BILL ANALYSIS Ó
SB 770
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Date of Hearing: July 1, 2015
ASSEMBLY COMMITTEE ON AGRICULTURE
Henry Perea, Chair
SB
770 (Mendoza) - As Amended April 29, 2015
SENATE VOTE: 36-0
SUBJECT: Department of Food and Agriculture: medicated feed.
SUMMARY: This bill requires the California Department of Food
and Agriculture (CDFA) to continue to be the primary regulatory
agency responsible for regulating medicated feed. Specifically,
this bill:
1)States findings and declarations regarding medicated feed,
consolidating governance expertise, and coordination with the
federal government on the implementation of feed safety laws,
including the federal Food and Drug Administration's (FDA)
guidance for industry (GIF) on the judicious use of
antimicrobial drugs in livestock.
2)Requires CDFA to be the primary state agency responsible for
regulating medicated feed, including medicated feed quality
assurance and safety, and enforcing any handling and
inspecting requirements imposed on medicated feed suppliers.
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3)Requires CDFA to be the primary state agency responsible for
overseeing medicated feed ingredients and the sale of
medicated feed that is subject to veterinarian oversight.
EXISTING LAW:
Federal law:
1)Authorizes FDA to protect public health by ensuring the
safety, effectiveness, quality, and security of human and
veterinary drugs.
2)Authorizes the Center for Veterinary Medicine, within FDA, to
regulate the manufacture and distribution of drugs that will
be administered to animals, as well as medicated feed.
State law:
1)Requires CDFA, through the Feed Inspection Program, to
regulate the manufacture of commercial feed through the
establishment of good manufacturing practices, hazard
analysis, and preventive control measures. This includes
medicated feed premixes and medicated feeds, where regulations
shall be based upon federal food and drug laws and
regulations.
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2)Requires CDFA, through the Livestock Drug Program, to regulate
the manufacture, sale, registration, and use of livestock
drugs, except when the livestock drug is sold by prescription
only, used exclusively by a veterinarian, or used only under a
veterinarian's direction. CDFA is required to register
over-the-counter livestock drugs and regulate their use for
safety and efficacy.
3)Authorizes the California State Board of Pharmacy (CBOP) to
license, regulate and enforce laws and regulations regarding
prescription drugs and drugs used exclusively by
veterinarians.
FISCAL EFFECT: Unknown. This bill has been keyed fiscal by
Legislative Counsel.
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 notes that the use of antimicrobial is the single most
important factor leading to antimicrobial resistance around the
world. Up to 50% of all antibiotics prescribed for people are
either not needed or not optimally effective as prescribed.
Antimicrobials are also used in food-producing animals for the
purpose of promoting growth, which CDC recommends phasing out.
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In the past decade, FDA has worked on creating GFIs regarding
the judicious use of antimicrobial drugs in food producing
animals. In December 2013, FDA released the final draft of GFI
#213. GFI #213 contains nonbinding recommendations to industry
regarding the use of antimicrobial 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
antimicrobial 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.
Currently, antimicrobial drugs may be obtained one of three
ways: over-the-counter (OTC), through a veterinarian's
prescription, or through a veterinary feed directive (VFD) which
does not require a prescription but does require veterinary
oversight of a food-animal drug that is administered through
feed or drinking water. The FDA's GFI #213 would change the
status of antimicrobial drugs administered in feed from OTC to
VFD. Due to this change, the FDA recognizes that current VFD
regulations must be revised and streamlined to minimize the
impact on veterinarians, the animal feed industry, and
producers. These revisions are scheduled to be completed before
the three-year implementation timeline for GFI #213.
CDFA currently serves as the regulatory and enforcement
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authority on livestock feed and has the expertise required to
verify that feed is safe and meets all quality assurance and
handling and inspection requirements. There are concerns that
future state or federal laws could change the status of
antimicrobials from OTC to VFD or prescription, which could
transfer the jurisdiction of medicated feed to CBOP, which does
not have experience regulating feed manufacturers.
According to the author, federal and state legislation is
currently being proposed that will transfer the responsibility
of defining the usage of drugs or food additives added to
commercial feed to CBOP. This transfer will create a situation
wherein feed manufacturers could be subject to inspections by
two different agencies - CDFA and CBOP. Furthermore, supporters
state the existing commercial feed program retaining the
oversight of the inspection and regulation of the feed mills
within CDFA will increase efficiency and cost effectiveness of
the program and provide well-trained staff. Supporters state
that feed mills are complex manufacturing facilities and in
order to have effective regulations and need inspectors that
understand the feed manufacturing process. This bill ensures
that CDFA will continue to oversee the manufacture and use of
medicated feed in California, regardless of which agency
regulates the medication being fed.
REGISTERED SUPPORT / OPPOSITION:
Support
California Grain and Feed Association (Sponsor)
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California Farm Bureau Federation
Agricultural Council of California
Association of California Egg Farmers
California Cattlemen's Association
California Farm Bureau Federation
California Pork Producers Association
California Poultry Federation
Pacific Egg and Poultry Association
Opposition
None on file.
Analysis Prepared by:Victor Francovich / AGRI. / (916)
319-2084
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