Clinic Registration Pub: Fill & Download for Free

We’re going to examine homicide statistics in the United States from 2010 to 2014. It’s a recent five year span which should be proportionately representative of the present and the period doesn’t contain any particularly large statistical anomalies. In this context, it’s important to note that murder is specifically defined as the willful, unlawful killing of another person. Murder is distinct from justifiable homicide which involves the willful, lawful killing of a felon by a law enforcement officer or private citizen.[1]Seen below is a table showing the number of murders in the United States categorized by weapon:Image by the Federal Bureau of Investigation (Expanded Homicide Data Table 8)One of the striking things about those statistics is the disproportionately large number of murders committed using handguns. That number is consistently more than twice that of every other single category of weapon and every other category of firearm combined (even assuming the category “Firearms, type not stated” excluded all handguns, which it most certainly does not).The disproportionate use of handguns in murders isn’t unique to the United States either. In most nations where handguns are in widespread circulation, they are the weapon of choice in murders. In most nations where handguns are not in widespread circulation, knives are the weapon of choice in murders. The prevalence of both handguns and knives as murder weapons can be reasonably assumed to be the result of both weapon types being convenient and easily accessible during an argument or concealable enough to allow a murderer to get fairly close to a victim. This assumption is reasonably well supported by the available data outlining the circumstances of murders.[2] However, an important difference between knives and handguns is that knife attacks are substantially less likely to result in a fatality than attacks using handguns. It’s also much easier to block or run away from a knife than a handgun.Things get even more interesting though when we look at justifiable homicide data.Image by the Federal Bureau of Investigation (Expanded Homicide Data Table 14)Image by the Federal Bureau of Investigation (Expanded Homicide Data Table 15)The numbers for law enforcement aren’t especially surprising because virtually every officer in the United States carries a handgun on a daily basis. It makes perfect sense that the bulk of justifiable homicides by law enforcement officers are performed using handguns. Likewise, it’s not surprising that the bulk of justifiable homicides by private citizens are performed using handguns given the prevalence and convenience of handguns. What is surprising is just how few justifiable homicides happen in comparison to murders. It would seem the common narrative that good guys with guns frequently kill bad guys with guns is grossly overamplified by proponents for gun ownership.However, it can be said with accuracy that many self defense cases involving guns do not end in a justifiable homicide. Unfortunately, there is no solid statistical data on just how many people defend themselves with guns every year. Research conducted by organizations biased towards gun ownership consistently use statistically unsound methods which result in estimates of multiple millions of defensive gun uses each year. Research conducted by organizations which use statistically sound methods results in yearly estimates in the 60,000–80,000 range, but the scope of the research may be too narrow and therefore omit a statistically significant number of defensive gun incidents.What good statistical data is available for is the number of robberies and aggravated assaults involving firearms. There are consistently around 120,000 robberies involving firearms every year and usually over 140,000 aggravated assaults involving firearms every year. Although the firearms used in these robberies and aggravated assaults are not broken down by type, there’s no reason to believe that the distribution would appear significantly different than that seen in homicide. In other words, it seems most likely that the type of firearm most commonly seen in these non-fatal violent crimes is a handgun.Image by the Federal Bureau of Investigation (Table 15)Image by the Federal Bureau of Investigation (Table 15)Regardless of the statistical frequency of non-lethal defensive gun use, it is readily apparent to me that the illegal use of handguns is a significant problem in the United States.Furthermore, it’s my experience that handguns are categorically the worst defensive firearms available. The problem isn’t that they can’t make holes that incapacitate people, they’re all clearly quite capable of that. The problem is that handguns are extraordinarily difficult for most people to shoot accurately in any conditions which remotely resemble a lethal confrontation because handguns can only be aimed using a single point of contact, the grip. It requires an asinine level of training to become competent in shooting a pistol under stress.By contrast, long guns, rifles and shotguns, can be shot much more accurately because the user can hold on to the grip with their firing hand, plant the buttstock against their firing shoulder, and stabilize the long gun with their non-firing hand by holding on to the forend. Those three points of contact make it quite possible for relatively new users to accurately shoot long guns with relatively little training and press long guns into defensively usage easily.So when people advocate for handguns as defensive weapons, I become highly skeptical about the credibility of those claims. The only things handguns are good at are being compact and convenient. Long guns are superior in every other way. In military combat where handguns and long guns are both convenient and available, you will always find that long guns are the cause of nearly all non-explosive related casualties and handguns cause so few casualties that they’re almost not statistically significant. Handgun accuracy among law enforcement officers, people ostensibly trained and competent in the use of handguns, is statistically abysmal. Essentially what I’m saying is that the reverence for handguns in the United States is severely misplaced and not grounded in reality.So what should be done about handguns in the United States?If you look at the weapons regulated by the National Firearms Act of 1934, the list is perplexing without historical context. Placing controls on machine guns makes sense from a public safety standpoint because machine guns fire immense volumes of bullets in a short period of time. Regulating silencers seems like an obvious attempt to prevent gunshots from going unnoticed when guns are fired illegally. Meanwhile, somewhat concealable firearms like short barreled rifles and shotguns have regulations placed on them while even more concealable handguns are unregulated.If you read through the 1934 congressional hearings on the National Firearms Act (NFA),[3] you’ll find that handguns were very much intended to be regulated in a similar manner to short barreled shotguns in the original legislation. Interestingly, when asked about dropping pistols from the NFA in favor of increased regulations on machine guns or sawed-off shotguns, the Attorney General of the United States in his testimony explicitly warned “I think it would be a terrible mistake to adopt any half-way measures about this. I think the sooner we get to the point where we are prepared to recognize the fact that the possession of deadly weapons must be regulated and checked, the better off we are going to be as a people.” In the end though, handguns weren’t regulated by the NFA. I happen to think that statistics have proven the Attorney General correct some 84 years later.At this point, I very much believe that handguns can and should be regulated like short barreled shotguns under the NFA. I believe that one of the major problems with various incarnations of the “Assault Weapons Ban” is that said laws are inherently not retroactive and do nothing about existing weapons. This is not the case in regards to guns regulated by the NFA; all firearms described by the NFA, with the exception of antiques, must be registered with the federal government.In order to come into possession of an NFA firearm, normally an individualmust obtain approval from the ATF, pass an extensive background check to include submitting a photograph and fingerprints, fully register the firearm, receive ATF written permission before moving the firearm across state lines, and pay a tax.