BILL ANALYSIS �
AB 1437
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Date of Hearing: April 30, 2014
ASSEMBLY COMMITTEE ON AGRICULTURE
Susan Talamantes Eggman, Chair
AB 1437 (Mullin) - As Amended: April 22, 2014
SUBJECT : Medically important antimicrobials: livestock and poultry.
SUMMARY : This bill would ban the sale, in California, of a livestock
or poultry product if the livestock or poultry was given a medically
important antimicrobial (MIAM) for nontherapeutic use. Specifically,
this bill :
1) Makes the following legislative findings and declarations:
a. The United States Food and Drug Administration
(FDA), in 1977, concluded that use of antibiotics in animal
feed could promote antibiotic resistance and pose a risk to
human health. Furthermore, FDA did not act on the finding.
In 2013, FDA issued voluntary Guidance for Industry (GFI)
for the use of antibiotics, but this guidance is unlikely
to reduce the use of nontherapeutic antibiotics due to
broad exemptions;
b. The health cost due to antibiotic resistance
bacteria range from $16.6 billion to $26 billion annually
and cost a further $35 billion in lost productivity;
c. The United States Government Accountability
Office's 1999 study concluded that three strains of
microorganisms that cause food borne illness are resistant
to antibiotics and are linked to the use of antibiotics in
animals;
d. The United States Department of Agriculture's
(USDA) multiyear voluntary survey revealed the following:
i. 83% or more of swine farms, cattle feed
lots, and sheep farms used antimicrobials in feed or
water for health or growth promotion;
ii. Many of the antimicrobials were
identical or related to drugs used in human medicine;
and,
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iii. These drugs are used to treat serious
diseases in humans.
e. The Clinical Infectious Diseases Journal published
a report that recommends that antimicrobials should not be
used in agriculture for nontherapeutic use;
f. The National Academy of Sciences stated that a
decrease in antimicrobials use in human medicine alone will
have little effect on the rise in antibiotic-resistant
bacteria, and that efforts should be made to decrease the
overuse of antimicrobials in animals and agriculture;
g. The Molecular Cell Journal published a study
demonstrating that a low-dosage use of antibiotics causes a
dramatic increase in genetic mutation;
h. The Danish Veterinary and Food Administration
testified that the Danish ban of the nontherapeutic use of
antibiotics in food animal production resulted in a
reduction in antimicrobial resistance in multiple bacterial
species;
i. FDA found that 80% of antibiotic drugs, and over
70% of medically important antibiotic drugs, in the United
States, were sold for use on food-producing animals;
j. A review of all scientific studies on antimicrobial
use in farm animals found the following:
i. That the use of antibiotics in
food-producing animals leads to the development of
reservoirs of antibiotic resistance and that
antibiotic -resistant bacteria can spread various
ways;
ii. A ban on nontherapeutic antibiotic use
in food-producing animals would preserve the use of
antibiotics for medicine; and,
iii. A Danish ban on nontherapeutic
antibiotics in food-producing animals resulted in
little change in animal health, and only a modest
increase in production cost.
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aa. The Centers for Disease Control and Prevention
(CDC) concluded that overuse or misuse of antibiotics
contributes to the spread of antibiotic resistance, whether
in human medicine or in agriculture, and estimated that
antibiotic resistance causes at least 23,000 deaths and two
million illnesses every year;
bb. Two recent studies showed that people living close
to swine farms, fields with swine manure, or swine feeding
operations, had higher than average rates of antibiotic
resistance infection;
cc. FDA routinely finds that recalled meat products
have bacteria that are resistance to antibiotics used in
human medicine.
dd. The American Academy of pediatrics states the use
of nontherapeutic antibiotics in animal production causes
antibiotic resistance and causes a greater risk to
children;
ee. 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; and,
ff. 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.
2) Defines Department as the California Department of Food and
Agriculture (CDFA).
3) Defines Director as the Director (Secretary) of CDFA.
4) Defines exempt producer as an owner of livestock or poultry
that raises less than 250 animals per year or 10,000 birds per
year.
5) Defines MIAM as a drug that is both of the following:
a. Intended for the use of food-producing animals;
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and,
b. Composed wholly or partly of a drug from an
antimicrobials class that is listed as either "highly
important," "critically important," or "important" by the
FDA's GFI #152, as specified.
