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91_HB4534
LRB9111538STsb
1 AN ACT to amend the Illinois Food, Drug and Cosmetic Act
2 concerning regulation, licensing, and inspection of food
3 manufacturers, processors, packers, and warehouses.
4 Be it enacted by the People of the State of Illinois,
5 represented in the General Assembly:
6 Section 5. The Illinois Food, Drug and Cosmetic Act is
7 amended by adding Sections 12.2, 21.3, and 21.4 and changing
8 Sections 21 and 22.4 as follows:
9 (410 ILCS 620/12.2 new)
10 Sec. 12.2. Certificates of free sale. The Department of
11 Public Health is authorized, upon request and nonrefundable
12 payment of $10 per certificate, to issue certificates of free
13 sale, or an equivalent, to Illinois dairy, drug, cosmetic,
14 and medical device manufacturers, processors, packers, or
15 warehouses. All fees collected shall be deposited into the
16 Food and Drug Safety Fund.
17 (410 ILCS 620/21) (from Ch. 56 1/2, par. 521)
18 Sec. 21. Enforcement; powers; rules.
19 (a) The authority to promulgate regulations for the
20 efficient enforcement of this Act is vested in the Director.
21 The Director is authorized to make the regulations
22 promulgated under this Act conform, in so far as practicable,
23 with those promulgated under the Federal Act.
24 (b) Hearings authorized or required by this Act shall be
25 conducted by the Director or an officer, agent or employee
26 designated by him.
27 (c) All pesticide chemical regulations and supplements
28 thereto or revisions thereof adopted under authority of the
29 Federal Food, Drug and Cosmetic Act are the pesticide
30 chemical regulations in this State, except insofar as
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1 modified or rejected by regulations for finished foods
2 promulgated by the Director.
3 (d) All food additive regulations and supplements
4 thereto or revisions thereof adopted under authority of the
5 Federal Food, Drug and Cosmetic Act are the food additive
6 regulations in this State, except insofar as modified or
7 rejected by regulations promulgated by the Director.
8 (e) All color additive regulations and supplements
9 thereto or revisions thereof adopted under authority of the
10 Federal Food, Drug and Cosmetic Act are the color additive
11 regulations in this State, except insofar as modified or
12 rejected by regulations promulgated by the Director.
13 (f) All special dietary use regulations and supplements
14 thereto or revisions thereof adopted under authority of the
15 Federal Food, Drug and Cosmetic Act are the special dietary
16 use regulations in this State, except insofar as modified or
17 rejected by regulations promulgated by the Director.
18 (g) All bottled water and vended water device
19 regulations and supplements thereto or revisions thereof
20 adopted under the authority of the Federal Food, Drug and
21 Cosmetic Act are the bottled water and vended water device
22 regulations in this State except insofar as modified or
23 rejected by regulations promulgated by the Director.
24 (h) All infant formula regulations and supplements
25 thereto or revisions thereof adopted under the authority of
26 the Federal Food, Drug and Cosmetic Act are the infant
27 formula regulations in this State except insofar as modified
28 or rejected by regulations promulgated by the Director.
29 (i) All food, drug, device and cosmetic Good
30 Manufacturing Practices Regulations and supplements thereto
31 or revisions thereof adopted under the authority of Federal
32 Food, Drug and Cosmetic Act are the food, drug, device and
33 cosmetic Good Manufacturing Practices Regulations in this
34 State, except insofar as modified or rejected by regulations
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1 promulgated by the Director.
2 (j) A federal regulation automatically adopted pursuant
3 to this Act takes effect in this State on the date it becomes
4 effective as a Federal regulation. No publication or hearing
5 is required. The Director shall promulgate all other proposed
6 regulations in compliance with the requirements of The
7 Illinois Administrative Procedure Act.
8 (k) All regulations concerning food and all supplements
9 to the regulations or revisions of the regulations adopted
10 under the authority of the Federal Food, Drug and Cosmetic
11 Act, including Sections 70 through 699 of Title 21 of the
12 Code of Federal Regulations, are the regulations concerning
13 food in this State, except as modified or rejected by
14 regulations adopted by the Director.
