Amended in Assembly April 22, 2014

California Legislature—2013–14 Regular Session

Assembly BillNo. 1437


Introduced by Assembly Member Mullin

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(Coauthors: Assembly Members Gordon and Ting)

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(Coauthors: Senators Evans and Jackson)

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January 6, 2014


An act tobegin delete amend Sections 14200, 14203, 14289, and 14381 of, to add Sections 14203.5, 14207.3, 14207.5, 14207.7, 14220, 14297, and 14366 to, and to add Article 5.5 (commencing with Section 14335) and Article 5.6 (commencing with Section 14340) to Chapter 4 of Division 7 of,end deletebegin insert add Chapter 4.6 (commencing with Section 19060) to Part 3 of Division 9 ofend insert the Food and Agriculture Code, relating tobegin delete livestock drugs.end deletebegin insert medically important antimicrobials.end insert

LEGISLATIVE COUNSEL’S DIGEST

AB 1437, as amended, Mullin. Medically important antimicrobials:begin delete nontherapeutic use.end deletebegin insert livestock and poultry.end insert

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Under existing law, the Department of Food and Agriculture is responsible for enforcing provisions relating to the importation of animals, milk and milk products, produce dealers, and other agricultural regulations. Existing law, the California Meat and Poultry Inspection Act, establishes a meat and poultry inspection program and, in connection with the operation of that program by the department, authorizes the Secretary of Food and Agriculture to adopt, by regulation, standards and requirements that meet those prescribed by the Federal Meat Inspection Act and the Federal Poultry Products Inspection Act.

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This bill would prohibit a livestock or poultry product from being sold in California if the livestock or poultry product is constituted of livestock or poultry that was administered a medically important antimicrobial for nontherapeutic use, such as growth promotion, feed efficiency, weight gain, or disease prevention. The bill would also prohibit a livestock or poultry product sold in California to be constituted of livestock or poultry that was administered a medically important antimicrobial for nonroutine disease control unless certain conditions are met. The bill would prohibit a livestock or poultry product from being sold in California unless the livestock or poultry product is constituted wholly or in part of livestock or poultry that was slaughtered at a registered slaughter facility and the slaughter facility annually reports specified information to the department regarding the use of medically important antimicrobials. The bill would also prohibit a medically important antimicrobial from being administered to a food-producing animal unless the medically important antimicrobial is administered for a therapeutic use and consistently with specified veterinarian provisions. The bill would require the department to establish, by regulation, a schedule for the implementation of these provisions and require that they be fully implemented on or before on January 1, 2020. The bill would require the department to post the information reported by the slaughter facilities on an Internet Web site commencing on or before December 31, 2017.

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This bill would require the department to adopt any regulations necessary to implement the provisions of the bill.

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Existing law requires the manufacturer of a livestock drug, including a restricted drug, as defined, to register with the Director of Food and Agriculture and requires the director to refuse to register the drug if he or she makes specified findings. Under existing law it is unlawful, among other things, to use or administer any registered livestock drug, except in accordance with the label instructions, as specified, and makes an initial violation of these provisions subject to an infraction and, for subsequent violations, a misdemeanor.

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This bill, as of January 1, 2017, would redefine “restricted drug” to also include a livestock drug that is recognized by either the Center for Disease Control and Prevention or the World Health Organization to increase the prevalence of antibiotic-resistant bacteria, as specified. The bill would prohibit registration of a restricted drug if the director finds that the restricted drug poses a risk to public health through the increased prevalence of antibiotic-resistant bacteria. The bill would also authorize the director to revoke the registration of a medically important antimicrobial, as defined, for use in livestock if he or she finds that the drug threatens the public health by increasing the prevalence of antibiotic-resistant bacteria.

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The bill would prohibit the administration of a medically important antimicrobial to a food-producing animal for nonroutine disease control unless certain conditions are met. By prohibiting the administration of a medically important antimicrobial, this bill would create a crime, thereby imposing a state-mandated local program. The bill would also require a livestock producer that does administer a medically important antimicrobial to a food-producing animal to annually report specified information to the director relating to the administration of the medically important antimicrobial and would make the failure to make that report an infraction subject to specified penalties. The bill would require the department post this information on an Internet Web site.

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The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

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This bill would provide that no reimbursement is required by this act for a specified reason.

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Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: begin deleteyes end deletebegin insertnoend insert.

The people of the State of California do enact as follows:

P3    1

SECTION 1.  