6) States MIAM includes, but is not limited to, penicillin,
tetracycline, macrolide, lincosamide, streptogramin,
aminoglycoside, sulfonamide, or cephalosporin.
7) Defines a non-customary situation as a situation that does
not include normal or standard practices and conditions on the
premises that facilitates the transmission of disease.
8) Defines non-routine disease control (NDC) as 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, non-customary situation.
9) Defines nontherapeutic use as 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 NDC; or,
b. Any repeated or regular pattern of administration
of MIAM to food-producing animals for purposes other than
therapeutic use or NDC.
10) Defines therapeutic use, with respect to MIAM, as use for the
specific purpose of treating an animal with a documented disease
or infection, and does not include the continued use after the
disease or infection has been resolved.
11) Prohibits the sale of livestock or poultry products, wholly
or in part, in California, if the livestock or poultry was given
MIAM for nontherapeutic uses.
12) Allows livestock or poultry products, if complying with #11
above, to be marketed with the claim "Raised with minimal
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antibiotics under California law."
13) Requires CDFA to implement regulations to phase in complying
with #11 above and applies to all livestock or poultry products
sold in California after January 1, 2020.
14) Prohibit the sale of livestock or poultry products, wholly or
in part, in California, if the livestock or poultry was given
MIAM for NDC 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 MIAM to the food-producing
animal was necessary to prevent or reduce the risk of
transmission of the disease or infection;
c. The MIAM 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; and,
d. The MIAM was administered to the fewest
food-producing animals possible in order to prevent or
reduce the risk of transmission of the disease or
infection.
15) Requires a producer, as specified, to maintain and keep for
five years, records including prescriptions, or veterinary feed
directives, documenting the use and reasons for the use of
antibiotic for NDC.
16) Prohibits the sale of a livestock or poultry product, in
California, unless the product is constituted of livestock or
poultry that was slaughtered at a slaughter facility that is
registered with CDFA and that annually reports all of the
information, as specified.
17) Prohibits MIAM to be administered to a food-producing animal
unless both of the following conditions are met:
a. The administration of MIAM is for a therapeutic
use; and,
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b. The MIAM is administered by, or caused to be
administered by, a licensed veterinarian, as specified, as
part of a valid veterinarian-client-patient relationship
(VVCPR) in accordance with the California Code of
Regulations, as specified, as those regulations existed on
January 1, 2015.
18) Requires CDFA to make regulations to establish a schedule to
phase in implementation of this bill and requires the
requirements in this bill be fully implemented on and before
January 1, 2020.
19) Requires a slaughter facility to annually report to the
Secretary all of the following information, as specified, on a
schedule and in the format specified by the Secretary:
a. The total number of food-producing animals given a
MIAM in their feed or water, or, for purposes of poultry
hatcheries, through any means;
b. The type of MIAM administered;
c. The total amount of each MIAM used;
d. The total number of days over which MIAM was
intended to be provided to the food-producing animals and
the dosage of the active MIAM 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; and,
e. Whether the purpose for administering MIAM was for
therapeutic or nontherapeutic use. The purpose shall be
categorized in a manner determined by the Secretary and
shall include, at a minimum, the following categories:
i. Growth promotion;
ii. Disease prevention;
iii. Disease treatment; and,
iv. Other information that may be deemed
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necessary or important by the Secretary, producer, or
slaughter facility.
f. The type of disease or infection to be treated or
addressed by MIAM.
g. The owners of the livestock or poultry.
i. Defines "owners of the livestock or
poultry" for purposes of reporting to CDFA, as 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 for
raising.
h. The owner of the slaughter facility.
i. Defines "owner of the slaughter
facility" for purposes of reporting to CDFA, as 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.
20) Exempts the slaughter facility from reporting the information
for an exempt producer.
21) Requires CDFA, by December 31, 2017, to develop and make
operational, a consumer-friendly, publicly accessible, Internet
Web site (web site) containing a database of the information
through reporting requirements.
a. Requires the database to be searchable and able to
be useable by a wide range of users, as specified.
b. Requires the web site to be designed to be easily
navigable and enable users to compare and contrast the
reported usage of MIAM, as specified.
c. Allows CDFA to send a copy of this information to
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the California Department of Public Health (DPH).
