greater than 5% but less than 10%, the sampling frequency shall be reduced to one per every 1000 tons;

b. If the distributors deficiency rate is 20% or greater the sampling frequency shall be increased to one for every 500 tons;

c. Mineral analyses shall be performed at a frequency of one per every 15,000 cumulative tons distributed per year with a minimum of one analysis per year.

d. Treats shall be exempt from nutrient sampling and analysis requirements.

2. Mycotoxins.

a. Aflatoxin analysis shall be performed on all types of mixed feed at a frequency of one for every 25,000 cumulative tons (excluding mineral or vitamin supplements and liquid feed) with a minimum of one per year per distributor. Aflatoxin analysis must be quantitative;

b. Fumonisin analysis shall be performed at a frequency of one per year per distributor for horse feed only;

c. Vomitoxin analysis shall be performed for all types of mixed feed (excluding mineral or vitamin supplements and liquid feed) at a frequency of one per every 50,000 cumulative tons with a minimum of one per year per distributor.

d. Treats shall be exempt from mycotoxin sampling and analysis requirements.

3. Pesticide Residues – No analysis required.

4. Drugs.

a. The FDA requirements as provided in 21 C.F.R. pts. 225, 226 (4/1/01) shall be considered adequate for the purposes of this testing requirement.

b. 21 C.F.R. pts. 225, 226 (4/1/01) are hereby incorporated by reference. Copies may be obtained from the Superintendent of Documents, U.S. Government Printing Office, 732 N. Capitol Street, N. W., Mail Stop #SDE, Washington, D.C. 20401.

(5) Hemp extract in pet food, pet treats, specialty pet food and specialty pet treats. 

(a) Hemp extract as defined in Section 581.217(3)(e), F.S. used in pet food, pet treats, specialty pet food and specialty pet treats must be tested and have a certificate of analysis prepared by an independent testing laboratory as required in Section 581.217(7), F.S.

(b) Pet food, pet treats, specialty pet food and specialty pet treat products shall not contain more than 0.3% total delta-9-tetrahydrocannabinol concentration on a dry weight basis.

(c) Pet food, pet treats, specialty pet food and specialty pet treat products having a total delta-9-tetrahydrocannabinol concentration that exceeds 0.3% on a dry weight basis, shall be detained pursuant to Section 580.111, F.S. Those products having a total delta-9-tetrahydrocannabinol concentration that exceeds 0.3% on a dry weight basis which have been detained pursuant to Section 580.111, F.S., shall not be further subdivided or renumbered such that the integrity of the lot for identification is not maintained. The manufacturer or distributor shall not dispose of the pet food, pet treats, specialty pet food and specialty pet treats in any manner until written permission is given by the Department or a court of competent jurisdiction.

(d) Upon receipt of written permission by the Department or a court of competent jurisdiction, the pet food, pet treats, specialty pet food and specialty pet treats shall be disposed of in accordance with the Hemp Waste Disposal Manual FDACS-08115, 10/19, incorporated in paragraph 5B-57.014(6)(b), F.A.C., or in the manner provided for by a court of competent jurisdiction. Upon destruction of the product, the manufacturer or distributor shall notify the Department via Notice of Disposal FDACS-13411, 10/19, incorporated herein by reference and available online at https://www.flrules.org/Gateway/reference.asp?No=Ref-11419.

(6) Reporting of Rejected Feed and Feedstuff.

(a) Shipments of feed that are rejected for use by registrants must be reported to the Feed Inspection Section within 48 hours of analysis via telephone [phone] or fax [phone] followed by written confirmation within 5 business days.

(b) Reports of rejected feed must include a description of the feed, name of the feed distributor, amount of feed rejected, destination of the rejected feed, if known, and reason for the rejection.

(7) Requirements for Reduced Sampling and Analysis for Persons with Approved Hazard Analysis Critical Control Point Programs.

