BILL ANALYSIS Ó
SENATE COMMITTEE ON AGRICULTURE
Senator Cathleen Galgiani, Chair
2015 - 2016 Regular
Bill No: SB 770 Hearing Date: 4/7/15
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|Author: |Mendoza |
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|Version: |2/27/15 |
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|Urgency: |No |Fiscal: |No |
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|Consultant:|Anne Megaro |
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Subject: Department of Food and Agriculture: medicated feed
SUMMARY :
This bill would require the California Department of Food and
Agriculture to continue to be the primary regulatory agency
responsible for regulating medicated feed.
BACKGROUND AND EXISTING
LAW :
Existing State Law:
The California Department of Food and Agriculture (CDFA),
through the Feed Inspection Program, is responsible for
regulating 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 (Food and
Agricultural Code § 14901 et seq.).
CDFA, through the Livestock Drug Program, is also responsible
for regulating 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 (OTC) livestock drugs and regulate
their use for safety and efficacy (Food and Agricultural Code
§14200 et seq.).
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The California State Board of Pharmacy is responsible for
licensing, regulating and enforcing laws and regulations
regarding prescription drugs and drugs used exclusively by
veterinarians (Business and Professions Code § 4000 et seq.).
Existing Federal Law:
The Food and Drug Administration (FDA) is responsible for
protecting public health by assuring the safety, effectiveness,
quality, and security of human and veterinary drugs. Within
FDA, the Center for Veterinary Medicine regulates the
manufacture and distribution of drugs that will be administered
to animals, as well as medicated feed.
The Animal Drug Availability Act enacted in 1996 created a new
regulatory category for certain animal drugs used in animal
feed. Previously, drugs were only available through two means:
over-the-counter and by prescription. As new drugs
(antimicrobials) were developed, FDA recognized the need for
these drugs to be administered though feed. However, FDA wanted
to establish greater control and safety measures than were
currently available under OTC status since some of these drugs
could contribute to drug toxicity and antimicrobial resistance
or have other unintended outcomes. Therefore, the Veterinary
Feed Directive (VFD) was created to allow more flexibility for
new animal drugs to be administered through medicated feed but
done so under the supervision of a licensed veterinarian (78
Federal Register 75517, December 12, 2013).
As concerns over antimicrobial resistance grew, the FDA created
guidelines for industry regarding the judicious use of medically
important antimicrobial drugs. In December 2013, the FDA
released the final draft of the Guidance for Industry #213 (GFI
#213), which contains nonbinding recommendations regarding the
use of medically important antimicrobial drugs in the feed and
drinking water of food-producing animals. These recommendations
include: 1) phasing out the use of medically important
antimicrobial drugs in food-producing animals for production
purposes (growth promotion and feed efficiency) and 2)
veterinary oversight of these drugs when used in the feed or
water of food-producing animals.
The federal Food Safety Modernization Act (FSMA), signed into
law on January 4, 2011, enables the FDA to strengthen the food
SB 770 (Mendoza) Page 3
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and feed safety system by primarily focusing on preventative
rather than response methods. CDFA is actively involved in
ensuring compliance with FSMA laws and regulations and has
recently been given authority by the legislature to establish
hazard analysis and preventive control methods for all
commercial feed (AB 1132 of 2013).
PROPOSED
LAW :
This bill:
States findings and declarations regarding medicated
feed, consolidating governance expertise, and coordination
with the federal government on the implementation of feed
safety laws such as the federal Food Safety Modernization
Act.
Requires CDFA, notwithstanding any other law, 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.
Requires CDFA, notwithstanding any other law, to be the
primary state agency responsible for overseeing medicated
feed ingredients and the sale of medicated feed that is
subject to veterinarian oversight.
ARGUMENTS IN SUPPORT:
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 the California State Board of Pharmacy
(CBOP). Should this occur, this transfer will create a situation
wherein feed manufacturers could be subject to inspections by
two different agencies - CDFA and CBOP. SB 770 ensures that the
California Department of Food and Agriculture (CDFA) will
continue to oversee the manufacture and use of medicated feed in
California, regardless of which agency regulates the medication
being fed." [sic]
According to those in support, "Because there is an existing
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Commercial feed program with licensed and trained inspectors,
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.
Feed mills are complex manufacturing facilities and in order to
have effective regulations, we need inspectors that understand
the feed manufacturing process."
ARGUMENTS IN OPPOSITION:
None received.
COMMENTS :
Drug Accessibility: 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 believed to be critically
important and are scheduled to be completed before the
three-year implementation timeline for GFI #213.
Feed Authority: CDFA currently serves as the regulatory and
enforcement authority on livestock feed and has the expertise
required to inspect, test, and verify that feed is safe and
meets all quality assurance and handling and inspection
requirements. However, there are concerns that future state or
federal laws could change the status of certain drugs (i.e.
antimicrobials) from OTC to VFD or prescription, which could
transfer the jurisdiction of medicated feed to the California
State Board of Pharmacy (CSBP), which does not have experience
regulating feed manufacturers. This issue was discussed but not
fully addressed in SB 835 (Hill) of 2014, and it remains a
concern for both the feed and livestock industries.
Food Safety Modernization Act: FSMA would strengthen feed and
food safety laws primarily through preventative measures as well
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as improve recall authority. FDA has proposed a regulation for
Current Good Manufacturing Practice and Hazard Analysis and
Risk-Based Preventative Controls for Food for Animals, which
could reduce the occurrences of medicated feed recalls thus
preventing unnecessary feed and financial losses. FDA works
with CDFA to regulate and enforce these practices.
The committee may wish to consider whether a reference to FDA's
guidances on antimicrobial drugs and other anticipated state and
federal changes to livestock antimicrobial drug use would be
appropriate to add to the intent language of this bill.
The committee may wish to consider whether CDFA should be
required to coordinate with the California Department of Public
Health (CDPH) when enforcing laws regarding medicated feed. CDPH
is not currently involved in regulating feed, however the
reference to CDPH in the intent language of this bill could have
been included due to the fact that there are discussions and
proposed legislation (SB 27) that would require tracking of
antimicrobial use and resistance. The committee may wish to
consider whether the intent language should provide better
clarity as to the role of CDPH or other agencies.
RELATED
LEGISLATION :
SB 27 (Hill) of 2015. This bill would prohibit the use of any
medically important antimicrobial drug in livestock for the
purpose of increased weight gain or feed efficiency and would
require a veterinarian's prescription for use in animal feed.
This bill would create a tracking program, create antimicrobial
stewardship guidelines, and provide penalties for violations of
these provisions. Currently in the Senate Committee on
Agriculture.
AB 49 (Mullin) of 2015, not yet assigned to a committee, would
make findings and declarations regarding antibiotic use in
food-producing animals and would state the intent of the
legislature to enact legislation that would address the overuse
of antibiotics in livestock production.
SB 835 (Hill) of 2014. This bill would have codified the Food
and Drug Administration's Guidance for Industry #213, dated
December 2013, by requiring the secretary of the California
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Department of Food and Agriculture 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
drug. Vetoed.
AB 1132 (Eggman), Chapter 622, Statutes of 2013. Authorizes the
secretary of the California Department of Food and Agriculture
to establish hazard analysis and preventive control measures for
all commercial feed, among other provisions.
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SUPPORT :
California Grain and Feed Association (Sponsor)
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 received
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