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S01239 Summary:

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S01239 Text:

 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                         1239--F
            Cal. No. 213
 
                               2025-2026 Regular Sessions
 
                    IN SENATE
 
                                     January 8, 2025
                                       ___________
 
        Introduced by Sens. KAVANAGH, SEPULVEDA, CLEARE, FAHY, FERNANDEZ, GONZA-
          LEZ,  JACKSON, MAY, MYRIE, OBERACKER, RHOADS, C. RYAN, SCARCELLA-SPAN-
          TON, WEBER, WEIK -- read twice and ordered printed, and  when  printed
          to   be  committed  to  the  Committee  on  Agriculture  --  committee
          discharged, bill amended, ordered reprinted as amended and recommitted
          to said committee  --  committee  discharged,  bill  amended,  ordered
          reprinted  as  amended  and  recommitted to said committee -- reported
          favorably from said committee and committed to the Committee on Health
          -- committee discharged, bill amended, ordered  reprinted  as  amended
          and  recommitted  to  said  committee  -- reported favorably from said
          committee, ordered to first and second  report,  ordered  to  a  third
          reading,  amended  and  ordered  reprinted, retaining its place in the
          order of third reading -- again amended and ordered reprinted, retain-
          ing its place in the order of third  reading  --  recommitted  to  the
          Committee  on  Agriculture in accordance with Senate Rule 6, sec. 8 --
          reported favorably from said committee, ordered to  first  and  second
          report,  ordered to a third reading, passed by Senate and delivered to
          the Assembly, recalled, vote reconsidered, restored to third  reading,
          amended  and  ordered  reprinted,  retaining its place in the order of
          third reading
 
        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:

         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD01051-16-6
        S. 1239--F                          2
 
     1    Prohibition as to adulterated or  misbranded  food  and  certain  food
     2  additives  and  food color additives used or intended for human consump-
     3  tion.
     4    5.  (a) Notwithstanding any other provision of law to the contrary, on
     5  or after the date one year after the effective date of this paragraph it
     6  shall be unlawful for any person, firm, association, or  corporation  to
     7  manufacture,  compound,  brew, distill, produce, process, sell, deliver,
     8  distribute, hold,  offer  or  expose  for  sale  any  of  the  following
     9  substances as food additives or food color additives or any food or food
    10  product  containing any of the following substances used or intended for
    11  human consumption:
    12    (i) FD&C Red No. 3;
    13    (ii) Potassium bromate; or
    14    (iii) Propylparaben.
    15    (b) Notwithstanding the provisions of paragraph (a) of  this  subdivi-
    16  sion,  a retail food store as defined in subdivision two of section five
    17  hundred-a of this chapter, a food service establishment  as  defined  in
    18  subdivision one of section five hundred-a of this chapter, a food relief
    19  organization  as  defined  in  subdivision  one  of section four hundred
    20  fifty-one of this chapter, a supermarket, a grocery store,  a  specialty
    21  food  store, a farmer's market, or any other vendor that, in the regular
    22  course of business, sells food at retail directly to the public on prem-
    23  ises located in the state shall be permitted to sell, deliver,  distrib-
    24  ute,  hold, offer or expose for sale any food or food product containing
    25  any of the substances listed in paragraph (a) of this subdivision  until
    26  the  expiration  date,  "best by" date, or "sell by" date printed on the
    27  packaging of the food or food product by the manufacturer  or  producer,
    28  but  no  later  than  three years after the effective date of this para-
    29  graph, provided that such food or food product  was  acquired  for  sale
    30  within  the state by such retail food store, food service establishment,
    31  food relief organization, supermarket,  grocery  store,  specialty  food
    32  store,  farmer's  market,  or  other vendor before the effective date of
    33  this paragraph.
    34    (c) No less than one hundred eighty days before the effective date  of
    35  paragraphs (a) and (b) of this subdivision, the commissioner shall amend
    36  the  exemption  list  maintained  pursuant  to subdivision three of this
    37  section to indicate that in this state the substances prohibited in this
    38  subdivision shall not be deemed to be safe for human consumption  on  or
    39  after the three hundred sixty-fifth day after the effective date of this
    40  subdivision,  and  to  further indicate that the provisions of paragraph
    41  (b) of this subdivision shall apply until three years after  the  effec-
    42  tive date of paragraphs (a) and (b) of this subdivision.
    43    §  3.  Section  198  of  the agriculture and markets law is amended by
    44  adding a new subdivision 7-a to read as follows:
    45    7-a. The term  "generally  recognized  as  safe  substance"  or  "GRAS
    46  substance"  means  any substance added to food that is exempted from the
    47  definition of "food additive" under subdivision seven  of  this  section
    48  because it is generally recognized, among experts qualified by scientif-
    49  ic  training  and  experience  to  evaluate  its  safety, as having been
    50  adequately shown to be safe under the conditions of its intended use:
    51    (a) either through scientific procedures using the same  quantity  and
    52  quality  of scientific evidence as is required to obtain approval of the
    53  substance as a food additive; or
    54    (b) for a substance used in food  prior  to  January  first,  nineteen
    55  hundred fifty-eight, through experience based on common use in food.
        S. 1239--F                          3
 