[4]Although legislating that existing handgun owners must register their handguns under the NFA sounds complex, it really isn’t and our existing legal code is already set up for adding new classes of firearms to the National Firearms Act with nothing more than simple legislation. The following provisions are buried within the Internal Revenue Code:[5]Section 207 of Pub. L. 90–618, as amended by Pub. L. 99–514, §2, Oct. 22, 1986, 100 Stat. 2095, provided that:“(a) Section 201 of this title [enacting this chapter] shall take effect on the first day of the first month following the month in which it is enacted [October 1968].“(b) Notwithstanding the provisions of subsection (a) or any other provision of law, any person possessing a firearm as defined in section 5845(a) of the Internal Revenue Code of 1986 [formerly I.R.C. 1954] (as amended by this title) which is not registered to him in the National Firearms Registration and Transfer Record shall register each firearm so possessed with the Secretary of the Treasury or his delegate in such form and manner as the Secretary or his delegate may require within the thirty days immediately following the effective date of section 201 of this Act [see subsec. (a) of this section]. Such registrations shall become a part of the National Firearms Registration and Transfer Record required to be maintained by section 5841 of the Internal Revenue Code of 1986 (as amended by this title). No information or evidence required to be submitted or retained by a natural person to register a firearm under this section shall be used, directly or indirectly, as evidence against such person in any criminal proceeding with respect to a prior or concurrent violation of law.“(c) The amendments made by sections 202 through 206 of this title [amending sections 6806 and 7273 of this title, repealing sections 5692 and 6107 of this title, and enacting provisions set out as a note under this section] shall take effect on the date of enactment [Oct. 22, 1968].“(d) The Secretary of the Treasury, after publication in the Federal Register of his intention to do so, is authorized to establish such period of amnesty, not to exceed ninety days in the case of any single period, and immunity from liability during any such period, as the Secretary determines will contribute to the purposes of this title [adding this chapter, and sections 6806 and 7273 of this title, repealing sections 5692 and 6107 of this title, and enacting provisions set out as notes under this section].”This means that the Secretary of the Treasury can at any time authorize an amnesty period in which owners of unregistered (read as illegally possessed) NFA firearms can register those firearms and never be prosecuted for anything related to those firearms. Additionally, while normal NFA registrations require a $200 tax, there is no requirement for a tax to be imposed on amnesty registrations, so there is no legally mandated financial disincentive. Although there hasn’t been an amnesty since 1968, the last one was implemented for the purposes of getting war trophy machine guns registered and was wildly successful. Everybody who registered their previously illegal (and in some cases outright stolen) machine gun got to keep their registered gun and the government got to know where more machine guns were to help with record keeping.There are several effects that regulating handguns under the NFA would have:Everybody who isn’t irrationally paranoid about the federal government confiscating guns would register during the amnesty period and be fine.People who are irrationally paranoid about the federal government confiscating guns and refuse to register could be prosecuted for NFA violations piecemeal as they became noticed.Straw purchases for new handguns would virtually disappear because NFA requirements are significantly more stringent than normal and link specific people to specific guns. Straw purchases are cases in which people buy guns for other people who can’t pass a background check.The black market for handguns will shrink and prices for black market handguns will rise as handguns are inevitably removed from circulation and fewer handguns flow into the black market as replacements due to a severe reduction in straw purchases.If future executives and lawmakers actually wanted to keep handgun buying constituents happy, those executives and lawmakers would have to properly and adequately fund the Bureau of Alcohol, Tobacco, Firearms, and Explosives if they wanted the NFA approval process to work in a timely manner. This would have the additional positive side effect of allowing the BATFE to better enforce all laws instead of being hamstrung by wholly inadequate funding. Finally, since NFA regulation has historically proven to decrease the frequency in which regulated firearms are used in crime, it is reasonable to assume that the frequency of handgun usage in criminal activity would decrease over time.Although I don’t think regulating handguns in this manner would see popular support, there are several regulations which I do think would see popular support.The Gun Control Act of 1968 mandated that manufacturers and commercial sellers of firearms had to obtain a Federal Firearms License (FFL). This was done under the guise of regulating interstate commerce, trade which crosses state lines. The federal government is generally not allowed to regulate intrastate commerce, trade which remains entirely within a state. In 1994, the Brady Handgun Violence Prevention Act mandated that FFL holders had to perform a background check on any firearm transferred through the FFL to a individual who does not hold an FFL. In 1998, this process was streamlined into the National Instant Criminal Background Check System (NICS).With that in mind, we’re going to look at how firearms are legally purchased currently so we can have a perspective on potential improvements to the process.When buying a gun through an FFL, buyers must fill out BAFTE form 4473. I strongly recommend readers view the form. Buyers must submit valid photo identification (usually a driver’s license) to the FFL holder to verify their identity and some of the information on their form 4473. There are three categories of firearm which can be bought through a standard FFL dealer: handguns, long guns (rifles and shotguns), and “other firearms”. Buyers must be 18 years of age to buy long guns and 21 years of age to buy handguns from an FFL. “Other firearms” are a weird category which includes receivers for firearms (which is generally the serialized portion of a firearm) or firearms which do not fit the legal definition of a handgun or long gun but are also not regulated by the National Firearms Act. If the “other firearm” can be made into a pistol, the buyer must be 21 years of age. After a buyer has completed their form 4473, the FFL holder calls NICS and relays the completed information to the FBI.Source: (NICS Process in Motion for the Gun Buyer Video Transcript)The FBI runs the information through the NICS database. If the buyer’s provided information has matches within the NICS database, this will generate a “hit”. At the moment, hits include indictments and convictions for felonies, indictments and convictions for domestic violence, indictments and convictions for other crimes which are punishable by one or more years of imprisonment, known fugitives, dishonorable discharges, adjudications which determined an individual to be mentally defective, restraining orders for children or intimate partners, renouncements of citizenship, unlawful users of controlled substances, illegal aliens, and resident aliens who do not meet very specific criteria.If no hits in the NICS database are generated, the FFL is told to “proceed” and the FFL may complete transferring the firearm at the business’s discretion. If the buyer’s provided information generates a hit, the call will be transferred to an FBI employee who will review the information and determine whether the hit matches the rest of the buyer’s provided information. If the hit is valid and the buyer is a prohibited purchaser, the FFL will be told to “deny” the transfer. If the FBI employee determines the hit is invalid, the FFL will be told to “proceed”. If the FBI employee can not immediately determine the validity of a hit, the FFL will be told to “delay” the transfer and the FBI will do more research to determine the validity of a hit. At this point, the FBI is allotted three business days to tell the FFL to “proceed” or “deny”. If those three business days pass without a final judgement, the FFL may proceed with the transfer at their discretion. The system is set up this way so the FBI can not delay a buyer they can not prove is a prohibited possessor of firearms indefinitely, essentially amounting to a denial without due process of law. Nevertheless, some FFL holders maintain a policy of not proceeding with transfers which have do not receive a definite “proceed”; that is the business’s prerogative.If at any point in this process the FFL holder or its employees believes