Bill Text: NJ A4640 | 2024-2025 | Regular Session | Introduced
Bill Title: Requires food manufacturers to disclose new food additives not reported to FDA.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Introduced) 2024-06-25 - Introduced, Referred to Assembly Consumer Affairs Committee [A4640 Detail]
Download: New_Jersey-2024-A4640-Introduced.html
Sponsored by:
Assemblyman CHRIS TULLY
District 38 (Bergen)
SYNOPSIS
Requires food manufacturers to disclose new food additives not reported to FDA.
CURRENT VERSION OF TEXT
As introduced.
An Act requiring the disclosure of certain information regarding food additives and supplementing Title 24 of the Revised Statutes.
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. a. As used in this act:
"Food" means the same as that term is defined in the "Food, Drug, and Cosmetic Act," 21 U.S.C. s.301 et seq., with the exception of alcohol.
"Food additive" means the same as that term is defined in the "Food, Drug, and Cosmetic Act," 21 U.S.C. s.301 et seq.
"Generally recognized as safe" or "GRAS" means any substance added to food because it is 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 through scientific procedure or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedure or experience based on prolonged use in food.
b. For each new use of a food additive, a manufacturer of food to be sold in this State shall provide notice to the Department of Health in an annual report, in a form and manner specified by the Commissioner of Health that includes the following information:
(1) a signed statement certifying the claim that a particular use of a substance is exempt from premarket approval requirements of the "Food, Drug, and Cosmetic Act," 21 U.S.C. s.301 et seq., because the notifier has determined that such use is GRAS. This exemption claim would include:
(a) the name and address of the reporter or reporting organization; (b) the date and signature of a responsible official of the reporter or reporting organization;
(c) the common or usual name of any GRAS substances reviewed in the report, using an appropriately descriptive term;
(d) the intended conditions for the use of any GRAS substance reviewed in the report, including the foods in which the substance will be used, the amounts or levels of such use in foods, and the purposes of which the substance will be used, including, when appropriate, a description of any subpopulation expected to consume such GRAS substances;
(e) the basis for the conclusion of the GRAS status, whether by scientific procedure or experience based on common use in food;
(f) a statement of assurance that if requested to procure the data that forms the basis of the GRAS conclusion, the reporter will agree to make the data available to the commissioner for review and replication electronically or otherwise; and
(g) an opinion as to whether any of the data in the GRAS report is exempt from disclosure under the federal "Freedom of Information Act" pursuant to 5 U.S.C. s.552 et seq.
(2) the identity, method of manufacture, specifications, and physical or technical effect of the notified substance including:
(a) scientific data about the identity of the notified substance such as its chemical name, its Chemical Abstracts Service (CAS) Registry Number, Enzyme Commission number, empirical formula, structural formula, and quantitative composition;
(b) a description of the method of manufacture of the GRAS substance in sufficient detail to evaluate the safety of the notified substance as manufactured;
(c) for a substance of natural biological origin, the source information such as genus and species, and any applicable sub-species level information, such as variety, strain;
(i) the part of any plant or animal used as the source of the GRAS substance; and
(ii) any content of potential human toxicants.
(d) specifications for food-grade material; and
(e) when necessary to demonstrate safety, shall include relevant data and information bearing on the physical or other technical effect the notified substance is intended to produce, including the quantity of the notified substance required to produce such effect.
(3) Dietary exposure to the notified substance (such as the amount of relevant substances a consumer is likely to eat or drink as part of a total diet), including:
(a) an estimate of the dietary exposure to the notified substance that includes exposure from its intended use and all sources in the diet;
(b) 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 (such as hydrolytic products or reaction products);
(c) when applicable, an estimate of the dietary exposure to any other substance that is present with the notified substance either naturally or due to its manufacture (such as contaminants or byproducts);
(d) source of any food consumption data used to estimate dietary exposure, in accordance with subparagraphs (a) through (c) of this paragraph; and
(e) any assumptions made to estimate dietary exposure, in accordance with clauses (a) through (c) of this paragraph.
(4) 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;
(5) for a substance with a statutory conclusion of GRAS status 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 1, 1958;
(6) a narrative that provides the basis for the conclusion of GRAS status that includes:
(a) an explanation as to the reason the data and information in the report provide a basis for the conclusion that the notified substance is safe under the conditions of its intended use. The explanation shall address the safety of the notified substance, a consideration of all dietary sources and take into account any chemically or pharmacologically related substances in the diet and identify what specific data and information reviewed in accordance with this subparagraph are generally available and not generally available by providing citations to the list of data and information required of this paragraph;
(b) an explanation of how the generally available data and information relied on to establish safety in accordance with subparagraph (a) of paragraph (6) of this subsection 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;
(c) either data and information that are, or may appear to be, inconsistent with the conclusion of the GRAS status, or 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;
(d) whether the data and information in the report is exempt from disclosure under the "Freedom of Information Act," a statement that identifies such data and information; and
(e) how there could be a determination of GRAS status if qualified experts generally do not have access to non-public, safety-related information.
