California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) will conduct a pre-regulatory public workshop on Proposition 65 (Prop. 65) warnings on April 14, 2014, in Sacramento. The event will be webcast. OEHHA Chief Counsel Carol Monahan-Cummings will discuss potential regulatory action, including clarifying questions and responses, discussion of proposed changes and public questions and answers, as well as next steps. Additional information about the proposed Prop. 65 warning changes appears in Issue 517 of this Update. See OEHHA News Release, April 7, 2014. Issue 520
Category Archives Legislation, Regulations and Standards
California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) has issued a notice of intent to list ethylene glycol (EG) as known to the state to cause reproductive toxicity under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). Used in the manufacture of polyethylene terephthalate resins (PET), which are used in bottling, the chemical has been reported for its potential human reproductive and developmental effects by the National Toxicology Program in a 2004 monograph that “identifies EG as causing developmental toxicity in laboratory animals, and satisfies the formal identification criteria in the Proposition 65 regulations,” according to OEHHA. Public comments “as to whether ethylene glycol meets the criteria set forth in the Proposition 65 regulations for authoritative bodies listings” are requested by May 12, 2014. Companies making and selling products containing chemicals listed under Proposition 65 are required to disclose exposures to California consumers or face fines…
The European Food Safety Authority (EFSA) has extended “the timeline to complete its full risk assessment of bisphenol A (BPA) to the end of 2014.” After receiving nearly 250 comments in response to the second part of its draft risk assessment, EFSA has emphasized the need for “a full understanding of these comments before finalizing its risk assessment of BPA.” Additional details about the draft risk assessment and an April 23, 2014, stakeholder meeting appear in Issues 511 and 515 of this Update. Issue 520
The U.S. Food and Drug Administration (FDA) has issued draft guidance concerning the proper labeling of honey and honey products to ensure that such products “are not adulterated or misbranded.” In light of its earlier refusal to create a new standard of identity for honey, the agency developed the guidance to respond to labeling issues raised by a March 8, 2006, petition submitted by the American Beekeeping Federation and other honey-related associations. According to FDA, the draft guidance (i) “summarizes FDA’s legal authority over honey and honey products”; (ii) “provides a commonly used definition of honey”; (iii) “offers advice on labeling issues such as the floral source of honey, blends of honey and other sweeteners, and blends of honey and other ingredients, such as flavors”; and (iv) “describes some of the measures FDA takes to guard against honey adulterated with cane sugar, corn syrup, or residues of chloramphenicol or fluoroquinolones.”…
The U.S. Food and Drug Administration (FDA) has issued a final rule adopting the interim final rule titled “Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements” for recordkeeping regulations under the Food Safety Modernization Act (FSMA). The amendments made under FSMA allow FDA access to records beyond those relating to specific suspect food articles if the agency believes that other food articles are likely to be affected in a similar manner. The amendments also permit FDA to access records relating to articles of food “for which there is a reasonable probability that the use of, or exposure to, the article of food will cause serious adverse health consequences or death to humans or animals.” The expanded records-access authority is intended to improve FDA’s ability to respond to and contain safety problems with the food supply for humans and animals. FDA has also issued two guidance documents, “FDA…
U.S. Rep. Mike Pompeo (R-Kansas) has introduced legislation (H.R. 4432) that would prohibit states from implementing labeling laws for foods that contain genetically modified (GM) ingredients. Titled the “Safe and Accurate Food Labeling Act,” the bill would (i) require the U.S. Food and Drug Administration (FDA) to mandate GM labeling only if those foods “are found to be unsafe or materially different from foods produced without biotech ingredients”; and (ii) establish a federal labeling standard for foods with GM ingredients, giving FDA sole authority to require labeling on such foods if they are ever deemed unsafe or materially different from foods produced without GM ingredients. According to news sources, Pompeo contends that state campaigns to label foods containing GM ingredients are intended to scare consumers, not inform them. GM crops have made “food safer and more abundant,” Pompeo said. “It has been an enormous boon to all of humanity.” GM…
New Jersey lawmakers have introduced a bill (A2990) that seeks to amend legislation requiring retail food establishments to provide calorie information for food and beverages. Proposed by Assemblywomen Nancy Pinken (D-Middlesex) and Linda Stender (D-Middlesex, Somerset and Union), the bill would require entertainment facilities to provide calorie information for food and beverage items offered for sale, subject to the same requirements that currently apply to chain restaurants. The bill defines “entertainment facility” as “any privately or publicly owned or operated facility that is used primarily for sports contests, entertainment, or both, such as a theater, stadium, museum, arena, automobile racetrack, or other place where performances, concerts, exhibits, games or contests are held.” Issue 519
After review by member states and unanimous agreement by the Member State Committee, the European Chemicals Agency (ECHA) has published a group of evaluation decisions on 14 substances considered to pose potential risks, creating obligations for companies in the European Union to conduct tests and provide further data about their use. The decisions are the culmination of the European Parliament Council’s substance evaluation process under Regulation No. 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). In addition to bisphenol A, ECHA has made final decisions on the following substances: isoheptane; imidazole; a mixture of cistetrahydro-2-isobutyl- 4-methylpyran-4-ol; transtetrahydro-2-isobutyl-4-methylpyran-4-ol; oligomerisation and alkylation reaction products of 2 phenylpropene and phenol; N,N’-bis(1,4-dimethylpentyl)-p-phenylenediamine; carbon tetrachloride; 1,3-diphenylguanidine; hexyl salicylate; 2,2’-iminodiethanol; 2-ethylhexanoic acid; decahydronaphthalene; alkanes, C14-17, chloro (MCCP, Medium chained chlorinated paraffins); and 2-(4-tertbutylbenzyl) propionaldehyde. Issue 519
The European Food Safety Authority (EFSA) will host a workshop on April 28, 2014, in Brussels, to discuss the agency’s work related to the re-evaluation of food additives, as required by Commission Regulation No. 257/2010 of the European Parliament and the Council on Food Additives. With an aim to “engage with interested business operators, scientific experts, the European Commission representatives, EFSA scientific staff and other interested parties,” the workshop will include sessions that address (i) “why, how and when scientific uses, use level data and other information should be made available to EFSA”; and (ii) “the extent to which the engagement of stakeholders during the re evaluation process would be of mutual benefit for EFSA and stakeholders themselves.” Participants may register until April 10, 2014. Issue 519
The U.S. Environmental Protection Agency (EPA) has issued a stop sale, use or removal order against New Jersey-based Pathway Investment Corp. concerning company food storage products containing nano silver. According to the agency, these products—Kinetic Go Green Premium food storage containers, Kinetic Smartwist Series containers, TRITAN food storage, and StackSmart Storage—are marketed “as containing nano silver, which the company claims helps reduce the growth of mold, fungus and bacteria.” As such the products contain pesticides and must be registered under the Federal Insecticide, Fungicide and Rodenticide Act. These products were not registered and were not subjected to efficacy testing. EPA has also notified retailers that have sold the products on their websites to cease doing so. See EPA News Release, March 31, 2014. Issue 519