(a) Those registrants successfully complying with all criteria established in section 580.091(3)(a), F.S., shall have their sampling and analysis requirements reduced to 50% of the requirements specified in paragraphs 5E-3.003(4)(a) and (b), F.A.C.

(b) Every registrant that conforms with the Hazard Analysis and Critical Control Point System published by the National Advisory Committee on Microbiological Criteria for Foods shall be deemed in compliance with section 580.091(3)(a), F.S.

(c) The Hazard Analysis and Critical Control Point System, National Advisory Committee on Microbiological Criteria for Foods, (March 20, 1992), is hereby incorporated by reference. Copies may be obtained from Executive Secretariat, FSIS, Room 3175, South Building, Independence Avenue, S. W., Washington, D.C. 20250.

(d) Registrants that request a reduced frequency of sampling and analysis requirements shall submit a written hazard-analysis-critical-control-point plan to the department. If this plan identifies critical control points and verifies implementation of good management practices, the department shall conduct an onsite evaluation to ensure the performance of the plan. If the onsite evaluation verifies adequate control of the processes identified in the plan and infrequent adulteration or other violations (50% or less), the registrant shall be subject to a 50% reduction in sampling frequency and analysis requirements. The department shall require quarterly reports documenting the continued and appropriate use of good management practices and hazard analysis of critical control points.

(8) Commercial Laboratory Certification; Fees.

(a) Analyses of feed and feedstuff as provided in chapter 580, F.S., shall be performed by the department, approved certified commercial laboratories and by approved exempt laboratory pursuant to its quality assurance/quality control plans.

(b) Certified commercial laboratories performing analytical work shall ensure performance of those analyses in the categories for which they have been certified. Certified commercial laboratories that subcontract analytical work to another laboratory must establish that the contracted laboratory has been certified under this section for the appropriate categories. Laboratory records shall indicate who performed the analysis, and the name of the contract laboratory shall appear in the records. The contract laboratory name shall be included in all data reports issued by the primary laboratory for results reported by the contract laboratory.

(c) Definitions.

1. Acceptable variation – Three standard deviations from arithmetic mean.

2. Acknowledged Acceptable Test Methods – Those methods specifically referenced in these rules or other methods which have been acknowledged in writing as acceptable by the department. Such acknowledgement shall be given when a test method has been submitted to the department for acknowledgement and the department has verified that the test method and its results are verifiable and reproducible.

3. Analyst – A chemist, microbiologist or technician qualified by academic training and experience who usually performs tests or participates in testing with other qualified personnel.

4. Analyte – The particular compound, element, radical, isotope, characteristic or contaminant for which one is testing.

5. Category of certification – A group of analytes and approved testing methods from which a laboratory may select to become certified. Laboratories may be certified in the following categories:

a. Nutrients,

b. Mycotoxins – Aflatoxin, Fumonisin and Vomitoxin only,

c. Microorganisms – Salmonella only,

d. Pesticide residues – Chlorinated hydrocarbons, organophosphates and carbamates – Screen only. Confirm all positive screens quantitatively,

e. Drugs.

6. Certification – Regulatory recognition given to a laboratory that meets the minimum criteria of this section as determined through department evaluation and satisfactory participation in a check sample program.

7. Commercial/Exempt Laboratory – A laboratory other than those operated by the State of Florida or its subdivisions, that performs nutrient, microbiological, mycotoxin, pesticide residue or drug analysis on a fee or contract basis on commercial feed and feedstuff distributed by any entity.

8. Decertification – Revocation of certification by the department for one or more of the reasons provided in paragraph 5E-3.003(8)(e), F.A.C.

9. Director, Supervisor or Consultant – A chemist, microbiologist or professional scientist qualified by academic training and experience to administer the technical and scientific operations of the laboratory, including supervision of testing procedures and reporting of results.