15 (l) The Department of Public Health is empowered to
16 establish and assess civil monetary penalties or fines
17 against a license holder for violations of this Act or
18 regulations adopted under this Act. In no circumstances will
19 any penalties or fines exceed $1,000 per day for each day the
20 license holder remains in violation. All penalties or fines
21 collected shall be deposited into the Food and Drug Safety
22 Fund.
23 (Source: P.A. 84-891.)
24 (410 ILCS 620/21.3 new)
25 Sec. 21.3. Licenses and inspections. It is unlawful for
26 any person to establish, maintain, conduct, or operate a
27 food manufacturer, processor, packer, or warehouse within
28 this State without first obtaining a license from the
29 Department of Public Health.
30 (a) Licenses expire one year from the date issued unless
31 revoked by the Department of Public Health for noncompliance
32 with the rules adopted under this Act or discontinuation of
33 the facility's operation.
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1 (b) Applications for original licenses or renewals shall
2 be made on forms furnished by the Department of Public Health
3 and shall include at least the following:
4 (1) the name and address of the applicant, or names
5 and addresses of the partners if the applicant is a
6 partnership, or the names and addresses of the officers
7 if the applicant is a corporation, or the names and
8 addresses of all persons having a financial interest
9 therein if the applicant is a group of individuals,
10 association, or trust; and
11 (2) the name of the food manufacturer, processor,
12 packer, or warehouse; its location; its mailing address;
13 and its telephone number.
14 (c) An initial, nonrefundable fee of $250 shall be
15 submitted to the Department of Public Health with the
16 application for a license. Each annual renewal application
17 shall be submitted with a nonrefundable $150 fee, except that
18 each facility with a license that has been expired for more
19 than 90 days shall pay a nonrefundable $250 fee for renewal
20 of the license. All fees collected shall be deposited into
21 the Food and Drug Safety Fund.
22 (d) Each Illinois food manufacturer, processor, packer,
23 or warehouse shall be inspected by the Department of Public
24 Health a minimum of once annually in addition to any
25 necessary follow-up inspections.
26 (410 ILCS 620/21.4 new)
27 Sec. 21.4. Units of local government; home rule
28 preemption. The regulation, licensing, and inspection of food
29 manufacturers, processors, packers, warehouses, manufactured
30 dairy farms, manufactured dairy plants, bulk milk
31 hauler-samplers, bulk milk pick up tanks, certified
32 pasteurizer sealers, and manufactured dairy products, but not
33 including food service establishments and retail food stores,
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1 are exclusive powers and functions of the State. A unit of
2 local government, including a home rule unit, may not perform
3 these powers and functions. This Section is a denial and
4 limitation of home rule powers under subsection (h) of
5 Section 6 of Article VII of the Constitution of the State of
6 Illinois.
7 (410 ILCS 620/22.4) (from Ch. 56 1/2, par. 522.4)
8 Sec. 22.4. Food and Drug Safety Fund. There is created in
9 the State Treasury a special fund to be known as the Food and
10 Drug Safety Fund. All subscription, fine, certificate,
11 license, and permit fees collected by the Department of
12 Public Health under this Act shall be deposited into the
13 Fund. Subject to appropriation by the General Assembly,
14 moneys deposited into this Fund shall be made available to
15 the Department of Public Health to administer the Drug
16 Product Selection Program or for other Department activities
17 related to food safety, drug safety, milk safety, and or drug
18 product selection. All interest that accrues on the moneys in
19 the Fund shall be deposited into the Fund.
20 (Source: P.A. 89-526, eff. 7-19-96.)
21 Section 99. Effective date. This Act takes effect
22 January 1, 2000.