     1    §  4.  Subdivision  4  of section 199-a of the agriculture and markets
     2  law, as amended by chapter 671 of the laws of 1966, is amended  to  read
     3  as follows:
     4    4.  All  data  submitted to the commissioner in support of the food or
     5  color additives report under this section shall be considered  confiden-
     6  tial  by  the commissioner and shall not be revealed to any person other
     7  than to a person authorized by the commissioner in  the  performance  of
     8  [his]  their  official  duties  under this article. In case of an actual
     9  controversy as to the validity of an order or decision  of  the  commis-
    10  sioner  respecting  the  test  data  or  report in which a proceeding to
    11  review has been instituted as authorized by section two hundred two-c of
    12  this article the petition, data and report shall be transmitted  by  the
    13  commissioner to the clerk of the court in which the review proceeding is
    14  instituted,  together  with  a  record  of  the proceedings on which the
    15  commissioner based [his] the order or  decision,  and  such  transmittal
    16  shall  not  be  construed to be a violation of confidence.  Subdivisions
    17  two and three of this section shall not apply to food additives or color
    18  additives which are safe within the meaning of the  federal  food,  drug
    19  and cosmetic act as amended.
    20    §  5.  The  agriculture  and  markets  law  is amended by adding a new
    21  section 199-h to read as follows:
    22    § 199-h. Reporting of GRAS substances. 1. a.  Except  as  provided  in
    23  subdivision  two  or  subdivision three of this section, unless a report
    24  described in paragraph b of this subdivision has been submitted  to  the
    25  commissioner and such report is made available in the database described
    26  in  subdivision  five of section one hundred ninety-nine-b of this arti-
    27  cle, and notwithstanding any other provision of law to the contrary,  it
    28  shall be unlawful for any person, firm, association, or corporation to:
    29    (i)  sell or offer or expose for sale for use in or on food, or to use
    30  in the manufacturing, compounding, brewing,  distilling,  producing,  or
    31  processing  of  any food or food product, any GRAS substance or combina-
    32  tion of GRAS substances;
    33    (ii) make any new use of any GRAS substance  or  combination  of  GRAS
    34  substances in or on food; or
    35    (iii)  sell  or  offer  or  expose  for  sale any food or food product
    36  containing any GRAS substance or combination of GRAS substances.
    37    b. The report required pursuant to paragraph  a  of  this  subdivision
    38  shall include but not be limited to the following information:
    39    (i) Signed statements and a certification, including:
    40    (1)  the  date and signature of a responsible official of the reporter
    41  or reporting organization;
    42    (2) the name and address of the reporter or reporting organization;
    43    (3) the name of any GRAS substances discussed in the report, using  an
    44  appropriately descriptive term;
    45    (4) intended conditions for the use of any GRAS substance discussed in
    46  the report, including the foods in which the substance will be used, the
    47  levels  of  such  use  in  such  foods,  and  the purposes for which the
    48  substance will be used, including, when appropriate,  a  description  of
    49  any subpopulation expected to consume such GRAS substance or substances;
    50    (5) the statutory basis for the conclusion of GRAS status;
    51    (6)  a  statement  that  the  reported substance is not subject to the
    52  premarket approval requirements of the federal food, drug, and  cosmetic
    53  act  based  on  the conclusion that the notified substance is GRAS under
    54  the conditions of its intended use;
    55    (7) a statement that, if asked to see the data  and  information  that
    56  are the basis for the GRAS conclusion, the reporter will agree to:
        S. 1239--F                          4
 
