California Legislature—2013–14 Regular Session

Assembly Bill No. 1437

Introduced by Assembly Member Mullin

January 6, 2014

An act to 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, the Food and Agriculture Code, relating to livestock drugs.

LEGISLATIVE COUNSEL’S DIGEST

AB 1437, as introduced, Mullin. Medically important antimicrobials: nontherapeutic use.

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.

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.

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.

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.

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

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes.

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

SECTION 1.  

The Legislature find and declare all of the
following:

(a) In 1977, the United States Food and Drug Administration
(FDA) concluded that feeding livestock low doses of antibiotics
that are used in human disease treatment could promote the
development of antibiotic-resistance in bacteria. The FDA,
however, did not act in response to these findings, despite laws
requiring the agency to do so.

(b) The FDA has promulgated voluntary regulations on the
nontherapeutic use of antibiotics, however these guidelines are
unlikely to significantly reduce the nontherapeutic use of antibiotics
in livestock.

(c) Not only do antibiotic-resistant bacteria affect the health of
our society, but they also have a monetary impact. In 1998, the
National Academy of Sciences noted that antibiotic-resistant
bacteria generate a minimum of four to five billion dollars in costs
to United States society and individuals every year.

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

(e) In 1999, 2011, and 2006, the United States Department of
Agriculture’s Animal and Plant Health Inspection Service
conducted large-scale, voluntary surveys that revealed all of the
following:

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

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

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

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

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

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

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

(j) In 2010, the Danish Veterinary and Food Administration
testified that the Danish ban of the nontherapeutic use of antibiotics
in food animal production resulted in a marked reduction in
antimicrobial resistance in multiple bacterial species, including
Campylobacter and Enterococci.

(k) In 2011, the FDA found that in 2010:

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

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

(3) Eighty percent of antibacterial drugs disseminated in the
United States were sold for use on food-producing animals, rather
than being used for human health.

(l) In 2011, a review of all scientific studies on antimicrobial
use in farm animals, published in Clinical Microbiology Reviews,
found the following:

(1) The use of antibiotics in food-producing animals leads to
the development of reservoirs of antibiotic resistance.

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

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

(m) The FDA’s National Antimicrobial Resistance Monitoring
System routinely finds that retail meat products are contaminated
with bacteria that are resistant to antibiotics that are important to
human medicine.

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

(o) Many scientific studies confirm that the nontherapeutic use
of antibiotics in food-producing animals contributes to the
development of antibiotic-resistant bacterial infections in people.

SEC. 2.  

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

14200.  

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

begin delete

It

end delete

begin insert (b) end insert begin insert   end insert begin insert It end insert is further declared that nothing in this chapter is intended
to prevent a livestock producer from administering livestock drugs
safely and effectively when begin delete such end delete begin insert the end insert use is in accordance with the
labeling directions for the drug used begin insert and when the use protects
public health end insert .

SEC. 3.  

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

14203.  

begin insert (a) end insert begin insert   end insert “Restricted drug” means begin delete any livestock end delete begin insert either of
the following: end insert

begin insert (1) end insert begin insert   end insert begin insert A livestock end insert drug which is sold in begin delete such end delete begin insert a end insert form that it might
be administered to begin delete humans and end delete begin insert a person and, end insert if so begin delete administered end delete
begin insert administered, end insert would be dangerous to the health of begin delete such humans
or any livestock end delete begin insert the person. end insert

begin insert (2) end insert begin insert   end insert begin insert A livestock end insert drug begin delete which end delete begin insert that end insert if improperly begin delete administered end delete
begin insert administered, as defined in Section 14203.5, end insert to livestock begin insert , end insert is
dangerous to the health of begin delete such end delete begin insert the end insert livestock or to begin delete humans end delete begin insert persons end insert
who consume products from begin delete such end delete begin insert the end insert livestock. begin delete Restricted end delete

begin insert

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

end insert

begin insert (b) end insert begin insert   end insert begin insert Restricted end insert drugs include all of the following:

begin delete

(a)

end delete

begin insert (1) end insert  Arsenic compounds and preparations.

begin delete

(b)

end delete

begin insert (2) end insert  Diethylstilbestrol and other substances which have a
hormonelike action.

begin delete

(c)

end delete

begin insert (3) end insert  Sulfanilamide or substitute sulfanilamides.

begin delete

(d)

end delete

begin insert (4) end insert  Antibiotic preparations.

begin delete

(e)

end delete begin insert

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

end insert begin delete

Such other

end delete

begin insert (6) end insert begin insert   end insert begin insert Other end insert drugs and their preparations begin delete which end delete begin insert that end insert the director
determines are hazardous to the health of livestock or the public
safety.

SEC. 4.  

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

14203.5.  

“Improperly administered” means either of the
following:

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

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

SEC. 5.  

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

14207.3.  

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

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

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

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

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

SEC. 6.  

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

14207.5.  

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

SEC. 7.  

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

14207.7.  

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

SEC. 8.  

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

14220.  

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

SEC. 9.  

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

14289.  

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

SEC. 10.  

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

14297.  

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

SEC. 11.  

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

 

Article 5.5.  Use of Medically Important Antimicrobials

 

14335.  

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

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

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

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

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

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

(5) Animal-patient records are maintained.

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

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

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

14336.  

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

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

(2) The type of medically important antimicrobial administered.

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

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

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

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

(A) Growth promotion.

(B) Disease prevention.

(C) Disease control.

(D) Disease treatment.

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

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

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

SEC. 12.  

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

 

Article 5.6.  Nontherapeutic Use of Medically Important
Antimicrobials

 

14340.  

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

(a) A registered drug.

(b) A drug exempted under Article 3 (commencing with Section
14261).

14341.  

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

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

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

SEC. 13.  

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

14366.  

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

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

(b) All of the following conditions are met:

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

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

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

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

SEC. 14.  

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

14381.  

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

begin insert

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

end insert

SEC. 15.  

This act shall become operative on January 1, 2017.

SEC. 16.  

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