a buyer is purchasing a firearm on behalf of another person, then the FFL will deny the transfer independent of any judgement made by the FBI. Purchasing a firearm on behalf of another person is illegal.Now what about “internet gun sales”?Websites in the business of selling firearms are legally required to acquire an FFL. Since the website which holds an FFL can not visually verify a buyer’s identity, this means the firearms they sell are legally required to be transferred to an FFL near the buyer. At the FFL which facilitates the transfer, the buyer will be required to complete a form 4473 and go through a background check as described above.On auction sites which deal with firearms, buyers and sellers who do not hold FFLs will submit the information of an FFL near each party and arrange for the firearm to be transferred. The seller’s FFL will ship the firearm to the buyer’s FFL and once again the buyer will complete a form 4473 and go through a background check.The final category would be classified websites which allow firearms to be posted for sale. These are essentially the 21st century equivalent of posting a classified advertisement in a newspaper. In these cases, a buyer contacts the seller who posted the advertisement and the two parties enter negotiations. If the buyer and seller legally reside within the same state and are able to meet face to face to conduct a transfer, the firearm in question may be legally bought under federal law without a background check being conducted provided the seller does not have reason to believe the buyer is a prohibited possessor. If any of those conditions are not met, or if state law prohibits intrastate commerce in this fashion, then FFL holders must once again be involved. These conditions apply to all private person to person sales. One noteworthy quirk, under federal law, persons between the ages of 18 and 21 are not prohibited from purchasing a handgun through a private sale. This is in fact one of the very few ways citizens in this age group can exercise their constitutional right to possess handguns.What about gun shows?If a person buys a firearm from an FFL participating in a gun show (this constitutes the majority of firearm sales at gun shows) then a 4473 is filled out as normal. If a person is buying a firearm from a private party, laws regarding private sales apply. Think of gun shows simply as a way for people who might be interested in buying or selling firearms to all be in the same place at the same time. There’s nothing sneaky or tricky about them, they literally happen in convention centers and on fairgrounds. Local police and BATFE agents are always present at gun shows.Now that we have all that basic information out of the way, we can talk about actual changes to federal law.First let’s take a look at prohibiting suspected terrorists from purchasing firearms. We can all agree we hate terrorists, but they still have due process rights. Fortunately, the FBI is in charge of both the Terrorist Screening Database (TSDB) and the NICS database. Prospective gun buyers with records that produce a match in the TSDB could generate a hit in the NICS database. The FBI could then investigate the hit and, assuming the hit actually matched the buyer in question, determine whether or not to tell the FFL to delay the transfer. Within the current three day delay window, the FBI could bring the case before a judge. Should the judge find probable cause, the transfer could be legally halted. At this point the buyer should be notified and be interviewed as part of the investigation. If charges are appropriate, the FBI can file charges in a timely manner. Otherwise, the suspect should be allowed to go about their business without further interference. That puts a lot of burden on the FBI, but it isn’t supposed to be easy to legally strip citizens’ rights in the United States. Remember, the burden of proof always lies upon the accuser, not the defendant.One rather common gun control proposal in the United States is that of universal background checks on all firearm sales, including private intrastate sales. On a practical level, compliance and enforcement of a universal background check would be very difficult without some kind of national firearm registry linking specific firearms to their owners. No national firearm registry exists for regular rifles, shotguns, or pistols at the moment and it’s actually illegal to create one because of the Firearm Owners Protection Act passed in 1986. There remains a visceral fear of a firearms registry among many conservatives; the concerned parties believe that all firearm registries are nothing more than a precursor to the total confiscation of all firearms. This belief is objectively refuted because numerous firearm registries in multiple US states and democratic countries as well as a national registry on firearms regulated by the National Firearms Act exist and have not been precursors to a total confiscation of all firearms. However, many conservatives latch onto the words of a select handful of extremist politicians who espouse a desire for confiscation as proof that confiscation is the inevitable result of all registries.With all that being said, what might be feasible as an alternative to a universal background check is creating an online version of form 4473 so the public could voluntarily conduct background checks without going to an FFL. This is actually something most gun owners want because, at the moment, there’s no way of conducting a background check for a private intrastate sale in most states without involving an FFL. Involving an FFL introduces a financial disincentive because FFLs are businesses and usually charge for their services. I’ll propose the best system I’ve thought of so far which allows for minimal fraud and abuse.First, create a secure electronic variant of the 4473. It should include the buyer and seller information along with contact information for both parties. Once the form is completed, a unique confirmation number is sent out to both parties using the provided contact information. Both parties enter their confirmation numbers, then the form is submitted to the FBI and run through the NICS database. A single transaction number is generated for the NICS check and provided to the buyer and seller. The parties then call a phone number for a NICS automated line and enter the transaction number along with their unique confirmation numbers. This transfers the call to a live operator who examines the results of the NICS check performed for the transaction. The operator then tells the seller to “proceed”, “delay”, or “deny” just as they would with an FFL.The idea behind the whole system is that it allows for an effective background check to be done while offering a reasonable measure of privacy for the buyer. Sure, somebody could abuse the system if they wanted to put in enough effort, but they wouldn’t get very much information. It also removes a financial disincentive; it only costs individuals time to do a check like this and the check and be performed virtually anywhere, not just at FFL locations.Now, let’s discuss assault weapons and magazines which hold more than ten rounds. The problem with the Federal Assault Weapons Ban of 1994 was that it didn’t do anything except drive up prices on the magazines and weapons described by the ban. There was no measurable impact on crime during the ten years the Assault Weapons Ban was in effect.Here is how assault weapons were defined in 1994:Semi-automatic rifles able to accept detachable magazines and two or more of the following:Folding or telescoping stockPistol gripBayonet mountFlash suppressor, or threaded barrel designed to accommodate oneGrenade launcher mountSemi-automatic pistols with detachable magazines and two or more of the following:Magazine that attaches outside the pistol gripThreaded barrel to attach barrel extender, flash suppressor, handgrip, or suppressorBarrel shroud safety feature that prevents burns to the operatorUnloaded weight of 50 oz (1.4 kg) or moreA semi-automatic version of a fully automatic firearm.Semi-automatic shotguns with two or more of the following:Folding or telescoping stockPistol gripDetachable magazine.All of those things are cosmetic features that can be designed around. In fact, they frequently were and are designed around. Even today in states with more stringent feature based assault weapon bans, like California, there exist so called “featureless” firearms which are perfectly legal and not objectively worse for killing people than assault weapons. Now we could try an assault weapon ban again and again have no impact on crime… or we could recognize that semiautomatic centerfire weapons are undeniably the arms of choice in a militia. Police and military forces all over the world use semiautomatic (or fully