Category: Regulations

Regulations Reduce Biotech Innovation

(p. A15) Modern genetic engineering, also called genetic modification or GM, has been around since the 1970s. Yet with the notable exception of biopharmaceuticals–beginning with the marketing of human insulin in 1982 and now accounting for more than 20% of U.S. drug expenditures–genetic engineering has failed to realize anything approaching its potential for vertical progress.
The reason is plain: In the non-pharmaceutical sectors, federal regulators for years seemingly have done everything they can to prevent U.S. researchers and companies from employing genetic engineering to create the “next big thing.”
. . .
Regulatory disincentives are potent. It costs about $136 million to bring a genetically engineered crop plant to market. This is the primary reason more than 99% of such crop plants are those that are grown at huge scale: . . .
. . .
“Biopharming”–the once-promising biotechnology area that uses genetic engineering techniques to induce crops such as corn, tomatoes and tobacco to produce high concentrations of high-value pharmaceuticals (one of which is the Ebola drug, ZMapp)–is moribund because of the Agriculture Department’s extraordinary regulatory burdens. Thanks to EPA’s policies, which discriminate against organisms modified with the most precise and predictable techniques, the high hopes for genetically engineered “biorational” microbial pesticides and microorganisms to clean up toxic wastes have evaporated.

For the full commentary, see:
HENRY I. MILLER. “Regulators Put the Brakes On Biotech; Thanks to EPA, hopes have evaporated for genetically engineered microorganisms to clean up toxic wastes.” The Wall Street Journal (Weds., Jan. 14, 2015): A15.
(Note: ellipses added.)
(Note: the online version of the commentary has the date Jan. 13, 2015.)

Occupational Licensing Raises Costs for Consumers and Reduces Jobs

(p. B1) What lesson should we draw from the success of Uber?
Customers have flocked to its service. In the final three months of last year, its so-called driver-partners made $656.8 million, according to an analysis of Uber data released last week by the Princeton economist Alan B. Krueger, who served as President Obama’s chief economic adviser during his first term, and Uber’s Jonathan V. Hall.
Drivers like it, too. By the end of last year, the service had grown to over 160,000 active drivers offering at least four drives a month, from near zero in mid-2012. And the analysis by Mr. Krueger and Mr. Hall suggests they make at least as much as regular taxi drivers and chauffeurs, on flexible hours. Often, they make more.
This kind of exponential growth confirms what every New Yorker and cab riders in many other cities have long suspected: Taxi service is woefully inefficient. It also raises a question of broader relevance: Why stop here?
. . .
(p. B5) . . . like taxi medallions, state licenses required to practice all sorts of jobs often serve merely to cordon off occupations for the benefit of licensed workers and their lobbying groups, protecting them from legitimate competition.
This comes at a substantial social cost. “Lower-income people suffer from licensing,” Professor Krueger told me. “It raises the costs of many services and prevents low-income people from getting into some professions.”
In a study commissioned by the Brookings Institution’s Hamilton Project, Morris Kleiner of the University of Minnesota found that almost three out of 10 workers in the United States need a license from state governments to do their jobs, up from one in 20 in the 1950s. By cordoning off so many occupations, he estimates, professional licensing by state governments ultimately reduces employment by up to 2.8 million jobs.

For the full commentary, see:
Eduardo Porter. “Job Licenses in Spotlight as Uber Rises.” The New York Times (Weds., JAN. 28, 2015): B1 & B5.
(Note: ellipses added.)
(Note: the online version of the commentary has the date JAN. 27, 2015.)

The working paper co-authored by Krueger, is:
Hall, Jonathan V., and Alan B. Krueger. “An Analysis of the Labor Market for Uber’s Driver-Partners in the United States.” Working paper. January 22, 2015.

Kleiner’s working paper at Brookings, is:
Kleiner, Morris M. “Reforming Occupational Licensing Policies.” In The Hamilton Project, Brookings, Discussion Paper 2015-01, January 2015.

