U.S. Response:  New Science Regulations Receive Mixed Reviews

By David Ruppe
Global Security Newswire

WASHINGTON — New federal regulations announced Tuesday to tighten controls on biological agents and toxins have received mixed reviews from microbiologists (see GSN, Dec. 4).

Experts said the regulations, intended to keep dangerous biological materials out of terrorists’ hands and mandated by a law passed this year, go too far in some areas and not far enough elsewhere.  The regulations affect the possession and transfer of “select agents” and toxins such as the anthrax bacteria and the smallpox and Ebola viruses, as well as lesser-known pathogens.

The new regulations, consisting of two sets of rules issued in tandem by Health and Human Services and Agriculture departments, are to take effect Feb. 7, pending public comments.

Richard Ebright, laboratory director at Rutgers University’s Waksman Institute of Microbiology, faults the regulations, for instance, for not requiring specific access-control and monitoring measures at facilities.

Ronald Atlas, president of the American Society for Microbiology, however, believes the new security requirements could dampen enthusiasm for work with select agents.

“If I had select agents in my lab, I think I’d have to give serious consideration in the morning as to whether I really want to do this or not,” he said in an interview yesterday.

“Which is not to say they [the new regulations] are wrong.  They might represent the right, essential steps,” Atlas added.  “But, they represent a significant culture change to at least how some of us in academia run laboratories,” he said.

Some of the paperwork requirements are “nothing short of draconian,” said Steven Block, a Stanford University biophysicist.  According to one key requirement, nongovernmental facilities are required to obtain a risk assessment from the Justice Department before they can receive, possess, use, or transfer any select agent.

“All these regulations in the end will be an enormous burden for those people trying to implement them,” said Block, who argued such restrictions on select agents ultimately “won’t stop the bad guys.”

With the exception of the smallpox virus, most agents and toxins are widely available around the world as is the information to weaponize them, he said.

Promoting the new rules in an announcement this week, HHS Secretary Tommy Thompson said, “Protecting the health of Americans is paramount, and this new rule strengthens our ability to ensure that essential research on these agents continues while making certain they don’t fall into the wrong hands.”

The regulations require laboratories handling select agents to be registered with the Centers for Disease Control and Prevention or the Agriculture Department, depending on the agent.

Previously, facilities had only to report transfers of such materials to federal authorities.  So far, 817 of an estimated 1,167 academic, commercial and government facilities have registered, according to the CDC.

The regulations also restrict access to such agents by certain groups of people.  To accomplish that requirement, laboratories must first submit names of people chosen to handle select agents to the Justice Department for screening using numerous databases.

The CDC anticipates an estimated 20,000 staff will be subjected to such “risk assessment” screening.

As required by the law, select agents, toxins or delivery systems can be possessed only if possession can be “reasonably justified” for specific “bona fide” research or other peaceful purposes, which has raised concerns biologists can no longer preserve specimens unspecific future use.

Security Risk Assessment

The classes of restricted people include aliens from a country on the State Department’s list of terrorism sponsors, admitted or convicted users of a controlled substance, persons indicted or convicted of a crime punishable by imprisonment for more than one year, dishonorably discharged veterans, fugitives from justice, illegal aliens, and persons adjudicated as mentally defective or committed to a mental institution.

HHS also may bar people suspected of involvement or association with organizations suspected of involvement in terrorism.

Violations can be punished with up to a $10,000 fine, 10 years imprisonment or both.  The regulations were published independently by the Health and Human Services and Agriculture departments, to implement requirements of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 signed into law last June and the USA Patriot Act signed October 2001 in the wake of the Sept. 11 attacks and anthrax mail attacks (see GSN, June 12 and Oct. 26, 2001).

“The [bioterrorism preparedness] act bolstered the authority to protect against misuse of select agents and toxins whether inadvertent or the result of terrorist acts against the United States homeland (such as the recent terrorist acts involving anthrax) or other criminal acts,” HHS said in a statement on the regulations.

Areas for Tightening Suggested

Ebright said the regulations represent an “important first step” in securing research laboratories with pathogens relevant to bioterrorism.

In a letter sent to the CDC yesterday, however, he called for strengthening the new rules in a number of areas.  He said the regulations should be more specific in describing how to control access to biological facilities and how to monitor security.  The new regulations leave those decisions to individual facilities, but Ebright said video surveillance and, in some cases, security personnel should be required.