The Legislature find and declare all of the
2following:

3(a) In 1977, the United States Food and Drug Administration
4(FDA) concluded that feeding livestock low doses of antibiotics
5begin delete thatend deletebegin insert from antibiotic classes thatend insert are used in human disease
6treatment could promote the development of antibiotic-resistance
7in bacteriabegin insert and pose a risk to human healthend insert. The FDA, however,
8did not act in response to these findings, despite laws requiring
9the agency to do so.

10(b) The FDAbegin delete has promulgatedend deletebegin insert issuedend insert voluntarybegin delete regulationsend delete
11begin insert guidance in December 2013end insert on the nontherapeutic use of
12antibiotics, howeverbegin delete these guidelines areend deletebegin insert this guidance isend insert unlikely
13to significantly reduce the nontherapeutic use of antibiotics in
14livestockbegin insert because of a broad exemption allowing for the use of
15antibiotics for disease preventionend insert
.

16(c) Not only do antibiotic-resistant bacteria affect the health of
17our society, but they also have a monetary impact. In 1998, the
P4    1National Academy of Sciences noted that antibiotic-resistant
2bacteria generate a minimum of four to five billion dollars in costs
3to United States society and individuals every year.begin insert In 2009, in a
4study funded by the federal Centers for Disease Control and
5Prevention, Cook County Hospital and Alliance for Prudent Use
6of Antibiotics estimated that the total health care cost of
7antibiotic-resistant infections in the United States was between
8$16.6 billion and $26 billion annually. Societal costs from lost
9productivity due to illnesses were estimated to be an additional
10$35 billion.end insert

11(d) In April 1999, the United States Government Accountability
12Office conducted a study concluding that three strains of
13microorganisms that cause foodborne illnesses or disease in humans
14are resistant to antibiotics and are linked to the use of antibiotics
15in animals. These microorganisms are salmonella, Campylobacter,
16and E. Coli.

17(e) In 1999,begin delete 2011, and 2006,end deletebegin insert 2006, and 2011,end insert the United States
18Department of Agriculture’s Animal and Plant Health Inspection
19Service conducted large-scale, voluntary surveys that revealed all
20of the following:

21(1) Eighty-four percent of grower and finisher swine farms, 83
22percent of cattle feedlots, and 84 percent of sheep farms administer
23antimicrobials in feed or water for either health or growth
24promotion reasons.

25(2) Many of the antimicrobials that were identified were
26identical or closely related to drugs used in human medicine,
27including tetracyclines, macrolides, bacitracin, penicillins, and
28sulfonamides.

29(3) These drugs are used in people to treat serious diseases, such
30as pneumonia, scarlet fever, rheumatic fever, sexually transmitted
31infections, and skin infections; pandemics such as malaria and
32plague; and bioterrorism agents such as anthrax.

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33(f) Overuse or misuse of antibiotics contributes to the spread of
34antibiotic resistance, whether in human medicine or in agriculture.

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35(g)

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36begin insert(f)end insert In June 2002, the peer-reviewed journal, “Clinical Infectious
37Diseases,” published a report based on a two-year review, by
38experts in human and veterinary medicine, public health,
39microbiology, biostatistics, and risk analysis, of more than 500
40scientific studies on the human health impacts of antimicrobial
P5    1use in agriculture. The report recommended that antimicrobial
2agents should not be used in agriculture in the absence of disease
3and should be limited to therapy for diseased individual animals
4or prophylaxis when disease is documented in a herd or flock.

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5(h)

end delete

6begin insert(g)end insert In a March 2003 report, the National Academy of Sciences
7stated that a decrease in antimicrobial use in human medicine alone
8will have little effect on the rise in antibiotic-resistant bacteria and
9that substantial efforts must be made to decrease the inappropriate
10overuse of antimicrobials in animals and agriculture.

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11(i)

end delete

12begin insert(h)end insert In 2010, the peer-reviewed journal, “Molecular Cell,”
13published a study demonstrating that a low-dosage use of
14antibiotics causes a dramatic increase in genetic mutation, raising
15new concerns about the agricultural practice of using low-dosage
16antibiotics in order to stimulate growth promotion and routinely
17prevent disease in unhealthy conditions.

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18(j)

end delete

19begin insert(i)end insert In 2010, the Danish Veterinary and Food Administration
20testified that the Danish ban of the nontherapeutic use of antibiotics
21in food animal production resulted in a marked reduction in
22antimicrobial resistance in multiple bacterial species, including
23Campylobacter and Enterococci.