     1    (A) make the data and information available to the commissioner; and
     2    (B)  upon the commissioner's request, both of the following procedures
     3  for making the data and information available to the commissioner:
     4    (I) allow the commissioner to review and copy the data and information
     5  during customary business hours at the address specified for where these
     6  data and information will be available; and
     7    (II) provide a complete copy of the data and information either in  an
     8  electronic format or on paper;
     9    (8)  views  as  to whether any of the data and information in the GRAS
    10  report are exempt from disclosure under the freedom of information law;
    11    (9) certifications that, to the best of the reporter's knowledge,  the
    12  GRAS  report is a complete, representative, and balanced submission that
    13  includes both unfavorable and favorable information known to the  repor-
    14  ter and pertinent to the evaluation of the safety and GRAS status of the
    15  use of the substance; and
    16    (10)  the  name and position or title of the person who signs the GRAS
    17  report.
    18    (ii) The identity, method of manufacture, specifications, and physical
    19  or technical effect of the notified substance, including:
    20    (1)  scientific  data  and  information  that  identifies   the   GRAS
    21  substance, including:
    22    (A)  examples of appropriate data and information including the chemi-
    23  cal name, applicable registry numbers  (such  as  a  chemical  abstracts
    24  service  (CAS)  registry  number  or  an enzyme commission (EC) number),
    25  empirical formula, structural  formula,  quantitative  composition,  and
    26  characteristic properties; and
    27    (B)  when the source of a notified substance is a biological material,
    28  data and information sufficient to identify:
    29    (I) the taxonomic source (e.g., genus, species) of the GRAS substance,
    30  including, as applicable, data and information at the sub-species  level
    31  (e.g., variety, strain);
    32    (II)  the  part  of any plant or animal used as the source of the GRAS
    33  substance; and
    34    (III) any known toxicants that could be in  the  source  of  the  GRAS
    35  substance;
    36    (2)  a  description of the method of manufacture of the GRAS substance
    37  in sufficient detail to evaluate the safety of the notified substance as
    38  manufactured;
    39    (3) specifications for food-grade material; and
    40    (4) when necessary to demonstrate safety, relevant data  and  informa-
    41  tion  bearing  on  the  physical  or  other  technical  effect  the GRAS
    42  substance is intended to produce, including the  quantity  of  the  GRAS
    43  substance required to produce such effect.
    44    (iii)  Dietary  exposure to the notified substance, including informa-
    45  tion about dietary exposure (i.e., the  amount  of  relevant  substances
    46  that  consumers  are  likely  to  eat or drink as part of a total diet),
    47  including:
    48    (1) an estimate of dietary exposure to  the  notified  substance  that
    49  includes exposure from its intended use and all sources in the diet;
    50    (2)  when  applicable,  an  estimate  of dietary exposure to any other
    51  substance that is expected to be formed in or on food because of the use
    52  of  the  notified  substance  (e.g.,  hydrolytic  products  or  reaction
    53  products);
    54    (3)  when  applicable,  an  estimate  of dietary exposure to any other
    55  substance that is present with the notified substance  either  naturally
    56  or due to its manufacture (e.g., contaminants or by-products);
        S. 1239--F                          5
 
