Today's Law As Amended


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AB-1437 Medically important antimicrobials: livestock and poultry.(2013-2014)



As Amends the Law Today


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 from antibiotic classes that are used in human disease treatment could promote the development of antibiotic-resistance in bacteria and pose a risk to human health. The FDA, however, did not act in response to these findings, despite laws requiring the agency to do so.
(b) The FDA issued voluntary guidance in December 2013 on the nontherapeutic use of antibiotics, however this guidance is unlikely to significantly reduce the nontherapeutic use of antibiotics in livestock because of a broad exemption allowing for the use of antibiotics for disease prevention.
(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. In 2009, in a study funded by the federal Centers for Disease Control and Prevention, Cook County Hospital and Alliance for Prudent Use of Antibiotics estimated that the total health care cost of antibiotic-resistant infections in the United States was between $16.6 billion and $26 billion annually. Societal costs from lost productivity due to illnesses were estimated to be an additional $35 billion.
(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, 2006, and 2011, 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) 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.
(g) 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.
(h) 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.
(i) 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.
(j) 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, and over 70 percent of medically important antibacterial drugs, disseminated in the United States were sold for use on food-producing animals, rather than being used for human health.
(k) In 2011, a review of all scientific studies on antimicrobial use in farm animals, published in Clinical Microbiology Reviews, found the following:
(1) That the use of antibiotics in food-producing animals leads to the development of reservoirs of antibiotic resistance, that antibiotic-resistant bacteria can spread through food, water, air, soil, and meat-industry workers, and that bacteria can share resistance genes with each other.
(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.
(l) The federal Centers for Disease Control and Prevention (CDC) concluded in a recent report, “Antibiotic Resistance Threats in the United States, 2013,” that overuse or misuse of antibiotics contributes to the spread of antibiotic resistance, whether in human medicine or in agriculture. The CDC estimated that antibiotic resistance causes at least 23,000 deaths and two million illnesses every year.
(m) In 2013, the peer-reviewed journal, “The Journal of the American Medical Association,” published a study showing higher levels of antibiotic-resistant skin and soft-tissue infections in people living in proximity to hog farms or fields treated with swine manure in Pennsylvania. Similarly, in 2014, the peer-reviewed journal, “Infection Control and Hospital Epidemiology,” published a study focused on hospitalized veterans in rural areas of Iowa, finding that people living in close proximity to a swine-feeding operation were nearly three times as likely to have been affected by methicillin-resistant Staphylococcus aureus (MRSA) at the time of admission to the hospital.
(n) 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.
(o) 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.”
(p) 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.
(q) The spread of antibiotic-resistant bacteria poses a risk to the health of Californians and reduced use of antibiotics for livestock production is likely to reduce the risks of the rise and spread of antibiotic-resistant bacteria through food and other pathways, thus reducing the risk to Californians.

SEC. 2.

 Chapter 4.6 (commencing with Section 19060) is added to Part 3 of Division 9 of the Food and Agricultural Code, to read:

