Category Archives Legislation, Regulations and Standards

After testing more than 200 rice products, Consumer Reports purportedly found levels of total arsenic, both organic and inorganic, far in excess of the federal limit of 10 parts per billion (ppb) for arsenic in drinking water. Among the products tested were baby cereals, crackers, milk, pasta, flour, and an array of brown, white and basmati rice. One infant cereal product apparently contained up to 329 ppb of arsenic. Consumer Reports recommended that consumers cook their rice in twice the amount of water, 6 cups to 1 cup of rice, eat a varied diet and experiment with other grains that are less prone to absorbing arsenic from soil and water as they grow. Its investigation included a data analysis by researchers experienced in National Health and Nutrition Examination Survey (NHANES) analyses. They found that of 3,633 rice consumers who participated in NHANES, those consuming one rice food item before their urine…

The European Food Safety Authority (EFSA) has launched a public consultation on new “draft Guidance on the Risk Assessment of Plant Protection Products [PPPs] on Bees (including Apis mellifera, Bombus spp. and solitary bees).” Intended to help applicants and authorities evaluate PPPs “and their active substances under Regulation (EC) 1107/2009,” the draft guidance outlines a process “by which [PPPs] can be evaluated for their potential risk in causing unacceptable harm to a group of non-target organisms (bees).” To these ends, EFSA has identified a maximum level of harm as defined by Specific Protection Goals (SPGs), which aim to protect the survival and development of bee colonies, preserve biomass and reproduction to ensure long-term survival, and minimize the effect of PPPs on larvae and bee behavior. Recognizing that the viability of a colony depends on the number of bees it contains, the SPGs establish that the magnitude of PPPs’ effects on…

The U.S. Department of Agriculture’s National Organic Program (NOP) has issued a final rule permitting the use of synthetic methionine in organic poultry production. Effective October 1, 2012, the final rule reduces the maximum levels of methionine per ton of feed as follows: (i) 2 pounds for laying and broiler chickens, and (ii) 3 pounds for turkeys and all other poultry. The final rule also amends the Chemicals Abstracts Service (CAS) numbers “for the allowable forms of synthetic methionine.” According to NOP, “[m]ethionine is classified as an essential amino acid for poultry because it is needed to maintain viability and must be acquired through the diet… Natural feed sources with a high percentage of methionine include blood meal, fish meal, crab meal, corn gluten meal, alfalfa meal, and sunflower seed meal.” In reviewing the rules governing the use of synthetic methionine, a water-soluble crystalline powder, in organic poultry production, the National…

The Food and Drug Administration (FDA) recently published a notice seeking “any industry organizations interested in participating in the selection of a nonvoting industry representative to the Transmissible Spongiform Encephalopathies Advisory Committee [TSEAC].” Organizations that wish to participate in the selection of this nonvoting member should submit a letter stating their interest to FDA by October 18, 2012. The agency has also requested nominations for the post by the same date. FDA has charged TSEAC with reviewing and evaluating “the available scientific data concerning the safety of products which may be at risk for transmission of spongiform encephalopathies having an impact on the public health.” The committee includes 15 voting members “knowledgeable in the fields of clinical and administrative medicine, hematology, virology, neurovirology, neurology, infectious diseases, immunology, transfusion medicine, surgery, internal medicine, biochemistry, biostatistics, epidemiology, biological and physical sciences, sociology/ethics, and other related professions.” See Federal Register, September 18, 2012.

Consumer organization Public Citizen has filed a citizen petition with the Food and Drug Administration (FDA) challenging its policy of instructing staff, when responding to requests under the Freedom of Information Act (FOIA), to not consider “minor deletions,” which can be up to 20 percent of the responsive documents, as a partial FOIA denial that would trigger a requester’s right to an administrative appeal. Public Citizen specifically requests that FDA revoke 21 C.F.R. § 20.49(d) which states, “Minor deletions of nondisclosable data and information from disclosable records shall not be deemed a denial of a request for records.” The organization also asks the agency to revoke parts of its staff manuals. According to the petition, more than 20 years ago, the General Accounting Office (now the Government Accountability Office) (GAO) “urged FDA to rescind its deletions regulation and a similar policy on ‘minor deletions’” because it violates FOIA. Attached to…

The Federal Trade Commission (FTC) has reopened the comment period for its October 2, 2012, workshop on competition and consumer protection issues in the pet medications industry. The commission is “seeking the views of consumers, veterinarians, pharmacists, manufacturers, business representatives, economists, lawyers, academics, and other interested parties” submitted by November 1, 2012. FTC’s workshop agenda includes discussions on how pet medications are distributed to consumers and “how these distribution practices affect consumer choice and price competition.” See FTC News Release, September 19, 2012.

The Louisville Metro Air Pollution Control District has reportedly issued violation notices concerning emissions from a whiskey warehouse owned by Diageo Americas Supply Inc., citing odor complaints and complaints about a black, sooty substance on neighboring properties between May 2011 and May 2012. The violations apparently carry a potential penalty of $10,000 per violation per day. An air district spokesperson reportedly said, “This is not a dangerous mold. But it’s a nuisance. These people’s homes are affected by it.” The company was given until November 3, 3012, to submit a plan on how it can comply with air-quality regulations. Information about the property damage lawsuit filed by Louisville residents against the company is included in Issue 444 of this Update. See Courier-Journal.com, September 12, 2012.

The New York City Board of Health has adopted Mayor Michael Bloomberg’s recommendation to establish a maximum serving size of 16 ounces for sugar-sweetened, non-alcoholic drinks sold at local food establishments. Board members reportedly voted 8-0 with one abstention, one absence and one vacancy to amend Article 81 of the Health Code to place a size restriction on beverages containing more than 25 calories per eight ounces and all self-service cups offered by food vendors, with exemptions for products that are more than 50 percent milk or 100 percent fruit or vegetable juice. Effective March 13, 2013, the new regulations will apply to restaurants, mobile food carts, delis, theater and stadium concessions, and any other food-service business regulated by the city’s Department of Health and Mental Hygiene, which will impose fines of $200 per violation. “Today’s vote is a historic and important step in fighting New York City’s epidemics of…

The Food and Drug Administration (FDA) has announced a draft compliance policy guide (CPG) concerning the “Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat, or Prevent Disease in Dogs and Cats.” According to the September 10, 2012, Federal Register notice, the draft CPG explains how FDA plans “to use its enforcement discretion with regard to the labeling and marketing of dog and cat food products that are labeled and/or marketed as intending to diagnose, cure, mitigate, treat, or prevent diseases and to provide nutrients in support of meeting the animal’s total daily nutrient requirements.” Issued in response to new animal drug provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the draft CPG seeks to address an observed increase in the number of cat and dog food products “that make labeling or marketing claims” about disease diagnosis, treatment or prevention. It also…

Senators Richard Durbin (D-Ill.) and Richard Blumethal (D-Conn.) have responded to the Food and Drug Administration’s (FDA’s) letter concerning actions the agency plans to take on energy drinks. While the senators “were pleased to learn that the FDA intends to release final guidance distinguishing liquid dietary supplements from beverages,” they contend that FDA’s response to their earlier request “did not address one of our greatest concerns, which include the potential interactions and cumulative effects of additives with stimulant properties in energy drinks with high levels of caffeine. While ginseng and other additives were not mentioned, your letter reviews taurine and guarana, which are generally regarded as safe (GRAS) food additives when used to add flavor.” The senators seek an explanation about the use of these ingredients to provide a stimulating effect and their safety when used this way. They also seek information about the agency’s consideration of “the unique health…

Close