Atlas said there was some merit to that idea, that the lack of specified measures “creates a certain angst for me and the community to know, ‘how do we know we did the right thing?’”

Ebright also recommended restricting additional types of research, such as efforts to make select agents resistant to vaccines, to make them more environmentally stable or to powderize or aerosolize them.

Atlas said such restrictions would need to be carefully scrutinized to prevent unnecessary limits on research into new vaccine delivery methods, or even something as common as deodorants.

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Smallpox:  Bush Prepares to Announce Vaccination Plan

U.S. President George W. Bush plans to announce tomorrow that military personnel and emergency workers will soon begin receiving smallpox immunizations, the New York Times reported today.  The vaccine will be available in 2004 to all U.S. residents who want it, administration officials said (see GSN, Nov. 25).

“I think it ought to be a voluntary plan,” Bush said in an ABC News interview broadcast yesterday.  “In other words, I don’t think people ought to be compelled to make the decision which they think is best for their family.  And what’s going to be very important is for us to make sure that there’s ample information for people to make a wise decision,” he added.

The United States plans to immunize up to 1 million military and emergency personnel in the first wave of vaccinations, which might begin in the next few weeks, administration officials said following the broadcast.

The television report seemed to surprise at least some top government health officials.

“We have no confirmation of the policy decision yet,” said Julie Gerberding, the director of the Centers for Disease Control and Prevention.  The CDC is currently evaluating smallpox immunization plans that states and large cities have submitted, she said (see GSN, Dec. 10).

“We have almost all the states’ plans and we are very pleased with the preliminary evaluation of them,” Gerberding said.

The administration has not decided, however, what to do about public demand for smallpox vaccine before sufficient stocks are licensed.  Officials can simply withhold the vaccine until 2004 — when sufficient amounts are expected to be available — or they can label the vaccine as an “investigational new drug” and make it available only to those who have a compelling need, according to the Times.

“The question is what do you do about John Q. Public between now and when licensed vaccine is widely available,” said a source familiar with the administration’s smallpox policy debate.  “That’s what the president hasn’t decided,” the source added (Stevenson/Altman, New York Times, Dec. 12).

“Preparing the emergency response teams is the highest priority,” an administration official said.  “Americans who feel they would like to be vaccinated will have access to it,” the official added.

Bush and his wife, Laura Bush, briefly addressed concerns about the vaccine’s side effects and said they would be comfortable having their 21-year-old twin daughters inoculated.

“If the vaccine were available, which I think it will be, I would feel like that was certainly safe for them to do,” Laura Bush said.  “I know there’s a slight risk.  That’s what people weigh when they make the decision whether or not to have their children vaccinated,” she added.

Meanwhile, the administration has come under fire for signing the Homeland Security Bill, which protects vaccine producers from lawsuits, without creating a compensation fund for those who suffer side effects from immunization, according to the Washington Post.

“Forcing people who are trying to do the right thing for the country to take care of themselves is wrong,” said Vermont Governor Howard Dean, a doctor and a Democratic presidential contender (Ceci Connolly, Washington Post, Dec. 12).

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Anthrax:  Brentwood Fumigation to Begin This Weekend

After preparing for almost a year, U.S. officials are expected to begin fully decontaminating the anthrax-tainted Brentwood Road postal facility in Washington this weekend (see GSN, Nov. 25).

During a community meeting yestereday, U.S. Postal Service officials provided details on the plan to sanitize the facility using chlorine dioxide gas.  Technicians plan to pump 2,000 pounds of gas into the facility starting Saturday, the Washington Post reported.  Scrubbers will then operate for 20 hours Monday to neutralize the gas, officials said.

Technicians are scheduled to enter Brentwood later in the week to collect thousands of spore strips and samples to determine whether the decontamination effort was a success.  A committee of Washington Health Department and U.S. Environmental Protection Agency specialists are expected to meet 30 days later to determine what, if any, further action is needed.

During yesterday’s meeting, postal officials told Brentwood-area residents and postal employees that the chlorine dioxide gas poses little risk.  Several safety measures have been established, including the installation of 26 air monitors around the facility and the establishment of a safety perimeter of 282 yards, officials said.  Additionally, technicians from the U.S. Environmental Protection Agency plan to patrol the area in a specially equipped bus and monitor air quality during the decontamination, the Post reported.

