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The FDA Has Revolutionized Drug Approvals Over the Past Decade

Mother Jones

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I was reading something yesterday about President Trump’s desire to speed up FDA approvals for new drugs, so I decided to check: how long does FDA approval take these days? Here are the numbers over the past decade:

I’ve used a 3-year rolling average to smooth out the spikes, but the trend is pretty obvious. In the past ten years, the time to approve new drugs has been cut in half and the approval rate has tripled. Note that this is only for “standard” drugs, not “priority” drugs, so it’s not contaminated by special treatment given for certain lifesaving compounds.

I’m sympathetic to arguments that our narrow escape from the thalidomide disaster traumatized FDA scientists, and they overreacted by making approvals too hard. The problem is that the lesson of thalidomide approval in Europe isn’t that approvals were done too quickly, it’s that approvals shouldn’t be based on handwaving from pharmaceutical companies. As long as the testing regimen is rigorous enough, there’s no reason that approvals shouldn’t be done in a timely way.

That said, how much faster does Trump want approvals to go? A recent study suggests that the average FDA approval time is now considerably faster than Europe’s, and that “the vast majority” of new drugs were first approved for use in the United States:

If anything, the FDA may have become too aggressive. They’ve made some far-reaching reforms in only a decade. Ten years from now, the chart to look at will be a comparison of drug catastrophes before and after this change.1

1I don’t mean this in a snarky way. There’s no cosmic “right answer” for how fast new drugs should be approved. It’s all a matter of how much risk we’re willing to take vs. how long we’re willing to delay potentially effective therapies. A decade from now, we’ll need to look back and see just how much extra risk, if any, the FDA has introduced into the system.

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The FDA Has Revolutionized Drug Approvals Over the Past Decade

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10 Uses for Rainwater

Collecting your own rainwater is an excellent way to conserve this precious resource. A basic rainwater collection system catches rainwater from your roof or other surface and channels it into a container for storage.

Rainwater itself is generally clean, but it can pick up microorganisms, pollutants and debris when it hits your roof. This is why systems for rainwater use inside your home often include filtration or other treatments for safety.

Outdoor rainwater collection systems dont need as much treatment because the water is typically used outside. One of the easiest rain collectors to make is a repurposed old garbage can. Whereas, you can install a rainwater cistern if you want a larger system.

There are many different uses for collected rainwater no matter what type of rainwater harvesting system you have.

1. Drinking and cooking

Rainwater can actually be very high-quality water for human consumption. Its relatively pure and doesnt contain any chlorine or other chemicals, which are often used to sanitize city tap water. The problem starts when rainwater is collected from roofs or other dirty surfaces. You can make rainwater safe to drink by installing a filtration system, boiling or distilling the water. Some systems can also directly collect clean rainwater to use for drinking.

2. Bathing and laundry

Washing clothes accounts for about 22 percent of indoor water use in the United States. Showers take 17 percent, and baths 2 percent. If you used harvested rainwater for all of these, you could reduce your municipal water use by over 40 percent. Depending on how clean you want your washing water, you could use either treated or untreated rainwater. SFGate has some suggestions on how you can treat rainwater to use for showering.

3. Flushing toilets

This is another huge water drain. Toilets use almost 27 percent of water in your home. To use collected rainwater instead, try keeping a bucket of it next to your toilet. When you need to flush, pour the rainwater straight into the bowl of the toilet. This will automatically flush your toilet. Make sure your bucket can hold the amount of your toilets tank. For instance, if you have a toilet with a 6 gallon (22.7 liter) tank, use at least a 6 gallon bucket of water

Another option is to plumb a pipe for rainwater directly into your house and connect it to your toilet for flushing. Check out a very low-tech method to do this.

4. Watering lawns, gardens and houseplants

Rainwater is naturally designed to water plants, and it can easily be used for your indoor and outdoor gardens. You can use rainwater in watering cans to water plants by hand. You can also attach any rainwater storage tanks directly to an automatic irrigation system.

Passive systems to conserve and collect water in your soil are also helpful. Plant garden beds along the edges of your driveway, or at the bottom of a hill, to take advantage of waters natural movement. Also, try planting a raingarden at the ends of your eavestroughs to catch any excess runoff.