     1    (4)  sources  of  any  food  consumption data used to estimate dietary
     2  exposure, in accordance with clauses one through three of this  subpara-
     3  graph; and
     4    (5)  any  assumptions made to estimate dietary exposure, in accordance
     5  with clauses one through three of this subparagraph.
     6    (iv) Self-limiting levels of use in circumstances where the amount  of
     7  the notified substance that can be added to human food or animal food is
     8  limited  because  the  food  containing levels of the notified substance
     9  above a particular level would  become  unpalatable  or  technologically
    10  impractical.
    11    (v) If the statutory basis for GRAS status is through experience based
    12  on  common use in food, evidence of a substantial history of consumption
    13  of the notified substance for  food  use  by  a  significant  number  of
    14  consumers prior to January first, nineteen hundred fifty-eight.
    15    (vi)  A  narrative  that provides the basis for the conclusion of GRAS
    16  status, including:
    17    (1) an explanation for why the data  and  information  in  the  report
    18  provide a basis for that the notified substance is safe under the condi-
    19  tions  of its intended use. Such explanation shall address the safety of
    20  the notified substance, considering all dietary sources and taking  into
    21  account  any  chemically or pharmacologically related substances in such
    22  diet, and identify what  specific  data  and  information  discussed  in
    23  accordance  with  this  clause are generally available and not generally
    24  available, by providing citations to the list of  data  and  information
    25  required in subparagraph (vii) of this paragraph;
    26    (2) an explanation of how the generally available data and information
    27  relied  on  to  establish  safety  in accordance with clause one of this
    28  subparagraph provides a basis  for  the  conclusion  that  the  reported
    29  substance  is  generally recognized, among qualified experts, to be safe
    30  under the conditions of its intended use;
    31    (3) either:
    32    (A) data and information that are, or may appear to  be,  inconsistent
    33  with the conclusion of GRAS status; or
    34    (B)  a  statement that the available data and information was reviewed
    35  and the reporter is not aware of any data and information that  are,  or
    36  may appear to be, inconsistent with the conclusion of GRAS status;
    37    (4)  if  any data and information in the report is exempt from disclo-
    38  sure under the freedom of information law, a statement  that  identifies
    39  such data and information; and
    40    (5)  for non-public, safety-related data and information considered in
    41  reaching a conclusion of GRAS status, an explanation of how there  could
    42  be  a  basis for a conclusion of GRAS status if qualified experts do not
    43  have access to such data and information.
    44    (vii) A list of the generally available data, information, and methods
    45  the notifier cites in the GRAS notice, including:
    46    (1) a list of all of the data and information required by subparagraph
    47  (vi) of this paragraph to provide a basis for determining that the noti-
    48  fied substance is safe under the conditions  of  its  intended  use,  as
    49  described  in  accordance  with  clause one of subparagraph (vi) of this
    50  paragraph; and
    51    (2) identification of specific data and information listed in  accord-
    52  ance  with  clause one of this subparagraph that are generally available
    53  and not generally available.
    54    (viii) Any previous GRAS substance notices submitted  to  the  federal
    55  food  and  drug administration on the reported substance and the federal
    56  food and drug administration's responses.
        S. 1239--F                          6
 