Several area residents and postal employees expressed concerns over the plan and criticized postal officials, the Post reported.

“Last year, they were ignorant (about how to respond to an anthrax attack), but this year, they’re experts,” said James Harper, a Brentwood worker and member of Brentwood Exposed, an employee support group (see GSN, Dec. 9; Manny Fernandez, Washington Post, Dec. 12).

For further information, see:

CDC Frequently Asked Questions About Anthrax

Journal of the American Medical Association Background on Anthrax

GSN Anthrax Attack Chronology (Dec. 12, 2001)

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British Response:  MPs Call for Stricter Controls on Research

Potential terrorists could easily obtain lethal pathogens just by signing up for certain research courses at British universities, members of the British House of Commons said today.

The current voluntary system for screening students from overseas needs to be strengthened, the Commons Foreign Affairs Committee said, urging the government to create a central authority to control all of the country’s dangerous biological materials (see GSN, Dec. 4).

“Our anxiety is that a fully qualified research scientist, who unknown to the authorities was a supporter of a terrorist group, could be admitted to a postgraduate or other research institution within the U.K. to pursue an approved program of research,” the committee said.

“Such a scientist could thus gain unhindered access to the dangerous materials or pathogens,” it added.

Officials do not believe that any terrorist groups that currently threaten the United Kingdom have obtained biological weapons, according to the Press Association.  A recent report from the Foreign Office, however, estimates that terrorists could possibly kill up to 3 million people by releasing 100 kilograms of anthrax from a tall building, the Press Association reported (Gavin Cordon, Press Association, Dec. 11).

For further information, see:

Biological Weapons Green Paper (British Foreign Affairs Committee)

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Smallpox I:  Israeli Inoculations Run Smoothly

Israeli officials have inoculated 15,000 emergency personnel, health workers and soldiers against smallpox, with almost no severe reactions to the vaccine, the New York Times reported today (see GSN, Oct. 24).

Israel is now poised to immunize its entire population in four days if a case of smallpox appears anywhere in the world, the Times reported.  The Israeli effort stemmed from discussion on the threat of smallpox in the United States, but the Jewish state has now “jumped far ahead” of U.S. efforts, according to Boaz Lev, director general of the Israeli Health Ministry.

“After Sept. 11, there was a profound change in our psychology,” Lev said.  “Although there was no new information on which to base our vaccination decision, the potential terrorist threat increased dramatically, especially in the minds of doctors,” he added.

Potential medical fallout from the vaccine has not surfaced even though a handful of every million people vaccinated would probably suffer severe side effects, and one or two of those people would probably die, according to health statisticians.

In the current batch of Israeli inoculations, only 5 percent of those immunized reported side effects that included headaches, muscle pain, fatigue and general weakness.  One woman who was not immunized was infected by her husband’s vaccine, but she responded quickly to treatment and recovered.

The vaccine that Israel uses, which is called Lister, is probably responsible for the lack of complications to date, Lev said.  The Lister vaccine is less dangerous than the U.S. vaccine, he said.  Extensive screening before vaccinations has also helped eliminate potential complications, he added.

Initially, up to half the Israeli candidates for immunization balked because of the vaccine’s potential dangers, the Times reported.  A public education program and doctors who set an example by being vaccinated reportedly increased immunization rates greatly.

Some medical professionals in Israel have protested the vaccination program for being too limited.  Upset that his recommendation to vaccinate the entire country was rejected, Aryeh Eldad this summer resigned his position as the head of a Health Ministry advisory team on immunization (see GSN, Aug. 14).  Israel is now considering widening the scope of its immunizations, Lev said.

The results of the Israeli vaccination campaign have fueled the drive of U.S. officials who support widespread smallpox immunizations in the near future, according to the Times.  U.S. President George W. Bush is expected soon to reveal his smallpox immunization plan, which might recommend immunizing as many as 500,000 emergency health workers and 500,000 military personnel (see GSN, Nov. 25).

“The United States has much to learn from Israel’s experience,” wrote Leonard Marcus, director of the health care negotiation and conflict resolution program at the Harvard School of Public Health in Massachusetts, in a recent report on Israel’s response to the threat of biological terrorism (Judith Miller, New York Times, Dec. 10).