5. Composting

Water is essential for proper decomposition of your compost pile. Make sure you water your compost with the rest of your garden. Harvested rainwater is also good for compost tea. Home Composting Made Easy describes a simple way to make compost tea.

6. Water for wildlife, pets or livestock

You can use recycled rainwater for birdbaths, troughs, or other containers for wildlife to visit. Rainwater is also typically safe for pets or livestock to drink or wash in, especially if you have a method to collect clean rainwater directly.

7. Outdoor ponds and water features

Rainwater can be filtered for use in fountains or other water features with pumps that could get clogged. Otherwise, you can fill outdoor ponds and pools with any type of collected rainwater.

8. Rinsing vegetables

Dirty rainwater is great for rinsing vegetables straight from your garden, especially root vegetables. Try filling a large bucket with rainwater, adding some carrots, potatoes, beets or other hard vegetables, and swish them together to knock the soil off.

9. Washing vehicles and equipment

Washing outdoor items is another excellent use for untreated rainwater. Cars, garden tools, lawnmowers, tractors and even the driveway and sides of your house are all perfect candidates.

10. Fire protection

A rainwater catchment system with a large storage tank could give you some extra protection if you live in an area prone to wildfires. Make sure you also install a good pump so you can access the water quickly if needed.

Related
12 Ways to Get Rid of Aggressive Weeds Without Resorting to Roundup
Weeds That Are Good for Your Garden
20 Ways to Conserve Water at Home

Disclaimer: The views expressed above are solely those of the author and may not reflect those of Care2, Inc., its employees or advertisers.

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10 Uses for Rainwater

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Wilderness Areas Worth Protecting Now

September is National Wilderness Month. What better time to focus on public lands that should be federally designated as wilderness under the Wilderness Act?

Here are 5 places that particularly deserve to become official wilderness. But first,what does it actually mean to be officially classified as wilderness under the Wilderness Act?

The Wilderness Act, which became law in 1964,recognized wilderness as an area where the earth and its community of life are untrammeled by man, where man himself is a visitor who does not remain.

The Wilderness Act created a National Wilderness Preservation System that now includes more than 106 million acres of federal public lands as wilderness, 44 million acres of whichare in 47 parks. Fifty-three percent of the lands in our national parks are also classified as wilderness.

Designated wilderness is the highest level of conservation protection for federal lands. Wilderness areas are supposed to be regions left to the forces of nature, though the Wilderness Act does acknowledge the need to provide for human health and safety, protect private property, control insect infestations and fight fires within the area.

Congress may designate wilderness or change the status of wilderness areas, which is why, given this era of political gridlock, so few public lands have been designated as wilderness in the last couple of decades. Conservationists, environmentalists, biologists and ecologists usually favor protecting wild public lands as wilderness. The coal, oil, natural gas and mineral extraction industries do not.

The President of the United States can protect public lands by giving them National Monument status when Congress won’t protect them as wilderness. However, national monument status may still allow mining, grazing and road development if these things were occurring at the time the area was designated. Wilderness designation prevents these activities from occurring on pristine public lands so they remain in their natural state.

Here are 5 proposed regions of the United States that environmentalists are working to get Congress to protect as federal wilderness.


Photo Credit: Wikimedia Commons

The Coastal Plain of the Arctic National Wildlife Refuge

The Udall-Eisenhower Wilderness Act would protect the birthing ground for thousands of caribou, migratory and resident birds and polar bearsan area of unmatched ecological importance for the human inhabitants and wildlife of the region. The region faces continual threats from oil drilling.


Photo Credit:The Armchair Explorer

Maine Coastal Islands

The Maine Coastal Islands Wilderness Actwould protect13 remote, uninhabited islands off the coast of Maine, especially the nesting habitat they provide for a variety of sea birds. Wilderness preservation would also enable kayakers and boaters to continue to enjoy the ocean and beaches there.


