S T A T E O F N E W Y O R K
________________________________________________________________________
8615
I N S E N A T E
February 21, 2024
___________
Introduced by Sen. KAVANAGH -- read twice and ordered printed, and when
printed to be committed to the Committee on Agriculture
AN ACT to amend the agriculture and markets law, in relation to report-
ing of GRAS substances
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. Section 198 of the agriculture and markets law is amended
by adding a new subdivision 7-a to read as follows:
7-A. THE TERM "GENERALLY RECOGNIZED AS SAFE SUBSTANCE" OR "GRAS
SUBSTANCE" MEANS ANY SUBSTANCE ADDED TO FOOD THAT IS NOT EXCEPTED FROM
THE DEFINITION OF "FOOD ADDITIVE" UNDER SUBDIVISION SEVEN OF THIS
SECTION BECAUSE IT IS GENERALLY RECOGNIZED, AMONG EXPERTS QUALIFIED BY
SCIENTIFIC TRAINING AND EXPERIENCE TO EVALUATE ITS SAFETY, AS HAVING
BEEN ADEQUATELY SHOWN TO BE SAFE UNDER THE CONDITIONS OF ITS INTENDED
USE:
(A) THROUGH SCIENTIFIC PROCEDURES; OR
(B) IN THE CASE OF A SUBSTANCE USED IN FOOD PRIOR TO JANUARY FIRST,
NINETEEN HUNDRED FIFTY-EIGHT, THROUGH EITHER SCIENTIFIC PROCEDURES OR
EXPERIENCE BASED ON PROLONGED USE IN FOOD.
§ 2. Subdivision 4 of section 199-a of the agriculture and markets
law, as amended by chapter 671 of the laws of 1966, is amended to read
as follows:
4. All data submitted to the commissioner in support of the FOOD OR
COLOR ADDITIVES report under this section shall be considered confiden-
tial by the commissioner and shall not be revealed to any person other
than to a person authorized by the commissioner in the performance of
his official duties under this article. In case of an actual controversy
as to the validity of an order or decision of the commissioner respect-
ing the test data or report in which a proceeding to review has been
instituted as authorized by section two hundred two-c of this article
the petition, data and report shall be transmitted by the commissioner
to the clerk of the court in which the review proceeding is instituted,
together with a record of the proceedings on which the commissioner
based his order or decision, and such transmittal shall not be construed
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD13991-01-4
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to be a violation of confidence. Subdivisions two and three of this
section shall not apply to food additives or color additives which are
safe within the meaning of the federal food, drug and cosmetic act as
amended.
§ 3. The agriculture and markets law is amended by adding a new
section 199-g to read as follows:
§ 199-G. REPORTING OF GRAS SUBSTANCES. 1. A. EXCEPT AS PROVIDED IN
SUBDIVISION TWO OF THIS SECTION, UNLESS A REPORT DESCRIBED IN PARAGRAPH
B OF THIS SUBDIVISION HAS BEEN SUBMITTED TO THE COMMISSIONER AND SUCH
REPORT IS MADE AVAILABLE IN THE DATABASE DESCRIBED IN SUBDIVISION FIVE
OF SECTION ONE HUNDRED NINETY-NINE-B OF THIS ARTICLE, IT SHALL BE UNLAW-
FUL FOR ANY PERSON, FIRM, ASSOCIATION, OR CORPORATION 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, ANY GRAS SUBSTANCE OR COMBINA-
TION OF GRAS SUBSTANCES;
(II) MAKE ANY NEW USE OF ANY GRAS SUBSTANCE OR COMBINATION OF GRAS
SUBSTANCES IN OR ON FOOD; OR
(III) SELL OR OFFER OR EXPOSE FOR SALE ANY FOOD OR FOOD PRODUCT
CONTAINING ANY GRAS SUBSTANCE OR COMBINATION OF GRAS SUBSTANCES.