(7) a list of supporting data and information in the GRAS notice, including:
(a) a list of all data and information required by paragraph (6) of this subsection to provide a basis for the conclusion that the notified substance is safe under the conditions of its intended use; and
(b) a specification of the items listed in subparagraph (a) of this paragraph as generally available or not generally available.
(8) any previous GRAS substance notices submitted to the Food and Drug Administration on the reported substance and any response from the agency; and
(9) all relevant, currently available safety information on the GRAS substance.
c. The following substances are exempt from the reporting requirements of subsection a. of this section:
(1) any GRAS substance for which the Food and Drug Administration 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;
(2) any substances recognized in federal regulations as prior sanctioned or GRAS substances for use in food or food packaging;
(3) any food contact substance for which there is an effective premarket notification demonstrating safety for its intended use;
(4) any substances subject to regulation approving 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, which is subject only to conventional processing as practiced prior to January 1, 1958, and for which no known safety hazard exists; and
(6) any substance determined safe to be added to foods by the commissioner.
d. The provisions of this section shall not apply to any cottage food operator, as defined by N.J.A.C.8:24-1.5.
e. Any person may file a report to the commissioner under this section.
f. Data establishing the general recognition of safety shall be based on publicly available information and shall not be based on trade secrets.
2. a. The Commissioner of Health shall adopt rules and regulations, pursuant to the provisions of the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B‑1 et seq.), to effectuate the purposes of this act.
b. The department shall publish on its Internet website, and update as appropriate, a searchable database of the reports submitted pursuant to section 1 of P.L. ,c. (C. ) (pending before the Legislature as this bill). The commissioner shall omit or redact any portion of the report that has been designated by the submitter as a trade secret, provided, however, that the data establishing the general recognition of safety shall not be omitted or redacted.
The commissioner may refuse to publish an incomplete report if the notifier has not corrected any insufficiency within a time frame to be determined by the commissioner.
c. The commissioner shall inform the notifier of when the report submitted pursuant to section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill) will be posted on the department's Internet website. The commissioner shall, within six months from the date of receipt, publish the report's information on the department's website.
3. a. A manufacturer shall not sell, distribute, or offer for sale in this State any food that contains a new use of a food additive unless the manufacturer fulfills the requirements of P.L. , c. (C. ) (pending before the Legislature as this bill) and any order, rule or regulation adopted by the Department of Health pursuant thereto.
b. Each sale or offer for sale made by a manufacturer in violation of P.L c. (C. ) (pending before the Legislature as this bill) or any order, rule or regulation made by the Commissioner of Health pursuant to the provisions of this act, shall be subject to a penalty of up to $1,000 for a first offense and up to $5,000 for each subsequent offense to be collected in a civil action by a summary proceeding under the "Penalty Enforcement Law of 1999," P.L.1999, c.274 (C.2A:58-10 et seq.). If the violation is of a continuing nature, each day during which it continues constitutes an additional, separate, and distinct offense. The Department of Health may institute a civil action in a court of competent jurisdiction for injunctive or any other appropriate relief to prohibit and prevent a violation of the provisions of this act or any rule or regulation adopted, or order issued, pursuant thereto, and the court may proceed in the action in a summary manner. The Commissioner of Health shall be entitled to the assistance of the Attorney General in the enforcement of this act.
4. This act shall take effect on the first day of the thirteenth month following enactment, except that the Commissioner of Health may take any anticipatory action in advance as shall be necessary for the implementation of the act.
STATEMENT
This bill requires manufacturers of food and nonalcoholic beverages for sale in this State to disclose certain additive information to the Commissioner of the Department of Health to be made publicly available.
Under the bill, every manufacturer of food and nonalcoholic beverages for sale in this State is required to disclose when a new additive has been deemed "generally recognized as safe" (GRAS) by that entity, and is planned for use in food and non-alcoholic beverages. Under sections 201(s) and 409 of the federal "Food, Drug, and Cosmetic Act," any substance that is intentionally added to food is a food additive, subject to premarket review and approval by the U.S. Food and Drug Administration (FDA), unless the substance is generally recognized among qualified experts as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive.
This bill requires industry to provide the Commissioner of Health with the premarket review rendering an additive GRAS, in the form of an annual report with certain requirements, for publication on the Department of Health Internet website. The department is to review and publish the report within six months of receipt. The commissioner may refuse to publish an incomplete report, after the submitting entity has been given an opportunity to correct any insufficiency within a reasonable time, to be determined by the commissioner. The bill requires the commissioner to promulgate rules and regulations for the collection of these reports and the publication of the data on the department's Internet website. It is the sponsor's view that the publication of a manufacturer's food additive assessment will enable the public to make an informed decision regarding their consumption choices.
Finally, the bill provides for the use of the "Penalty Enforcement Law of 1999", P.L.1999 ,c.274 (C.2A:58-10 et seq.), in carrying out the bill's provisions and makes available to the Commissioner of Health the assistance of the Attorney General in recovering penalties, including enforcing an injunction to protect the public interest. The penalties are up to $1,000 for a first offense and up to $5,000 for each subsequent offense. For a violation of a continuing nature, each day constitutes an additional, separate and distinct offense.
The bill becomes effective one year after enactment, but permits the Commissioner of Health to take anticipatory action.
