BILL ANALYSIS �
SB 835
Page 1
Date of Hearing: June 18, 2014
ASSEMBLY COMMITTEE ON AGRICULTURE
Susan Talamantes Eggman, Chair
SB 835 (Hill) - As Amended: June 4, 2014
SENATE VOTE : 35-1
SUBJECT : Food animals: medically important antimicrobial drugs.
SUMMARY : This bill would codify the Food and Drug
Administration's (FDA) Guidance for Industry (GIF) #213 dated
December 2013, by requiring the Secretary (Secretary) of the
California Department of Food and Agriculture (CDFA) to refuse
to register a livestock drug administered in the feed or
drinking water of food animals if such drug is a medically
important antimicrobial (MIAM) drug. Specifically, this bill :
1)Codifies the FDA Guidance for Industry #213 dated December
2013.
2)Defines "medically important antimicrobial drug" to mean a
drug listed in the FDA Guidance for Industry #152 which
categorizes these drugs as critically important, highly
important, or important antimicrobial drugs.
3)Requires the Secretary of DFA to refuse to register a MIAM
drug administered to food animals through feed or drinking
water unless the drug complies with the specified requirements
below:
a) Requires drug manufacturers to remove from the label of
said drugs the approved use for growth promotion or feed
efficiency;
b) Requires drug manufacturers to change the
over-the-counter availability of said drugs to:
i) requiring a veterinary feed directive (VFD) if the
drug is administered in animal feed or;
ii) requiring a veterinary prescription if the drug is
administered in drinking water; and,
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c) Requires that MIAM drugs administered through feed or
water may only be used under the supervision of a
veterinarian to treat, prevent, or control disease.
4)Requires a veterinarian-client-patient relationship to ensure
that medically important antimicrobial drugs are used
according to professionally accepted best practices.
5)Requires drug manufacturers to comply with these provisions by
January 1, 2017, and reregister MIAM drugs with the Secretary
of CDFA.
6)Authorizes the Secretary to continue registering a drug during
FDA's GFI #213 review period should the review be delayed
beyond January 1, 2017.
7)Authorizes the Secretary to extend the implementation date if
revisions to the VFD cause FDA to delay implementation of GFI
#213.
8)Authorizes the Secretary to promulgate regulations to ensure
that California regulations are consistent with GFI #213
should revisions to the VFD cause the FDA to revise GFI #213.
EXISTING LAW requires CDFA to register over-the-counter
livestock drugs and regulate their use for safety and efficacy.
Retail sales of restricted livestock drugs require a license.
Each licensee shall 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.
The Centers for Disease Control (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
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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 GFIs, 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 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
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has not compromised animal health or has had a significant cost
increase in swine production.
According to the author, this bill is necessary to preserve the
effectiveness of MIAM by putting into California law the
voluntary guidelines issued by FDA to phase out the
nontherapeutic use of MIAM in food-producing animals and to
require veterinary oversight of these drugs.
Supporters state this bill would prohibit the registration of
MIAM in livestock and poultry for purposes of growth promotion
and feed efficiency, or other uses without veterinary oversight.
Furthermore, producers would no longer be able to acquire
antibiotics over the counter, but would have to get a
veterinarian's prescription or VFD for MIAM use in feed or
water. Supporters state this oversight will help ensure
antibiotics are used to treat sick animals, to control the
spread of diseases present in the flock or herd, and under
well-defined circumstances, to prevent disease when necessary.
This will in turn help ensure that MIAMs are used in a more
judicious manner.
Opponents state because the recent FDA guidelines only recommend
an end to antibiotic use for growth promotion, the guidelines
will do little to curb the inappropriate use of antibiotics on
livestock. Opponents point out that most antibiotics that are
used for growth promotion in livestock are also used for disease
prevention. As this will only require a label change in many
cases, a Businessweek article published in May, 2014, suggested
that the guidelines will not have a significant impact on the
companies that sell antibiotics for animal health. According to
opponents, the most effective way to lower MIAM use is to
prohibit all antibiotic use in livestock production except for
the treatment of sick animals.
Some supporters and opponents to this bill expressed the desire
to collect data in-state on veterinary prescriptions for
antibiotics administered in feed. This information could shed
substantial light on the use of MIAM in food animal production.
Without some form of tracking, there isn't a way to gauge the
success of federal and state policies aimed at reducing
antibiotic overuse and curbing the spread of drug-resistant
bacteria. Furthermore, the data may enable both producers and
public health officials to spot and remedy problematic overuse
that raise human health concerns.
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RELATED LEGISLATION :
AB 1437 (Mullin) of 2014, would have banned the sale, in
California, of a livestock or poultry product if the livestock
or poultry was given a MIAM for nontherapeutic use. In the
Assembly Committee on Agriculture, the hearing was canceled at
the request of author.
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. SB 416
failed passage in the Senate.
SB 532 (Florez), of 2009 would have required a warning label on
any commercial product derived from animals produced with
non-therapeutic antibiotics sold for human consumption, and
defines antibiotics and nontherapeutics as they pertain to
animals raised for the production of commercial human food
products beginning January 1, 2011. In the Assembly Committee
on Agriculture, the hearing was canceled at the request of
author.
REGISTERED SUPPORT / OPPOSITION :
Support
California Cattlemen's Association
California Veterinary Medical Association
Health Care without Harm
Health Officers Association of California
Infectious Disease Association of California
Pew Charitable Trusts
Opposition
California State Grange
CALPIRG
Center for Food Safety
Environmental Working Group
Food and Water Watch
Consumers Union
Natural Defense Resource Council
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Analysis Prepared by : Victor Francovich / AGRI. / (916)
319-2084