B. THE REPORT REQUIRED PURSUANT TO PARAGRAPH A OF THIS SUBDIVISION
SHALL INCLUDE BUT NOT BE LIMITED TO THE FOLLOWING INFORMATION:
(I) SIGNED STATEMENTS AND A CERTIFICATION, INCLUDING:
(1) THE DATE AND SIGNATURE OF A RESPONSIBLE OFFICIAL OF THE REPORTER
OR REPORTING ORGANIZATION;
(2) THE NAME AND ADDRESS OF THE REPORTER OR REPORTING ORGANIZATION;
(3) THE NAME OF ANY GRAS SUBSTANCES DISCUSSED IN THE REPORT, USING AN
APPROPRIATELY DESCRIPTIVE TERM;
(4) INTENDED CONDITIONS FOR THE USE OF ANY GRAS SUBSTANCE DISCUSSED IN
THE REPORT, INCLUDING THE FOODS IN WHICH THE SUBSTANCE WILL BE USED, THE
LEVELS OF SUCH USE IN SUCH FOODS, AND THE PURPOSES FOR WHICH THE
SUBSTANCE WILL BE USED, INCLUDING, WHEN APPROPRIATE, A DESCRIPTION OF
ANY SUBPOPULATION EXPECTED TO CONSUME SUCH GRAS SUBSTANCE OR SUBSTANCES;
(5) THE STATUTORY BASIS FOR THE CONCLUSION OF GRAS STATUS;
(6) A STATEMENT THAT THE REPORTED SUBSTANCE IS NOT SUBJECT TO THE
PREMARKET APPROVAL REQUIREMENTS OF THE FEDERAL FOOD, DRUG, AND COSMETIC
ACT BASED ON THE CONCLUSION THAT THE NOTIFIED SUBSTANCE IS GRAS UNDER
THE CONDITIONS OF ITS INTENDED USE;
(7) A STATEMENT THAT, IF ASKED TO SEE THE DATA AND INFORMATION THAT
ARE THE BASIS FOR THE GRAS CONCLUSION, THE REPORTER WILL AGREE TO:
(A) MAKE THE DATA AND INFORMATION AVAILABLE TO THE COMMISSIONER; AND
(B) UPON THE COMMISSIONER'S REQUEST, BOTH OF THE FOLLOWING PROCEDURES
FOR MAKING THE DATA AND INFORMATION AVAILABLE TO THE COMMISSIONER:
(I) ALLOW THE COMMISSIONER TO REVIEW AND COPY THE DATA AND INFORMATION
DURING CUSTOMARY BUSINESS HOURS AT THE ADDRESS SPECIFIED FOR WHERE THESE
DATA AND INFORMATION WILL BE AVAILABLE; AND
(II) PROVIDE A COMPLETE COPY OF THE DATA AND INFORMATION EITHER IN AN
ELECTRONIC FORMAT OR ON PAPER;
(8) VIEWS AS TO WHETHER ANY OF THE DATA AND INFORMATION IN THE GRAS
REPORT ARE EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION LAW;
(9) CERTIFICATIONS THAT, TO THE BEST OF THE REPORTER'S KNOWLEDGE, THE
GRAS REPORT IS A COMPLETE, REPRESENTATIVE, AND BALANCED SUBMISSION THAT
INCLUDES BOTH UNFAVORABLE AND FAVORABLE INFORMATION KNOWN TO THE REPOR-
TER AND PERTINENT TO THE EVALUATION OF THE SAFETY AND GRAS STATUS OF THE
USE OF THE SUBSTANCE; AND
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(10) THE NAME AND POSITION OR TITLE OF THE PERSON WHO SIGNS THE GRAS
REPORT.
