An Act amending Title 3 (Agriculture) of the Pennsylvania Consolidated Statutes, in food protection, further providing for definitions and providing for reporting of GRAS substances and for public database of GRAS reports.

PRINTER'S NO. 1415
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No. 1130
Session of
2025
INTRODUCED BY MIHALEK, SHUSTERMAN, ROWE, SCIALABBA, O'MARA,
MAJOR, FLEMING, HOGAN, WARNER, KAIL, LABS, LEADBETER, GLEIM,
BOROWSKI, BENHAM, METZGAR, SAPPEY, PICKETT, GIRAL, SANCHEZ,
VENKAT, KULIK, NEILSON, KAUFFMAN, OTTEN, KAZEEM, RIVERA,
GREEN, KERWIN, COOPER, BANTA AND PUGH, APRIL 21, 2025
REFERRED TO COMMITTEE ON CONSUMER PROTECTION, TECHNOLOGY AND
UTILITIES, APRIL 21, 2025
AN ACT
Amending Title 3 (Agriculture) of the Pennsylvania Consolidated
Statutes, in food protection, further providing for
definitions and providing for reporting of GRAS substances
and for public database of GRAS reports.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Section 5722 of Title 3 of the Pennsylvania
Consolidated Statutes is amended by adding a definition to read:
§ 5722. Definitions.
The following words and phrases when used in this subchapter
shall have the meanings given to them in this section unless the
context clearly indicates otherwise:
* * *
"Generally recognized as safe substance" or "GRAS substance."
A substance that is added to food, is not a food additive and is
generally recognized, among experts qualified by scientific
training and experience to evaluate its safety, as having been
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adequately shown to be safe under the conditions of its intended
use through:
(1) scientific procedures using the same quantity and
quality of scientific evidence as is required to obtain
approval of the substance as a food additive; or
(2) if the substance was used in food prior to January
1, 1958, experience based on common use in food.
* * *
Section 2. Title 3 is amended by adding sections to read:
§ 5725.1. Reporting of GRAS substances.
(a) Prohibited conduct.--
(1) Unless a report has been filed with the secretary as
required under subsection (b) for the GRAS substance and the
GRAS substance is listed on the database established under
section 5725.2 (relating to public database of GRAS reports),
it is unlawful for a person to:
(i) sell or offer or expose for sale for use in or
on food, or to use in the manufacturing, compounding,
brewing, distilling, producing or processing of any food
or food product containing a GRAS substance or
combination of GRAS substances;
(ii) make a new use of a GRAS substance or
combination of GRAS substances in or on food; or
(iii) sell or offer or expose for sale food or food
product containing a GRAS substance or combination of
GRAS substances.
(2) For purposes of paragraph (1), a person does not
include a small business as defined in 62 Pa.C.S. § 2102
(relating to definitions).
(b) Report.--A person may file a report with the secretary
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that includes the following information relating to a GRAS
substance:
(1) All the data and information required for submission
of a GRAS notice under 21 CFR 170.220 (relating to general
requirements applicable to a GRAS notice), 170.225 (relating
to part 1 of a GRAS notice: signed statements and
certification), 170.230 (relating to part 2 of a GRAS notice:
identity, method of manufacture, specifications, and physical
or technical effect), 170.235 (relating to part 3 of a GRAS
notice: dietary exposure), 170.240 (relating to part 4 of a
GRAS notice: self-limiting levels of use), 170.245 (relating
to part 5 of a GRAS notice: experience based on common use in
food before 1958), 170.250 (relating to part 6 of a GRAS
notice: narrative) and 170.255 (relating to part 7 of a GRAS
notice: list of supporting data and information in your GRAS
notice) , as those provisions exist on the effective date of
this section. Data establishing the general recognition of
safety must be based on publicly available information and
not on trade secrets.
(2) A statement as to whether any of the data and
information in the report is a record not subject to
inspection and duplication under the act of February 14, 2008
(P.L.6, No.3), known as the Right-to-Know Law.
(c) Applicability.--This section does not apply to the
following substances:
(1) A GRAS substance for which the Food and Drug
Administration has received a GRAS notice and issued a letter
stating that the Food and Drug Administration has no
questions regarding the conclusion that the substance is
generally recognized as safe under its intended conditions of
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use.
(2) A substance recognized in Federal regulations as
prior sanctioned or a GRAS substance for use in food or food
packaging.
(3) A food contact substance for which there is an
effective premarket notification demonstrating safety for its
intended use.
(4) A substance subject to a regulation that approves
its intended use for food.
(5) A food ingredient of natural biological origin that
has been widely consumed for its nutrient properties in the
United States prior to January 1, 1958, without known
detrimental effects, that is subject only to conventional
processing as practiced prior to January 1, 1958, and for
which no known safety hazard exists.
(6) A substance for which the Food and Drug
Administration has received a new dietary ingredient
notification and issued a letter of acknowledgment without
objection that the substance is safe under the intended
conditions of use stated in the letter.
(7) A substance determined safe to be added to foods by
the secretary through rulemaking.
§ 5725.2. Public database of GRAS reports.
(a) Duties of secretary.--The secretary shall:
(1) Make reports submitted in accordance with section
5725.1 (relating to reporting of GRAS substances) available
to the public from a database on the department's publicly
accessible Internet website. The database shall:
(i) be searchable by members of the public;
(ii) enable consumers to download and print
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displayed information; and
(iii) accommodate reasonably anticipated and actual
public use.
(2) Redact from the public report information that has
been designated by the person that submitted the information
as a trade secret or that is not subject to inspection and
duplication under the act of February 14, 2008 (P.L.6, No.3),
known as the Right-to-Know Law, provided, however, that data
establishing the general recognition of safety is not
required to be redacted.
(3) Update the database with any new information that
the secretary receives relating to the safety of a GRAS
substance.
(b) Refusal to list.--The secretary may refuse to list a
GRAS substance in the database if the secretary determines the
information reported on the GRAS substance does not contain the
information required by section 5725.1.
(c) Fees.--The secretary may establish and charge a fee to a
person that files a report of a GRAS substance in order to
recover the costs incurred in listing the GRAS substance and
maintaining the database.
(d) Report to General Assembly.--The secretary shall provide
an interim progress report to the General Assembly concerning
efforts to develop and implement the database. The report shall
include:
(1) A projected completion date.
(2) A description of obstacles to development and
implementation of the database system.
(3) An estimate of the costs to complete the
implementation of the database system.
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Section 3. This act shall take effect in six months.
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