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24(k)

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25begin insert(j)end insert In 2011, the FDA found that in 2010:

26(1) Thirteen million five hundred thousand kilograms of
27antibacterial drugs were sold for use on food animals in the United
28States.

29(2) Three million three hundred thousand kilograms of
30antibacterial drugs were used for human health.

31(3) Eighty percent of antibacterialbegin delete drugsend deletebegin insert drugs, and over 70
32percent of medically important antibacterial drugs,end insert
disseminated
33in the United States were sold for use on food-producing animals,
34rather than being used for human health.

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35(l)

end delete

36begin insert(k)end insert In 2011, a review of all scientific studies on antimicrobial
37use in farm animals, published in Clinical Microbiology Reviews,
38found the following:

39(1) begin deleteThe end deletebegin insertThat the end insertuse of antibiotics in food-producing animals
40leads to the development of reservoirs of antibioticbegin delete resistance.end delete
P6    1begin insert resistance, that antibiotic-resistant bacteria can spread through
2food, water, air, soil, and meat-industry workers, and that bacteria
3can share resistance genes with each other.end insert

4(2) A ban on nontherapeutic antibiotic use in food-producing
5animals would preserve the use of antibiotics for medicine.

6(3) A Danish ban on nontherapeutic antibiotics in
7food-producing animals resulted in little change in animal
8morbidity and mortality, and only a modest increase in production
9cost.

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10(l) The federal Centers for Disease Control and Prevention
11(CDC) concluded in a recent report, “Antibiotic Resistance Threats
12in the United States, 2013,” that overuse or misuse of antibiotics
13contributes to the spread of antibiotic resistance, whether in human
14medicine or in agriculture. The CDC estimated that antibiotic
15resistance causes at least 23,000 deaths and two million illnesses
16every year.

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17(m) In 2013, the peer-reviewed journal, “The Journal of the
18American Medical Association,” published a study showing higher
19levels of antibiotic-resistant skin and soft-tissue infections in people
20living in proximity to hog farms or fields treated with swine manure
21in Pennsylvania. Similarly, in 2014, the peer-reviewed journal,
22“Infection Control and Hospital Epidemiology,” published a study
23focused on hospitalized veterans in rural areas of Iowa, finding
24that people living in close proximity to a swine-feeding operation
25were nearly three times as likely to have been affected by
26methicillin-resistant Staphylococcus aureus (MRSA) at the time
27of admission to the hospital.

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28(m)

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29begin insert(n)end insert The FDA’s National Antimicrobial Resistance Monitoring
30System routinely finds that retail meat products are contaminated
31with bacteria that are resistant to antibiotics that are important to
32human medicine.

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33(n)

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34begin insert(o)end insert According to the American Academy of Pediatrics, “[t]he
35largest nonhuman use of antimicrobial agents is in food-producing
36animal production, and most of this is in healthy animals to increase
37growth or prevent diseases. Evidence now exists that these uses
38of antimicrobial agents in food-producing animals have a direct
39negative impact on human health and multiple impacts on the
40selection and dissemination of resistance genes in animals and the
P7    1environment. Children are at increased risk of acquiring many of
2these infections with resistant bacteria and are at great risk of
3severe complications if they become infected.”

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4(o)

end delete

5begin insert(p)end insert Many scientific studies confirm that the nontherapeutic use
6of antibiotics in food-producing animals contributes to the
7development of antibiotic-resistant bacterial infections in people.

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8(q) The spread of antibiotic-resistant bacteria poses a risk to
9the health of Californians and reduced use of antibiotics for
10livestock production is likely to reduce the risks of the rise and
11spread of antibiotic-resistant bacteria through food and other
12pathways, thus reducing the risk to Californians.

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13

SEC. 2.  

Section 14200 of the Food and Agricultural Code is
14amended to read:

15

14200.  

(a) The Legislature hereby declares that this chapter,
16which prescribes the distribution and use of livestock drugs, is
17intended to assure that the drugs are available to livestock
18producers for their use in protecting the health of the livestock
19population of the state, and that the use will in turn benefit the
20general public by providing an abundant supply of wholesome
21food and fiber.

22(b) It is further declared that nothing in this chapter is intended
23to prevent a livestock producer from administering livestock drugs
24safely and effectively when the use is in accordance with the
25labeling directions for the drug used and when the use protects
26public health.