(II) THE IDENTITY, METHOD OF MANUFACTURE, SPECIFICATIONS, AND PHYSICAL
OR TECHNICAL EFFECT OF THE NOTIFIED SUBSTANCE, INCLUDING:
(1) SCIENTIFIC DATA AND INFORMATION THAT IDENTIFIES THE GRAS
SUBSTANCE, INCLUDING:
(A) EXAMPLES OF APPROPRIATE DATA AND INFORMATION INCLUDING THE CHEMI-
CAL NAME, APPLICABLE REGISTRY NUMBERS (SUCH AS A CHEMICAL ABSTRACTS
SERVICE (CAS) REGISTRY NUMBER OR AN ENZYME COMMISSION (EC) NUMBER),
EMPIRICAL FORMULA, STRUCTURAL FORMULA, QUANTITATIVE COMPOSITION, AND
CHARACTERISTIC PROPERTIES; AND
(B) WHEN THE SOURCE OF A NOTIFIED SUBSTANCE IS A BIOLOGICAL MATERIAL,
DATA AND INFORMATION SUFFICIENT TO IDENTIFY:
(I) THE TAXONOMIC SOURCE (E.G., GENUS, SPECIES) OF THE GRAS SUBSTANCE,
INCLUDING, AS APPLICABLE, DATA AND INFORMATION AT THE SUB-SPECIES LEVEL
(E.G., VARIETY, STRAIN);
(II) THE PART OF ANY PLANT OR ANIMAL USED AS THE SOURCE OF THE GRAS
SUBSTANCE; AND
(III) ANY KNOWN TOXICANTS THAT COULD BE IN THE SOURCE OF THE GRAS
SUBSTANCE;
(2) A DESCRIPTION OF THE METHOD OF MANUFACTURE OF THE GRAS SUBSTANCE
IN SUFFICIENT DETAIL TO EVALUATE THE SAFETY OF THE NOTIFIED SUBSTANCE AS
MANUFACTURED;
(3) SPECIFICATIONS FOR FOOD-GRADE MATERIAL; AND
(4) WHEN NECESSARY TO DEMONSTRATE SAFETY, RELEVANT DATA AND INFORMA-
TION BEARING ON THE PHYSICAL OR OTHER TECHNICAL EFFECT THE GRAS
SUBSTANCE IS INTENDED TO PRODUCE, INCLUDING THE QUANTITY OF THE GRAS
SUBSTANCE REQUIRED TO PRODUCE SUCH EFFECT.
(III) DIETARY EXPOSURE TO THE NOTIFIED SUBSTANCE, INCLUDING INFORMA-
TION ABOUT DIETARY EXPOSURE (I.E., THE AMOUNT OF RELEVANT SUBSTANCES
THAT CONSUMERS ARE LIKELY TO EAT OR DRINK AS PART OF A TOTAL DIET),
INCLUDING:
(1) AN ESTIMATE OF DIETARY EXPOSURE TO THE NOTIFIED SUBSTANCE THAT
INCLUDES EXPOSURE FROM ITS INTENDED USE AND ALL SOURCES IN THE DIET;
(2) WHEN APPLICABLE, AN ESTIMATE OF DIETARY EXPOSURE TO ANY OTHER
SUBSTANCE THAT IS EXPECTED TO BE FORMED IN OR ON FOOD BECAUSE OF THE USE
OF THE NOTIFIED SUBSTANCE (E.G., HYDROLYTIC PRODUCTS OR REACTION
PRODUCTS);
(3) WHEN APPLICABLE, AN ESTIMATE OF DIETARY EXPOSURE TO ANY OTHER
SUBSTANCE THAT IS PRESENT WITH THE NOTIFIED SUBSTANCE EITHER NATURALLY
OR DUE TO ITS MANUFACTURE (E.G., CONTAMINANTS OR BY-PRODUCTS);
(4) SOURCES OF ANY FOOD CONSUMPTION DATA USED TO ESTIMATE DIETARY
EXPOSURE, IN ACCORDANCE WITH CLAUSES ONE THROUGH THREE OF THIS SUBPARA-
GRAPH; AND
(5) ANY ASSUMPTIONS MADE TO ESTIMATE DIETARY EXPOSURE, IN ACCORDANCE
WITH CLAUSES ONE THROUGH THREE OF THIS SUBPARAGRAPH.