Over-Taxed and Over-Regulated Castles for Sale in Italy

(p. A3) While castles and historic mansions in Italy have long been family inheritances, today dozens of them are for sale, even in one of the most conservative real estate markets in Europe.
. . .
On historic buildings, where owners used to pay little as compensation for the elevated costs of maintaining centuries-old structures, the taxes increased by 20 or 30 times, depending on the property’s location.
On some buildings, taxes spiked from 3,000 euros (about $3,400) in 2011 to 75,000 euros (about $84,000) by 2013. That might be a small figure for castle dwellers in the United Kingdom, but it is a burden for Italian pockets, especially in regions where the property’s market value or tourism interest is low.
The trends, to many here, are indicative of Italy’s place as a country caught between its past glory and its modern difficulty in producing an innovative climate capable of ensuring its future.
. . .
. . . buyer beware: Living a nobleman’s life in Italy comes at a cost, even for many tycoons. New owners face the same onerous bureaucracy as Italians to make even minimal changes to many older properties.
Under Italian law, the owner of a historic building is its custodian, bound to maintain it and grant its security and, in some cases, its use to the public. Many buyers give up on properties of great historic value, but in bad condition, for this reason, brokers said.
“This is a problem for possible investors, who want to have modern comforts like a spa, air-conditioning or a lift,” said Mr. Pallavicini, of the Italian Historic Houses Association.
“We no longer live like in 1800,” he added. “But 99 percent of those changes are either impossible or extremely bureaucratic and complicated in an Italian historic building.”

For the full story, see:
GAIA PIANIGIANI. “PONTASSIEVE JOURNAL; Life of Italian Nobility for Sale, Complete With Regulations and Taxes.” The New York Times (Weds., JAN. 28, 2015): A11.
(Note: ellipses are added.)
(Note: the online version of the story has the date JAN. 27, 2015.)

“It’s My Life, and I Want the Chance to Save It”

(p. 18) LYONS, Colo. — Since May [2014], a string of states have passed laws that give critically ill patients the right to try medications that have not been approved by the Food and Drug Administration.
Deemed “Right to Try” laws, they have passed quickly and often unanimously in Colorado, Michigan, Missouri, Louisiana and Arizona, bringing hope to patients like Larry Kutt, who lives in this small town at the edge of the Rocky Mountains. Mr. Kutt, 65, has an advanced blood cancer and says his state’s law could help him gain access to a therapy that several pharmaceutical companies are testing. “It’s my life,” he said, “and I want the chance to save it.”
The laws do not seem to have helped anyone obtain experimental medicine, as the drug companies are not interested in supplying unapproved medications outside the supervision of the F.D.A. But that seems almost beside the point to the Goldwater Institute, the libertarian group behind legislative efforts to pass Right to Try laws. “The goal is for terminally ill patients to have choice when it comes to end-stage disease,” said Craig Handzlik, state policy coordinator for the Goldwater Institute, based in Arizona. “Right to Try is something that will help terminally ill people all over the country.”

For the full story, see:
JULIE TURKEWITZ. “Patients Seek ‘Right to Try’ New Drugs.” The New York Times, First Section (Sun., JAN. 11, 2015): 18.
(Note: the bracketed year is added.)
(Note: the online version of the story has the date JAN. 10, 2015.)