27

SEC. 3.  

Section 14203 of the Food and Agricultural Code is
28amended to read:

29

14203.  

(a) “Restricted drug” means either of the following:

30(1) A livestock drug which is sold in a form that it might be
31administered to a person and, if so administered, would be
32dangerous to the health of the person.

33(2) A livestock drug that if improperly administered, as defined
34in Section 14203.5, to livestock, is dangerous to the health of the
35livestock or to persons who consume products from the livestock.

36(3) A livestock drug that is recognized by either the federal
37Centers for Disease Control and Prevention or the World Health
38Organization to increase the prevalence of antibiotic-resistant
39bacteria.

40(b) Restricted drugs include all of the following:

P8    1(1) Arsenic compounds and preparations.

2(2) Diethylstilbestrol and other substances which have a
3hormonelike action.

4(3) Sulfanilamide or substitute sulfanilamides.

5(4) Antibiotic preparations.

6(5) A drug from an antimicrobial class that is listed as “highly
7important,” “critically important,” or “important” by the World
8Health Organization’s “Critically Important Antimicrobial for
9Human Medicine,” as updated by the World Health Organization,
10or its successor publication, unless the drug is used for therapeutic
11use, as defined in Section 14220.

12(6) Other drugs and their preparations that the director
13determines are hazardous to the health of livestock or the public
14safety.

15

SEC. 4.  

Section 14203.5 is added to the Food and Agricultural
16Code
, to read:

17

14203.5.  

“Improperly administered” means either of the
18following:

19(a) Administration of a medically important antimicrobial to a
20food-producing animal through either feed or water, or for purposes
21of poultry hatcheries through any means, for purposes other than
22therapeutic use, such as growth promotion, feed efficiency, weight
23gain, disease prevention, or nonroutine disease control.

24(b) A repeated or regular pattern of administration of a medically
25important antimicrobial in food-producing animals for purposes
26other than therapeutic use or nonroutine disease control.

27

SEC. 5.  

Section 14207.3 is added to the Food and Agricultural
28Code
, to read:

29

14207.3.  

“Medically important antimicrobial” means a drug
30that is both of the following:

31(a) Intended for use in food-producing animals.

32(b) Composed wholly or partly of either of the following:

33(1) Any kind of penicillin, tetracycline, macrolide, lincosamide,
34streptogramin, aminoglycoside, sulfonamide, or cephalosporin.

35(2) A drug from an antimicrobial class that is listed as either
36“highly important,” “critically important,” or “important” by the
37World Health Organization’s “Critically Important Antimicrobial
38for Human Medicine,” as updated by the World Health
39Organization, or its successor publication.

P9    1

SEC. 6.  

Section 14207.5 is added to the Food and Agricultural
2Code
, to read:

3

14207.5.  

“Noncustomary situation” means a situation that does
4not include normal or standard practices and conditions on the
5premises that facilitate the transmission of disease.

6

SEC. 7.  

Section 14207.7 is added to the Food and Agricultural
7Code
, to read:

8

14207.7.  

“Nonroutine disease control” means the use of
9antimicrobials in the feed or water of a food-producing animal that
10is not sick, and where a particular disease or infection is, or is
11likely to be, present on the premises because of a specific,
12noncustomary situation.

  

13

SEC. 8.  

Section 14220 is added to the Food and Agricultural
14Code
, to read:

15

14220.  

“Therapeutic use,” with respect to a medically important
16antimicrobial, means the use of the antimicrobial for the specific
17purpose of treating an animal with a documented disease or
18infection. Therapeutic use does not include the continued use of
19the antimicrobial in the animal after the disease or infection has
20been resolved.

21

SEC. 9.  

Section 14289 of the Food and Agricultural Code is
22amended to read:

23

14289.  

If the livestock drug is a restricted drug, the director
24shall also refuse registration if he or she finds that the instructions
25for use do not contain adequate and satisfactory directions as to
26the methods of handling, caring for, holding, or otherwise
27managing the livestock to which the drug is administered so as to
28eliminate any danger to the health of any person who might
29consume food products that are derived from that livestock or if
30he or she finds that the restricted drug poses a risk to public health
31by increasing the prevalence of antibiotic-resistant bacteria.

32

SEC. 10.  

Section 14297 is added to the Food and Agricultural
33Code
, to read:

34

14297.  