(IV) SELF-LIMITING LEVELS OF USE IN CIRCUMSTANCES WHERE THE AMOUNT OF
THE NOTIFIED SUBSTANCE THAT CAN BE ADDED TO HUMAN FOOD OR ANIMAL FOOD IS
LIMITED BECAUSE THE FOOD CONTAINING LEVELS OF THE NOTIFIED SUBSTANCE
ABOVE A PARTICULAR LEVEL WOULD BECOME UNPALATABLE OR TECHNOLOGICALLY
IMPRACTICAL.
(V) IF THE STATUTORY BASIS FOR GRAS STATUS IS THROUGH EXPERIENCE BASED
ON COMMON USE IN FOOD, EVIDENCE OF A SUBSTANTIAL HISTORY OF CONSUMPTION
OF THE NOTIFIED SUBSTANCE FOR FOOD USE BY A SIGNIFICANT NUMBER OF
CONSUMERS PRIOR TO JANUARY FIRST, NINETEEN HUNDRED FIFTY-EIGHT.
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(VI) A NARRATIVE THAT PROVIDES THE BASIS FOR THE CONCLUSION OF GRAS
STATUS, INCLUDING:
(1) AN EXPLANATION FOR WHY THE DATA AND INFORMATION IN THE REPORT
PROVIDE A BASIS FOR THAT THE NOTIFIED SUBSTANCE IS SAFE UNDER THE CONDI-
TIONS OF ITS INTENDED USE. SUCH EXPLANATION SHALL ADDRESS THE SAFETY OF
THE NOTIFIED SUBSTANCE, CONSIDERING ALL DIETARY SOURCES AND TAKING INTO
ACCOUNT ANY CHEMICALLY OR PHARMACOLOGICALLY RELATED SUBSTANCES IN SUCH
DIET, AND IDENTIFY WHAT SPECIFIC DATA AND INFORMATION DISCUSSED IN
ACCORDANCE WITH THIS CLAUSE ARE GENERALLY AVAILABLE AND NOT GENERALLY
AVAILABLE, BY PROVIDING CITATIONS TO THE LIST OF DATA AND INFORMATION
REQUIRED IN SUBPARAGRAPH (VII) OF THIS PARAGRAPH;
(2) AN EXPLANATION OF HOW THE GENERALLY AVAILABLE DATA AND INFORMATION
RELIED ON TO ESTABLISH SAFETY IN ACCORDANCE WITH CLAUSE ONE OF THIS
SUBPARAGRAPH PROVIDES A BASIS FOR THE CONCLUSION THAT THE REPORTED
SUBSTANCE IS GENERALLY RECOGNIZED, AMONG QUALIFIED EXPERTS, TO BE SAFE
UNDER THE CONDITIONS OF ITS INTENDED USE;
(3) EITHER:
(A) DATA AND INFORMATION THAT ARE, OR MAY APPEAR TO BE, INCONSISTENT
WITH THE CONCLUSION OF GRAS STATUS; OR
(B) A STATEMENT THAT THE AVAILABLE DATA AND INFORMATION WAS REVIEWED
AND THE REPORTER IS NOT AWARE OF ANY DATA AND INFORMATION THAT ARE, OR
MAY APPEAR TO BE, INCONSISTENT WITH THE CONCLUSION OF GRAS STATUS;
(4) IF ANY DATA AND INFORMATION IN THE REPORT IS EXEMPT FROM DISCLO-
SURE UNDER THE FREEDOM OF INFORMATION LAW, A STATEMENT THAT IDENTIFIES
SUCH DATA AND INFORMATION; AND
(5) FOR NON-PUBLIC, SAFETY-RELATED DATA AND INFORMATION CONSIDERED IN
REACHING A CONCLUSION OF GRAS STATUS, AN EXPLANATION OF HOW THERE COULD
BE A BASIS FOR A CONCLUSION OF GRAS STATUS IF QUALIFIED EXPERTS DO NOT
HAVE ACCESS TO SUCH DATA AND INFORMATION.
