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92_HB2551
LRB9204278DJpc
1 AN ACT in relation to public health.
2 Be it enacted by the People of the State of Illinois,
3 represented in the General Assembly:
4 Section 5. The Illinois Food, Drug and Cosmetic Act is
5 amended by changing Sections 21 and 22.4 and adding Sections
6 21.3 and 21.4 as follows:
7 (410 ILCS 620/21) (from Ch. 56 1/2, par. 521)
8 Sec. 21. Enforcement of Act.
9 (a) The authority to promulgate regulations for the
10 efficient enforcement of this Act is vested in the Director.
11 The Director is authorized to make the regulations
12 promulgated under this Act conform, in so far as practicable,
13 with those promulgated under the Federal Act.
14 (b) Hearings authorized or required by this Act shall be
15 conducted by the Director or an officer, agent or employee
16 designated by him.
17 (c) All pesticide chemical regulations and supplements
18 thereto or revisions thereof adopted under authority of the
19 Federal Food, Drug and Cosmetic Act are the pesticide
20 chemical regulations in this State, except insofar as
21 modified or rejected by regulations for finished foods
22 promulgated by the Director.
23 (d) All food additive regulations and supplements
24 thereto or revisions thereof adopted under authority of the
25 Federal Food, Drug and Cosmetic Act are the food additive
26 regulations in this State, except insofar as modified or
27 rejected by regulations promulgated by the Director.
28 (e) All color additive regulations and supplements
29 thereto or revisions thereof adopted under authority of the
30 Federal Food, Drug and Cosmetic Act are the color additive
31 regulations in this State, except insofar as modified or
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1 rejected by regulations promulgated by the Director.
2 (f) All special dietary use regulations and supplements
3 thereto or revisions thereof adopted under authority of the
4 Federal Food, Drug and Cosmetic Act are the special dietary
5 use regulations in this State, except insofar as modified or
6 rejected by regulations promulgated by the Director.
7 (g) All bottled water and vended water device
8 regulations and supplements thereto or revisions thereof
9 adopted under the authority of the Federal Food, Drug and
10 Cosmetic Act are the bottled water and vended water device
11 regulations in this State except insofar as modified or
12 rejected by regulations promulgated by the Director.
13 (h) All infant formula regulations and supplements
14 thereto or revisions thereof adopted under the authority of
15 the Federal Food, Drug and Cosmetic Act are the infant
16 formula regulations in this State except insofar as modified
17 or rejected by regulations promulgated by the Director.
18 (i) All food, drug, device and cosmetic Good
19 Manufacturing Practices Regulations and supplements thereto
20 or revisions thereof adopted under the authority of Federal
21 Food, Drug and Cosmetic Act are the food, drug, device and
22 cosmetic Good Manufacturing Practices Regulations in this
23 State, except insofar as modified or rejected by regulations
24 promulgated by the Director.
25 (j) A federal regulation automatically adopted pursuant
26 to this Act takes effect in this State on the date it becomes
27 effective as a Federal regulation. No publication or hearing
28 is required. The Director shall promulgate all other proposed
29 regulations in compliance with the requirements of The
30 Illinois Administrative Procedure Act.
31 (k) On and after July 1, 2002, all federal regulations
32 concerning food and supplements, or revisions to the
33 regulations adopted under the authority of the Federal Food,
34 Drug and Cosmetic Act, including 21 C.F.R. 70 through 699,
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1 are the regulations concerning food in this State, except as
2 modified or rejected by rules adopted by the Director.
3 (l) On and after July 1, 2002, the Department may
4 establish and assess civil monetary penalties against a
5 license holder for violations of this Act or regulations
6 adopted under this Act. Before assessing a penalty, the
7 Department must give the alleged violator an opportunity to
8 request an administrative hearing on the matter of the
9 alleged violation. In no circumstances may any penalty
10 exceed $1,000 per day for each day the license holder remains
11 in violation. All penalties collected under this Act shall
12 be deposited into the Food and Drug Safety Fund. The
13 Attorney General may bring a civil action in the circuit
14 court to enforce the collection of a penalty imposed under
15 this subsection.
16 (Source: P.A. 84-891.)
