In response to requests by chemical industry interests, the Environmental Protection Agency (EPA) has extended the deadline for comments on its proposal to apply a 10-fold (10X) safety factor to its pesticide risk assessments in relation to the exposure of agricultural workers and their children in agricultural fields. CropLife America and the American Chemistry Council made the request, noting that the proposal is related to several others, such as new labeling rules to control drift, that have not yet been finalized. Comments must now be received by April 12, 2010. The industry groups also pointed to studies the agency does not appear to have considered in drafting its policy paper, “Revised Risk Assessment Methods for Workers, Children of Workers in Agricultural Fields, and Pesticides with No Food Uses,” and expressed concerns that some supporting materials have not been made public. They urge EPA to consider a National Academy of Sciences…
Category Archives Issue 338
The Food and Drug Administration (FDA) has published a notice seeking public comments on its proposed collection of information on foods derived from new plant varieties including those created through biotechnology. Comments must be submitted by April 19, 2010. The types of information that developers of new plant varieties would be required to provide to the agency include (i) a description of the applications or uses of the bioengineered food, (ii) information about the sources, identities and functions of the introduced genetic material, (iii) information about any known or suspected allergenicity and toxicity, and (iv) information relevant to the safety and nutritional assessment of the bioengineered food. Commenters are asked to address whether the proposed collection “is necessary for the proper performance of FDA’s functions,” the accuracy of the agency’s estimate of the burden of the proposed information collection, ways to improve the quality of the information to be collected,…
The Food and Drug Administration (FDA) has submitted a proposed collection of information involving antimicrobial animal drugs to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act. According to the Federal Register notice, a 2008 amendment to the Federal Food, Drug, and Cosmetic Act requires that “the sponsor of each new animal drug that contains an antimicrobial agent submit an annual report to FDA on the amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals.” The first report under the law will be due March 31, 2010, and must specify (i) “The amount of each antimicrobial active ingredient by container size, strength, and dosage form”; (ii) “quantities distributed domestically and quantities exported”; and (iii) “a listing of the target animals, indications, and production classes that are specified on the approved label of the…
The U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) have issued a joint statement to announce a collaborative effort to improve the safety and quality of fresh produce. As part of the announcement, the agencies report that USDA’s Agricultural Marketing Service “is in the midst of evaluating a proposed marketing agreement for the leafy green industry,” while the FDA “is currently developing a proposed produce safety regulation.” The notice calls for feedback and comments from stakeholders, noting that FDA would establish “a docket to receive information about current practices and conditions for the production and packing of fresh produce and practical approaches to improving produce safety.” See FDA News & Events, February 18, 2010.
The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service has issued a final rule that amends National Organic Program (NOP) regulations to establish “a pasture practice standard for ruminant animals.” Seeking “to satisfy consumer expectations that ruminant livestock animals graze on pastures during the grazing season,” the final rule requires producers to (i) “provide year-round access for all animals to the outdoors”; (ii) “recognize pasture as a crop”; (iii) “establish a functioning management plan for pasture”; (iv) “incorporate the pasture management plan into their organic system plan (OSP)”; (v) “provide ruminants with pasture throughout the grazing season for their geographical location”; and (vi) “ensure ruminants derive not less than an average of 30 percent of their dry matter intake (DMI) requirement from pasture grazed over the course of the grazing season.” This rule takes effect June 17, 2010, for operations seeking organic certification by this date. Operations already certified as of…
The Federal Trade Commission (FTC) has announced that it sent letters to 11 unnamed companies in late January 2010, warning that their promotions and product packaging for omega-3 fatty acid supplements may violate the law “by making baseless claims about how the supplements benefit children’s brain and vision function and development.” FTC apparently gave the companies until February 8 to respond and explain what they have done or will do to ensure they are complying with the law, that is, that their health-related claims “are substantiated.” FTC provides as an example of substantiation “well-conducted, clinical cause-and-effect studies demonstrating that the use of the combination of Omega-3 fatty acids provided in Product X, in the same dosage as provided by one serving of the product, improves or promotes brain function, cognitive function, attention span, intelligence, memory, learning ability, and visual acuity in normal children ages 2 years and older.” The agency…
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