(VII) A LIST OF THE GENERALLY AVAILABLE DATA, INFORMATION, AND METHODS
THE NOTIFIER CITES IN THE GRAS NOTICE, INCLUDING:
(1) A LIST OF ALL OF THE DATA AND INFORMATION REQUIRED BY SUBPARAGRAPH
(VI) OF THIS PARAGRAPH TO PROVIDE A BASIS FOR DETERMINING THAT THE NOTI-
FIED SUBSTANCE IS SAFE UNDER THE CONDITIONS OF ITS INTENDED USE, AS
DESCRIBED IN ACCORDANCE WITH CLAUSE ONE OF SUBPARAGRAPH (VI) OF THIS
PARAGRAPH; AND
(2) IDENTIFICATION OF SPECIFIC DATA AND INFORMATION LISTED IN ACCORD-
ANCE WITH CLAUSE ONE OF THIS SUBPARAGRAPH THAT ARE GENERALLY AVAILABLE
AND NOT GENERALLY AVAILABLE.
(VIII) ANY PREVIOUS GRAS SUBSTANCE NOTICES SUBMITTED TO THE FEDERAL
FOOD AND DRUG ADMINISTRATION ON THE REPORTED SUBSTANCE AND THE FEDERAL
FOOD AND DRUG ADMINISTRATION'S RESPONSES.
(IX) ALL RELEVANT CURRENTLY AVAILABLE SAFETY INFORMATION.
2. THE FOLLOWING SUBSTANCES ARE EXEMPT FROM THE REPORTING REQUIREMENTS
OF SUBDIVISION ONE OF THIS SECTION:
A. ANY GRAS SUBSTANCE FOR WHICH THE FEDERAL FOOD AND DRUG ADMINIS-
TRATION HAS RECEIVED A GRAS NOTICE AND ISSUED A LETTER STATING THAT THE
FEDERAL FOOD AND DRUG ADMINISTRATION HAS NO QUESTIONS REGARDING THE
CONCLUSION THAT THE SUBSTANCE IS GENERALLY RECOGNIZED AS SAFE UNDER ITS
INTENDED CONDITIONS OF USE;
B. ANY SUBSTANCES RECOGNIZED IN FEDERAL REGULATIONS AS PRIOR SANC-
TIONED OR GRAS SUBSTANCES FOR USE IN FOOD OR FOOD PACKAGING;
C. ANY FOOD CONTACT SUBSTANCE FOR WHICH THERE IS AN EFFECTIVE PREMAR-
KET NOTIFICATION DEMONSTRATING SAFETY FOR ITS INTENDED USE;
D. ANY SUBSTANCES SUBJECT TO REGULATION APPROVING ITS INTENDED USE FOR
FOOD;
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E. A FOOD INGREDIENT OF NATURAL BIOLOGICAL ORIGIN THAT HAS BEEN WIDELY
CONSUMED FOR ITS NUTRIENT PROPERTIES IN THE UNITED STATES PRIOR TO JANU-
ARY FIRST, NINETEEN HUNDRED FIFTY-EIGHT WITHOUT KNOWN DETRIMENTAL
EFFECTS, WHICH IS SUBJECT ONLY TO CONVENTIONAL PROCESSING AS PRACTICED
PRIOR TO JANUARY FIRST, NINETEEN HUNDRED FIFTY-EIGHT, AND FOR WHICH NO
KNOWN SAFETY HAZARD EXISTS; AND
F. ANY SUBSTANCE DETERMINED SAFE TO BE ADDED TO FOODS BY THE COMMIS-
SIONER THROUGH RULEMAKING.
3. ANY PERSON MAY FILE A REPORT TO THE COMMISSIONER UNDER THIS
SECTION.
4. SMALL BUSINESSES, AS DEFINED SECTION ONE HUNDRED THIRTY-ONE OF THE
ECONOMIC DEVELOPMENT LAW, SHALL BE EXEMPT FROM THE REQUIREMENTS OF THIS
SECTION.
