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A01556 Summary:

BILL NOA01556C
 
SAME ASSAME AS S01239-C
 
SPONSORKelles
 
COSPNSRColton, Epstein, Gibbs, Glick, Jackson, Lee, Levenberg, Raga, Reyes, Rosenthal, Sayegh, Seawright, Shimsky, Simon, Steck, Stirpe, Tapia, Clark, Carroll P, Hevesi, Torres, Cruz, Norber, Dinowitz, Kay, Lunsford, Gallagher, Slater, Paulin, Burroughs, Schiavoni, De Los Santos, Tague, Angelino, Meeks, Gallahan, Alvarez
 
MLTSPNSR
 
Amd §§199-a, 199-b, 198 & 202-c, add §199-g, Ag & Mkts L
 
Enacts the "food safety and chemical disclosure act"; prohibits certain food additives and food color additives; provides that in an action to enforce compliance, the recognition by the federal food and drug administration of any of these substances as safe may not be alleged as a defense; establishes requirements for the reporting of GRAS (generally recognized as safe) substances.
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A01556 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                         1556--C
 
                               2025-2026 Regular Sessions
 
                   IN ASSEMBLY
 
                                    January 10, 2025
                                       ___________
 
        Introduced  by  M. of A. KELLES, COLTON, EPSTEIN, GIBBS, GLICK, JACKSON,
          LEE, LEVENBERG, RAGA, REYES, ROSENTHAL,  SAYEGH,  SEAWRIGHT,  SHIMSKY,
          SIMON,  STECK, STIRPE, TAPIA, CLARK, P. CARROLL, HEVESI, TORRES, CRUZ,
          NORBER, DINOWITZ, KAY, LUNSFORD, GALLAGHER, SLATER, PAULIN, BURROUGHS,
          SCHIAVONI, DE LOS SANTOS -- read once and referred to the Committee on
          Agriculture -- committee discharged, bill amended,  ordered  reprinted
          as  amended  and  recommitted to said committee -- again reported from
          said committee with  amendments,  ordered  reprinted  as  amended  and
          recommitted  to  said  committee -- again reported from said committee
          with amendments, ordered reprinted as amended and recommitted to  said
          committee
 
        AN ACT to amend the agriculture and markets law, in relation to enacting
          the "food safety and chemical disclosure act"
 
          The  People of the State of New York, represented in Senate and Assem-
        bly, do enact as follows:
 
     1    Section 1.  Short title. This act shall be known and may be  cited  as
     2  the "food safety and chemical disclosure act".
     3    §  2.    The  section  heading of section 199-a of the agriculture and
     4  markets law, as amended by chapter 797 of the laws of 1961,  is  amended
     5  and a new subdivision 5 is added to read as follows:
     6    Prohibition  as  to  adulterated  or  misbranded food and certain food
     7  additives and food color additives intended for human consumption.
     8    5. (a) Notwithstanding any other provision of law to the contrary,  it
     9  shall  be  unlawful for any person, firm, association, or corporation to
    10  manufacture, compound, brew, distill, produce, process,  sell,  deliver,
    11  distribute,  hold,  offer  or  expose  for  sale  any  of  the following
    12  substances as food additives or food color additives or any food or food
    13  product containing any of the following substances  intended  for  human
    14  consumption:
    15    (i) FD&C Red No. 3;
    16    (ii) Potassium bromate; or
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD01051-07-5