automatic) centerfire weapons almost exclusively. As such, it makes more sense to more stringently regulate all semiautomatic centerfire weapons, not just a certain subset with specific cosmetic features. At the same time, we can breathe new life into the militia concept described by the Second Amendment to the United States Constitution, even make the militia well regulated.In the United States, we currently have an organization called the Civilian Marksmanship Program, a federally chartered corporation whose purpose is:To instruct citizens of the United States in marksmanship;To promote practice and safety in the use of firearms;To conduct competitions in the use of firearms and to award trophies, prizes, badges, and other insignia to competitors.Among numerous other things, the CMP sells M1 Garand rifles. The Garand is a .30–06 semiautomatic battle rifle roughly twice as powerful as common AR-15 or Kalashnikov rifles. The Garand was the primary infantry rifle of the US military during the Second World War and the Korean War. The CMP literally sells them so people can practice target shooting with a weapon of war.Image by Curiosandrelics - Own work, CC BY-SA 3.0, File:M1-Garand-Rifle.jpg - Wikimedia CommonsLet’s take a look at eligibility requirements for the CMP:REQUIREMENTS FOR PURCHASEBy law, the CMP can sell surplus military firearms, ammunition, parts and other items only to members of CMP affiliated clubs who are also U.S. citizens, over 18 years of age and who are legally eligible to purchase a firearm.PROOF OF U.S. CITIZENSHIP:You must provide a copy of a U.S. birth certificate, passport, proof of naturalization, or any official government document (When using a military ID to prove citizenship, must be an E5 or above) that shows birth in the U.S. or states citizenship as U.S.PROOF OF AGE:You must provide proof of age. Usually proof of citizenship also provides proof of age. In those cases where it may not, a driver’s license is sufficient.MEMBERSHIP IN CMP AFFILIATED ORGANIZATION:You must provide a copy of your current membership card or other proof of membership. This requirement cannot be waived. The CMP currently has over 2,000 affiliated organizations located in many parts of the country. CMP Club Member Certification Form- If your CMP affiliated club does not issue individual membership cards, please have the club fill out the CMP Club Member Certification Form and return it with your order.Membership in many of these organizations costs $25.00 or less and can be accomplished online. A listing of affiliated organizations can be found by clicking on our Club Search web page at http://ct.thecmp.org/app/v1/index.php?do=clubSearch. If you have any difficulty in locating a club, please contact the CMP at 256-835-8455 or by emailing CMP Customer Service. We will find one for you. In addition to shooting clubs, the CMP also has several special affiliates. Membership in these organizations satisfies our requirement for purchase. These special affiliates include: Congressionally chartered veterans' organizations such as the VFW, AL, DAV, MCL, etc. U.S. Military services (active or reserves), National Guard, to include retirees. Professional 501(c)3 law enforcement organizations and associations such as the FOP, NAPO, NSA, etc. The Garand Collector's Association is a CMP Affiliated Club. You can download a Garand Collector's Association Application Form.Note: Club membership IS required for purchase of rifles, parts, and ammunition.Club membership is NOT required for instructional publications or videos or CMP memorabilia.MARKSMANSHIP OR OTHER FIREARMS RELATED ACTIVITY:You must provide proof of participation in a marksmanship related activity or otherwise show familiarity with the safe handling of firearms and range procedures. Your marksmanship related activity does not have to be with highpower rifles; it can be with smallbore rifles, pistols, air guns or shotguns. Proof of marksmanship participation can be provided by documenting any of the following:Current or past military service.Current or past law enforcement serviceParticipation in a rifle, pistol, air gun or shotgun competition (provide copy of results bulletin).Completion of a marksmanship clinic that included live fire training (provide a copy of the certificate of completion or a statement from the instructor).Distinguished, Instructor, or Coach status.Concealed Carry License.Firearms Owner Identification Cards that included live fire training. - FFL or C&R license.Completion of a Hunter Safety Course that included live fire training.Certification from range or club official or law enforcement officer witnessing shooting activity. Complete the CMP Marksmanship Form to certify your range firing and the required marksmanship related activity for an individual to purchase from the CMP.No proof of marksmanship required if over age 60. Proof of club membership and citizenship required for all ages. NOTE: Proof of marksmanship activity is not required for purchase of ammunition, parts, publications or memorabilia.BE LEGALLY ELIGIBLE TO PURCHASE A FIREARM:The information you supply on your application will be submitted by the CMP to the FBI National Instant Criminal Check System (NICS) to verify you are not prohibited by Federal, State or Local law from acquiring or possessing a rifle. Your signature on the Purchaser Certification portion of the purchase application authorizes the CMP to initiate the NICS check and authorizes the FBI to inform CMP of the result. IMPORTANT: If your State or locality requires you to first obtain a license, permit, or Firearms Owner ID card in order to possess or receive a rifle, you must enclose a photocopy of your license, permit, or card with the application for purchase.As you can see, the CMP eligibility process is quite a bit more involved than the background check system we have now. It seems to have worked for keeping the powerful semiautomatic Garand rifles out of the hands of mass murderers. The last mass shooting on US soil that I know of which involved an M1 Garand was the Kent State massacre and that involved the Ohio National Guard shooting anti-war protesters, not civilians who were sold rifles through the CMP. I haven’t been able to find any records of crimes committed with guns sold through the CMP. I’m sure it has happened at one point in time or another, but the occurrence is so rare that there hasn’t been any documentation. My point is that the CMP has a really great track record in the United States for making sure guns don’t go to bad guys.Since the Assault Weapons Ban of 1994 didn’t have any measurable impacts on crime and the CMP has great results, I propose we extend the CMP eligibility requirements to all semiautomatic centerfire firearms and centerfire magazines with more than ten rounds of capacity. This means only people who meet the listed criteria will be able to buy the types of weapons most useful in a militia which are also the weapons we primarily see used in mass shootings from an FFL. The proposal also effectively introduces a mandatory training and basic competency requirement before individuals can purchase semiautomatic centerfire weapons from a gun store. The inclusion of CMP eligibility for the purchase of centerfire magazine over ten rounds creates a strong incentive for existing gun owners and individuals who purchase firearms through private intrastate sales to get training and join the CMP if they want easy access to centerfire magazines over ten rounds.The word centerfire is really important because there is another class of firearms which use rimfire cartridges.A collection of rimfire and centerfire cartridges, left to right: .22lr (rimfire), .22WMR (rimfire), .357 magnum (centerfire), .30–06 Springfield (centerfire), 12 gauge shotshell (centerfire)Rimfire cartridges aren’t very powerful; they’re mostly used for small game hunting and target shooting. Most countries allow ownership of semiautomatic rimfire rifles with only basic licensing; countries like Canada and the UK don’t even have restrictions on magazine capacity for rimfire rifles. Could they be used by a mass shooter? Sure, anything could, but semiautomatic rimfire firearms just aren’t a threat compared to semiautomatic centerfire firearms or even non-semiautomatic centerfire firearms. Wounds caused by bullets fired from rimfire cartridges are almost always less severe than wounds caused by bullets fired from centerfire cartridges. Very precise shot placement is required for rimfire weapons to instantly kill a person and mass shooters are unlikely to take the time to precisely place their shots.Seen above are four rimfire rifles made by Marlin.Regulating firearms in this way allows new gun owners to hunt, shoot targets, and defend themselves using semiautomatic rimfire or manually operated firearms. If new gun