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Smallpox II:  Vaccination Plans Vary Widely Among U.S. States

Most U.S. states have submitted smallpox vaccination plans to federal officials by this week’s deadline, the Associated Press reported today.

State’s vaccine requests vary greatly, from Georgia’s plans to inoculate up to 500 people to California’s request for 70,000 doses of the vaccine, AP reported.  Strategies on vaccination are also greatly varied.  Michigan, for example, has requested 5,000 to 7,000 doses to offer at roughly 30 hospitals.

“We don’t necessarily need it in every corner or at every hospital,” said Geralyn Lasher of the Michigan Department of Community Health.

North Dakota, however, plans to have at least 15 immunized workers at each of its 46 hospitals.

“We really believe that it’s likely that smallpox patients could present themselves at any of our hospitals,” said Tim Wiedrich, biological terrorism coordinator for the North Dakota Health Department.

The widespread nature of the requests was expected, according to at least one U.S. health official.

“We wanted to give them that flexibility,” said Jerome Hauer, the chief biological terrorism official at the U.S. Department of Health and Human Services.

U.S. officials plan to begin a public education campaign on the smallpox vaccine to coincide with the immunizations, which would begin after the Bush administration issues orders to state officials.  Once vaccinations are underway, states would be required to carefully monitor reactions and report twice a week to the Centers for Disease Control and Prevention.

Officials have said that fewer than 500,000 people will probably receive the shots because not all of those selected will agree to be vaccinated, and some will have conditions that put them at risk of side effects.

The effort will be “one of the most complicated logistic activities any state and local agency will have to undergo,” said Michael Osterholm, a University of Minnesota bioterrorism expert (Laura Meckler, Associated Press, Dec. 10).

Meanwhile, Arizona and a several other states missed the Monday deadline to submit smallpox vaccination plans, according to the Associated Press (see GSN, Nov. 22).

Arizona health officials said they expect Governor Jane Hull to approve their plan this week.  U.S. officials would receive the plan thereafter, but a state official said that immunizations are not imminent.

“We will not be giving any smallpox vaccinations until liability and compensation issues are cleared up,” said David Engelthaler, bioterrorism coordinator for the Arizona Department of Health Services (see GSN, Nov. 15).

The state’s plan includes phased vaccinations over six weeks, allowing medical personnel to learn more about side effects (Associated Press, Dec. 10).

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U.S. Response:  NIH Seeks to Sustain Increased Biological Defense Funding

By David Ruppe
Global Security Newswire

WASHINGTON — U.S. health officials are hoping to sustain unprecedented funding for bioterrorism defense-related research in the coming years, following a sizable increase by Congress this fiscal year (see GSN, Feb. 6).

That goal may be hard to achieve, however, in the face of a tough fiscal climate and the stated determination by the White House budget office to scrutinize new research funding requests closely for “high payoff” and “maximum efficiency and effectiveness.”

The National Institutes of Heath in fiscal 2003 was awarded $1.75 billion for biological defense-related work, an increase of nearly $1.5 billion over the previous year.  The fiscal 2003 funding will be distributed roughly in thirds for drug and vaccine development and testing, for basic and clinical research, and for constructing four regional biological defense research centers, each with Biosafety Level-3 or -4 biological containment facilities.

NIH forecasts a $421 million decrease in required funding for such facilities from fiscal 2003 to fiscal 2006 as up to 10 are built, but is hoping to see a corresponding $497 million increase for research funding including at the new centers, according to long-range budget data provided by National Institute of Allergy and Infectious Diseases Director Anthony Fauci in a presentation last week (see GSN, Aug. 16).

Fauci, speaking at a conference on biological defense funding here, seemed optimistic, saying, “I think we’re going to get reasonable increases from one year to another.”

Fauci spokesman Gregory Folkers said the overall funding level would basically remain the same according to the NIH plan, but struck a note of caution about the outcome.

“Of course, we can’t predict future budget levels, and numerous external factors may impact future funding.  Thus, the numbers Dr. Fauci discussed are possible scenarios, based on assumptions that may or may not come true,” he said.

Folkers said the biological defense funding plan was based on a careful assessment of what would be needed.