CHAPTER  4.6. Medically Important Antimicrobials in Meat and Poultry
Article  1. Definitions
19060.
 “Department” means the Department of Food and Agriculture.
19061.
 “Director” means the Director of Food and Agriculture.
19062.
 “Exempt producer” means an owner of livestock or poultry that raises less than 250 animals per year or 10,000 birds per year.
19063.
 (a) “Medically important antimicrobial” means a drug that is both of the following:
(1) Intended for use in food-producing animals.
(2) Composed wholly or partly of a drug from an antimicrobial class that is listed as either “highly important,” “critically important,” or “important” by the United States Food and Drug Administration’s Guidance for Industry #152, Appendix A, as updated by the United States Food and Drug Administration, or its successor publication.
(b) Medically important antimicrobial includes, but is not limited to, penicillin, tetracycline, macrolide, lincosamide, streptogramin, aminoglycoside, sulfonamide, or cephalosporin.
19064.
 “Noncustomary situation” means a situation that does not include normal or standard practices and conditions on the premises that facilitates the transmission of disease.
19065.
 “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.
19066.
 “Nontherapeutic use” means either of the following:
(a) The one-time administration of a medically important antimicrobial to a food-producing animal through feed or water, or, for purposes of poultry hatcheries, through any means, for purposes such as growth promotion, feed efficiency, weight gain, or disease prevention, other than therapeutic use or nonroutine disease control.
(b) Any repeated or regular pattern of administration of a medically important antimicrobial to food-producing animals for purposes other than therapeutic use or nonroutine disease control.
19067.
 “Therapeutic use,” with respect to a medically important antimicrobial, means use for the specific purpose of treating an animal with a documented disease or infection. Therapeutic use does not include the continued use after the disease or infection has been resolved.
Article  2. General Provisions
19070.
 (a) (1) A livestock or poultry product sold in California shall not be constituted wholly or in part of livestock or poultry that was administered a medically important antimicrobial for a nontherapeutic use.
(2) A meat or poultry product that is not constituted wholly or in part of livestock or poultry that was administered a medically important antimicrobial for nontherapeutic use may be marketed with the claim, “Raised with minimal antibiotics under California law.”
(b) This section shall be implemented according to schedule adopted by the department as provided in Section 19074, and shall apply to all livestock and poultry products sold in California on and after January 1, 2020.
19071.
 (a) (1) A livestock or poultry product sold in California shall not be constituted wholly or in part of livestock or poultry that was administered a medically important antimicrobial for nonroutine disease control unless all of the following conditions are met:
(A) There was a significant risk that a disease or infection that was present on, or was likely to be present on, the premises would be transmitted to the food-producing animal.
(B) The administration of the medically important antimicrobial to the food-producing animal was necessary to prevent or reduce the risk of transmission of the disease or infection.
(C) The medically important antimicrobial was administered to the food-producing animal for the shortest duration possible to prevent or reduce the risk of transmission of the disease or infection.
(D) The medically important antimicrobial was administered to the fewest food-producing animals possible in order to prevent or reduce the risk of transmission of the disease or infection.
(2) A producer, other than exempt producer, shall maintain records, including prescriptions or veterinary feed directives, documenting the use and reasons for the use of antibiotics for nonroutine disease control. The records shall be kept for five years.
(b) This section shall be implemented according to schedule adopted by the department as provided in Section 19074, and shall apply to all livestock and poultry products sold in California on and after January 1, 2020.
19072.
 (a) A livestock or poultry product shall not be sold in California unless the livestock or poultry product is constituted of livestock or poultry that was slaughtered at a slaughter facility that is registered with the department and that annually reports all of the information specified in Section 19080.
(b) This section shall be implemented according to schedule adopted by the department as provided in Section 19074, and shall apply to all livestock and poultry products sold in California on and after January 1, 2020.
19073.
 (a) A medically important antimicrobial shall not be administered to a food-producing animal unless both of the following conditions are met:
(1) The administration of the medically important antimicrobial is for a therapeutic use.
(2) The medically important antimicrobial is administered by, or caused to be administered by, a veterinarian, licensed pursuant to Chapter 11 (commencing with Section 4800) of Division 2 of the Business and Professions Code, as part of a valid veterinarian-client-patient relationship in accordance with Sections 2032.1 and 2032.15 of Title 16 of the California Code of Regulations, as those sections existed on January 1, 2015.
(b) As provided in Section 19074, this section shall become operative on January 1, 2020.
19074.
 The department shall by regulation establish a schedule to phase in implementation of the requirements imposed by this article. Those requirements shall be fully implemented on or before January 1, 2020.
Article  3. Reporting Requirements
19080.
 (a) A slaughter facility shall annually report to the director all of the following information, according to the target food-producing animal species and production class of the food-producing animal, on a schedule and in the format specified by the director:
(1) The total number of food-producing animals given a medically important antimicrobial in their feed or water, or, for purposes of poultry hatcheries, through any means.
(2) The type of medically important antimicrobial administered.
(3) The total amount of each medically important antimicrobial used.
(4) The total number of days over which the medically important antimicrobial was intended to be provided to the food-producing animals and the dosage of the active medically important antimicrobial given to the food-producing animals. The dosage shall be listed by the total milligrams of antibiotic used per animal per day or the total milliliters of the antibiotic solution used per animal per day and label concentration.
(5) Whether the purpose for administering the medically important antimicrobial was for therapeutic or nontherapeutic use. 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 treatment.
(D) Other information that may be deemed necessary or important by the director, producer, or slaughter facility.
(6) The type of disease or infection to be treated or addressed by the medically important antimicrobial.
(7) The owners of the livestock or poultry. “Owners of the livestock or poultry” for purposes of this paragraph, means a person who either has an ownership interest in the animals or birds or otherwise establishes management and production standards for the maintenance, care, and raising of the animals or birds. An ownership interest includes a right or option to purchase the animals or birds for maintenance, care, or raising.
(8) The owner of the slaughter facility. “Owner of the slaughter facility” for purposes of this paragraph, means a person who either has an ownership interest in the facility or otherwise establishes management and production standards for the facility. An ownership interest of a slaughter facility includes a right or option to purchase the animal or poultry to be processed by the slaughter facility.
(b) The slaughter facility shall not be required to report the information required under this subdivision for an exempt producer.
19081.
 On or before December 31, 2017, the department shall develop and make operational a consumer-friendly, publicly accessible Internet Web site that contains a database of the information collected pursuant to this article. 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 enable users to compare and contrast the reported usage of medically important antimicrobials between animal species and other parameters. The department may send a copy of this information to the State Department of Public Health.
Article  4. Violations
19090.
 (a) (1) Except as provided in subdivision (b), a violation of this chapter or of any regulation adopted by the director pursuant to this chapter is subject to a civil penalty of not more than five hundred dollars ($500) for the first violation. A second violation of this chapter is subject to a civil penalty of not less than five hundred dollars ($500) and not more than one thousand dollars ($1,000). A third or subsequent violation of this chapter is subject to a civil penalty of not less than three hundred dollars ($300) and not more than two thousand dollars ($2,000). Civil penalties for violations shall be imposed on the owner of the slaughter facility at which the animals or birds are slaughtered.
(2) An owner of a slaughter facility shall not be subject to a civil penalty under this subdivision if the owner made a good faith effort to ensure that livestock or poultry products sold in this state made from livestock or poultry slaughtered at his or her facility were in compliance with the provisions of this chapter.
(b) A violation of the reporting requirement in Section 19081 or of any regulation that is adopted by the director pursuant to that section is subject to a civil penalty of one hundred dollars ($100) for the first violation. A second or subsequent violation is subject to a civil penalty of not less than two hundred dollars ($200) and not more than one thousand dollars ($1,000). Civil penalties for violations shall be imposed on the owner of the slaughter facility.
(c) Moneys collected pursuant to this chapter shall be deposited into the Department of Food and Agriculture Fund, to be available to the department upon appropriation for purposes of carrying out this chapter.
Article  5. Implementation
19100.
 The department shall adopt any regulations necessary to implement the provisions of this chapter, including those regulations necessary to phase in the requirements of Article 2 (commencing with Section 19070), as provided in Section 19074.
19101.
 The provisions of this chapter are severable. If any provision of this chapter or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.