10. The Quality Assurance/Quality Control Manual – The Quality Assurance/Quality Control Manual shall follow the general outline of the Quality Assurance/Quality Control Manual adopted by the department (Laboratory Quality Assurance/Quality Control Guideline Document, August 23, 1994). The Laboratory Quality Assurance/Quality Control Guideline Document (August 23, 1994) is hereby incorporated by reference. Copies may be obtained from the Florida Department of Agriculture and Consumer Services, Bureau of Feed, Seed and Fertilizer Laboratories, 3125 Conner Boulevard, Building 7, Tallahassee, FL 32399-1650, [phone].

11. Recertification – Reinstatement of certification by the department following correction of the deficiencies for which the laboratory was decertified. Such recertification shall require submission of a new application as required for initial certification.

(d) Commercial Laboratory Certification – Application, Evaluation and Renewal.

1. The Application/Renewal for Certification as a Certified Feed Laboratory (Form DACS-13401, Rev. 10/02) which is hereby incorporated by reference, must be properly completed and submitted with the appropriate fees. Copies may be obtained from and submitted to the Florida Department of Agriculture, Bureau of Feed, Seed and Fertilizer Laboratories, 3125 Conner Boulevard, Building 7, Tallahassee, Florida 32399-1650, [phone]. Separate applications must be submitted for each laboratory location without regard to ownership. Applications must be accompanied by the laboratory’s Quality Assurance/Quality Control manual, assay methods, results from check sample programs and participation number, detailed organizational chart showing name and position title for all key personnel, description of the laboratory and laboratory equipment as it applies to the department certification activities, and a description of the scope of the laboratory operations;

2. Each commercial laboratory seeking certification may be assessed and evaluated by department personnel. These inspections of the premises and operations of certified, commercial laboratories or those laboratories seeking certification may be unannounced and may include the on-site analysis of proficiency test samples as well as the photographing, filming or videotaping of any portion of the laboratory, equipment, activity, samples taken, records, test results or other information related to certification under this chapter;

3. Each commercial laboratory must be able to demonstrate that it is able to perform the tests representative of those for which certification is sought;

4. In order to maintain its certification, a certified laboratory must:

a. Be capable of performing tests for which it is certified based on AOAC or acknowledged acceptable test methods;

b. Limit the representation of the scope of its certification to only those tests for which certification is granted;

c. Report all deficiencies, excesses and adulterations to the department within 48 hours of completion of analysis;

d. Maintain all final laboratory reports and documentation of all samples for three years;

e. Maintain an independent decisional relationship between itself and its clients, affiliates, or other organizations so that the laboratory’s capacity to render test reports objectively and without bias is not adversely affected;

f. Report to the department within (30) days any major changes involving the location, ownership, management structure, authorized representative, approved signatories, methodologies or facilities of the laboratory;

5. Each certified commercial laboratory must return to the department the Certificate of Certification for revision or other action should it be requested to do so by the department or become unable to conform to any of these conditions and the applicable criteria of chapter 580, F.S. and chapter 5E-3, F.A.C.;

6. The department will renew certifications annually. Renewal must be submitted on Application/Renewal for Certification as a Certified Feed Laboratory (Form number DACS-13401, Rev. 10/02) provided by the department.

(e) Denial or Decertification. A commercial laboratory’s certification shall be suspended for any of the following violations:

1. Making false statements on an application or on any document associated with certification or exemption.

2. Demonstrating incompetence or making consistent errors in analyses or erroneous reporting.

3. Permitting unqualified personnel to perform analyses.

4. Falsifying the results of analyses.

5. Violation or aiding and abetting in the violation of any provision of these rules or chapter 580, F.S.

6. Failure to properly maintain facilities and equipment.

7. Failing to comply with the required quality control program.

8. Advertising false services or credentials.

9. Failing to correct deficiencies within the time required by the department.

10. Failure to submit laboratory check samples during the period of probation for the category of certification which resulted in probation.

(f) Methodology and Quality Assurance Requirements – An alternate laboratory method may be acceptable only if it is equivalent to the prescribed test in both accuracy and reproducibility as it relates to the determination of compliance with any minimum/maximum levels. Use of authorized alternate test methods shall require written permission of the department.

