The Environmental Protection Agency is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 15 chemical substances that were the subject of premanufacture notices (PMNs). As a result of the SNURs, persons planning to manufacture, import, or process any of the chemicals for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days in advance. The direct final rule is effective July 8. Comments in opposition are due June 10.
On May 7 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued the April Interstate Certified Shellfish Shippers List (ICSSL). The ICSSL is published monthly for the information and use by food control officers, the seafood industry and other interested persons. The shippers listed have been certified by regulatory authorities in the U.S., Canada, Chile, Korea, Mexico and New Zealand under the uniform sanitation requirements of the National Shellfish Program.
Care Diagnostica’s devices are subject to import refusal for violations of current good manufacturing practice requirements, said the Food and Drug Administration in a warning letter dated April 23. The Moellesrsdorf, Austria company has 15 days from receipt of FDA’s letter to correct the violations.
The Food and Drug Administration may refuse admission of imports of pharmaceuticals from Canada-based CMI Cosmetic Manufacturers, the agency said in a warning letter dated April 25. According to the letter, a recent FDA inspection found violations of current good manufacturing practice requirements at the Concord, Ontario facility. The company also failed to register with FDA, but still offered its pharmaceuticals for import into the U.S., the agency said.
The Food and Drug Administration is proposing to reclassify ultraviolet tanning lamps from class I to class II. The reclassification would make the tanning lamps subject to premarket notification, and would designate special controls the agency deemed necessary for safe use. FDA would also change the name of the products from “ultraviolet lamps for tanning” to “sunlamp products.” Comments on the reclassification, which is being proposed on FDA’s own initiative, are due by Aug. 7.
The Food and Drug Administration posted transcripts and archived webcasts of its meeting on the Food Safety Modernization Act proposed rules on product safety and preventative controls in human food, held in Washington, D.C., Feb. 28-March 1. FDA already posted presentations from the session (see 13031417).At the meeting, FDA officials discussed the proposals, asked for comments, and responded to questions on the rules. FDA also held meetings in Chicago and Portland on the food safety rules (see 13020627).
On May 7, the Foreign Agricultural Service posted the following GAIN reports:
The Animal and Plant Health Inspection Service announced changes May 7 to Plant Protection and Quarantine (PPQ) electronic manuals. While some changes are minor, other changes may affect the admissibility of the plant products, including fruits, vegetables, and flowers.
Riddell appealed a Court of International Trade decision that the company’s football pants, jerseys, and girdles are correctly classified for tariff purposes as apparel, and not sports equipment. The football uniform components were imported without pads, and as goods are classified in their condition as imported, they did not qualify as sports protective equipment, CIT had said (see 13032221).