instruction:
Given a paragraph, generate a claim that is supported by the given paragraph. 1) The claim must contain information from within the paragraph. 2) A sentence within the paragraph can be used as a claim. 3) The claim should not have contradictions within the paragraph. 4) The claim should be at most one sentence long.
question:
The U.S. Food and Drug Administration questioned the differences in size and formulation of the patch used in trials and the to-be-marketed patch. The generic drugs maker, which received a “complete response letter” from the FDA, said it planned to work closely with the agency to address the questions. Such letters typically lay out FDA concerns that need to be addressed before a treatment is approved. Actavis’ contraceptive skin patch is designed to provide continuous delivery of the hormone norethindrone, a type of progestin, during a once-weekly, seven-day dosing regimen. Progestin, the synthetic form of female sex hormone progestogen, inhibits ovulation and thickens the layer of mucus at the cervix so sperm cannot enter the uterus. The treatment will compete with Johnson and Johnson’s Ortho Evra, an estrogen/progestin combination contraceptive patch. Estrogen is another female sex hormone. A progestin-only patch can be safer than combination patches as high levels of estrogen are often linked to blood clotting disorders and an increased risk of cancer. The company also filed on Tuesday an application to market the generic version of Merck & Co Inc’s NuvaRing, a estrogen/progestin combination hormonal contraceptive vaginal ring. Actavis said it may be the first applicant to file the application, which, if approved may entitle it to 180 days of generic market exclusivity. Shares of Dublin, Ireland-based Actavis were down 0.6 percent at $165.16 in early trading on the New York Stock Exchange on Tuesday.
answer:
FDA rejects Actavis' contraceptive patch, seeks more data.


question:
A lawsuit filed this week in Eagle County District Court contends Vail town officials violated local rules when they approved a Triumph Development project to build high-density worker housing along Interstate 70 where the bighorns forage during winter. The residents also argue that a Vail Resorts employee on the local Planning and Environmental Commission, which approved the project on a 4-3 vote, should have recused himself due to a conflict of interest. Their lawsuit asks Judge Russell Granger to send the case back to town officials with instructions for proper decision-making. “Developers tried to come up with mitigation. But it doesn’t seem the mitigation measures are sufficient to comply with the code,” which requires the implementation of “all necessary mitigating measures,” attorney Kim Perdue said Thursday. “My understanding is that there are other sites … that would be better for residents and also not have catastrophic impacts on this herd,” Perdue said. This battle pits the mountain resort’s economic demands against the needs of wildlife, in this case Rocky Mountain bighorn sheep, Colorado’s state animal. Bighorns once numbering more than 2 million around the west have been declining, hammered by disease — including sickness spread by domestic sheep — as development eclipses bighorn habitat. The Colorado bighorn population has dwindled to about 6,800, down from about 7,600 in 2012 and 8,000 in 2001, state data shows. Vail Valley bighorns have decreased to about 5% of their historic numbers, along with other species, and the herd that forages east of Vail has been reduced by 40% over the past 12 years to around 50 bighorns. Meanwhile, mountain resort operators around the state have been developing properties and struggling to ensure enough housing for workers as tourism and recreation industries expand. Triumph Development has proposed to construct the housing for Vail on 5.4 acres at one end of a 23.3-acre parcel that Vail obtained from the Colorado Department of Transportation. Local governments have broad discretion. The lawsuit targets town decision-making on narrow grounds, alleging that proposed “mitigation” measures are not sufficient to comply with town rules aimed at protecting the natural environment and wildlife. The developers’ proposals included the construction of a berm between the housing complex and a meadow where bighorns forage, limited lighting and restricted dog ownership. Residents walking to town would have to use an underpass designed for vehicles to cross I-70. The lawsuit also alleges town officials gave improper guidance to planning and environmental commission members by asserting they had no choice but to allow the development of the property, owned by Vail, because otherwise their action would amount to an illegal “regulatory taking” of the property. Vail officials declined to comment on the lawsuit. “We received the complaint, and we have forwarded it to our insurance carrier for review,” assistant town manager Patty McKenny said. Former Mayor Rob Ford, a longtime resident opposing the construction, said even people who recognize a need for affordable worker housing have been questioning Vail leaders’ decision-making. “It was not transparent. Residents were lied to. It is a poorly planned project, a crummy project,” Ford said. The conflict has escalated over the past two years. Colorado Parks and Wildlife biologists have provided guidance, warning that bighorns likely would suffer harm and questioning whether mitigation is possible. Vail officials have countered that the resort needs housing for service workers, in part to create a sense of community and reduce worker driving. Only 20% of Vail’s 8,500 workers live in town. Others commute as far as 75 miles. Houses in Vail cost $1.3 million on average. Renting an apartment typically costs around $1,200 a month. The Vail Homeowners Association has opposed the development. A 40-member group called Citizens to Protect Our Wildlife asked Gov. Jared Polis for help. The local chamber of commerce asked Polis to stay out of the matter unless he planned to support the construction. ___ Information from: The Denver Post, http://www.denverpost.com
answer:
Lawsuit challenges Vail development in bighorn sheep habitat.