        A. 1556--C                          2
 
     1    (iii) Propylparaben.
     2    (b)  Notwithstanding  the provisions of paragraph (a) of this subdivi-
     3  sion, a store shall be permitted to  sell,  deliver,  distribute,  hold,
     4  offer  or expose for sale any food or food product containing any of the
     5  substances listed in paragraph (a) of this subdivision until the expira-
     6  tion date, "best by" date, or "sell by" date printed on the packaging of
     7  the food or food product by the manufacturer or producer, but  no  later
     8  than three years after the effective date of this subdivision, provided,
     9  however, that:
    10    (i)  the store sells food or food products at retail and is not prima-
    11  rily engaged in the sale of food for consumption on the premises;
    12    (ii) the store is independently owned and operated by a business  that
    13  employs ten or fewer persons; and
    14    (iii) the food or food product was acquired by the business.
    15    (c)  Within thirty days of the effective date of this subdivision, the
    16  commissioner shall amend  the  exemption  list  maintained  pursuant  to
    17  subdivision  three  of  this  section to indicate that in this state the
    18  substances prohibited in this subdivision shall not be deemed to be safe
    19  for human consumption on or after one year after the effective  date  of
    20  this subdivision.
    21    §  3.  Section  198  of  the agriculture and markets law is amended by
    22  adding a new subdivision 7-a to read as follows:
    23    7-a. For purposes of this section, the term "generally  recognized  as
    24  safe  substance"  or  "GRAS substance" means any substance added to food
    25  that is exempted from the definition of "food additive"  under  subdivi-
    26  sion  seven  of  this  section because it is generally recognized, among
    27  experts qualified by scientific training and experience to evaluate  its
    28  safety,  as having been adequately shown to be safe under the conditions
    29  of its intended use:
    30    (a) either through scientific procedures using the same  quantity  and
    31  quality  of scientific evidence as is required to obtain approval of the
    32  substance as a food additive; or
    33    (b) for a substance used in food  prior  to  January  first,  nineteen
    34  hundred fifty-eight, through experience based on common use in food.
    35    §  4.  Subdivision  4  of section 199-a of the agriculture and markets
    36  law, as amended by chapter 671 of the laws of 1966, is amended  to  read
    37  as follows:
    38    4.  All  data  submitted to the commissioner in support of the food or
    39  color additives report under this section shall be considered  confiden-
    40  tial  by  the commissioner and shall not be revealed to any person other
    41  than to a person authorized by the commissioner in  the  performance  of
    42  [his]  their  official  duties  under this article. In case of an actual
    43  controversy as to the validity of an order or decision  of  the  commis-
    44  sioner  respecting  the  test  data  or  report in which a proceeding to
    45  review has been instituted as authorized by section two hundred two-c of
    46  this article the petition, data and report shall be transmitted  by  the
    47  commissioner to the clerk of the court in which the review proceeding is
    48  instituted,  together  with  a  record  of  the proceedings on which the
    49  commissioner based [his] the order or  decision,  and  such  transmittal
    50  shall  not  be  construed to be a violation of confidence.  Subdivisions
    51  two and three of this section shall not apply to food additives or color
    52  additives which are safe within the meaning of the  federal  food,  drug
    53  and cosmetic act as amended.
    54    §  5.  The  agriculture  and  markets  law  is amended by adding a new
    55  section 199-g to read as follows:

        A. 1556--C                          3
 
     1    § 199-g. Reporting of GRAS substances. 1. a.  Except  as  provided  in
     2  subdivision  two of this section, unless a report described in paragraph
     3  b of this subdivision has been submitted to the  commissioner  and  such
     4  report  is  made available in the database described in subdivision five
     5  of  section one hundred ninety-nine-b of this article, and notwithstand-
     6  ing any other provision of law to the contrary, it shall be unlawful for
     7  any person, firm, association, or corporation to:
     8    (i) sell or offer or expose for sale for use in or on food, or to  use
     9  in  the  manufacturing,  compounding, brewing, distilling, producing, or
    10  processing of any food or food product, any GRAS substance  or  combina-
    11  tion of GRAS substances;
    12    (ii)  make  any  new  use of any GRAS substance or combination of GRAS
    13  substances in or on food; or
    14    (iii) sell or offer or expose  for  sale  any  food  or  food  product
    15  containing any GRAS substance or combination of GRAS substances.
    16    b.  The  report  required  pursuant to paragraph a of this subdivision
    17  shall include but not be limited to the following information:
    18    (i) Signed statements and a certification, including:
    19    (1) the date and signature of a responsible official of  the  reporter
    20  or reporting organization;
    21    (2) the name and address of the reporter or reporting organization;
    22    (3)  the name of any GRAS substances discussed in the report, using an
    23  appropriately descriptive term;
    24    (4) intended conditions for the use of any GRAS substance discussed in
    25  the report, including the foods in which the substance will be used, the
    26  levels of such use in  such  foods,  and  the  purposes  for  which  the
    27  substance  will  be  used, including, when appropriate, a description of
    28  any subpopulation expected to consume such GRAS substance or substances;
    29    (5) the statutory basis for the conclusion of GRAS status;
    30    (6) a statement that the reported substance  is  not  subject  to  the
    31  premarket  approval requirements of the federal food, drug, and cosmetic
    32  act based on the conclusion that the notified substance  is  GRAS  under
    33  the conditions of its intended use;
    34    (7)  a  statement  that, if asked to see the data and information that
    35  are the basis for the GRAS conclusion, the reporter will agree to:
    36    (A) make the data and information available to the commissioner; and
    37    (B) upon the commissioner's request, both of the following  procedures
    38  for making the data and information available to the commissioner:
    39    (I) allow the commissioner to review and copy the data and information
    40  during customary business hours at the address specified for where these
    41  data and information will be available; and
    42    (II)  provide a complete copy of the data and information either in an
    43  electronic format or on paper;
    44    (8) views as to whether any of the data and information  in  the  GRAS
    45  report are exempt from disclosure under the freedom of information law;
    46    (9)  certifications that, to the best of the reporter's knowledge, the
    47  GRAS report is a complete, representative, and balanced submission  that
    48  includes  both unfavorable and favorable information known to the repor-
    49  ter and pertinent to the evaluation of the safety and GRAS status of the
    50  use of the substance; and
    51    (10) the name and position or title of the person who signs  the  GRAS
    52  report.
    53    (ii) The identity, method of manufacture, specifications, and physical
    54  or technical effect of the notified substance, including:
    55    (1)   scientific   data  and  information  that  identifies  the  GRAS
    56  substance, including:

        A. 1556--C                          4
 
     1    (A) examples of appropriate data and information including the  chemi-
     2  cal  name,  applicable  registry  numbers  (such as a chemical abstracts
     3  service (CAS) registry number or  an  enzyme  commission  (EC)  number),
     4  empirical  formula,  structural  formula,  quantitative composition, and
     5  characteristic properties; and
     6    (B)  when the source of a notified substance is a biological material,
     7  data and information sufficient to identify:
     8    (I) the taxonomic source (e.g., genus, species) of the GRAS substance,
     9  including, as applicable, data and information at the sub-species  level
    10  (e.g., variety, strain);
    11    (II)  the  part  of any plant or animal used as the source of the GRAS
    12  substance; and
    13    (III) any known toxicants that could be in  the  source  of  the  GRAS
    14  substance;
    15    (2)  a  description of the method of manufacture of the GRAS substance
    16  in sufficient detail to evaluate the safety of the notified substance as
    17  manufactured;
    18    (3) specifications for food-grade material; and
    19    (4) when necessary to demonstrate safety, relevant data  and  informa-
    20  tion  bearing  on  the  physical  or  other  technical  effect  the GRAS
    21  substance is intended to produce, including the  quantity  of  the  GRAS
    22  substance required to produce such effect.
    23    (iii)  Dietary  exposure to the notified substance, including informa-
    24  tion about dietary exposure (i.e., the  amount  of  relevant  substances
    25  that  consumers  are  likely  to  eat or drink as part of a total diet),
    26  including:
    27    (1) an estimate of dietary exposure to  the  notified  substance  that
    28  includes exposure from its intended use and all sources in the diet;
    29    (2)  when  applicable,  an  estimate  of dietary exposure to any other
    30  substance that is expected to be formed in or on food because of the use
    31  of  the  notified  substance  (e.g.,  hydrolytic  products  or  reaction
    32  products);
    33    (3)  when  applicable,  an  estimate  of dietary exposure to any other
    34  substance that is present with the notified substance  either  naturally
    35  or due to its manufacture (e.g., contaminants or by-products);
    36    (4)  sources  of  any  food  consumption data used to estimate dietary
    37  exposure, in accordance with clauses one through three of this  subpara-
    38  graph; and
    39    (5)  any  assumptions made to estimate dietary exposure, in accordance
    40  with clauses one through three of this subparagraph.
    41    (iv) Self-limiting levels of use in circumstances where the amount  of
    42  the notified substance that can be added to human food or animal food is
    43  limited  because  the  food  containing levels of the notified substance
    44  above a particular level would  become  unpalatable  or  technologically
    45  impractical.
    46    (v) If the statutory basis for GRAS status is through experience based
    47  on  common use in food, evidence of a substantial history of consumption
    48  of the notified substance for  food  use  by  a  significant  number  of
    49  consumers prior to January first, nineteen hundred fifty-eight.
    50    (vi)  A  narrative  that provides the basis for the conclusion of GRAS
    51  status, including:
    52    (1) an explanation for why the data  and  information  in  the  report
    53  provide a basis for that the notified substance is safe under the condi-
    54  tions  of its intended use. Such explanation shall address the safety of
    55  the notified substance, considering all dietary sources and taking  into
    56  account  any  chemically or pharmacologically related substances in such

