The Environmental Protection Agency is proposing two significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for (i) di-n-pentyl phthalate (DnPP), and (ii) a short chain chlorinated paraffin (SCCP), and proposing to add nine benzidine-based chemical substances to the relevant existing SNUR. In the case of benzidine-based chemical substances, the EPA is also proposing to make inapplicable the exemption relating to persons that import or process substances as part of an article.
Sources at the Food and Drug Administration state that a working group from the New York district office is currently reviewing the import filer evaluation process and will be making changes in the next few months. This follows a statement by the FDA that they recognize that the filer evaluation process currently does not distinguish between serious mistakes or omissions and typographical errors, and is working to improve this process. The FDA is also exploring procedures that would speed up this re-evaluation, which would provide an incentive for filers to improve their outcomes quickly.
The Environmental Protection Agency has issued a direct final rule to revoke certain testing requirements for six chemical substances and all the testing requirements for four chemical substances due to information received since publication of the first test rule for certain high production volume chemical substances (HPV1). HPV1 had established testing requirements for these 10 chemical substances.
On March 21 2012, 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 has announced that E. & J. Gallo Winery has filed a petition proposing that the color additive regulations in 21 CFR 73.350 be expanded. Specifically, it proposes to provide for the expanded safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives in certain distilled spirits containing not less than 18% and not more than 23% alcohol by volume, but not including distilled spirits mixtures containing more than 5% wine on a proof gallon basis.
On March 20 2012, 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 its weekly Enforcement Report for March 14, 2012 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On March 19 2012, 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 has issued a final rule amending the packaging and labeling control provisions of the current good manufacturing practice (CGMP) regulations for human and veterinary drug products. The final rule amends 21 CFR Part 211 by limiting the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons.
U.S. Customs and Border Protection reports that the Food and Drug Administration experienced server issues on March 19, 2012 that caused multiple applications to be unavailable for the processing of entry data, including PNSI, MARCS Entry Review, and OASIS. At 5:50 pm eastern time, FDA announced these problems were resolved; the backlog of entries is considerable, but will continue to be worked through until normal processing times return.