Photo Credit: Wikimedia Commons

The Rocky Mountain Front

The Rocky Mountain Front forms the eastern edge of the already existingBob Marshall wilderness. It provides habitat for elk and native trout and is one of the last places in America where grizzly bears still roam the plains. The Front is a world-class destination for hunting, wildlife viewing, birding, backpacking and horseback riding. The Rocky Mountain Front Heritage Act will provide permanent protection for this ecosystem.

Photo Credit: Wikimedia Commons

Cerros del Norte in New Mexico

The Cerros del Norte Conservation Act would expand protection of lands northwest of Taos, New Mexico to safeguard what the

Campaign for America’s Wilderness

calls “one of the world’s great avian migratory routes.” The areas are also home to elk, deer, turkeys, golden eagles, and other wildlife.


Photo Credit: Flickr

Devil’s Staircase, Oregon

The Devils Staircase Wilderness Actwould permanently protect 30,000 acres of forest close to the southern coast of Oregon as wilderness. It would also place stretches of Wasson and Franklin Creeks into the National Wild and Scenic Rivers System. Theproposed wildernessis characterizedby rare old-growth forest and an abundance of wildlife,including elk, deer, river otters, black bears and spotted owls.

Related:

President Obama Creates Three New National Monuments
Support Tennessee Wilderness and Protect Our Wildlife and Outdoor Heritage

Disclaimer: The views expressed above are solely those of the author and may not reflect those of Care2, Inc., its employees or advertisers.

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Wilderness Areas Worth Protecting Now

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Inmates Are Kicking Off a Nationwide Prison Strike Today

Mother Jones

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Prisoners across the country are gearing up for what they hope will be one of the largest prison strikes in history. According to activists, today prisoners in at least 21 states, including at least 800 inmates in California, will refuse to go to work to protest what they call “modern-day slavery.”

“This is a call to end slavery,” reads the official call for the strike, which coincides with the 45th anniversary of the Attica prison uprising. “They cannot run these facilities without us.” Though there have been prison strikes in the past, including one in Texas in April and one in Alabama in May, this will be one of the first times that inmates have tried to coordinate a strike on a national level.

“Work is good for anyone,” says Melvin Ray, an inmate at the W.E. Donaldson Correctional Facility in Bessemer, Alabama, and a member of an organizing group called the Free Alabama Movement. “The problem is that our work is producing services that we’re being charged for, that we don’t get any compensation from.”

Inmates throughout the country generally hold jobs that help maintain their prisons, such as landscaping, cleaning, and kitchen work. Wages vary from state to state. In at least three states—Texas, Arkansas, and Georgia—prisoners are not paid anything for their labor. In federal prisons, inmates earn about 12 to 40 cents an hour. Nor can prisoners opt out of working, says Paul Wright, an editor at Prison Legal News. “Typically prisoners are required to work, and if they refuse to work, they can be punished by having their sentences lengthened and being placed in solitary confinement,” Wright says.

Phillip Ruiz, an organizer with the Incarcerated Workers Organizing Committee (IWOC), was incarcerated in California for nearly 10 years. He recalls having a job baking bread that earned him just nine cents a month, while a can of soda at the commissary cost around $2 and a packet of ramen cost $1. “You have to save up for six months just to buy some food products,” he says. “It reminds me of a sweatshop on a huge, much larger level.”

Ray, who is serving a sentence for murder, says one of the strike’s goals is to raise awareness among prisoners “that not only do we have a significant role in our incarceration, we have a significant opportunity to bring about our own freedom.” The Free Alabama Movement came up with the idea for the strike. Last fall, it circulated a pamphlet encouraging prisoners in each state to come up with their own demands for improving prison conditions.

“We’re realistic. We know that all our demands aren’t going to be given to us,” Ruiz says of the strike. “The hope is that some concrete things develop as far as changing the conditions.” He hopes the protest will send the message to prison authorities that “You guys aren’t going to get away with what you’re doing to prisoners anymore.”

Cole Dorsey, an IWOC organizer in the Bay Area, says that inmates understand that going on strike comes with serious risks: inmates could be put into solitary confinement or segregation, and could lose phone call and visiting privileges—”all the things that prisoners look forward to,” says Ruiz. But both Dorsey and Ruiz say that inmates are prepared to face them. “It’s a slow death that we’re facing anyway,” says Dorsey, “so we’re going to confront the system head-on.”