5. DATA ESTABLISHING THE GENERAL RECOGNITION OF SAFETY SHALL BE BASED
ON PUBLICLY AVAILABLE INFORMATION AND SHALL NOT BE BASED ON TRADE
SECRETS.
§ 4. Section 199-b of the agriculture and markets law is amended by
adding a new subdivision 5 to read as follows:
5. THE COMMISSIONER:
A. SHALL MAKE REPORTS SUBMITTED PURSUANT TO SECTION ONE HUNDRED NINE-
TY-NINE-G OF THIS ARTICLE AVAILABLE TO THE PUBLIC IN A DATABASE ON ITS
WEBSITE. THE DATABASE SHALL:
(I) BE SEARCHABLE BY MEMBERS OF THE PUBLIC;
(II) ENABLE CONSUMERS TO DOWNLOAD AND PRINT DISPLAYED INFORMATION; AND
(III) ACCOMMODATE REASONABLY ANTICIPATED AND ACTUAL PUBLIC USE.
B. SHALL REDACT FROM THE PUBLIC REPORT ANY INFORMATION THAT HAS BEEN
DESIGNATED BY THE SUBMITTER AS A TRADE SECRET, PROVIDED, HOWEVER, THAT
DATA ESTABLISHING THE GENERAL RECOGNITION OF SAFETY SHALL NOT BE REDACT-
ED;
C. SHALL UPDATE THE DATABASE WITH ANY NEW INFORMATION THAT THE COMMIS-
SIONER RECEIVES RELATING TO THE SAFETY OF THE GRAS SUBSTANCE;
D. MAY REFUSE TO LIST A GRAS SUBSTANCE IF THE COMMISSIONER DETERMINES
THE REPORT DOES NOT CONTAIN THE INFORMATION REQUIRED BY SECTION ONE
HUNDRED NINETY-NINE-G OF THIS ARTICLE;
E. SHALL PROVIDE AN INTERIM PROGRESS REPORT CONCERNING EFFORTS TO
DEVELOP AND IMPLEMENT THE DATABASE SYSTEM REQUIRED BY THIS SUBDIVISION,
WHICH SHALL INCLUDE:
(I) A PROJECTED COMPLETION DATE;
(II) A DESCRIPTION OF OBSTACLES TO DEVELOPMENT AND IMPLEMENTATION OF
THE DATABASE SYSTEM; AND
(III) AN ESTIMATE OF THE COSTS TO COMPLETE THE IMPLEMENTATION OF THE
DATABASE SYSTEM; AND
F. MAY CHARGE A FEE TO THE REPORTER OF A GRAS SUBSTANCE IN ORDER TO
RECOVER THE COSTS INCURRED IN LISTING SUCH GRAS SUBSTANCE AND MAINTAIN-
ING THE DATABASE.
§ 5. The second undesignated paragraph of section 202-c of the agri-
culture and markets law, as amended by chapter 671 of the laws of 1966,
is amended to read as follows:
The commissioner may institute such action at law or in equity as may
appear necessary to enforce compliance with sections one hundred nine-
ty-nine-a, ONE HUNDRED NINETY-NINE-G, two hundred and two hundred one of
this article, and any rule or order respecting a GRAS SUBSTANCE, food
additive, or color additive promulgated pursuant to sections one hundred
ninety-nine-b and two hundred fourteen-b of this article and, in addi-
tion to any other remedy under this chapter or otherwise, may apply for
relief by injunction to protect the public interest without being
S. 8615 6
compelled to allege or prove that an adequate remedy at law does not
exist. In an action instituted by the commissioner to enforce compliance
with said sections one hundred ninety-nine-a, two hundred and two
hundred one the commissioner shall not be required to prove that the
food, food additive or color additive mentioned in the complaint is
unsafe and the claim or defense of the defendant as to its safety shall
be immaterial, provided, however, that the recognition by the federal
food and drug administration of a food additive or color additive as
safe may be alleged as a proper defense.
§ 6. This act shall take effect immediately.