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Federal Food, Drug, and Cosmetic Act (FFDCA)

League of United Latin American Citizens v. New York

The Ninth Circuit granted environmental groups' petition to review EPA's 2017 order maintaining a tolerance for the pesticide chlorpyrifos, and vacated the Agency's order. The groups argued that the Agency's need for additional...

Natural Resources Defense Council, Inc. v. United States Food & Drug Administration

The Second Circuit reversed a lower court decision that FDA was required to hold hearings to determine whether to withdraw approval for the use of penicillin and tetracyclines in animal feed. Looking at the text of the Federal Food,...

Natural Resources Defense Council v. United States Food & Drug Administration

A district court held that the FDA violated the APA and the Food, Drug, and Cosmetic Act (FDCA) when it denied two petitions requesting that it withdraw approval of some uses of certain classes of antibiotics in food-producing...

Natural Resources Defense Council, Inc. v. United States Food & Drug Administration

A district court held that the FDA must reconsider its approval of certain antibiotics used in animal feed unless, after a hearing, the drug uses at issue are determined to be safe. In 1977, the FDA issued notices of an opportunity...

Use of Human Subjects Data for Regulating Chemical Exposures

On December 14, 2001, the U.S. Environmental Protection Agency (EPA) issued a press release establishing an "interim" human testing policy for pesticides that suspended EPA's long-established policy of using human testing data to...

Our Tainted Environment and Juvenile Violence: A Look to Legislators

I. Introduction

In the 19th century, doctors prescribed Soothing Syrup for cranky babies. The syrup was actually laudanum, which is opium, dissolved in water. While it did quiet and calm unruly behaved children, the side...

An Agreement Between EPA and Pesticide Manufacturers to Mitigate the Risks of Chlorpyrifos

Introduction

On June 7, 2000, the U.S. Environmental Protection Agency (EPA) reached an agreement1 with the basic manufacturers of chlorpyrifos to reduce potential risks from exposure to residues...

Some Dangers of Taking Precautions Without Adopting the Precautionary Principle: A Critique of Food Safety Regulation in the United States

A more substantive precautionary principle of international law is evolving as new treaties articulate new measures of precaution in different contexts.2 Although there is considerable controversy over how to...

The Food Quality Protection Act: A New Way of Looking at Pesticides

Editors' Summary: In 1996, the Food Quality Protection Act (FQPA) made major changes in the law governing pesticide residues in food, including elimination of the zero-risk standard for carcinogenic food additives. The FQPA instead...

The Food Quality Protection Act + EPA's Pesticide Adverse Effects Reporting Rule = New Data and Better Pesticide Risk Decisions

Editors' Summary: With the enactment of the Food Quality Protection Act of 1996 (FQPA) amending both FIFRA and the Federal Food, Drug, and Cosmetic Act, EPA must perform a broad reassessment of pesticide risks and benefits, using...