22) Requires civil penalties, for slaughter facilities, for
violations related to the sale of prohibited livestock or
poultry products under this bill, and regulations adopted by
CDFA, are as follows:
a. First violation: civil penalty of up to $500;
b. Second violation: civil penalties on not less than
$500 and not more than $1,000; and,
c. Third violation: civil penalties on not less than
$300 and not more than $2,000.
23) Exempts slaughter facilities from civil penalties if the
owners made a good faith effort to ensure livestock or poultry
products sold in California were made from livestock and poultry
that meet the requirements of this bill.
24) Requires civil penalties, for slaughter facilities, for
violations related to reporting requirements under this bill,
and regulations adopted by CDFA, are as follows:
a. First violation: civil penalty of $100; and
b. Second violation: civil penalties on not less than
$200 and not more than $1,000.
25) Requires moneys collected from civil penalties imposed, be
deposited into the CDFA Fund and made available, upon
appropriation, to CDFA for the purposes of this bill.
26) Requires CDFA to adopt any necessary regulations to implement
this bill.
27) Provides that the provisions are severable.
EXISTING LAW :
1)Requires CDFA to enforce provisions relating to the importation of
animals, milk and milk products, produce dealers, and other
agricultural regulations.
2)Establishes a meat and poultry inspection program and, in
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connection with the operation of that program by CDFA, authorizes
the Secretary of CDFA to adopt, by regulation, standards and
requirements that meet those prescribed by the Federal Meat
Inspection Act and the Federal Poultry Products Inspection Act.
3)Requires the Secretary of CDFA to register over-the-counter
livestock drugs and regulate their use for safety and efficacy.
Requires a license for the retail sales of restricted livestock
drugs. Requires each licensee to keep a record of each sale of a
restricted drug, including the kind and quantity of the drug; sale
date; purchaser's name, address and signature; and, any other
information deemed necessary by the Secretary.
FISCAL EFFECT : Unknown.
COMMENTS :
Antimicrobial drugs have been widely used in human medicine since the
1940s. Antimicrobial drugs have significant health benefits in both
human and animal medicine, and are important and valuable tools used
to treat and prevent illness and infection. Incidences of
antimicrobial resistance have been recorded over time and, if left
unchecked, pose a threat to public health.
CDC estimates that in the United States, more than two million people
are sickened every year with antibiotic-resistant infections, with at
least 23,000 infections resulting in death. In a recent report, CDC
lists four core actions that fight the spread of antibiotic
resistance: 1) preventing infections from occurring and preventing
resistant bacteria from spreading; 2) tracking resistant bacteria; 3)
improving the use of antibiotics; and, 4) promoting the development
of new antibiotic and new diagnostic tests for resistant bacteria.
CDC notes that the use of antibiotics is the single most important
factor leading to antibiotic resistance around the world. Up to 50%
of all antibiotics prescribed for people are either not needed or not
optimally effective as prescribed. Antibiotics are also used in
food-producing animals for the purpose of promoting growth, which CDC
recommends phasing out.
In the past decade, FDA has worked on creating GFIs regarding the
judicious use of MIAM drugs in food producing animals. In three GFI,
FDA has: 1) GFI #152, compiled a list of MIAM drugs categorized by
their importance to human health; 2) GFI #219, developed principals
that determine the appropriate or judicious use of such drugs, by
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limiting use to only when necessary to maintain animal health, and
with veterinary oversight or consultation; and, 3) GFI #213),
provided recommendations as to the implementation of the guidelines.
The FDA concludes that using MIAM drugs for animal growth promotion
or feed efficiency is not a judicious use, and that veterinary
oversight or consultation is necessary when using these drugs.
In December 2013, FDA released the final draft of GFI #213. GFI #213
contains nonbinding recommendations to industry regarding the use of
MIAM drugs in the feed and drinking water of food-producing animals.
The FDA intends to work with drug companies to help them voluntarily
implement the recommendations, which include: 1) phasing out the use
of MIAM drugs in food-producing animals for production purposes
(growth promotion and feed efficiency); and, 2) include veterinary
oversight of these drugs when used in the feed or water of
food-producing animals.