“The plan is designed to carefully balance and orchestrate the complex yet delicate interplay needed to successfully engage the best elements of academic and private sector research, to build and sustain research momentum, to identify and exploit research opportunities, to build and use critical research tools and infrastructure, and to make the optimum use of biodefense funds,” he said.

Fauci, Folkers and other experts jointly wrote in an American Society of Microbiology News article in August, “There is a dearth of investigators involved in research on some of the most important pathogens that could potentially be used in a bioterrorist attack.”

“Much of the 500 percent increase in funding will be wasted on research that lacks scientific merit, and thus has been unable to compete successfully for funding under previous standards for proposal review,” Richard Ebright, a chemistry professor at Rutgers University, wrote in an e-mail.

“Worse, the 500 percent increase will significantly increase the number of institutions and persons with access to, and training in handling of, BW agents, and thus will increase the probability of future accidental or deliberate releases of BW agents,” he said.

Biological Defense Given High Priority

In the wake of the Sept. 11 attacks and subsequent anthrax attacks last year, the Bush administration has declared bioterrorism defense a high priority.  Congress this year approved administration requests for approximately $600 million for Pentagon biological warfare defense research and $1.1 billion to strengthen state and local first response capabilities.

NIH says its biological defense research funds will be spent on expanding existing research on potential bioterrorist agents, developing new vaccines, therapeutic drugs and diagnostic tests, and expanding clinical research on newly discovered and developed products.

The new research facilities, called “regional centers of excellence for biodefense and emerging infectious diseases research,” will “enable biomedical research efforts on pathogenic microbes, including potential bioterrorism agents,” according to an NIH release describing its plan.

The centers also will be on hand to provide expert assistance to first responders in the event of a biological incident.

Tight Fiscal Climate

While the amount of money appropriated for biological defense research is dwarfed by the $400 billion national military budget this year, White House willingness to increase funding for biological defense research appears to remain an open question.

In two prominent documents, White House officials gave indications that additional funding requests for research and development in general in fiscal 2004 may be hard to come by.

In a May memo, Office of Science and Technology Policy Director John Marburger and Office of Management and Budget Director Mitchell Daniels encouraged agencies to “fund new, high priority activities by reallocating resources from lower-priority or recently completed activities.”

The memo said requests for additional funding would require “a compelling rationale that the activity is important …  and that funds from lower priority or recently completed programs cannot be substituted within the agency’s guidance level.”

Also, the administration’s budget document for fiscal 2003 said the overall $2.4 billion requested for biological defense research work at various agencies was intended for “jump-starting” research and development.

Federal finances currently are tight particularly in light of the struggling economy, expected ramping up of the administration’s 10-year tax reduction program, and significant funding increases for defense.

Fauci said he has had a number of discussions with senior administration officials, including Bush, inquiring into how the current level of funding would be spent.

Fauci said the message he took from those meetings is that research must be driven by defined goals and he said as a result greater emphasis will be placed within his institute on making basic research, the institute’s “classic” work, applicable to specific challenges.

When how research money would be spent in the future, he said, “We’re not going to skip over the basic research, but we are going to be very attentive to the basic research getting spelled out in definable endpoints.”

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Anthrax:  Postal Officials Hid Contamination, Watchdog Group Says

By Mike Nartker
Global Security Newswire

WASHINGTON — Judicial Watch, a nonprofit watchdog organization, announced Friday that it has requested a federal investigation into the U.S. Postal Service’s handling of last year’s anthrax contamination at a Washington postal facility (see GSN, Oct. 25).

In a Dec. 6 complaint to the U.S. Attorney’s Office for the District of Columbia, Judicial Watch alleged that the Postal Service knew by Oct. 18 last year that the Brentwood Road postal facility had become contaminated with anthrax.  Officials even knew specifically which mail-sorting machine had handled the contaminated letter, according to the complaint.

Despite written emergency regulations for the Postal Service, however, officials waited to close the facility until four days later, when the anthrax-related deaths of two Brentwood employees were announced, Judicial Watch said in a press statement.  The delay was caused, in part, by the Postal Service’s desire to avoid an estimated cost of $500,000 per day to close the facility, according to Judicial Watch.

As a result of the Postal Service’s delay, Brentwood employees were prevented from obtaining tests for anthrax exposure and preventive antibiotics in a timely manner, Judicial Watch said (see GSN, March 8).  The group has called on federal prosecutors to investigate whether to charge postal officials with any crimes, possibly including involuntary manslaughter, conspiracy, and obstruction of justice.