17 (410 ILCS 620/21.3 new)
18 Sec. 21.3. Food manufacturers, processors, packers, and
19 warehouses; permits and inspections.
20 (a) It is unlawful for any person to establish,
21 maintain, conduct, or operate a food manufacturer, processor,
22 packer, or warehouse within this State without first
23 obtaining a permit from the Department.
24 Permits shall expire on September 30 of each year,
25 unless revoked by the Department for noncompliance with the
26 rules adopted under this Act or discontinuation of the
27 facility's operation.
28 Applications for original permits or renewals shall be
29 made on forms furnished by the Department and shall include
30 at least the following:
31 (1) The name and address of the applicant, or the
32 names and addresses of the partners if the applicant is
33 a partnership, or the names and addresses of the officers
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1 if the applicant is a corporation, or the names and
2 addresses of all persons having a financial interest in
3 the applicant if the applicant is a group of individuals,
4 association, or trust; and
5 (2) The name of the food manufacturer, processor,
6 packer or warehouse, location, mailing address, and
7 telephone number.
8 An initial, non-refundable fee of $100 must be submitted
9 to the Department with the application for a license. Each
10 annual renewal application must be submitted with a
11 non-refundable $100 fee, except that each facility with a
12 license that has been expired for more than 90 days must pay
13 a non-refundable $150 fee for renewal of the license. All
14 fees collected shall be deposited into the Food and Drug
15 Safety Fund.
16 Those food manufacturers, processors, packers, or
17 warehouses permitted by the Department under Section 21.2 of
18 this Act or under the Grade A Pasteurized Milk and Milk
19 Products Act or by the Illinois Department of Agriculture
20 under the Meat and Poultry Inspection Act or the Illinois Egg
21 and Egg Products Act are exempt from the permit fees in this
22 Section, but not from other provisions of this Act.
23 The Department is authorized, upon request and the
24 non-refundable payment of $10 per certificate, to issue
25 certificates of free sale, health certificates, or an
26 equivalent, to Illinois food, dairy, drug, cosmetic, or
27 medical device manufacturers, processors, packers, or
28 warehousers. All fees collected shall be deposited into the
29 Food and Drug Safety Fund.
30 The Department shall issue an Illinois shellfish
31 certificate, upon request, to shellfish firms in compliance
32 with the Interstate Shellfish Sanitation Conference.
33 (b) Every Illinois food manufacturer, processor, packer,
34 or warehouse shall be inspected by the Department at a
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1 frequency that is necessary to ensure compliance with this
2 Act.
3 (c) This Section applies on and after July 1, 2002.
4 (410 ILCS 620/21.4 new)
5 Sec. 21.4. Units of local government; home rule.
6 (a) The regulation, permitting, and inspection of food
7 manufacturers, processors, packers, warehouses, manufactured
8 dairy farms, manufactured dairy plants, bulk milk
9 hauler-samplers, bulk milk pickup tanks, certified
10 pasteurizer sealers, and manufactured dairy products, but not
11 including food service establishments and retail food stores,
12 are exclusive powers and functions of the State. A home rule
13 unit may not regulate these entities. This Section is a
14 denial and limitation of home rule powers and functions under
15 subsection (h) of Section 6 of Article VII of the Illinois
16 Constitution.
17 (b) This Section applies on and after July 1, 2002.
18 (410 ILCS 620/22.4) (from Ch. 56 1/2, par. 522.4)
19 Sec. 22.4. Food and Drug Safety Fund. There is created in
20 the State Treasury a special fund to be known as the Food and
21 Drug Safety Fund. All subscription, fine, and permit fees,
22 certificate fees, and other moneys collected by the
23 Department of Public Health under this Act shall be deposited
24 into the Fund. Subject to appropriation by the General
25 Assembly, moneys deposited into this Fund shall be made
26 available to the Department of Public Health to administer
27 the Drug Product Selection Program or for other Department
28 activities related to food safety, drug safety, milk safety,
29 or drug product selection. All interest that accrues on the
30 moneys in the Fund shall be deposited into the Fund.
31 (Source: P.A. 89-526, eff. 7-19-96.)