State Inspection Contracts
State Contracts
The Division of Federal-State Relations manages various sole source and fixed
price contract programs with states. These contract programs benefits states
with technical training, familiarity with federal requirements and more uniform
enforcement of consumer laws through cooperation and coordination with FDA.
The contract programs allow FDA to enlarge coverage of the Official Establishment
Inventory (OEI) and also to redirect resources to other priorities.
- The major 6 contract programs include Food Safety, Feed/BSE, Tissue Residue,
MQSA, Milk Drug, and Medical Device. These contracts are with over 145 state
regulatory agencies and acquire over 25,000� inspections and data for over
4 million samples.
Food Inspection Contract Program: Under this program,
inspections are performed in selected food manufacturers/processors to determine
compliance with the Federal Food, Drug and Cosmetic (FD&C) Act, state law,
or both;� The major inspectional emphasis will be placed upon determining significant
GMP, unsanitary conditions and practices which may render the food injurious
to health, particularly those involving the introduction, lack of controls,
and/or growth promotion of pathogenic organisms and other conditions which
may have caused food to become filthy, putrid, decomposed or contaminated with
foreign objects which present a reasonable possibility of causing the contamination
of food.�
- Number of Contracts with states:�42
- Number of inspection accomplished via contracts: Over 10,500
- Type of Inspections: GMP Sanitation, Seafood HACCP, Juice HACCP, LACF,
and Import trace backs
Feed / BSE Inspection Contract Program:� The Medicated
Feeds Program has been implemented with the assistance of the states under
contract since 1973. For the last several years, states have accomplished
surveillance inspections to determine whether firms manufacturing medicated
feeds were in compliance with key good manufacturing practices (GMP) regulations.
The Second Generation Medicated Feed Regulations, published by the FDA in 1986,
set forth revised requirements concerning approval procedures for the manufacture
of animal feeds containing new animal drugs. These regulations focus on high-risk
drugs, i.e., carcinogens and drugs requiring withdrawal times at their lowest
use level. Firms using Category II Type medicated articles to make medicated
feeds are required to register with FDA and hold approved licenses. FDA is
required to inspect these firms once every two years
On June 5, 1997, FDA published a final rule prohibiting the use of mammalian
protein in ruminant feeds. This action was taken to prevent the spread of
bovine spongiform encephalopathy (BSE) in the United
States; thus, the phrase "BSE rule" to describe it. The rule, which is codified
in 21 CFR 589.2000, provides for labeling, record keeping and clean out requirements
for renderers, feed manufacturers, haulers of feed, and producers.
- Number of Contracts with states:�35
- Number of inspection accomplished via contracts :
- Feed Mill GMP: 354
- BSE: 4684
- Type of Inspections: Feed Mill GMP and BSE
Tissue Residue Inspection Contract Program - 18
State Contracts:� Under this program, inspections of producers/owners
as identified by USDA/FSIS of a tissue residue violation are conducted. The
primary objectives of the inspection will be to determine and document the
cause of the violative tissue residue. The inspection will obtain information
on the producer's/owner's operations, drug usage, animal husbandry practices,
feed delivery systems, responsibility for the violation, and disposition
of any remaining animals. Inspections will include assuring compliance with
the 21CFR 589.2000, "Substance Prohibited from Use in Animal Food or
Feed; Animal Proteins Prohibited in Ruminant Feed", commonly known as
the "BSE Rule".
- Number of Contracts with states: 18
- Number of inspection accomplished via contracts: 635
MQSA Inspection Contract Program: The Mammography
Quality Standards Act (MQSA) of 1992, was signed into law on October 27, 1992.
The intent of the Act is to ensure that women receive high quality mammography
for early breast cancer detection by requiring the establishment of a federal
certification and inspection program for mammography facilities. The Act authorizes
FDA to obtain state and local assistance in enforcing the MQSA requirements
including annual inspections of all certified mammography facilities.�
- Number of Contracts with states: 47
- Number of inspection accomplished via contracts: 7950
National Milk Drug Residue Database: The Food and
Drug Administration (FDA) and the states share responsibility for assuring
that the nation's milk supply is safe and not contaminated with harmful residues
of drugs. This task is accomplished through a cooperative agreement between
FDA and the states under the National Conference on Interstate Milk Shipments
(NCIMS).
The National Milk Drug Residue Database was implemented in cooperation with
the National Conference on Interstate Milk shipments, and organization of
state officials responsible for the Grade A fluid milk production in this country.
The contract is part of an effort to improve control over drug residues in
the milk supply, and to be able to demonstrate the amount and results of collective
industry and government milk testing.
- Number of Contracts: 1
- Number of sample data compiled via contract: 4 million
Medical Device Inspection Program: Inspection of
Class I and Class II medical device manufacturers to determine compliance with
the QSIT/GMP regulations. Section 510 (h) of the Federal Food, Drug and Cosmetic
Act states, "Every establishment in any state registered with the Secretary
pursuant to this section shall be subject to inspection pursuant to Section
704 and every such establishment engaged in the manufacture, propagation, compounding
or processing of a drug or drugs or of a device or devices classified in Class
II or III shall be so inspected by one or more officers or employees duly designated
by the secretary at least once in the two-year period beginning with the date
of registration of such establishment pursuant to this section and at least
once in every successive two-year period thereafter."
- Number of Contracts: 1
- Number of inspection accomplished via contracts: 24
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