The organization has filed the complaint on behalf of hundreds of postal employees and a postal employee support group called Brentwood Exposed.  Judicial Watch has based its complaint on documents obtained from the Postal Service through a court order, including a log kept by a senior Brentwood official, according to the Judicial Watch statement.

“The criminal act of terrorism perpetrated by a still unidentified person or persons, by the transmission of anthrax pathogen through the U.S. mail, has been exponentially compounded by crimes of commission and omission at Brentwood by [the U.S. Postal Service] and/or U.S. government officials,” Judicial Watch said in the complaint.

The Postal Service considers the allegations to be “without merit,” a spokeswoman said, according to an Associated Press report Saturday.

Judicial Watch has also filed a complaint with the Equal Employment Opportunity Commission for an investigation into whether the Postal Service’s actions violated the civil rights of Brentwood employees, the Judicial Watch said in the press statement.  While the Postal Service delayed action at Brentwood, where employees are 97 percent African-American, the predominately white staff members in the offices of Senators Tom Daschle (D-S.D.) and Patrick Leahy (D-Vt.), which also received anthrax-tainted letters, received more timely care, Judicial Watch alleged.

For further information, see:

GSN Anthrax Attack Chronology (Dec. 12, 2001)

Journal of the American Medical Association Background on Anthrax

CDC Frequently Asked Questions About Anthrax

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Smallpox:  WHO Plans to Increase Vaccine Stocks

World health officials have agreed to increase global stocks of smallpox vaccine, Reuters reported Friday (see GSN, Dec. 3).

Health officials from Mexico, the World Health Organization and the Group of Seven industrialized countries — who met Dec. 6 in Mexico City for the Ministerial Meeting on Health Security and Bioterrorism — have agreed to increase funding for the WHO’s smallpox vaccine stocks, according to Reuters (see GSN, Dec. 3).

“We don’t want to alarm our people,” British Health Minister Alan Milburn said.  “And yet we’d be failing in our obligation if we didn’t prepare for the worst,” he added (Richard Jacobsen, Reuters, Dec. 6).

Meanwhile, five groups that represent emergency health workers in the United States have formed a smallpox task force to weigh in on the inoculation debate, the Baltimore Sun reported today.  U.S. President George W. Bush is reportedly considering a voluntary plan to immunize 500,000 health care workers and 500,000 military personnel against smallpox.

The worker organizations acted because “no one has asked our advice,” said Robert McNamara, chair of emergency medicine at Temple University Hospital in Pennsylvania.

Emergency workers might not want to be inoculated, according to the Sun.  For example, half of the participants in a recent survey of 80 nurses were unwilling or unsure whether they would want to be immunized, according to William Chiang, an emergency specialist at Bellevue Hospital in New York who conducted the survey.  Those who said they would refuse to take the vaccine totaled 11 percent, according to the Sun, and 39 percent said they had not yet decided.

“Unfortunately, there hasn’t been a lot of outreach from the government to the people who are going to be asked to be immunized,” McNamara said (Knight Ridder/Baltimore Sun, Dec. 8).

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U.S. Response:  CDC Issues New Laboratory Guidelines

The U.S. Centers for Disease Control and Prevention issued new guidelines yesterday to increase security at laboratories that handle dangerous biological pathogens (see GSN, Dec. 4).

The recommendations — which call on laboratories to limit access to sensitive areas, to keep pathogens secure and to monitor areas where they are stored — are meant to aid facilities in developing soon-to-be required security plans, the Associated Press reported.  Previous information on such plans was a “fairly scampy” two pages, said Steve Ostroff, deputy director of the CDC National Center for Infectious Diseases.

The CDC is expected to require all laboratories to develop a biological security plan when it publishes new regulations next week to help improve security of dangerous pathogens.  The regulations also are expected to order tighter security at laboratories that handle “select agents,” which consist of more than 40 of the most dangerous pathogens such as anthrax and Ebola, AP reported.  The regulations will require personnel who work with select agents to undergo background checks, and they will require every facility that possesses a select agent to register with federal regulators and submit to inspections, according to AP.  Previously, only laboratories that transferred or received samples of select agents were required to register (Laura Meckler, Associated Press/Baltimore Sun, Dec. 6).

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