        A. 1556--C                          5
 
     1  diet, and identify what  specific  data  and  information  discussed  in
     2  accordance  with  this  clause are generally available and not generally
     3  available, by providing citations to the list of  data  and  information
     4  required in subparagraph (vii) of this paragraph;
     5    (2) an explanation of how the generally available data and information
     6  relied  on  to  establish  safety  in accordance with clause one of this
     7  subparagraph provides a basis  for  the  conclusion  that  the  reported
     8  substance  is  generally recognized, among qualified experts, to be safe
     9  under the conditions of its intended use;
    10    (3) either:
    11    (A) data and information that are, or may appear to  be,  inconsistent
    12  with the conclusion of GRAS status; or
    13    (B)  a  statement that the available data and information was reviewed
    14  and the reporter is not aware of any data and information that  are,  or
    15  may appear to be, inconsistent with the conclusion of GRAS status;
    16    (4)  if  any data and information in the report is exempt from disclo-
    17  sure under the freedom of information law, a statement  that  identifies
    18  such data and information; and
    19    (5)  for non-public, safety-related data and information considered in
    20  reaching a conclusion of GRAS status, an explanation of how there  could
    21  be  a  basis for a conclusion of GRAS status if qualified experts do not
    22  have access to such data and information.
    23    (vii) A list of the generally available data, information, and methods
    24  the notifier cites in the GRAS notice, including:
    25    (1) a list of all of the data and information required by subparagraph
    26  (vi) of this paragraph to provide a basis for determining that the noti-
    27  fied substance is safe under the conditions  of  its  intended  use,  as
    28  described  in  accordance  with  clause one of subparagraph (vi) of this
    29  paragraph; and
    30    (2) identification of specific data and information listed in  accord-
    31  ance  with  clause one of this subparagraph that are generally available
    32  and not generally available.
    33    (viii) Any previous GRAS substance notices submitted  to  the  federal
    34  food  and  drug administration on the reported substance and the federal
    35  food and drug administration's responses.
    36    (ix) All relevant currently available safety information.
    37    2. The following substances are exempt from the reporting requirements
    38  of subdivision one of this section:
    39    a. Any GRAS substance for which the federal  food  and  drug  adminis-
    40  tration  has received a GRAS notice and issued a letter stating that the
    41  federal food and drug administration  has  no  questions  regarding  the
    42  conclusion  that the substance is generally recognized as safe under its
    43  intended conditions of use;
    44    b. Any substances recognized in federal  regulations  as  prior  sanc-
    45  tioned or GRAS substances for use in food or food packaging;
    46    c.  Any food contact substance for which there is an effective premar-
    47  ket notification demonstrating safety for its intended use;
    48    d. Any substances subject to regulation approving its intended use for
    49  food;
    50    e. A food ingredient of natural biological origin that has been widely
    51  consumed for its nutrient properties in the United States prior to Janu-
    52  ary  first,  nineteen  hundred  fifty-eight  without  known  detrimental
    53  effects,  which  is subject only to conventional processing as practiced
    54  prior to January first, nineteen hundred fifty-eight, and for  which  no
    55  known safety hazard exists;