The director may revoke the registration of a medically
35important antimicrobial for use in livestock if he or she finds that
36the drug as used poses a risk to the public health by increasing the
37prevalence of antibiotic-resistant bacteria.

38

SEC. 11.  

Article 5.5 (commencing with Section 14335) is
39added to Chapter 4 of Division 7 of the Food and Agricultural
40Code
, to read:

 

P10   1Article 5.5.  Use of Medically Important Antimicrobials
2

 

3

14335.  

(a) A person who administers or causes to be
4administered a medically important antimicrobial to a
5food-producing animal shall have a valid veterinarian-client-patient
6relationship with a veterinarian to ensure that the medically
7important antimicrobial is used in a manner that is consistent with
8professionally accepted best practices.

9(b) For purposes of this section, “veterinarian-client-patient
10relationship” means a relationship in which all of the following
11are met:

12(1) The veterinarian has assumed the responsibility for making
13medical judgments regarding the health of the animal-patient, and
14the client has agreed to follow the veterinarian’s instructions.

15(2) The veterinarian has sufficient knowledge of the
16animal-patient to initiate at least a general or preliminary diagnosis
17of the medical condition of the animal-patient.

18(3) The veterinarian is readily available for follow-up evaluation,
19or has arranged for veterinary emergency coverage, and continuing
20care and treatment.

21(4) The veterinarian provides oversight of treatment, compliance,
22and outcome of the administration of the medically important
23antimicrobial.

24(5) Animal-patient records are maintained.

25(c) For purposes of this section, “sufficient knowledge” means
26the veterinarian is personally acquainted with the keeping and care
27of the animal-patient by virtue of either of the following:

28(1) A timely examination of the animal-patient by the
29veterinarian.

30(2) Medically appropriate and timely visits by the veterinarian
31to the premises where the animal-patient is kept.

32

14336.  

(a) If a livestock producer administers or causes to be
33administered a medically important antimicrobial to a
34food-producing animal, the producer, or the contracted entity, shall
35annually report to the director the following information on a
36schedule and in a format specified by the director:

37(1) The total number of food-producing animals given a
38medically important antimicrobial in their feed.

39(2) The type of medically important antimicrobial administered.

P11   1(3) The total amount of each medically important antimicrobial
2used.

3(4) The target food-producing animal species that were
4administered the medically important antimicrobial.

5(5) The length of time over which the medically important
6antimicrobial was intended to be provided to the food-producing
7animals and the dose of the active medically important
8antimicrobial ingredient the food-producing animals were intended
9to receive.

10(6) The purpose for administering the medically important
11antimicrobial to a food-producing animal. The purpose shall be
12categorized in a manner determined by the director and shall
13include, at a minimum, the following categories:

14(A) Growth promotion.

15(B) Disease prevention.

16(C) Disease control.

17(D) Disease treatment.

18(7) The type of disease or infection to be treated by the medically
19important antimicrobial, if applicable.

20(8) The name of the processor, as defined in Section 20019,
21where the livestock product will be processed.

22(b) On or before December 31, 2017, the department shall
23develop and make operational a consumer-friendly, publicly
24accessible Internet Web site that creates a database of the
25information collected pursuant to this section. The database shall
26be searchable and able to accommodate a wide range of users,
27including users with limited technical and scientific literacy. The
28Internet Web site shall be designed to be easily navigable and to
29enable users to compare and contrast livestock producers and the
30reported usage of medically important antimicrobials.

31

SEC. 12.  

Article 5.6 (commencing with Section 14340) is
32added to Chapter 4 of Division 7 of the Food and Agricultural
33Code
, to read:

34 

35Article 5.6.  Nontherapeutic Use of Medically Important
36Antimicrobials
37

 

38

14340.  

This article shall apply to the nontherapeutic use in a
39food-producing animal of a drug that is a medically important
40antimicrobial and is either of the following:

P12   1(a) A registered drug.

2(b) A drug exempted under Article 3 (commencing with Section
314261).

4

14341.  

The registration or exemption of a drug subject to this
5article shall be ineffective on and after January 1, 2017, unless the
6director makes a final written determination that there is, with
7reasonable certainty, no harm to human health due to the
8development of antimicrobial resistance that is attributable in whole
9or in part to the nontherapeutic use of the drug, based on one of
10the following:

11(a) The holder of the registration or exemption has demonstrated
12this fact.

13(b) A risk analysis of the drug, taking into consideration other
14relevant information, conducted by the director.

15

SEC. 13.  

