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 i