     1    (ix) All relevant currently available safety information.
     2    c.  A report that includes the information specified in paragraph b of
     3  this subdivision and has been submitted to  the  commissioner  and  made
     4  available  in  the database described in subdivision five of section one
     5  hundred ninety-nine-b of this article, shall be applicable to subsequent
     6  uses of a GRAS substance that is the subject of such report that  is  to
     7  be  used  under  the  same conditions of intended use, regardless of who
     8  submitted such report.
     9    2. The following substances are exempt from the reporting requirements
    10  of subdivision one of this section:
    11    a. Any GRAS substance for which the federal  food  and  drug  adminis-
    12  tration  has received a GRAS notice and issued a letter stating that the
    13  federal food and drug administration  has  no  questions  regarding  the
    14  conclusion  that the substance is generally recognized as safe under its
    15  intended conditions of use;
    16    b. Any substances recognized in federal  regulations  as  prior  sanc-
    17  tioned or GRAS substances for use in food or food packaging;
    18    c.  Any food contact substance for which there is an effective premar-
    19  ket notification demonstrating safety for its intended use;
    20    d. Any substances subject to regulation approving its intended use for
    21  food;
    22    e. A food ingredient that has  been  widely  consumed  in  the  United
    23  States  prior  to  January  first,  nineteen hundred fifty-eight without
    24  known detrimental effects, which is subject only to  conventional  proc-
    25  essing  as  practiced  prior  to  January first, nineteen hundred fifty-
    26  eight, and for which no known safety hazard exists;
    27    f. Any substance for which the federal food  and  drug  administration
    28  has  received  a new dietary ingredient notification and issued a letter
    29  of acknowledgement without objection that the substance  is  safe  under
    30  its notification's intended conditions of use; and
    31    g.  Any  substance determined safe to be added to foods by the commis-
    32  sioner through rulemaking.
    33    3. Notwithstanding the provisions of subdivision one of this  section,
    34  a  retail  food  store  as  defined  in  subdivision two of section five
    35  hundred-a of this chapter, a food service establishment  as  defined  in
    36  subdivision  one  of  section  five hundred-a of this chapter, or a food
    37  relief organization as defined in section four hundred fifty-one of this
    38  chapter, a supermarket, a grocery store, a specialty food store, a farm-
    39  er's market, or any other vendor that, in the regular  course  of  busi-
    40  ness, sells food at retail directly to the public on premises located in
    41  the  state  shall be permitted to sell, deliver, distribute, hold, offer
    42  or expose for sale any food or food product  the  sale  of  which  would
    43  otherwise  be  prohibited  by  the provisions of subdivision one of this
    44  section, until the expiration date, "best by" date, or  "sell  by"  date
    45  printed on the packaging of the food or food product by the manufacturer
    46  or  producer,  but no later than three years after the effective date of
    47  this subdivision. This subdivision shall not affect the applicability of
    48  any provision of  law  other  than  subdivision  one  of  this  section,
    49  provided that such food or food product was acquired for sale within the
    50  state by such retail food store, food service establishment, food relief
    51  organization, supermarket, grocery store, specialty food store, farmer's
    52  market, or other vendor before the effective date of this section.
    53    4.  Notwithstanding the provisions of subdivision one of this section,
    54  a retail food store as  defined  in  subdivision  two  of  section  five
    55  hundred-a  of  this  chapter, a food service establishment as defined in
    56  subdivision one of section five hundred-a of this chapter, a food relief
        S. 1239--F                          7
 