Section 14366 is added to the Food and Agricultural
16Code
, to read:

17

14366.  

It is unlawful to administer, including through means
18of feed, a medically important antimicrobial to a food-producing
19animal for nonroutine disease control, unless either of the following
20apply:

21(a) The director determines, with reasonable certainty, that there
22is no harm to human health due to the development of
23antibiotic-resistant bacteria that is attributable in whole or in part
24to the use of the medically important antimicrobial and the use
25does not threaten public health.

26(b) All of the following conditions are met:

27(1) There is a significant risk that a disease or infection that is
28present on, or is likely to be present on, the premises will be
29transmitted to the food-producing animal.

30(2) The administration of the medically important antimicrobial
31to the food-producing animal is necessary to prevent or reduce the
32risk of transmission of the disease or infection.

33(3) The medically important antimicrobial is administered to
34the food-producing animal for the shortest duration possible to
35prevent or reduce the risk of transmission of the disease or
36infection.

37(4) The medically important antimicrobial is administered to
38the fewest food-producing animals possible in order to prevent or
39reduce the risk of transmission of the disease or infection.

P13   1

SEC. 14.  

Section 14381 of the Food and Agricultural Code is
2amended to read:

3

14381.  

(a) Except as provided for in subdivision (b), a
4violation of this chapter or of any regulation that is adopted by the
5director pursuant to this chapter is an infraction punishable by a
6fine of not more than five hundred dollars ($500) for the first
7violation. A second or subsequent violation of this chapter is a
8misdemeanor punishable by a fine of not less than one hundred
9dollars ($100) and not more than one thousand dollars ($1,000).

10(b) A violation of the reporting requirement in Section 14336
11or of any regulation that is adopted by the director pursuant to that
12section is an infraction punishable by a fine of one hundred dollars
13($100) for the first violation. A second or subsequent violation is
14an infraction punishable by a fine of not less than two hundred
15dollars ($200) and not more than one thousand dollars ($1,000).

16

SEC. 15.  

This act shall become operative on January 1, 2017.

17

SEC. 16.  

No reimbursement is required by this act pursuant to
18Section 6 of Article XIII B of the California Constitution because
19the only costs that may be incurred by a local agency or school
20district will be incurred because this act creates a new crime or
21infraction, eliminates a crime or infraction, or changes the penalty
22for a crime or infraction, within the meaning of Section 17556 of
23the Government Code, or changes the definition of a crime within
24the meaning of Section 6 of Article XIII B of the California
25Constitution.

end delete
26begin insert

begin insertSEC. 2.end insert  

end insert

begin insertChapter 4.6 (commencing with Section 19060) is added
27to Part 3 of Division 9 of the end insert
begin insertFood and Agricultural Codeend insertbegin insert, to read:end insert

begin insert

28 

29Chapter  begin insert4.6.end insert Medically Important Antimicrobials in
30Meat and Poultry
31

31 

32Article begin insert1.end insert  Definitions
33

 

34

begin insert19060.end insert  

“Department” means the Department of Food and
35Agriculture.

36

begin insert19061.end insert  

“Director” means the Director of Food and Agriculture.

37

begin insert19062.end insert  

“Exempt producer” means an owner of livestock or
38poultry that raises less than 250 animals per year or 10,000 birds
39per year.

P14   1

begin insert19063.end insert  

(a) “Medically important antimicrobial” means a drug
2that is both of the following:

3(1) Intended for use in food-producing animals.

4(2) Composed wholly or partly of a drug from an antimicrobial
5class that is listed as either “highly important,” “critically
6important,” or “important” by the United States Food and Drug
7Administration’s Guidance for Industry #152, Appendix A, as
8updated by the United States Food and Drug Administration, or
9its successor publication.

10(b) Medically important antimicrobial includes, but is not limited
11to, penicillin, tetracycline, macrolide, lincosamide, streptogramin,
12aminoglycoside, sulfonamide, or cephalosporin.

13

begin insert19064.end insert  

“Noncustomary situation” means a situation that does
14not include normal or standard practices and conditions on the
15premises that facilitates the transmission of disease.

16

begin insert19065.end insert  

“Nonroutine disease control” means the use of
17antimicrobials in the feed or water of a food-producing animal
18that is not sick, and where a particular disease or infection is, or
19is likely to be, present on the premises because of a specific,
20noncustomary situation.

