BILL ANALYSIS Ó
-----------------------------------------------------------------
|SENATE RULES COMMITTEE | SB 770|
|Office of Senate Floor Analyses | |
|(916) 651-1520 Fax: (916) | |
|327-4478 | |
-----------------------------------------------------------------
THIRD READING
Bill No: SB 770
Author: Mendoza (D)
Introduced:2/27/15
Vote: 21
SENATE AGRICULTURE COMMITTEE: 5-0, 4/7/15
AYES: Galgiani, Cannella, Berryhill, Pan, Wolk
SUBJECT: Department of Food and Agriculture: medicated feed
SOURCE: California Grain and Feed Association
DIGEST: This bill requires the California Department of Food
and Agriculture to continue to be the primary regulatory agency
responsible for regulating medicated feed.
ANALYSIS: Existing federal law authorizes the Food and Drug
Administration (FDA) to protect 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.
Existing state law:
1)Requires the California Department of Food and Agriculture
(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 (Food and Agricultural Code
SB 770
Page 2
§ 14901 et seq.).
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 (Food and Agricultural Code §14200 et
seq.).
3)Authorizes the California State Board of Pharmacy to license,
regulate and enforce laws and regulations regarding
prescription drugs and drugs used exclusively by veterinarians
(Business and Professions Code § 4000 et seq.).
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
such as the federal Food Safety Modernization Act.
2)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.
3)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.
Background
Antimicrobial resistance: 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
SB 770
Page 3
these drugs when used in the feed or water of food-producing
animals.
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.
Comments
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, which does not have experience
regulating feed manufacturers. This issue was discussed but not
fully addressed in SB 835 (Hill, 2014), which was vetoed, and it
remains a concern for both the feed and livestock industries.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:NoLocal: No
SUPPORT: (Verified4/7/15)
California Grain and Feed Association (source)
Agricultural Council of California
Animal Health Institute
Association of California Egg Farmers
California Cattlemen's Association
SB 770
Page 4
California Farm Bureau Federation
California Pork Producers Association
California Poultry Federation
Pacific Egg and Poultry Association
OPPOSITION: (Verified4/7/15)
None received
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 the sponsor, "Because there is an existing
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."
Prepared by:Anne Megaro / AGRI. / (916) 651-1508
4/8/15 15:13:12
**** END ****
SB 770
Page 5