        A. 1556--C                          6

     1    f.  Any  substance  for which the federal food and drug administration
     2  has received a new dietary ingredient notification and issued  a  letter
     3  of  acknowledgement  without  objection that the substance is safe under
     4  its notification's intended conditions of use; and
     5    g.  Any  substance determined safe to be added to foods by the commis-
     6  sioner through rulemaking.
     7    3. Any person may  file  a  report  to  the  commissioner  under  this
     8  section.
     9    4. A small business, defined as a business that is independently owned
    10  and  operated and employs ten or fewer persons, shall be exempt from the
    11  requirements of this section.
    12    5. Data establishing the general recognition of safety shall be  based
    13  on  publicly  available  information  and  shall  not  be based on trade
    14  secrets.
    15    § 6. Section 199-b of the agriculture and markets law  is  amended  by
    16  adding a new subdivision 5 to read as follows:
    17    5. The commissioner:
    18    a.  shall make reports submitted pursuant to section one hundred nine-
    19  ty-nine-g of this article available to the public in a database  on  its
    20  website. The database shall:
    21    (i) be searchable by members of the public;
    22    (ii) enable consumers to download and print displayed information; and
    23    (iii) accommodate reasonably anticipated and actual public use.
    24    b.  shall  redact from the public report any information that has been
    25  designated by the submitter as a trade secret, provided,  however,  that
    26  data establishing the general recognition of safety shall not be redact-
    27  ed;
    28    c. shall update the database with any new information that the commis-
    29  sioner receives relating to the safety of the GRAS substance;
    30    d.  may refuse to list a GRAS substance if the commissioner determines
    31  the report does not contain the  information  required  by  section  one
    32  hundred ninety-nine-g of this article;
    33    e.  shall  provide  an  interim  progress report concerning efforts to
    34  develop and implement the database system required by this  subdivision,
    35  which shall include:
    36    (i) a projected completion date;
    37    (ii)  a  description of obstacles to development and implementation of
    38  the database system; and
    39    (iii) an estimate of the costs to complete the implementation  of  the
    40  database system; and
    41    f.  may  charge  a fee to the reporter of a GRAS substance in order to
    42  recover the costs incurred in listing such GRAS substance and  maintain-
    43  ing the database.
    44    §  7.  The second undesignated paragraph of section 202-c of the agri-
    45  culture and markets law, as amended by chapter 671 of the laws of  1966,
    46  is amended to read as follows:
    47    The  commissioner may institute such action at law or in equity as may
    48  appear necessary to enforce compliance with sections one  hundred  nine-
    49  ty-nine-a, one hundred ninety-nine-g, two hundred and two hundred one of
    50  this  article,  and  any rule or order respecting a GRAS substance, food
    51  additive, or color additive promulgated pursuant to sections one hundred
    52  ninety-nine-b and two hundred fourteen-b of this article and,  in  addi-
    53  tion  to any other remedy under this chapter or otherwise, may apply for
    54  relief by injunction  to  protect  the  public  interest  without  being
    55  compelled  to  allege  or  prove that an adequate remedy at law does not
    56  exist. In an action instituted by the commissioner to enforce compliance

        A. 1556--C                          7
 
     1  with said sections  one  hundred  ninety-nine-a,  two  hundred  and  two
     2  hundred  one  the  commissioner  shall not be required to prove that the
     3  food, food additive or color additive  mentioned  in  the  complaint  is
     4  unsafe  and the claim or defense of the defendant as to its safety shall
     5  be immaterial, provided, however, that the recognition  by  the  federal
     6  food  and  drug  administration  of a food additive or color additive as
     7  safe may be alleged as a proper defense.
     8    § 8. This act shall take effect one year after it shall have become  a
     9  law.
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