21

begin insert19066.end insert  

“Nontherapeutic use” means either of the following:

22(a) The one-time administration of a medically important
23antimicrobial to a food-producing animal through feed or water,
24or, for purposes of poultry hatcheries, through any means, for
25purposes such as growth promotion, feed efficiency, weight gain,
26or disease prevention, other than therapeutic use or nonroutine
27disease control.

28(b) Any repeated or regular pattern of administration of a
29medically important antimicrobial to food-producing animals for
30purposes other than therapeutic use or nonroutine disease control.

31

begin insert19067.end insert  

“Therapeutic use,” with respect to a medically
32important antimicrobial, means use for the specific purpose of
33treating an animal with a documented disease or infection.
34Therapeutic use does not include the continued use after the disease
35or infection has been resolved.

36 

37Article begin insert2.end insert  General Provisions
38

 

39

begin insert19070.end insert  

(a) (1) A livestock or poultry product sold in California
40shall not be constituted wholly or in part of livestock or poultry
P15   1that was administered a medically important antimicrobial for a
2nontherapeutic use.

3(2) A meat or poultry product that is not constituted wholly or
4in part of livestock or poultry that was administered a medically
5important antimicrobial for nontherapeutic use may be marketed
6with the claim, “Raised with minimal antibiotics under California
7law.”

8(b) This section shall be implemented according to schedule
9adopted by the department as provided in Section 19074, and shall
10apply to all livestock and poultry products sold in California on
11 and after January 1, 2020.

12

begin insert19071.end insert  

(a) (1) A livestock or poultry product sold in California
13shall not be constituted wholly or in part of livestock or poultry
14that was administered a medically important antimicrobial for
15nonroutine disease control unless all of the following conditions
16are met:

17(A) There was a significant risk that a disease or infection that
18was present on, or was likely to be present on, the premises would
19be transmitted to the food-producing animal.

20(B) The administration of the medically important antimicrobial
21to the food-producing animal was necessary to prevent or reduce
22the risk of transmission of the disease or infection.

23(C) The medically important antimicrobial was administered
24to the food-producing animal for the shortest duration possible to
25prevent or reduce the risk of transmission of the disease or
26infection.

27(D) The medically important antimicrobial was administered
28to the fewest food-producing animals possible in order to prevent
29or reduce the risk of transmission of the disease or infection.

30(2) A producer, other than exempt producer, shall maintain
31records, including prescriptions or veterinary feed directives,
32documenting the use and reasons for the use of antibiotics for
33nonroutine disease control. The records shall be kept for five years.

34(b) This section shall be implemented according to schedule
35adopted by the department as provided in Section 19074, and shall
36 apply to all livestock and poultry products sold in California on
37and after January 1, 2020.

38

begin insert19072.end insert  

(a) A livestock or poultry product shall not be sold in
39California unless the livestock or poultry product is constituted of
40livestock or poultry that was slaughtered at a slaughter facility
P16   1that is registered with the department and that annually reports
2all of the information specified in Section 19080.

3(b) This section shall be implemented according to schedule
4adopted by the department as provided in Section 19074, and shall
5apply to all livestock and poultry products sold in California on
6and after January 1, 2020.

7

begin insert19073.end insert  

(a) A medically important antimicrobial shall not be
8administered to a food-producing animal unless both of the
9following conditions are met:

10(1) The administration of the medically important antimicrobial
11is for a therapeutic use.

12(2) The medically important antimicrobial is administered by,
13or caused to be administered by, a veterinarian, licensed pursuant
14to Chapter 11 (commencing with Section 4800) of Division 2 of
15the Business and Professions Code, as part of a valid
16veterinarian-client-patient relationship in accordance with Sections
172032.1 and 2032.15 of Title 16 of the California Code of
18Regulations, as those sections existed on January 1, 2015.

19(b) As provided in Section 19074, this section shall become
20operative on January 1, 2020.

21

begin insert19074.end insert  

The department shall by regulation establish a schedule
22to phase in implementation of the requirements imposed by this
23article. Those requirements shall be fully implemented on or before
24January 1, 2020.

25 

26Article begin insert3.end insert  Reporting Requirements
27

 

28

begin insert19080.end insert  

(a) A slaughter facility shall annually report to the
29director all of the following information, according to the target
30food-producing animal species and production class of the
31food-producing animal, on a schedule and in the format specified
32by the director:

33(1) The total number of food-producing animals given a
34medically important antimicrobial in their feed or water, or, for
35purposes of poultry hatcheries, through any means.