question:
Calyxt said it can’t reveal its first customer for competitive reasons, but CEO Jim Blome said the oil is “in use and being eaten.” The Minnesota-based company is hoping the announcement will encourage the food industry’s interest in the oil, which it says has no trans fats and a longer shelf life than other soybean oils. Whether demand builds remains to be seen, but the oil’s transition into the food supply signals gene editing’s potential to alter foods without the controversy of conventional GMOs, or genetically modified organisms. Among the other gene-edited crops being explored: Mushrooms that don’t brown, wheat with more fiber, better-producing tomatoes, herbicide-tolerant canola and rice that doesn’t absorb soil pollution as it grows. Unlike conventional GMOs, which are made by injecting DNA from other organisms, gene editing lets scientists alter traits by snipping out or adding specific genes in a lab. Startups including Calyxt say their crops do not qualify as GMOs because what they’re doing could theoretically be achieved with traditional crossbreeding. So far, U.S. regulators have agreed and said several gene-edited crops in development do not require special oversight. It’s partly why companies see big potential for gene-edited crops. “They’ve been spurred on by the regulatory decisions by this administration,” said Greg Jaffe of the Center for Science in the Public Interest, a health watchdog group. But given the many ways gene editing can be used, Jaydee Hanson of the Center for Food Safety said regulators should consider the potential implications of each new crop. He cited the example of produce gene-edited to not brown. “You’ve designed it to sit around longer. Are there problems with that?” he said. Already, most corn and soy grown in the U.S. are herbicide-tolerant GMOs. Just last week, regulators cleared a hurdle for salmon genetically modified to grow faster. The fish is the first genetically modified animal approved for human consumption in the U.S. Though regulators say GMOs are safe, health and environmental worries have persisted, and companies will soon have to disclose when products have “bioengineered” ingredients. Calyxt says its oil does not qualify as a GMO. The oil is made from soybeans with two inactivated genes to produce more heart-healthy fats and no trans fats. The company says the oil also has a longer shelf life, which could reduce costs for food makers or result in longer-lasting products. Soybean oils took a hit when regulators moved to ban oils with trans fats. Other trans fat-free soybean oils have become available in the years since, but the industry has found it difficult to win back food makers that already switched to different oils, said John Motter, former chair of the United Soybean Board. Calyxt said the first customer is a company in the Midwest with multiple restaurant and foodservice locations, such as building cafeterias. It said the customer is using it in dressings and sauces and for frying, but didn’t specify if the oil’s benefits are being communicated to diners. Calyxt is working on other gene-edited crops that it says are faster to develop than conventional GMOs, which require regulatory studies. But Tom Adams, CEO of biotech company Pairwise, said oversight of gene-edited foods could become stricter if public attitude changes. “You should never think of regulation as settled,” Adams said. Pairwise is partnering with Monsanto-parent Bayer on developing gene-edited crops. Views on gene-editing vary too. The National Organic Standards Board said foods made with gene editing cannot qualify as organic . And last year, Europe’s highest court said gene-edited foods should be subject to the same rules as conventional GMOs. ____ Follow Candice Choi at www.twitter.com/candicechoi ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
answer:

Gene-edited food quietly arrives in restaurant cooking oil.