owners want easy access to semiautomatic centerfire firearms which are useful in a militia context, they can join the CMP, effectively becoming a member of a well regulated militia, after demonstrating themselves to be competent and well trained.I have some final thoughts on the CMP related proposal before moving on to the next topic. CMP eligibility introduces additional layers of human interaction between people and semiautomatic centerfire weapons and centerfire magazines over ten rounds. Barring major advances in mental healthcare and adjudication in the United States, layers of human interaction are the best way for red flags to be raised about somebody who might want to kill large numbers of people with a firearm. Additional layers of human interaction also introduce a larger hurdle for straw purchasers, people who buy firearms for people who can’t pass background checks because they’re ineligible to own firearms. Additional layers of human interaction make law enforcement investigations slightly easier as well.At the moment, laws, standards, and permits for carrying concealed handguns vary wildly. Some states have no requirements while other states functionally don’t allow anybody except police officers to carry handguns in any way. While the percentage of the US population which actually carries handguns regularly, concealed or openly, is relatively small, those who do carry handguns regularly can often face great legal peril for no particularly good reason when crossing state lines. At the same time, it would be good for the public to know that people carrying concealed handguns are actually competent and not a hazard to the public. In essence, a balance would be preferable to the extremes which currently exist.I propose creating an national permit for carrying concealed handguns in any state. Police officers already enjoy something similar to this. The permitting process should include a standardized class which can be taught by police officers or other qualified instructors. Before attending the class, applicants should undergo a background check. Among other things, the class should cover the legal use of deadly force, safe firearms handling practices, and conflict deescalation practices. Then applicants should be given a written test on the subjects. If the applicants pass, they should then undergo a practical handgun handling and shooting competency test. If applicants are able to both handle handguns safely and shoot accurately, they will then be issued a carry permit which is valid for a certain number of years; three to five years seems reasonable. If applicants fail either test then they go home without a permit and can retake the whole class the next time it is offered if they still wish to carry a concealed handgun.It’s worth noting that if my suggestion to regulate handguns under the National Firearms Act were ever implemented, creating a national permit for carrying concealed handguns would practically become a necessity. At the moment, written approval from the BATFE is required before crossing state lines with an NFA firearm. That system would not be sustainable in terms of labor costs and paperwork if handguns suddenly came under the purview of the NFA.Footnotes[1] Murder[2] https://ucr.fbi.gov/crime-in-the-u.s/2014/crime-in-the-u.s.-2014/tables/expanded-homicide-data/expanded_homicide_data_table_11_murder_circumstances_by_weapon_2014.xls[3] National Firearms Act[4] National Firearms Act - Wikipedia[5] U.S.C. Title 26 - INTERNAL REVENUE CODE

ICMR-DBT GUIDELINES FOR EVALUATION OF PROBIOTICS IN FOOD Department of Biotechnology Ministry of Science and Technology New Delhi Indian Council of Medical Research Department of Health Research Ministry of Health & Family Welfare New Delhi 2011 Published by: Director General Indian Council of Medical Research New Delhi - 110 029 Indian Council of Medical Research © Indian Council of Medical Research July 2011 Further details: Dr. G.S. Toteja [email protected] 011-23731633 Production Controller: J.N. Mathur, Press Manager Published by the Division of Publication, Information & Communication on behalf of the Director General, Indian Council of Medical Research, New Delhi -110029 Printed at: Aravali Printers & Publishers Pvt. Ltd., W-30, Okhla Industrial Area, Phase-II, New Delhi - 110 020 CONTENTS Foreword v Preface vii Acknowledgements viii Composition of Task Force ix Abbreviations x 1. Introduction 1 2. Guidelines and requirements for probiotic products 2 2.1 Scope 2 2.2 Definition of probiotics 2 2.3 Genus, species and strain identification 2 2.4 In vitro tests to screen potential probiotic strains 2 2.5 In vivo safety studies in animal models 3 2.6 In vivo efficacy studies in animal models 3 2.7 Evaluation of safety of probiotics for human use 3 2.8 Evaluation of efficacy studies in humans 3 2.9 Effective dosage of probiotic strain/ strains 4 2.10 Labeling Requirements 4 2.11 Manufacturing and handling procedures 4 3. References 6 4. Glossary 9 v Dr. Maharaj Kishan Bhan Secretary to Government of India MD, DSc, FNA, FASc, FAMS Department of Biotechnology Ministry of Science and Technology FOREWORD [ Probiotics are bacteria that help maintain the natural balance of microflora in the intestines. The normal human digestive tract contains about 400 types of probiotic bacteria that reduce the growth of harmful bacteria and promote a healthy digestive system. Experiments into the benefits of probiotic therapies suggest a range of potentially beneficial medicinal uses for probiotics. Recent research on the molecular biology and genomics of Lactobacillus has focused on the interaction with the immune system, anti-cancer potential, and potential as a biotherapeutic agent in cases of antibiotic-associated diarrhoea, travellers’ diarrhea, paediatric diarrhoea, inflammatory bowel disease and irritable bowel syndrome. The increasing globalization of food trade has resulted in India being a fast emerging market for probiotic products. With the availability of these products increasing exponentially and the multiple claims made regarding the beneficial health effects, there is the need to put in place sufficient safeguards to protect the consumers from any adverse effects, ensure standardization of commercial products and their efficacy. The present ICMR-DBT guidelines comprehensively address the various concerns regarding safety, efficacy and reliability as well as labeling of probiotic products being sold in India. I hope the scientific community, the regulatory agencies and the public at large will be benefited by these guidelines. (M.K. Bhan) vii Dr. Vishwa Mohan Katoch Secretary to Government of India MD, FNASc, FAMS, FASc, FNA Department of Health Research Ministry of Health & Family Welfare & Director General Indian Council of Medical Research PREFACE The concept of probiotics was introduced in early 20th century, however they gained importance in recent years with the emerging scientific evidences suggesting their role in digestive and immunological functions. During the last decade there has been increased influx of probiotic products in Indian market. However, there was no systematic approach for evaluation of probiotics in food to ensure their safety and efficacy. Being the apex body in India for the formulation, coordination and promotion of biomedical research, Indian Council of Medical Research (ICMR) along with Department of Biotechnology (DBT) took the initiative to formulate the guidelines for evaluation of probiotics in food in India. A Task Force was constituted to examine various guidelines available in different parts of the world and deliberate on the relevant issues keeping in view the local conditions. The guidelines formulated and presented in this document define a set of parameters required for a product/ strain to be termed as ‘probiotic’. These include identification of stain, in vitro screening for probiotic characteristics, animal studies to establish safety and in vivo animal and human studies to establish efficacy. These also include requirements for labeling of the probiotic products with strain specification, viable numbers at the end of shelf life, storage conditions etc which would prevent misleading the consumer. These guidelines have been developed for scientific purpose with the main aim to guide the regulatory authority for evaluating probiotic products in our country. I hope that these will also stimulate thinking among scientists interested in developing this area in India. (V.M. Katoch) viii ACKNOWLEDGEMENTS We gratefully acknowledge the help rendered by all the people involved in the formulation of guidelines. We are grateful to Dr. N.K. Ganguly, Chairperson of the Task Force on ‘Guidelines for evaluation of Probiotics in Food’ and Former Director General, Indian Council of Medical Research for identifying the need