Free Market Tour Guide Challenges Savannah’s Attack on Free Speech

(p. A25) SAVANNAH, Ga. — Especially when she sips French onion soup at a restaurant that was featured in the Julia Roberts movie “Something to Talk About,” Michelle Freenor is an irrepressible tour guide.
She rattles off the history of Methodism in this city, as well as tidbits about William T. Sherman’s March to the Sea. She discusses the canopy of Spanish moss that hangs above Savannah’s streets, whether “Jingle Bells” was actually composed here, and just how haunted one of the country’s largest historic landmark districts might be.
But Ms. Freenor has also emerged in recent weeks in a new role: plaintiff in a federal lawsuit that could reshape Savannah’s lucrative and potent tourism industry. Backed by a nonprofit law firm with libertarian leanings, Ms. Freenor and three others, including her husband, are challenging the Savannah ordinance that requires tour guides to hold licenses and pass regular academic and medical examinations.
“It’s the free market that made us successful, not the City of Savannah,” said Ms. Freenor, 43. “You shouldn’t have to pass a test to be able to tell people where the best ice cream in Savannah is.”
. . .
“What tour guides do is talk for a living,” said Robert Johnson, one of Ms. Freenor’s lawyers. “They’re just like stand-up comedians, journalists or novelists. And in this country, you don’t need a license from the government to be able to talk.”

For the full story, see:
ALAN BLINDER. “Lawsuit May Reshape Tourist Industry in History-Rich Savannah.” The New York Times, First Section (Sun., DEC. 21, 2014): A25 & A31.
(Note: ellipsis added.)
(Note: the online version of the story has the date DEC. 20, 2014. The online version says that the New York paper version of the article started on p. 28. It does not say on what page of that edition, the article continued. My page numbers are from the National Edition, which I usually receive.)

Yucca Mountain Has Multiple Barriers to Isolate Nuclear Materials

(p. A20) The Nuclear Regulatory Commission on Thursday [Oct. 16, 2014] released a long-delayed report on the suitability of Yucca Mountain as a disposal spot for nuclear waste, finding that the design met the commission’s requirements, laying the groundwork to restart the project . . .
. . .
. . . the report released Thursday, mostly done in 2010 but frozen until a recent court decision, concluded that the design had the required multiple barriers, to assure long-term isolation of radioactive materials.

For the full story, see:
MATTHEW L. WALD “Calls to Use a Proposed Nuclear Site, Now Deemed Safe.” The New York Times (Fri., OCT. 17, 2014): A20.
(Note: ellipses, and bracketed date, added.)
(Note: the online version of the story has the date OCT. 16, 2014., and has the title “Calls to Use Yucca Mountain as a Nuclear Waste Site, Now Deemed Safe.”)

As with Airplanes, Lives Must Be Risked to Achieve Routine Safety in Spaceships

(p. A21) SEATTLE — ONE clear winter day in 1909, in Hampshire, England, a young man named Geoffrey de Havilland took off in a twin-propeller motorized flying machine of his own design, built of wood, piano wire and stiff linen hand-stitched by his wife. The launch was flawless, and soon he had an exhilarating sensation of climbing almost straight upward toward the brilliant blue sky. But he soon realized he was in terrible trouble.
The angle of ascent was unsustainable, and moments later de Havilland’s experimental plane crashed, breaking apart into a tangled mass of shards, splinters and torn fabric, lethal detritus that could easily have killed him even if the impact of smashing into the ground did not. Somehow, he survived and Sir Geoffrey — he was ultimately knighted as one of the world’s great aviation pioneers — went on to build an astonishing array of military and civilian aircraft, including the world’s first jet airliner, the de Havilland Comet.
I thought immediately of de Havilland on Friday when I heard that Virgin Galactic’s SpaceShipTwo, a rocket-powered vehicle designed to take well-heeled tourists to the edge of space, had crashed on a flight over the Mojave Desert, killing one test pilot and seriously injuring the other.
. . .
Certainly the Wright brothers and others like de Havilland were involved in what we now view as an epic quest, but many experts of the day were certain that flight, however interesting, was destined to be not much more than a rich man’s hobby with no practical value.
“The public has greatly over-estimated the possibilities of the aeroplane, imagining that in another generation they will be able to fly over to London in a day,” said a Harvard expert in 1908. “This is manifestly impossible.” Two other professors patiently explained that while laymen might think that “because a machine will carry two people another may be constructed that will carry a dozen,” in fact “those who make this contention do not understand the theory of weight sustentation in the air.”
. . .
There will be tragedies like the crash of SpaceShipTwo and nonlethal setbacks such as the fiery explosion, also last week, of a remote-controlled rocket intended for a resupply mission to the International Space Station. There will be debates about how to improve regulation without stifling innovation. Some will say private industry can’t do the job — though it’s not as if the NASA-sponsored Apollo or space shuttle missions went off without a hitch (far from it, sadly).
But at the heart of the enterprise there will always be obsessives like Sir Geoffrey, who forged ahead with his life’s work of building airplanes despite his own crash and, incredibly, the deaths of two of his three sons while piloting de Havilland aircraft, one in an attempt to break the sound barrier. Getting to routine safety aloft claimed many lives along the way, and a hundred years from now people will agree that in that regard, at least, spaceships are no different from airplanes.