(g) Check Sample Testing Requirements for Certified Laboratories.

1. Laboratories shall participate in the department check sample program, if required. Quarterly, the department may provide a feed sample to each certified laboratory. The laboratory must conduct an analysis of this sample for each certified category and report results to the department within 45 days of sample shipping. This testing may include analysis of split feed and feedstuff samples as part of the requirement for certification. Participation shall mean the analysis and reporting of all proficiency/check sample tests to the department within specified time frames.

2. Each laboratory shall bear its own cost for compliance with this check sample program.

(9) Quality Assurance/Quality Control Requirements for Registrants Requesting Exemption from Laboratory Certification for In-house Laboratories; Exempt Laboratory’s Quality Assurance/Quality Control Plan Fees.

(a) Quality Assurance/Quality Control Plan – The in-house laboratory plan submitted for approval by the department that exempts the laboratory from the certification requirements set forth in subsection 5E-3.003(8), F.A.C.

(b) Application for exemption from the requirement for laboratory certification through submission of an approved quality assurance/quality control plan shall be made in writing to the department on the Request/Renewal For Exemption From Certified Feed Laboratory Testing (Form number DACS-13402, Rev. 10/02). The Request/Renewal For Exemption From Certified Feed Laboratory Testing (Form number DACS-13402, Rev. 8/06) is hereby incorporated by reference. Copies may be obtained from Florida Department of Agriculture and Consumer Services, Bureau of Feed, Seed and Fertilizer Laboratories, Building 7, 3125 Conner Boulevard, Tallahassee, FL 32399-1650, [phone].

(c) The laboratory shall prepare and follow a written quality assurance/quality control plan including a quality assurance/quality control manual as defined in subparagraph 5E-3.003(8)(c)10., F.A.C. A copy of this plan including a quality assurance/quality control manual must be included with the original application for exemption. A registrant’s quality assurance/quality control plan shall be approved upon determination that the plan meets the requirements of this rule and is being implemented at the registrant’s facility.

(d) Reporting Procedures For Exempt Laboratories.

1. Each exempt laboratory must forward regulatory test results to the department quarterly on form numbers DACS-13403, 13404, 13405, 13406, 13407 as referenced in paragraph 5E-3.003(3)(b), F.A.C.;

2. Each exempt laboratory must report all deficiencies/excesses and adulterations to the department within 48 hours of completion of analysis;

3. Each exempt laboratory must report to the department within (30) days any major changes involving the location, ownership, management structure, authorized representative, approved signatories, methodologies or facilities of the laboratory.

(e) Check Sample Testing Requirements for Exempt Laboratories. Exempt laboratories shall participate in the departments check sample program, if required. Quarterly, the department may provide a feed sample to each exempt laboratory. The laboratory must conduct an analysis of this sample for each category of analysis and report results to the department within 45 days of sample shipping. This testing may include analysis of split feed and feedstuff samples as part of the requirement for exemption. Participation shall mean the analysis and reporting of all proficiency/check sample tests to the department within specified time frames.

(f) Quality Assurance/Quality Control Program Fees. Registrants requesting an exemption from the requirement for laboratory certification in section 580.091(5), F.S., through application for department approval of a quality assurance/quality control program shall pay a fee in the amount to cover the direct costs associated with evaluation of the program and program approval. The direct costs shall include the salary and benefits costs of employees involved in the initial review process based on a per hour rate. This fee shall be paid in full as a condition of program approval. Subsequent evaluations shall be conducted every three years in accordance with section 580.091(5)(b), F.S.

Rulemaking Authority 570.07(23), 580.036(2), 580.065, 581.217(12)(b) FS. Law Implemented 580.036(2), 580.051, 580.065, 580.071, 580.091, 580.111, 580.121, 580.131, 581.217(7)(a) FS. History–New 12-30-70, 5-14-85, Formerly 5E-3.03, Amended 3-4-87, 6-1-95, 11-14-01, 8-31-06, 1-1-20.