and significance of guidelines on probiotics in food. The Task force has met thrice to formulate and thoroughly discuss every aspect of the guidelines. Further, Core group and follow up meetings were also held to go over certain technical details of the document. We are grateful to all the Task Force member for their contributions in preparing guidelines and refinement of the manuscript. We also acknowledge the inputs received from the NGOs/Industry representatives present in the scientific deliberations and the suggestions received from others following posting of draft guidelines on ICMR website. Efforts of ICMR and DBT secretariat for putting together the available information and co-ordinating the activities of the Task Force is also acknowledged. (Dr. K. Satyanarayana) Head Division of Reproductive Health & Nutrition and Publication and Information ICMR Hqrs, New Delhi ix TASK FORCE ON ‘GUIDELINES FOR EVALUATION OF PROBIOTICS IN FOOD’ Chairperson Dr. N.K. Ganguly President, JIPMER, Puducherry Former Director-General, ICMR, New Delhi Former Director In-charge, PGIMER, Chandigarh Members Dr. S.K. Bhattacharya Former Addl. Director General ICMR, New Delhi Dr. B. Sesikeran Director National Institute of Nutrition Hyderabad Dr. G.B.Nair Director, National Institute of Cholera & Enteric Diseases Kolkata Dr. B.S. Ramakrishna Professor & Head Department of Clinical Gastroenterology & Hepatology Christian Medical College, Vellore Dr. H.P.S. Sachdev Senior Consultant Department of Pediatrics and Clinical Epidemiology Sitaram Bhartia Institute of Science & Research, New Delhi Dr. V.K. Batish Former Head, Dept of Microbiology National Dairy Research Institute Karnal Dr. A.S. Kanagasabapathy Consultant Biochemist Kamineni Hospitals Hyderabad Dr. Vasantha Muthuswamy Former Head (RHN & BMS) ICMR Hqrs, New Delhi Dr. S.C. Kathuria Deputy Assistant Director General (PFA) Food Safety & Standards Authority of India New Delhi Co-ordinating unit Indian Council of Medical Research, New Delhi Dr. V.M. Katoch Secretary, DHR & DG, ICMR Dr. K. Satyanarayana Head RHN and P&I Dr. G.S. Toteja Scientist ‘F’ Member Secretary & Convener Dr. Manju Rahi Scientist ‘C’ Ms. Spriha Rao Research Scholar Department of Biotechnology, New Delhi Dr. M.K. Bhan Secretary, Department of Biotechnology Dr. Rajesh Kapur Advisor (Food & Nutrition) x ABBREVIATIONS BMS : Basic Medical Sciences CFU : Colony Forming Units DBT : Department of Biotechnology DHR : Department of Health Research DNA : Deoxyribonucleic Acid FAO : Food and Agricultural Organization GCP : Good Clinical Practices GMO : Genetically Modified Organisms GMP : Good Manufacturing Practices GRAS : Generally Recognized as Safe HACCP : Hazard Analysis and Critical Control Point ICMR : Indian Council of Medical Research ICPS : International Committee on Systematics of Prokaryotes JIPMER : Jawaharlal Institute of Post Graduate Medical Education and Research PCR : Polymerase Chain Reaction PFGE : Pulsed Field Gel Electrophoresis PGIMER : Postgraduate Institute of Medical Education & Research PI : Publication & Information RNA : Ribonucleic Acid RHN : Reproductive Health & Nutrition SOPs : Standard Operating Procedures WHO : World Health Organization 1 ICMR-DBT GUIDELINES FOR EVALUATION OF PROBIOTICS IN FOOD 1. INTRODUCTION The concept of probiotics (which means, “for life”) was introduced in early 20th century by Elie Metschnikoff (1), it however gained momentum only recently with considerable and significant advances in functional and health food market across the world. India is also fast emerging as a potential market for probiotics in food. The global probiotic market generated US $15.9 billion in 2008 and is expected to be worth US$ 32.6 billion by 2014 with a compound annual growth rate of 12.6% from 2009 to 2014 (2). On the other hand the probiotic product industry in India was estimated to be around Rs 20.6 million with a projected annual growth rate of 22.6% until 2015 (3). Probiotics, especially Lactobacillus and Bifidobacterium have been suggested to be associated with alleviation of lactose intolerance (4); prevention and cure of viral, bacterial and antibiotic or radiotherapy induced diarrhoeas (5,6,7); immunomodulation (8); antimutagenic (9) and anticarcinogenic effects (10); and even blood cholesterol reduction (11). The optimism associated with probiotics is, however, counter-balanced by skepticism as many “probiotic” products in the market are unreliable in content and unproven clinically (12-15). Also, Lactobacilli and Bifidobacteria have been rarely associated with human clinical infections which are likely to be a result of opportunistic infections especially in immunocompromised individuals (16-17). Many probiotic strains in use for several decades have been validated for their safety and efficacy and are therefore, safe to use (18,19). Any new strain used as a probiotic should be evaluated for safety and efficacy. However, Enterococcus is emerging as an important cause of nosocomial infections and isolates are increasingly becoming vancomycin resistant (20). Some side effects, though rare with probiotics are i) systemic infections ii) deleterious metabolic activities iii) excessive immune stimulation in susceptible individuals and iv) gene transfer (21). The absence of pathogenicity and infectivity thus is an essential pre-requisite of probiotic safety (22). International guidelines (23,24) on probiotics in food broadly specify the kind of tests that may be required to determine the safety and to assess the health claim of a probiotic product in food. Such tests are based on the current understanding of the subject. The regulatory mechanism for probiotics differs from country to country and also even within a country (23,25). In India there are no regulatory guidelines for probiotic foods. In the absence of any such standards and guidelines, there is great scope for spurious products with false claims being marketed. It therefore, becomes imperative that these products fulfill some essential prerequisite conditions before being labeled as a ‘probiotic product’. A holistic approach is therefore needed for formulating 2 guidelines and regulations for evaluating the safety and efficacy of probiotics in India which should be in consonance with current international standards. Keeping in view the above, a Task Force was constituted by ICMR, comprising of experts from varied fields to develop guidelines for evaluation of probiotics in food in India. The Task Force took into consideration the guidelines available in different parts of the world (20, 26-31) and deliberated on the various aspects to be covered (32-36). The guidelines set forth in this document are meant to be followed for a strain or food to be termed as ‘probiotic’ for marketing in India. 2. GUIDELINES AND REQUIREMENTS FOR PROBIOTIC PRODUCTS 2.1. Scope: The guidelines deal with the use of probiotics in food and provide requirements for assessment of safety and efficacy of the probiotic strain and health claims and labeling of products with probiotics. Note: These guidelines are not meant for probiotics which by definition would come under drugs, beneficial microorganisms not used in foods or genetically modified microorganisms (GMOs). 2.2 Definition of Probiotics: Probiotics are ‘live microorganisms which when administered in adequate amounts confer a health benefit on the host’ (FAO/WHO, 2002) (20). 2.3 Genus, species and strain identification: Effects of probiotics are strain specific. Strain identity is important to link a strain to a specific health effect as well as to enable accurate surveillance and epidemiological studies. Both phenotypic and genotypic tests should be done using validated standard methodology. Nomenclature of the bacteria must conform to the current, scientifically recognized names as per the International Committee on Systematics of Prokaryotes (ICPS) (available at Home) (37). A flow diagram indicating various steps for evaluation of candidate probiotic strains is given at figure 1. The current molecular techniques used for identification include PCR based techniques, 16S rRNA sequencing and DNA finger printing techniques like Ribotyping and Pulsed Field Gel Electrophoresis (PFGE). It is recommended that probiotic strains in use in India should be deposited in an internationally recognized culture collection/repositories. 2.4 In vitro tests to screen potential probiotic strains: The following in vitro tests* with standard methodology are recommended for screening putative probiotic strains: 2.4.1 Resistance to gastric acidity. 2.4.2 Bile acid resistance. 