For the full commentary, see:
SAM HOWE VERHOVEK. “Not a Flight of Fancy.” The New York Times (Tues., NOV. 4, 2014): A21.
(Note: ellipses added.)
(Note: the online version of the commentary has the date NOV. 3, 2014.)

FAA Requires Drones to Carry Onboard Manuals

(p. B1) BERLIN–In four years, Service-drone.de GmbH has emerged as a promising player here in the rapidly expanding commercial-drone industry. The 20-employee startup has sold more than 400 unmanned aircraft to private-sector companies and now is pitching its fourth-generation device.
Over the same period, Seattle-based Applewhite Aero has struggled to get permission from the Federal Aviation Administration just to fly its drones, which are designed for crop monitoring. The company, founded the same year as Service-drone, has test-flown only one of its four aircraft, and is now moving some operations to Canada, where getting flight clearance is easier.
“We had to petition the FAA to not carry the aircraft manual onboard,” said Applewhite founder Paul Applewhite. “I mean, who’s supposed to read it?” Mr. Applewhite, like many of his U.S. peers, fears the drone industry “is moving past the U.S., and we’re just getting left behind.”

For the full story, see:
JACK NICAS. “U.S. Rules Clips Drone Makers’ Wings.” The Wall Street Journal (Mon., Oct. 6, 2014): B1 & B4.
(Note: the online version of the story has the date Oct. 5, 2014, and has the title “Regulation Clips Wings of U.S. Drone Makers.”)

Simplot’s Company Keeps Innovating with Potatoes

(p. B1) A potato genetically engineered to reduce the amounts of a potentially harmful ingredient in French fries and potato chips has been approved for commercial planting, the Department of Agriculture announced on Friday [November 7, 2014].
The potato’s DNA has been altered so that less of a chemical called acrylamide, which is suspected of causing cancer in people, is produced when the potato is fried.
The new potato also resists bruising, a characteristic long sought by potato growers and processors for financial reasons. Potatoes bruised during harvesting, shipping or storage can lose value or become unusable.
The biotech tubers were developed by the J. R. Simplot Company, a privately held company based in Boise, Idaho, which was the initial supplier of frozen French fries to McDonald’s in the 1960s and is still a major supplier. The company’s founder, Mr. Simplot, who died in 2008, became a billionaire.
The potato is one of a new wave of genetically modified crops that aim to provide benefits to consumers, not just to farmers as the widely grown biotech crops like herbicide-tolerant soybeans and corn do. The nonbruising aspect of the potato is similar to that of genetically engineered nonbrowning apples, developed by Okanagan Specialty Fruits, which are awaiting regulatory approval.
. . .
The question now is whether the potatoes — which come in the Russet Burbank, Ranger Russet and Atlantic varieties — will be adopted by food companies and restaurant chains. At least one group opposed to such crops has already pressed McDonald’s to reject them.

For the full story, see:
ANDREW POLLACK. “New Potato, Hot Potato: U.S. Approves Modified Crop. Next Up: French-Fry Fans.” The New York Times (Sat., NOV. 8, 2014): B1-B2.
(Note: ellipsis, and bracketed date, added.)
(Note: the online version of the story has the date NOV. 7, 2014, and has the title “U.S.D.A. Approves Modified Potato. Next Up: French Fry Fans.”)