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Inmates Are Kicking Off a Nationwide Prison Strike Today

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Clinton might pick whatshisname — that ag guy — for Veep

Clinton might pick whatshisname — that ag guy — for Veep

By on Jul 19, 2016Share

Rumor has it that Hillary Clinton may pick Tom Vilsack, President Obama’s Secretary of Agriculture, as her veep. Sen. Tim Kaine of Virginia and other names come up more frequently, but Vilsack has a good shot according to Politico reporters Gabriel Debenetti and Helena Bottemiller Evich.

What to say about Vilsack? As Vanity Fair put it: “Vilsack is boring, as even his staunchest defenders will admit.”

Vilsack spins his dullness as a virtue. “I’m a workhorse, not a show horse,” he told Politico.

The former governor of Iowa is the longest serving member of Obama’s cabinet. People seem to like him on both sides of the aisle. His record is squeaky clean, except for one real scandal. In 2010, he fired a USDA employee and all around admirable person, Shirley Sherrod, after Breitbart News made allegations about her that turned out to be false. He apologized a couple of days later and said he’d made a mistake.

Vilsack has pushed programs to fight poverty and worked closely with Michelle Obama on school lunch standards. He’s also overseen a big increase in funding for local and organic farm programs — too much according to some row-crop farmers, and not enough according to some activists. He’s a reformer, working within the system rather than tearing it down, much like a certain presidential candidate.

Election Guide ★ 2016Making America Green AgainOur experts weigh in on the real issues at stake in this electionGet Grist in your inbox

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Why Fireworks Are Even More Dangerous This Year

Mother Jones

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For years, teenagers from the Southern United States have made a trip to South Carolina to stop at the dozens of shops, stands, and warehouses that sell fireworks with names like “Red, White, and Boom,” “Bad Blonde Joke,” and “One Bad Mother-in-law.” The Palmetto State has long been a destination for pyro-loving patriots because of its lax fireworks laws: The minimum age to buy celebratory explosives is 16, and nearly every type of firework is for sale.

But crossing state lines for July Fourth party favors may not be as common this year. States are increasingly relaxing their fireworks laws, by dropping the minimum age requirement below 18 or allowing a wider variety of backyard explosives to be sold. Georgia, West Virginia, and New York are among the states that have made changes to the laws over the past year.

The looser laws haven’t come without controversy. Fireworks are notoriously dangerous (remember last year when two NFL players lost fingers during fireworks accidents?), and child safety groups are raising concerns that allowing minors to get hold of fireworks will lead to more firework-related injuries around the summer holiday.

There’s some evidence backing that worry. Twelve-year-olds are injured by fireworks more than any other age group, according to an analysis by StatNews. And boys are mostly to blame: Of the 225 12-year-olds injured by fireworks between the late ’90s and 2015, only 50 were girls.

Source: National Electronic Injury Surveillance System Chart by Natalia Bronshtein/Statnews

A recent study by pediatric researchers at the University of Louisville found that the severity of firework burns in kids has increased over the last decade, and that the average age of kids burned decreased from 12 to 11 years old. Though he can’t pin it completely on changes in the law, the study’s lead author, Dr. John Myers, says there’s definitely a connection.

“When states switched from 18 to 16, that’s the big difference we’ve seen,” Myers said. “We advocate states to go back to 18.”

Source: National Electronic Injury Surveillance System Chart by Natalia Bronshtein/StatNews

Other groups oppose fireworks for reasons other than the injuries they cause. The National Fire Protection Association takes an avid stance against the use of any backyard firework because of their link to summer fires. According to the association, fireworks caused an estimated 15,600 fires in 2013. Nearly 30 percent of all firework-caused blazes between 2009 and 2013 happened on July Fourth.

On the other side of the debate are advocates for backyard fireworks, who argue that people will mess around with the things whether or not they’re allowed to. Julie Heckman, executive director of the American Pyro Association, which represents various firework and pyrotechnic companies, says the at-home explosives are actually more dangerous when they’re illegal because people use even less caution.

