Chapter 15. Use of Antimicrobial Drugs
Regulation .01 Purpose.LinkCopy Citation
The purpose of this chapter is to describe the restrictions on the use of medically important antimicrobial drugs in the production of cattle, swine and poultry.
Regulation .02 Definitions.LinkCopy Citation
A.
In this chapter, the following terms have the meanings indicated.
B.
Terms Defined.
(1)
“Administered in a regular pattern” means used:
(a)
For multiple courses of therapy in the same animal or group of animals; or
(b)
As a standard operating procedure, including:
(i)
In correspondence with a particular life stage of an animal, such as in ovo, at birth or hatch, or at weaning;
(ii)
As an ongoing management strategy or tool, such as in correspondence with a particular age or weight of an animal, time of the week, month, or year, or season; or
(iii)
When moving animals from one location to another.
(2)
“Animal” means cattle, swine or poultry.
(3)
“Dry cycle” means a period of time when a cow is not lactating.
(4)
Elevated Risk.
(a)
“Elevated risk” means a risk that is significantly higher than that present under normal or standard operating conditions.
(b)
“Elevated risk” does not include a risk typically or frequently present under normal or standard operating conditions.
(5)
“Prophylaxis” or “Prophylactic” means the prevention of disease or infection in the absence of documented clinical signs of disease or infection.
(6)
“Medically important antimicrobial drug” means any drug from a class of drug or a derivative of a class of drug that is either:
(a)
Made from a mold or bacterium that kills or slows the growth of other microbes, specifically bacteria, and used in human beings or intended for use in human beings to treat or prevent disease or infection; or
(b)
Listed in:
(i)
Appendix A of the federal Food and Drug Administration’s Guidance for Industry #152, including critically important, highly important, or important antimicrobial drugs; or
(ii)
A subsequent guidance document created by the federal Food and Drug Administration that ranks the medical importance of antimicrobial drugs.
Regulation .03 When Permitted.LinkCopy Citation
A.
Except as provided in this regulation, a person may administer a medically important antimicrobial drug to cattle, swine, or poultry if, in the professional judgment of a licensed veterinarian, the medically important antimicrobial drug is necessary:
(1)
To treat a disease or infection;
(2)
To control the spread of a disease or infection; or
(3)
For a surgery or medical procedure.
B.
A person may administer a medically important antimicrobial drug to cattle, swine, or poultry if, in the professional judgment of a licensed veterinarian, the medically important antimicrobial drug is necessary for prophylaxis to address an elevated risk of contraction of a particular disease or infection.
C.
Unless administration of a medically important antimicrobial drug is consistent with §A of this regulation, a person may not administer a medically important antimicrobial drug in a regular pattern to cattle, swine, or poultry.
D.
A person may not administer a medically important antimicrobial drug to cattle, swine, or poultry solely for the purpose of:
(1)
Promoting weight gain; or
(2)
Improving feed efficiency.
E.
Dry Cow Treatment.
(1)
General Rule Requiring Assessment. The administration of a medically important antimicrobial drug to a cow entering a dry cycle is prohibited except when the cow is diagnosed with a bacterial intramammary infection (mastitis).
(2)
Methods of Assessing Mastitis in an Individual Cow.
(a)
Tests. A person may assess the presence of mastitis in an individual cow through one or more of the following tests:
(i)
A positive bacterial culture test;
(ii)
A positive California Mastitis Test;
(iii)
A somatic cell count for an individual cow greater than 200,000 cells per milliliter in the most recent lactation; and
(iv)
Any other assessment method approved by the Secretary generally recognized by the American Association of Bovine Practitioners.
(b)
Signs of Mastitis. A person may assess the presence of mastitis in an individual cow using one or more of the following indicators:
(i)
Visibly abnormal milk including the presence of clots, blood, or discoloration; or
(ii)
Heat, pain, tenderness, or swelling of a gland.
(c)
A licensed veterinarian may assess the presence of mastitis in an individual cow through the observation of clinical signs of mastitis.
Regulation .04 Applicability.LinkCopy Citation
Except as otherwise provided in federal law or regulation, this chapter does not apply to antimicrobial use in:
A.
Cattle on a farm operation that sells fewer than 200 cattle per year;
B.
Dairy cattle on a farm operation with a herd size of fewer than 300 dairy cattle;
C.
Swine on a farm operation that sells fewer than 200 swine per year; or
D.
Poultry on a farm operation that sells fewer than 60,000 birds per year.
Regulation .05 Civil Penalty.LinkCopy Citation
A.
The Department may impose a civil penalty on any person who violates the requirements of this chapter up to $2,000 for each violation.
B.
Before imposing any civil penalty under this chapter, the Department shall consider the following:
(1)
The nature and gravity of each violation;
(2)
The willfulness of the violation and the extent to which the existence of the violation was known to the person but uncorrected by the person; and
(3)
A history of prior violations, if any.
C.
The Department shall issue a written notice of violation to the person subject to this chapter upon finding that a violation has occurred or is ongoing. The written notice of violation shall include:
(1)
A statement of the regulation violated by the person;
(2)
A description of the evidence of a violation;
(3)
A statement informing the person of the right to an informal meeting with the Department;
(4)
The amount of the proposed civil penalty;
(5)
A statement of the remedial action necessary to bring the person into compliance; and
(6)
A reasonable amount of time, as determined by the Department, to correct a violation.
D.
A person may petition the Department for a contested case hearing on the violation and penalty within 30 calendar days of the issuance of the notice of violation by the Department.
E.
Unless a person requests a contested case hearing, the person shall promptly pay the penalty. Payment of a penalty is not a substitute for compliance. If the person continues to violate this chapter, the Department may impose additional civil penalties.
Chapter annotations
Authority: Agriculture Article, §§3-1001—3-1003, 3-1005, and 3-1006, Annotated Code of Maryland
History: Effective date: January 28, 2019 (46:2 Md. R. 53)
History: Regulation .02 amended as an emergency provision effective April 12, 2019 (46:9 Md. R. 444); amended permanently effective September 9, 2019 (46:18 Md. R. 775)
History: Regulation .02B amended effective January 14, 2021 (48:1 Md. R. 10)
History: Regulation .03E adopted effective January 14, 2021 (48:1 Md. R. 10)
History: Regulation .04 amended effective January 14, 2021 (48:1 Md. R. 10)