Consumers Cannot Count on Regulators for Safety

(p. A1) WASHINGTON — The nation’s top auto regulator faced withering criticism across Capitol Hill on Tuesday over its failure to identify a deadly defect in General Motors cars — even as its top official tried again and again to shift the blame back to the automaker.
Hours after a House committee released a scathing report about the agency’s yearslong failure to spot the ignition-stalling defect that has now been linked to 19 deaths, a Senate subcommittee hearing turned angry and tense. Lawmakers from both parties accused the agency, the National Highway Traffic Safety Administration, of overlooking evidence that could have saved lives and of deferring to the auto industry rather than standing up to it.
The agency was “more interested in singing ‘Kumbaya’ with the manufacturers than being a cop on the beat,” said Senator Claire McCaskill, the subcommittee’s chairwoman, in sharp questioning reminiscent of her interrogation of G.M.’s chief executive, Mary T. Barra, in a hearing before the same panel in the spring.
. . .
(p. B2) “You want to obfuscate responsibility, rather than take responsibility,” Ms. McCaskill, a Missouri Democrat, said, her voice rising. “We’ve all said shame on G.M.” She added, “You’ve got to take some responsibility that this isn’t being handled correctly.”
. . .
Watching from a seat just behind Mr. Friedman [deputy administrator of the N.H.T.S.A.] was Laura Christian, the birth mother of Amber Rose, a teenager who was killed in 2005 when her Cobalt ran off the road, into a tree, and the air bags did not deploy.
As Mr. Friedman continued to speak, Ms. Christian said she could feel herself getting flushed and increasingly upset over the agency’s lack of remorse.
“It was extremely frustrating to hear David Friedman go on about how his agency was this wonderful thing,” she said. “All along they missed the glaringly obviously defects.”

For the full story, see:
HILARY STOUT and AARON M. KESSLER. “Congress Castigates Auto Regulator Over a Deadly G.M. Defect.” The New York Times (Weds., SEPT. 17, 2014): A1 & B2.
(Note: ellipses, and bracketed words, added.)
(Note: the online version of the story has the date SEPT. 16, 2014, and has the title “Senators Take Auto Agency to Task Over G.M. Recall.” In the Midwest edition that I receive, this article started on p. A1; according to the indexes, and the online edition, in the New York edition, the article started on p. B1.)

Esther Dyson Sees a Lot of Silicon Valley as Just Motivated to Make Money

(p. C11) The U.S. Commerce Department recently said that it plans to relinquish its oversight of Icann, handing that task to an international body of some kind. The details are still being worked out, but Ms. Dyson hopes that governments won’t be the new regulators. . . .
For now, she thinks there are many Silicon Valley Internet companies with inflated market values. “There is the desire to make money that motivates a lot of that in Silicon Valley, and yes, I think it’s totally a bubble,” she says. “It’s not like the last bubble in that there are a lot of real companies there [now], but there are a lot of unreal companies and…many of them will disappear.” She thinks too many people are starting similar companies. “You have people being CEOs of teeny little things who would be much better as marketing managers of someone else’s company,” she says.
And though her work often takes her to California, she’s happy to stay in New York. These days, she finds Silicon Valley “very fashionable,” she says, “and I don’t really like fashion.”

For the full interview, see:
ALEXANDRA WOLFE, interviewer. “WEEKEND CONFIDENTIAL; Esther Dyson’s Healthy Investments; The investor is hoping to produce better health through technology with a new nonprofit.” The Wall Street Journal (Sat., May 3, 2014): C11.
(Note: first ellipsis added; second ellipsis in original.)
(Note: the online version of the interview has the date May 2, 2014, and has the title “WEEKEND CONFIDENTIAL; Esther Dyson’s Healthy Investments; The investor is hoping to produce better health through technology with a new nonprofit.”)