“Independence Day is so recognized as the holiday that people use backyard consumer fireworks—it’s part of our American culture,” Heckman said. “In the areas that have prohibition, people choose to use them anyway…They are very careless.”

Heckman points out that in the three states that have a complete ban on consumer fireworks—Massachusetts, Delaware, and New Jersey—firework-related injuries still occur. For example, the Massachusetts Fire Incident Reporting System found there were 775 fire-related incidents over a 10-year period, with 15 people injured. Those numbers still pale in comparison to numbers from states that have more relaxed laws: In South Carolina, 182 people were injured by fireworks in 2010 alone.

Either way, states are moving ahead and making it easier for teens to get hold of sparklers and other fireworks. The big bucks they’ll rake in as a result can’t hurt: In New York, which just relaxed its firework laws in some counties, tax revenue from firework sales could reach as much as $2 million.

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Why Fireworks Are Even More Dangerous This Year

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Don’t Worry Super-Rich, Paul Ryan’s Tax Plan Still Has Your Back

Mother Jones

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House Republicans rolled out a roadmap for tax reform Friday that drastically cuts corporate taxes and benefits high-income taxpayers—but not nearly as much as the plan proffered by the party’s presumptive presidential nominee, Donald Trump.

House Speaker Paul Ryan unveiled the GOP proposal—the sixth and final policy blueprint that the House GOP has issued this month under Ryan’s direction—at a news conference in Washington. The plan would slash corporate rates from the current 35 percent to 20 percent and lower the top individual rate from 39.6 to 33 percent. (Trump has proposed cuts to 15 and 25 percent, respectively.) The blueprint also eliminates the estate tax, long a target of Republicans in Congress, and lowers the tax rate on income from investments.

“The way I’d sum it up is: We want a tax code that works for the taxpayers—not the tax collectors,” Ryan said. “We want to make it simpler, flatter, fairer…Make it so simple that the average American can do their taxes on a postcard.”

Since taking the House in 2011, Republicans have repeatedly promised to overhaul the tax system, which hasn’t seen a major update since 1986. But they have stumbled over a political roadblock: Every major deduction or tax credit has a devoted constituency who would be enraged were it to be eliminated. The last comprehensive Republican proposal was submitted in 2014 by retired Rep. Dave Camp (R-Mich.), former chairman of the House Ways and Means Committee. His scheme varied significantly from the new blueprint. It lowered the corporate rate to 25 percent rather than 20 percent and cut the top individual rate just to 35 percent, while at the same time sacrificing popular deductions on charitable giving and mortgage interest. It failed to attract much support within the party and never received a vote.

The new blueprint is more circumspect, maintaining the mortgage and charitable deductions, as well as the Earned Income Tax Credit, a key poverty-fighting tool, and a deduction for spending on higher education. It leaves it to the Ways and Means Committee to reform these programs. Otherwise, the plan makes an effort to simplify the system, replacing itemized deductions with a higher standard deduction and eliminating most business tax breaks. It also reduces the number of income tax brackets from seven to three.

It is not yet clear whether the plan would add to the deficit. But as Howard Gleckman of the nonpartisan Tax Policy Center writes, “It is hard to imagine how these tax cuts could pay for themselves.” The House GOP’s scheme is bound to cost less than Trump’s tax cuts. Experts estimate that the presumptive nominee’s plan would shrink revenues by $9.2 trillion over 10 years, forcing draconian cuts in government spending.

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Don’t Worry Super-Rich, Paul Ryan’s Tax Plan Still Has Your Back

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The Supreme Court Just Shot Down a Big Challenge to Affirmative Action. Read the Decision Here.

Mother Jones

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The Supreme Court delivered a major victory for affirmative action on Thursday, rejecting a challenge to a University of Texas admissions system that uses race as a factor to ensure diversity for a portion of its student body. The case, Fisher v. University of Texas, concerns the school’s use of a “holistic” system for 25 percent of its class—the rest of the class as admitted purely on the basis of high school grades—that includes race among other factors. A white applicant who was rejected by the school challenged the system.

