February 12, 2013

EPA Issues Chlorpyrifos Assessment:  A Model for Addressing Spray Drift?

The U.S. Environmental Protection Agency (EPA) released on February 6, 2013, its preliminary volatilization assessment for the registration review of chlorpyrifos. 76 Fed. Reg. 8522. In a letter to the Natural Resources Defense Council (NRDC) and to the Pesticide Action Network North America (PANNA) dated January 25, 2013, updating these groups on EPA’s response to their September 12, 2007, joint petition regarding chlorpyrifos, EPA stated that “[t]his assessment represents a...
February 6, 2013

DTSC Releases Revised Proposed Safer Consumer Products Regulations

On January 30, 2013, the California Department of Toxic Substances Control (DTSC) released revised proposed Safer Consumer Products Regulations (Revised Proposed Regulations). The Revised Proposed Regulations are subject to a 30-day comment period, ending February 28, 2013. Memoranda providing background information are available online. The Revised Proposed Regulations are available online. Below is a summary of the core elements of the Revised Proposed Regulations —...
January 30, 2013

EPA Issues NOIC, Seeking Ban of 12 D-Con Mouse and Rat Control Products

The U.S. Environmental Protection Agency (EPA) announced on January 30, 2013, that it will issue a final notice of intent to cancel the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registrations for the 12 D-Con mouse and rat control products produced by Reckitt Benckiser Inc. (Reckitt). This notice is intended to effectuate a Risk Mitigation Decision for rodenticides issued by EPA on May 28, 2008. EPA contends that these cancellations are necessary because “these products...
January 18, 2013

EPA Clarifies Requirements for Labeling of Pesticide Products and Devices for Export

On January 18, 2013, the U.S. Environmental Protection Agency (EPA) promulgated a final rule revising the regulations on the labeling of pesticide products and devices intended solely for export. EPA states that the final rule restructures the current regulations to clarify which provisions apply under various circumstances. The final rule also provides increased specificity in the regulations by requiring that people who transfer unregistered pesticide products between registered establishments...
January 16, 2013

EPA Seeks Comment on Draft PR Notice on Web-Distributed Labeling

The U.S. Environmental Protection Agency (EPA) published on January 16, 2013, a Federal Register notice announcing the availability of and seeking public comment on a draft Pesticide Registration (PR) Notice entitled “Web-Distributed Labeling for Pesticide Products.” EPA states that the draft PR Notice provides “guidance concerning the process by which registrants can make legally valid versions of pesticide labeling available through the Internet.” According to...
January 10, 2013

EPA Issues Long-Awaited Final Rule Revising Standards for Commercial and Industrial Solid Waste Incineration Units and Revising the Definition of Nonhazardous Secondary Materials

On December 20, 2012, U.S. Environmental Protection Agency (EPA) Administrator Jackson signed a much-anticipated rulemaking package revising the emission standards for commercial and industrial solid waste incineration units (CISWI). The rule has not yet been published in the Federal Register. The final rule accomplishes two broad goals: it revises the Clean Air Act (CAA) emission limits for CISWIs, and it revises the definition under the Resource Conservation and Recovery Act (RCRA) of...
January 7, 2013

EPA Announces Availability of Draft Chemical Risk Assessments

The U.S. Environmental Protection Agency (EPA) announced on January 4, 2013, the availability of the first draft risk assessments developed under the Toxic Substances Control Act (TSCA) Work Plan. The draft risk assessments are for particular uses of five chemicals found in household products: methylene chloride or dichloromethane (DCM) and N-methylpyrrolidone (NMP) in paint stripper products; trichloroethylene (TCE) as a degreaser and a spray-on protective coating; antimony trioxide (ATO) as a...
January 4, 2013

EPA Issues Draft Pesticide Registration Notice on Mold-Related Label Claims

On December 12, 2012, the U.S. Environmental Protection Agency (EPA) announced in a Federal Register notice the availability of a draft Pesticide Registration (PR) Notice entitled “Guidance for Antimicrobial Pesticide Products with Mold-Related Label Claims (Draft PR Notice). 77 Fed. Reg. 74003. The Draft PR Notice has some potentially alarming implications regarding the continued use of certain claims under the treated articles exemption that any registrants of active...
December 31, 2012

EPA Proposes Revisions to Minimum Risk Exemption for Pesticides

The U.S. Environmental Protection Agency (EPA) proposed on December 31, 2012, a new rule intended to address a long-standing enforcement issue that has vexed federal and state inspectors for years. 77 Fed. Reg. 76979. The proposed rule would require that active and inert ingredients permitted in products eligible for the exemption from registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b)(2) for minimum risk pesticides be described more clearly on...
December 18, 2012

FDA Compliance Update: Dietary Supplements

This is the first in a series of updates concerning compliance initiatives underway by the U.S. Food and Drug Administration (FDA) that affect various segments of the regulated industry. This issue focuses on court actions, Warning Letters, recalls, and other matters pertaining to dietary supplements. We will periodically outline actions and issues affecting prescription and over-the-counter (OTC) drugs, medical device and diagnostic products, food, cosmetics, animal drugs, and biologics....