36(2) The type of medically important antimicrobial administered.

37(3) The total amount of each medically important antimicrobial
38used.

39(4) The total number of days over which the medically important
40antimicrobial was intended to be provided to the food-producing
P17   1animals and the dosage of the active medically important
2antimicrobial given to the food-producing animals. The dosage
3shall be listed by the total milligrams of antibiotic used per animal
4per day or the total milliliters of the antibiotic solution used per
5animal per day and label concentration.

6(5) Whether the purpose for administering the medically
7important antimicrobial was for therapeutic or nontherapeutic
8use. The purpose shall be categorized in a manner determined by
9the director and shall include, at a minimum, the following
10categories:

11(A) Growth promotion.

12(B) Disease prevention.

13(C) Disease treatment.

14(D) Other information that may be deemed necessary or
15important by the director, producer, or slaughter facility.

16(6) The type of disease or infection to be treated or addressed
17by the medically important antimicrobial.

18(7) The owners of the livestock or poultry. “Owners of the
19livestock or poultry” for purposes of this paragraph, means a
20person who either has an ownership interest in the animals or
21birds or otherwise establishes management and production
22standards for the maintenance, care, and raising of the animals
23or birds. An ownership interest includes a right or option to
24purchase the animals or birds for maintenance, care, or raising.

25(8) The owner of the slaughter facility. “Owner of the slaughter
26facility” for purposes of this paragraph, means a person who either
27has an ownership interest in the facility or otherwise establishes
28management and production standards for the facility. An
29ownership interest of a slaughter facility includes a right or option
30to purchase the animal or poultry to be processed by the slaughter
31facility.

32(b) The slaughter facility shall not be required to report the
33information required under this subdivision for an exempt
34producer.

35

begin insert19081.end insert  

On or before December 31, 2017, the department shall
36develop and make operational a consumer-friendly, publicly
37accessible Internet Web site that contains a database of the
38information collected pursuant to this article. The database shall
39be searchable and able to accommodate a wide range of users,
40including users with limited technical and scientific literacy. The
P18   1Internet Web site shall be designed to be easily navigable and
2enable users to compare and contrast the reported usage of
3medically important antimicrobials between animal species and
4other parameters. The department may send a copy of this
5information to the State Department of Public Health.

6 

7Article begin insert4.end insert  Violations
8

 

9

begin insert19090.end insert  

(a) (1) Except as provided in subdivision (b), a
10violation of this chapter or of any regulation adopted by the
11director pursuant to this chapter is subject to a civil penalty of not
12more than five hundred dollars ($500) for the first violation. A
13second violation of this chapter is subject to a civil penalty of not
14less than five hundred dollars ($500) and not more than one
15thousand dollars ($1,000). A third or subsequent violation of this
16chapter is subject to a civil penalty of not less than three hundred
17dollars ($300) and not more than two thousand dollars ($2,000).
18Civil penalties for violations shall be imposed on the owner of the
19slaughter facility at which the animals or birds are slaughtered.

20(2) An owner of a slaughter facility shall not be subject to a
21civil penalty under this subdivision if the owner made a good faith
22effort to ensure that livestock or poultry products sold in this state
23made from livestock or poultry slaughtered at his or her facility
24were in compliance with the provisions of this chapter.

25(b) A violation of the reporting requirement in Section 19081
26or of any regulation that is adopted by the director pursuant to
27that section is subject to a civil penalty of one hundred dollars
28($100) for the first violation. A second or subsequent violation is
29subject to a civil penalty of not less than two hundred dollars
30($200) and not more than one thousand dollars ($1,000). Civil
31penalties for violations shall be imposed on the owner of the
32slaughter facility.

33(c) Moneys collected pursuant to this chapter shall be deposited
34into the Department of Food and Agriculture Fund, to be available
35to the department upon appropriation for purposes of carrying
36out this chapter.

 

P19   1Article begin insert5.end insert  Implementation
2

 

3

begin insert19100.end insert  

The department shall adopt any regulations necessary
4to implement the provisions of this chapter, including those
5regulations necessary to phase in the requirements of Article 2
6(commencing with Section 19070), as provided in Section 19074.

7

begin insert19101.end insert  

The provisions of this chapter are severable. If any
8provision of this chapter or its application is held invalid, that
9invalidity shall not affect other provisions or applications that can
10be given effect without the invalid provision or application.

end insert


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