     1  organization as defined in  subdivision  one  of  section  four  hundred
     2  fifty-one  of  this chapter, a supermarket, a grocery store, a specialty
     3  food store, a farmer's market, or any other vendor that, in the  regular
     4  course of business, sells food at retail directly to the public on prem-
     5  ises  located  in the state, shall not be found in violation of subpara-
     6  graph (iii) of paragraph a of subdivision one of this section for  sell-
     7  ing or offering or exposing for sale any food or food product containing
     8  an  unreported  GRAS substance or combination of GRAS substances if such
     9  retailer, as  identified  in  this  subdivision,  has  a  valid  written
    10  contract or renewal agreement with the  manufacturer, producer, distrib-
    11  utor,  or  supplier  for  the  purchase of any food or food product that
    12  provides such food or food product sold to such retailer, as  identified
    13  in  this  subdivision,  is compliant with this section. This subdivision
    14  shall not affect the applicability of this act to manufacturers, produc-
    15  ers, distributors, or  suppliers  of  GRAS  substances,  food,  or  food
    16  products.
    17    5.  This  section  shall  only  apply to food or food products used or
    18  intended for human consumption.
    19    6. A small business, defined as a business that is independently owned
    20  and operated, and employs one hundred or fewer persons, shall be  exempt
    21  from the requirements of this section.
    22    7.  Data establishing the general recognition of safety shall be based
    23  on publicly available information  and  shall  not  be  based  on  trade
    24  secrets.
    25    8. Nothing in this section shall impose any requirement regarding food
    26  labelling not otherwise required by law.
    27    §  6.  Section  199-b of the agriculture and markets law is amended by
    28  adding a new subdivision 5 to read as follows:
    29    5. The commissioner:
    30    a. shall make reports submitted pursuant to section one hundred  nine-
    31  ty-nine-h  of  this article available to the public in a database on its
    32  website. The database shall:
    33    (i) be searchable by members of the public;
    34    (ii) enable consumers to download and print displayed information; and
    35    (iii) accommodate reasonably anticipated and actual public use.
    36    b. shall redact from the public report any information that  has  been
    37  designated  by  the submitter as a trade secret, provided, however, that
    38  data establishing the general recognition of safety shall not be redact-
    39  ed;
    40    c. shall update the database with any new information that the commis-
    41  sioner receives relating to the safety of the GRAS substance;
    42    d. may refuse to list a GRAS substance if the commissioner  determines
    43  the  report  does  not  contain  the information required by section one
    44  hundred ninety-nine-h of this article;
    45    e. shall provide an interim  progress  report  concerning  efforts  to
    46  develop  and implement the database system required by this subdivision,
    47  which shall include:
    48    (i) a projected completion date;
    49    (ii) a description of obstacles to development and  implementation  of
    50  the database system; and
    51    (iii)  an  estimate of the costs to complete the implementation of the
    52  database system; and
    53    f. may charge a fee to the reporter of a GRAS substance  in  order  to
    54  recover  the costs incurred in listing such GRAS substance and maintain-
    55  ing the database.
        S. 1239--F                          8
 
     1    § 7. The second undesignated paragraph of section 202-c of  the  agri-
     2  culture  and markets law, as amended by chapter 671 of the laws of 1966,
     3  is amended to read as follows:
     4    The  commissioner may institute such action at law or in equity as may
     5  appear necessary to enforce compliance with sections one  hundred  nine-
     6  ty-nine-a, one hundred ninety-nine-h, two hundred and two hundred one of
     7  this  article,  and  any rule or order respecting a GRAS substance, food
     8  additive, or color additive promulgated pursuant to sections one hundred
     9  ninety-nine-b and two hundred fourteen-b of this article and,  in  addi-
    10  tion  to any other remedy under this chapter or otherwise, may apply for
    11  relief by injunction  to  protect  the  public  interest  without  being
    12  compelled  to  allege  or  prove that an adequate remedy at law does not
    13  exist. In an action instituted by the commissioner to enforce compliance
    14  with said sections  one  hundred  ninety-nine-a,  two  hundred  and  two
    15  hundred  one  the  commissioner  shall not be required to prove that the
    16  food, food additive or color additive  mentioned  in  the  complaint  is
    17  unsafe  and the claim or defense of the defendant as to its safety shall
    18  be immaterial, provided, however, that the recognition  by  the  federal
    19  food  and  drug  administration  of a food additive or color additive as
    20  safe may be alleged as a proper defense.
    21    § 8. This act shall take effect one year after it shall have become  a
    22  law;  provided,  however, that paragraph (c) of subdivision 5 of section
    23  199-a of the agriculture and markets law as added by section two of this
    24  act shall take effect immediately. Effective immediately, the  addition,
    25  amendment  and/or  repeal  of  any  rule or regulation necessary for the
    26  implementation of this act on its effective date are  authorized  to  be
    27  made  and completed by the commissioner of agriculture and markets on or
    28  before such effective date.