Denmark is a case study for the banning of nontherapeutic use of
antibiotics on food production animals. In 1995, Denmark banned the
use of antimicrobial drugs for growth promotion in livestock and has
continually recorded antimicrobial drug use and impacts on animal
health. Denmark reports that overall use of antimicrobials in
livestock has decreased by 46% since 1994 and has not compromised
animal health or has had a significant cost increase in swine
production. From 1999 to 2012, the average size of a Danish swine
herd has grown from 612 pigs to 2,599 pigs. Furthermore, from 2010
to 2012, there was a loss of 19% of Danish pig farms.
This bill proposes addressing the use of MIAMs in food producing
animals by prohibiting the sale of livestock or poultry products
produced with nontherapeutic use of MIAM, requiring livestock or
poultry products sold in California to have been slaughtered in a
CDFA registered slaughter house, and that the slaughter houses report
levels of MIAM used in food producing animals. These provisions will
be phased in, until 2020, when they would apply to all sales of
livestock or poultry products in California.
Supporters point out that the vast majority of all antibiotics sold
in the United States are for cattle, pigs, poultry, and other
livestock, with the greatest use to speed up growth and compensate
for crowded, unsanitary conditions. Supporters point out that
numerous studies demonstrate that the use of antibiotics in animals
results in resistant bacteria in food animals, that these resistant
bacteria can spread through the food supply and the environment, and
can be transmitted to humans, and, as a result, more and more humans
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are experiencing adverse health effects.
Thus, supporters state that the solution is clear: antibiotics
should be used to treat sick animals, and in limited circumstances,
to control disease outbreaks, not as a production tool, and always
under the supervision of a veterinarian. Furthermore, supporters
state there should be a report of antibiotics in food producing
animals use so state public health officials can better track how
these drugs are being used, and if there are impacts on the spread of
antibiotic resistant bacteria. This bill addresses these issues and
will help stem the antibiotic resistance crisis.
Opponents state this bill would create a costly regulatory program
and reporting requirements that will not add to the health of the
animals, and are out of step with recent FDA actions. Under this
bill, farmers and ranchers would not be able to immediately respond
to an animal's health needs. and instead, would require them to
obtain a prescription for all MIAMs. This requirement could add costs
and delays, and in some circumstances, in certain rural or more
remote locations, even prevent care for the animal.
Opponents raise concerns over the legality of this legislation. AB
2098, (Krekorian), Statutes of 2008, Chapter 194, requires slaughter
facilities to euthanize all non-ambulatory livestock. Federal law
only requires slaughter facilities to euthanize non-ambulatory
cattle. California was sued over its attempt to regulate federally
inspected slaughter facilities beyond what the Federal Meat
Inspection Act (FMIA) requires. FMIA prohibits states from
regulating slaughter facilities beyond what is required by federal
law. This bill, according to opponents, attempts to do just that,
despite the 2012 Supreme Court decision in National Meat Association
v. Harris.
CDFA's Meat, Poultry and Egg Safety Branch (MPES) licenses and
inspects meat, poultry and egg production establishments that are
exempt from USDA inspections. MPES does not register or inspect meat
processing plants under USDA jurisdiction within the state, out of
state plants or international plants. The committee may wish to
consider how the bill's slaughter house reporting requirement to CDFA
will work and if they conflict with USDA jurisdiction.
This bill bans the sale of a livestock or poultry product if the
livestock or poultry was given a MIAM for nontherapeutic use, in
California. Previous legislation, AB 1437 (Huffman), Statutes of
2010, Chapter 51, prohibits selling shelled eggs for human
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consumption in California, if the eggs are not produced with
California animal care standards. Currently, six states, Missouri,
Nebraska, Alabama, Oklahoma, Kentucky, and Iowa, have filed a lawsuit
against California over its law requiring out of state egg producers
to comply with California animal care standards (Missouri vs.
Harris). The committee may wish to consider if this bill will
provoke similar lawsuits.