2.4.3 Antimicrobial activity against potentially pathogenic bacteria (acid and bacteriocin production) * Adherence to mucus and/or human epithelial cells and cell lines has in the past been used to screen candidate probiotics. The Committee debated this and concluded that there are probiotics which are not adherent. Hence this should not be used as a mandatory criterion or to claim superiority of one strain over another in terms of probiotic attributes and functionality. 3 2.4.4 Ability to reduce pathogen adhesion to surfaces 2.4.5 Bile salt hydrolase activity These tests are based on the hostile gut environment which they mimic under in vitro conditions. The cultures evaluated as probiotics based on these tests should be subjected to preclinical validation in appropriate animal models before clinical trials are conducted in human subjects. 2.5 In vivo safety studies in animal models: Assessment of the acute, subacute and chronic toxicity of ingestion of extremely large amounts of probiotics should be carried out for all potential strains. Such assessment may not be necessary for strains with established documented use. 2.6 In vivo efficacy studies in animal models: To substantiate in vitro effects, appropriate, validated animal models must be used first, prior to human trials. 2.7 Evaluation of safety of probiotics for human use: In recognition of the importance of assuring safety, even among group of bacteria that are Generally Recognized as Safe (GRAS)**, probiotics strains needs to be characterized at a minimum with the following tests: 2.7.1 Determination of antibiotic resistance patterns. It should be ascertained that any given probiotic strain is not at significant risk with regard to transferable antibiotic resistance. 2.7.2 Assessment of undesirable side-effects. 2.7.3 If the strain under evaluation belongs to a species that is a known mammalian toxin producer or of hemolytic potential, it must be tested for toxin production and hemolytic activity respectively. Assessment of lack of infectivity by a probiotics strain in immunocompromised individuals would be an added measure. 2.8 Evaluation of efficacy studies in humans: The principal outcome of efficacy studies on probiotics should be proven with similar benefits in human trials, such as statistically and clinically significant improvement in condition, symptoms, signs, well-being or quality of life, reduced risk of disease or longer time to next occurrence or faster recovery from illness. Each of the parameter should have proven correlation with the probiotics tested. Probiotics delivered in food may not be tested in Phase 3 studies (effectiveness), unless the product makes a specific health claim wherein it becomes imperative to generate the required evidence necessitating carrying out Phase 3 studies. If a probiotic food has a record of documented long and safe use outside the country, the data regarding this could be reviewed and deemed as sufficient to allow its marketing within the ** As defined by Food and Drug Administration (FDA), USA (38) 4 country. However, labeling of health benefits may require evaluation in a different manner. While taking into account studies done abroad, efficacy studies of probiotics (which are of proven benefit in ‘other’ populations) should also be conducted on Indian subjects. It is recommended that such ‘bridging’ human trials should comply with the principles laid down by the Drug Regulatory Authority. Adverse effects, if any, should be monitored and incidents reported to the appropriate authority. 2.9 Effective dosage of probiotic strain / strains: The minimal effective dose or the level of viable cells of the probiotic strain in terms of cfu/ml/day in the carrier food that demonstrates general health promoting functions or well being or specific health claims in target population should be clearly indicated. 2.10 Labeling Requirements: In addition to the general labeling requirements under the food laws, the following information should also be mentioned on the label (23,39): • Genus, species and strain designation following the standard international nomenclature. • The minimum viable numbers of each probiotic strain should be specified at the level at which efficacy is claimed and at the end of shelf- life. • Evidence-based health claim(s) should be clearly stated. • The suggested serving size to deliver the minimum effective quantity of the probiotic related to the health claim. • Proper storage conditions to be mentioned. 2.11 Manufacturing and handling procedures: Adequate quality assurance programmes should be in place. Good Manufacturing Practices should be followed in the manufacture of probiotic foods. The Codex General Principles of Food Hygiene and Guidelines for Application of Hazard Analysis and Critical Control Point (HACCP) (40) should be followed. 5 Figure 1: Guidelines for evaluation of candidate probiotic strains Strain Identification by Phenotypic and Genotypic Methods • Genus, Species and Strain • Deposit strain in an Internationally Recognized collection Screening of Potential Probiotic Strains • In vitro Tests In vivo studies in validated animal models for: • Safety • Efficacy In vivo studies in humans for clinical evaluations • Phase1 (safety) • Phase 2 (efficacy) • Phase 3 (effectiveness)* PROBIOTIC FOODS Labeling Requirements • Genus, Species, Strain • Minimum viable numbers of probiotics at the level at which efficacy is claimed and at the end of shelf- life. • Health claim(s) • Serving size for efficacy • Storage conditions * Only required if a specific health claim is made 6 3. REFERENCES 1. Metchnikoff E: Lactic acid as inhibiting intestinal putrefaction. In: The prolongation of life: Optimistic studies. W. Heinemann, London: 1907;161-183. 2. Probiotic Market- Advanced Technologies and Global Market (2009 - 2014). By: marketsandmarkets. com. Publishing Date: September 2009. Report Code: FB 1046. Accessed at http://www. New Market Reports 69.html 3. Probiotics in Foods and Beverages—Strategic Assessment of the Indian Market. Frost & Sullivan (2009). Pub ID: MC2745451. Publishing date: December 31, 2009. Accessed at: http://www. Probiotics in Foods and Beverages-Strategic Assessment of the Indian Market. 4. Levri KM, Ketvertis K, Deramo M, Merenstein JH, D’Amico F. Do probiotics reduce adult lactose intolerance? A systematic review. J Fam Pract 2005;54(7):613-20. 5. Guandalini S. Probiotics for children: use in diarrhea. J Clin Gastroenterol 2006;40(3):244-8. 6. Szajewska H, Mrukowicz JZ. Use of probiotics in children with acute diarrhea. Pediatric drugs 2005;7(2):111-22. 7. Parvez S, Malik KA, Ah Kang S, Kim HY. Probiotics and their fermented food products are beneficial for health. J App Microbiol 2006;100(6):1171-85. 8. Forsythe P, Bienenstock J. Immunomodulation by commensal and probiotic bacteria. Immunol Invest. 2010;39(4-5):429-48. 9. Chalova VI, Lingbeck JM, Kwon YM, Ricke SC. Extracellular antimutagenic activities of selected probiotic Bifidobacterium and Lactobacillus spp. as a function of growth phase. J Environ Sci Health B. 2008;43(2):193-8. 10. Liong MT. Roles of probiotics and prebiotics in colon cancer prevention: Postulated mechanisms and in-vivo evidence. Int J Mol Sci. 2008;9(5):854-63. 11. Ooi LG, Liong MT. Cholesterol-lowering effects of probiotics and prebiotics: a review of in vivo and in vitro findings. Int J Mol Sci. 2010;11(6):2499-522. 12. Hughes VL, Hillier SL. Microbiologic characteristics of Lactobacillus products used for colonization of the vagina. Obstet Gynecol 1990;75:244-8. 13. Hamilton-Miller JM, Shah S, Winkler JT. Public health issues arising from microbiological and labelling quality of foods and supplements containing probiotic microorganisms. Public Health Nutr 1999;2:223-9. 14. Zhong W, Millsap K, Bialkowska-Hobrzanska H, Reid G. Differentiation of Lactobacillus species by molecular typing. Appl Environ Microbiol 1998;64:2418-23. 15. Consumer http://Lab.com. Product Review: Probiotic Supplements for Adults, Children and Pets. Accessed at Review of Probiotic Supplements and Kefirs 16. Mackay AD, Taylor MB, Kibbler CC, Hamilton-Miller JMT. Lactobacillus endocarditis caused by a probiotic organism. Clin Microbiol Infect 1999;5:290-292. 7 17. Rautio M, Jousimies-Somer H, Kauma H, Pietarinen I, Saxelin M, Tynkkynen S et al. Liver abscess due to a Lactobacillus rhamnosus strain indistinguishable from L. rhamnosus strain GG. Clin Infect Dis 1999;28:1159-60. 18. Salminen S, von Wright A, Morelli L, Marteau P, Brassart D, de Vos WM et al. Demonstration of safety of probiotics – a review. Int J Food Microbiol 1998;44: 93-106. 19. Adams MR, Marteau P. On the safety of lactic acid bacteria. Int J Food Microbiol, 1995;27:263- 264. 20. Guidelines for evaluation of probiotics in food. Report of a Joint FAO/WHO Working Group on Drafting Guidelines for the Evaluation of Probiotics in Food. London, Ontario, Canada, April 30 and May 1, 2002. 