PRINTER'S NO. 1044
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No.
883
Session of
2023
INTRODUCED BY MASTRIANO AND HUTCHINSON, AUGUST 16, 2023
REFERRED TO AGRICULTURE AND RURAL AFFAIRS, AUGUST 16, 2023
AN ACT
Amending Title 35 (Health and Safety) of the Pennsylvania
Consolidated Statutes, providing for prohibition of and
disclosures for certain products.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Title 35 of the Pennsylvania Consolidated
Statutes is amended by adding a chapter to read:
CHAPTER 56A
PROHIBITION OF AND DISCLOSURES
FOR CERTAIN PRODUCTS
Sec.
56A01. Definitions.
56A02. Prohibition of gene therapy products.
56A03. Informed consent.
§ 56A01. Definitions.
The following words and phrases when used in this chapter
shall have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Cosmetic." An article intended to be rubbed, poured,
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
sprinkled or sprayed on, introduced into or otherwise applied to
the human body or any part of the human body for cleansing,
beautifying, promoting attractiveness or altering the appearance
and an article intended for use as a component of the article.
"Expose." Transmit to another through skin-to-skin contact,
sexual activity, droplets or aerosols suspended in the air,
introduction into the blood supply or food supply or any other
means.
"Food." An article used for food or drink for humans or
animals, chewing gum and an article used for components of the
article.
"Gene therapy product." A product with a capacity to alter,
interfere with or otherwise act in any manner similar or
equivalent to genes.
"Genetically modified." The alteration of genetic material
through modern biotechnology, directed evolution or any other
mechanism in a way that does not occur naturally or that does
not occur at its natural rate.
"Product." An article that is:
(1) A food, cosmetic or other substance intended to be
ingested, introduced into or applied to the human body or
intended to induce physiological effects.
(2) Made available for sale in this Commonwealth to the
general public at retail.
§ 56A02. Prohibition of gene therapy products.
(a) Potential gene therapy products.--A product that has
been created to act as, or exposed to processes that have
resulted or could result in the product potentially acting as, a
gene therapy or that could otherwise possibly impact, alter or
introduce genetic material or a genetic change into the user of
20230SB0883PN1044 - 2 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
the product, shall be prohibited from being sold for consumption
in this Commonwealth.
(b) Enforcement.--The Department of Agriculture, Bureau of
Food Safety and Laboratory Services, shall promulgate rules and
regulations necessary to ensure compliance with this section.
§ 56A03. Informed consent.
An entity that makes a product available in this Commonwealth
that could infect, transmit to or be absorbed in an individual
in any way that would act as a medical intervention, vaccine,
drug or genetic modification shall obtain fully informed consent
from all individuals who could be exposed to the product before
exposure could occur. Fully informed consent requires, at a
minimum, that an individual is made aware of all benefits and
risks, including side effects, of the product, any adverse
events of special interest and any other reasonably possible
impacts of the product.
Section 2. This act shall take effect in 60 days.
20230SB0883PN1044 - 3 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17