On Thursday, the Supreme Court sided with the university in a 4-3 decision. Read the full ruling here:

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Read more about the man who brought this case to the Supreme Court and statements by the late Justice Antonin Scalia earlier in the case suggesting that black students belong at “slower” colleges.

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The Supreme Court Just Shot Down a Big Challenge to Affirmative Action. Read the Decision Here.

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Finally You Can See How Much Added Sugar Is Hidden in Your Food

Mother Jones

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After years of delay, the Food and Drug Administration finalized new nutrition facts labels on Friday. The label you’re used to seeing on processed foods was more than 20 years old; the government says the new one reflects updated scientific information and “will make it easier for consumers to make better informed food choices.”

The changes include a magnified calorie count and the addition of a line showing added sugar (highlighted below).

Food and Drug Administration

It’s a big deal that companies will now have to identify the added sugar in their food. Once corn-syrup-filled sodas and cheap processed snacks started overtaking our supermarkets in the 1960s, added sweeteners infiltrated nearly every corner of the American diet. As I’ve written in the past:

Naturally occurring sugars (the kind in fruit, for example) come with fiber, which helps us regulate the absorption of food. Without fiber, sugar can overwhelm your system, eventually leading to obesity, diabetes, heart disease, and other health problems.

Given these risks, experts have warned that no more than ten percent of your daily calorie intake should come from added sugar, or around 12 teaspoons a day; Americans wolf down 30 teaspoons on average by some estimates. It doesn’t help that three-quarters of processed snacks include such added sweeteners. But until now, consumers had no real way of knowing how much of the sugar in their food was naturally occurring, and how much was added in manufacturing. Adding to shoppers’ confusion is how tricky it can be to determine whether sugar is an ingredient in a food: it goes by at least 57 names.

With the new labels, manufacturers will have to reveal more about how they use this ubiquitous ingredient. Time will tell whether the transparency spurs big food companies to look past adding sugar and find new ways to make their food palatable.

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Finally You Can See How Much Added Sugar Is Hidden in Your Food

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Congressional Committee Says We Should Draft Women

Mother Jones

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Last year, the Pentagon announced that women would be allowed to join men in front-line combat positions in the military for the first time. This year, women may also have to join men in registering for the draft.

The House Armed Services Committee narrowly passed an amendment to the 2017 defense spending bill on Wednesday that would require women to register with the Selective Service System, the federal agency that administers military drafts. A draft hasn’t been held since the Vietnam war, but all American men between the ages of 18 and 25 are still required to register. Some members of Congress now want women to share the burden.

“If we want equality in this country, if we want women to be treated precisely like men are treated and that they should not be discriminated against, then we should support a universal conscription,” said Rep. Jackie Speier (D-Calif.), according to The Hill. The Army and Marine Corps’ top generals have already endorsed making women register. Most countries that draft soldiers only do so for men, but a handful, including Norway and Israel, also conscript women.

The amendment, introduced by former Marine officer Rep. Duncan Hunter (R-Calif.), essentially backfired for him. In fact, Hunter does not support drafting women or allowing them to serve in jobs like the infantry, but has said that Congress should debate the issue of women in combat instead of allowing the Obama administration to simply change the military’s regulations. This amendment was his attempt to push the issue to the limits and thereby dissuade others from supporting putting women on the front lines. “The draft is there to get more people to rip the enemy’s throats out,” Hunter said. “I don’t want to see my daughters put in a place where they have to get drafted.”

Other members want to do away with draft registration altogether, saying a volunteer military is more effective. “The bar would have to be dramatically lowered if we were to return to conscription again,” said Rep. Mike Coffman (R-Colo.), according to the Washington Post. Coffman co-sponsored a bill introduced in February that would end Selective Service altogether. Rep. Peter DeFazio (D-Ore.), who also sponsored the bill to end selective service, argues the draft also needlessly punishes those who don’t register by cutting them off from federal aid and jobs. “It’s mean-spirited, stupid, unnecessary, and a huge waste of taxpayer money,” DeFazio told Mother Jones.

The Selective Service System currently costs about $23 million dollars per year. Lawrence Romo, the director of the Selective Service System, estimates the agency would require another $8 million per year if women were included in the draft.

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Congressional Committee Says We Should Draft Women

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