HB 1130 — 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
 1   Amending Title 3 (Agriculture) of the Pennsylvania Consolidated
 2      Statutes, in food protection, further providing for
 3      definitions and providing for reporting of GRAS substances
 4      and for public database of GRAS reports.
 5      The General Assembly of the Commonwealth of Pennsylvania
 6   hereby enacts as follows:
 7      Section 1.    Section 5722 of Title 3 of the Pennsylvania
 8   Consolidated Statutes is amended by adding a definition to read:
 9   § 5722.    Definitions.
10      The following words and phrases when used in this subchapter
11   shall have the meanings given to them in this section unless the
12   context clearly indicates otherwise:
13      * * *
14      "Generally recognized as safe substance" or "GRAS substance."
15   A substance that is added to food, is not a food additive and is
16   generally recognized, among experts qualified by scientific
17   training and experience to evaluate its safety, as having been
 1   adequately shown to be safe under the conditions of its intended
 2   use through:
 3            (1)    scientific procedures using the same quantity and
 4      quality of scientific evidence as is required to obtain
 5      approval of the substance as a food additive; or
 6            (2)    if the substance was used in food prior to January
 7      1, 1958, experience based on common use in food.
 8      * * *
 9      Section 2.        Title 3 is amended by adding sections to read:
10   § 5725.1.      Reporting of GRAS substances.
11      (a)   Prohibited conduct.--
12            (1)    Unless a report has been filed with the secretary as
13      required under subsection (b) for the GRAS substance and the
14      GRAS substance is listed on the database established under
15      section 5725.2 (relating to public database of GRAS reports),
16      it is unlawful for a person to:
17                  (i)    sell or offer or expose for sale for use in or
18            on food, or to use in the manufacturing, compounding,
19            brewing, distilling, producing or processing of any food
20            or food product containing a GRAS substance or
21            combination of GRAS substances;
22                  (ii)    make a new use of a GRAS substance or
23            combination of GRAS substances in or on food; or
24                  (iii)    sell or offer or expose for sale food or food
25            product containing a GRAS substance or combination of
26            GRAS substances.
27            (2)    For purposes of paragraph (1), a person does not
28      include a small business as defined in 62 Pa.C.S. § 2102
29      (relating to definitions).
30      (b)   Report.--A person may file a report with the secretary

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 1   that includes the following information relating to a GRAS
 2   substance:
 3            (1)   All the data and information required for submission
 4      of a GRAS notice under 21 CFR 170.220 (relating to general
 5      requirements applicable to a GRAS notice), 170.225 (relating
 6      to part 1 of a GRAS notice: signed statements and
 7      certification), 170.230 (relating to part 2 of a GRAS notice:
 8      identity, method of manufacture, specifications, and physical
 9      or technical effect), 170.235 (relating to part 3 of a GRAS
10      notice: dietary exposure), 170.240 (relating to part 4 of a
11      GRAS notice: self-limiting levels of use), 170.245 (relating
12      to part 5 of a GRAS notice: experience based on common use in
13      food before 1958), 170.250 (relating to part 6 of a GRAS
14      notice: narrative) and 170.255 (relating to part 7 of a GRAS
15      notice: list of supporting data and information in your GRAS
16      notice), as those provisions exist on the effective date of
17      this section. Data establishing the general recognition of
18      safety must be based on publicly available information and
19      not on trade secrets.
20            (2)   A statement as to whether any of the data and
21      information in the report is a record not subject to
22      inspection and duplication under the act of February 14, 2008
23      (P.L.6, No.3), known as the Right-to-Know Law.
24      (c)   Applicability.--This section does not apply to the
25   following substances:
26            (1)   A GRAS substance for which the Food and Drug
27      Administration has received a GRAS notice and issued a letter
28      stating that the Food and Drug Administration has no
29      questions regarding the conclusion that the substance is
30      generally recognized as safe under its intended conditions of

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 1      use.
 2             (2)    A substance recognized in Federal regulations as
 3      prior sanctioned or a GRAS substance for use in food or food
 4      packaging.
 5             (3)    A food contact substance for which there is an
 6      effective premarket notification demonstrating safety for its
 7      intended use.
 8             (4)    A substance subject to a regulation that approves
 9      its intended use for food.
10             (5)    A food ingredient of natural biological origin that
11      has been widely consumed for its nutrient properties in the
12      United States prior to January 1, 1958, without known
13      detrimental effects, that is subject only to conventional
14      processing as practiced prior to January 1, 1958, and for
15      which no known safety hazard exists.
16             (6)    A substance for which the Food and Drug
17      Administration has received a new dietary ingredient
18      notification and issued a letter of acknowledgment without
19      objection that the substance is safe under the intended
20      conditions of use stated in the letter.
21             (7)    A substance determined safe to be added to foods by
22      the secretary through rulemaking.
23   § 5725.2.       Public database of GRAS reports.
24      (a)    Duties of secretary.--The secretary shall:
25             (1)    Make reports submitted in accordance with section
26      5725.1 (relating to reporting of GRAS substances) available
27      to the public from a database on the department's publicly
28      accessible Internet website. The database shall:
29                   (i)    be searchable by members of the public;
30                   (ii)    enable consumers to download and print

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 1            displayed information; and
 2                  (iii)   accommodate reasonably anticipated and actual
 3            public use.
 4            (2)   Redact from the public report information that has
 5      been designated by the person that submitted the information
 6      as a trade secret or that is not subject to inspection and
 7      duplication under the act of February 14, 2008 (P.L.6, No.3),
 8      known as the Right-to-Know Law, provided, however, that data
 9      establishing the general recognition of safety is not
10      required to be redacted.
11            (3)   Update the database with any new information that
12      the secretary receives relating to the safety of a GRAS
13      substance.
14      (b)     Refusal to list.--The secretary may refuse to list a
15   GRAS substance in the database if the secretary determines the
16   information reported on the GRAS substance does not contain the
17   information required by section 5725.1.
18      (c)     Fees.--The secretary may establish and charge a fee to a
19   person that files a report of a GRAS substance in order to
20   recover the costs incurred in listing the GRAS substance and
21   maintaining the database.
22      (d)     Report to General Assembly.--The secretary shall provide
23   an interim progress report to the General Assembly concerning
24   efforts to develop and implement the database. The report shall
25   include:
26            (1)   A projected completion date.
27            (2)   A description of obstacles to development and
28      implementation of the database system.
29            (3)   An estimate of the costs to complete the
30      implementation of the database system.

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1     Section 3.    This act shall take effect in six months.




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