One issue often raised about FDA's GIFs on antimicrobials, is there
is no mechanism to quantify if the GIF are effectively lowering the
use of antimicrobials or ensuring antimicrobials are used in a
judicious manner. This bill does set up a mechanism for tracking the
use of MIAMs via the reporting requirements by slaughter houses, and
for slaughter houses to register with CDFA. This raises the practical
question of, does CDFA have the ability or the legal status to
register and request records from slaughter houses under USDA
jurisdiction or outside of the state? The committee may wish to
consider exploring other options for tracking the use of MIAMs in
food animal production, such as on farm antimicrobial use tracking,
veterinary antimicrobial use tracking, or tracking of antimicrobial
farm use sales.
This bill defines VVCPR, as it relates to administration of MIAMs for
therapeutic use, by codifying current regulations for VVCPR. Over
time, if the regulations change, this could lead to different
definitions for VVCPR. The committee may wish to consider if
codifying VVCPR for use of MIAMs, while leaving VVCPR for all other
aspects of veterinary medicine in regulations, is prudent public
policy. The committee may further wish to consider amendments to
either leave VVCPR exclusively in regulations or to codify VVCPR for
all veterinary medicine.
Related Legislation :
SB 835 (Hill) of 2014, would codify the FDA's GIF #213, dated
December 2013, by requiring the Secretary of CDFA to refuse to
register a livestock drug administered in the feed or drinking water
of food animals if such drug is a MIAM drug. SB 835 is in the Senate
Committee on Appropriations.
SB 1311 (Hill) of 2014, would require DPH to include antibiotic
resistant infections on the list of reportable diseases and
conditions. SB 1311 is set for hearing in the Senate Committee on
Health.
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SCA 23 (Florez) of 2009, would have amended the California
Constitution to ban the use of nontherapeutic antibiotics in any
animal raised for the production of any human food product starting
January 1, 2015. SCA 23 was held in the Senate Committee on Rules.
SB 416 (Florez) of 2009, would have authorized a school district to
make every effort to purchase poultry and meat products that have not
been treated with nontherapeutic antibiotics. The bill failed passage
in the Senate.
SB 562 (Florez) of 2009, would have required a warning label on any
commercial products derived from animals produced with nontherapeutic
antibiotics sold for human consumption. The hearing was canceled at
the request of the author in the Assembly Agriculture Committee.
SB 1058 (Alquist), Chapter 296, Statutes of 2008, established the
Medical Facility Infection Control and Prevention Act, which requires
specified hospitals to implement procedures for screening,
prevention, and reporting of hospital-related infections, including
MRSA, an antimicrobial-resistant bacterium.
SB 739 (Speier), Chapter 526, Statutes of 2006, established the
Hospital Infectious Disease Control Program, which requires DPH and
specified hospitals, to implement a disease surveillance and
hospital-associated infection prevention program.
REGISTERED SUPPORT / OPPOSITION :
Support
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American Academy of Pediatrics
Applegate
Black Women for Wellness
Blood System Research group
Bloomberg School of Public Health
Breast Cancer Action
Breast Cancer Fund
California Certified Organic Farmers
California Public Health Association-North
California State Grange
CALPIRG
Center for Food Safety
Children's Advocacy Institute
Children's Hospital & Research Center, Oakland
Clean Water Action
Coast Action Group
Community Environmental Council
Consumer Federation of California
Consumers Union
Endangered Habitats League
Environment California
Environmental Working Group
Food & Water Watch
Food Animals Concerns Trust
Food Chain Workers Alliance
Friends of the Earth
Health Care without Harm
Humane Farming Association
Infectious Disease Association of California
John Hopkins Center for a Livable Future
Keep Antibiotics Working
Klamath Forest Alliance
Natural Resources Defense Council Palomar Audubon Society
Pesticide Action Network North America
PEW Charitable Trust
Physicians for Social Responsibility, Sacramento
Physicians for Social Responsibility, SF-Bay Area
Prevention Institute
Roots of Change
Sierra Club California
Slow Food California
Sustain LA
Western Watersheds Project
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22 Medical and Public Health Professors
Opposition
Agricultural Council of California
Animal Health Institute
Association of California Egg Farmers
California Cattlemen's Association
California Chamber of Commerce
California Farm Bureau Federation
California Grain and Feed Association
California Pork Producers Association
California Poultry Federation
California Veterinary Medical Association
California Wool Growers Association
Western United Dairymen
Analysis Prepared by : Victor Francovich / AGRI. / (916)
319-2084