21. Marteau P. Safety aspects of probiotic products. Scand J Nutr 2001;45:22-242 22. Ishibashi N, Yamazaki S. Probiotics and safety. Am J Clin Nutr 2001;73:465S-470S. 23. Reid G. Regulatory and clinical aspects of dairy probiotics. Background paper for FAO/WHO Expert Consultation on Evaluation of Health and Nutritional Properties of Probiotics in Food including Powder Milk and Live Lactic Acid Bacteria. Cordoba, Argentina. 1-4 October 2001. 24. Sanders ME, Huis in’t Veld J. Bringing a probiotic-containing functional food to the market: microbiological, product, regulatory and labeling issues. Antonie van Leeuwenhoek 1999;76:293- 315. 25. Patel D, Dufour Y, Domigan N. Functional food and nutraceutical registration process in Japan and China. Similarities and differences. J Pharm Pharmaceut Sci. 2008;11(4):1-11. 26. EFFCA Guidelines for Probiotics in Food and Dietary Supplements. European Food and Feed Culture Association, 2008. Accessed at http://bbs.bio668.com/simple/index.php?t35919.html 27. Establishing standards for Probiotics: ISAPP’s Role. International Scientific Association for Probiotics and Prebiotics, 2005. Accessed at http://www.isapp.net/docs/probiotic%20standards%20 justification.pdf 28. Evidence for safety and efficacy of finished natural health products, Natural Health Products Directorate, Canada. December 2006. 29. IPA releases Guidelines for probiotic supplements. International Probiotics Association, 2008. Accessed at Natural Products INSIDER hotnews/ipa-guidelines-probiotic-supplements. html 30. Introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected micro organisms referred to EFSA. The EFSA Journal 2007; 587:1-16. 31. Guidance for Industry on Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration. Draft Guidance. U.S. Department of Health and Human Services. Food and Drug Administration, December 2006 32. Health and Nutritional Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria. Report of a Joint FAO/WHO Expert Consultation on Evaluation of Health and Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria. Córdoba, Argentina, October 1-4, 2001. 8 33. Von Wright A. Regulating the safety of probiotics – The European Approach. Curr Pharm Des 2005;11:17-23. 34. Przyrembel H. Consideration of possible legislation within existing regulatory frameworks. Am J Clin Nutr 2001;73:471S-475S. 35. Reid G. The importance of guidelines in the development and application of probiotics. Curr Pharm Des 2005;11:11-16. 36. Specifications for the Identity and Purity of Food Additives and their Toxicological Evaluation: Some Antimicrobials, Antioxidants, Emulsifiers, Stabilizers, Flour-Treatment Agents, Acids and Bases. Ninth Report. FAO Nutrition Meetings Report Series, 1966, No. 40; Wld Hlth Org. techn. Rep. Ser., 1966, No. 339. 37. International Committee on Systematics of Prokaryotes (ICPS). Accessed at: http://www.the-icsp. org/. 38. US Food and Drug Administration. Generally Recognized As Safe (GRAS). Accessed at: http:// http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedas SafeGRAS/default.htm. 39. Saldanha LG. US Food and Drug Administration regulations governing label claims for food products, including probiotics. Clin Infect Dis 2008; 46 Suppl 2: S119-121. 40. Codex Alimentarius Commission. Recommended International Code of Practice: General Principles of Food Hygiene. CAC/RCP 1-1969, Rev 4-2003. Accessed at: www.codexalimentarius. net/download/standards/23/cxp_001e.pdf. 9 4. GLOSSARY Probiotics: Probiotics are ‘live microorganisms which when administered in adequate amounts confer a health benefit on the host’ Shelf-life: Survival of sufficient viable organisms (≥108 CFU/gram) to confer health benefits to the host when stored at a specified temperature. Health Claims: A statement, which characterizes the relationship of any substance to a disease or health-related condition, and these should be based upon well-established, generally accepted knowledge from evidence in the scientific literature and/or recommendations from national or international public health bodies with clinical validation of safety and efficacy. HACCP: Hazard Analysis and Critical Control Point is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. Codex Alimentarius: The Codex Alimentarius is a collection of internationally recognized standards, codes of practice, guidelines and other recommendations relating to foods, food production and food safety. The Codex Alimentarius Commission was created in 1963 by FAO and WHO with the purpose of protecting health of the consumers, ensuring fair trade practices in the food trade, and promoting coordination of all food standards work undertaken by international governmental and non-governmental organizations. GMP: Good manufacturing practice is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.

Israel: The ugly truthAs it slides further into open and violent racism, Israel offers the Western world a reflection of itself.There was that jarring week in December – a protest against Arab-Jewish couples, a south Tel Aviv march and demonstration against migrant workers and African asylum seekers, the arrest of Jewish teenagers accused of beating Palestinians and the expulsion of five Arab men from their home in south Tel Aviv. It left me with the question: What is next?It is impossible to predict the future. But there are signs that violence, perpetrated by citizens, could be spreading.In mid-January, dozens of young Jews attacked Muslims at a mosque in Yafo or Jaffa, the historically Arab city just south of Tel Aviv. An Israeli media outlet reports that the youth, who were armed with stones and Israeli flags, shouted “Mohammed is a pig” and “Death to Arabs” just as the Muslims were preparing to pray.When the police arrived, they did not arrest any of the assailants.And just a few days before that march in south Tel Aviv, seven Sudanese men were attacked in Ashdod, a coastal city in the south of Israel.According to Israeli media reports, someone threw a flaming tyre into the apartment the men shared. Five suffered from smoke inhalation, two were hospitalised.Another alarming act of violence took place in south Tel Aviv that same night. The Hotline for Migrant Workers, an Israeli NGO, reports that three teenage girls – Israeli-born, Hebrew-speaking daughters of African migrant workers – were beaten by a group of Jewish teenagers. The attackers, one of whom was armed with a knife, allegedly called them “dirty niggers”. One of the girls needed medical treatment for her injuries.“It’s worth noting that the girls had already experienced such violence in the neighbourhood,” Poriya Gal, the spokeswoman for the Hotline for Migrant Workers, says. “But they chose not to report it to the police out of the fear that they would be attacked again.”Another frightening indicator of the mood here: In south Tel Aviv, on the day of the protest, a number of afterschool programmes closed early so that children could get home safely before the demonstration began. Administrators were worried that the children might otherwise get caught up in the march and attacked by protestors.Because asylum seekers are often reluctant to ask for help – and they are unlikely to turn to the police – it is hard to determine the precise number of racially motivated attacks.But the African Refugee Development Committee (ARDC) reports that asylum seekers are increasingly being evicted from their homes, despite the fact that they have paid rent. And the committee has been alerted to another alarming trend. Dara Levy-Bernstein of the ARDC says: “There have been a lot of [asylum seekers] complaining about being stopped by police or soldiers – we’re not entirely sure which – but they’re people in uniform who have been taking their visas and tearing them up.”Some argue that asylum seekers and Palestinians represent distinct issues that are distinctly complicated. In some ways, they do. But the police or soldiers who tear asylum seekers’ visas are the same people who fail to arrest Jewish citizens for throwing stones at Muslim worshippers. And it boils down to something very simple: How Israel, and some of its citizens, views those it considers ‘others’.Turning away the otherWhen I ask Orit Rubin, a psycho-social coordinator at ASSAF Aid Organisation for Refugees and Asylum Seekers in Israel, if she has noticed a rise in violence, she asks me to define violence.While she has not seen an increase in physical attacks, she has recently received reports from Sudanese café and pub owners who say that police have entered their places of business and sprayed tear gas into the air, without any provocation.The most common problem Rubin sees is African children that are being refused the public education that they are legally entitled to. Right here in Tel Aviv – the supposed bastion of Israeli liberalism – five children from two Eritrean families were recently refused registration.And for four months, four Eritrean children have been turned away from a school in Bnei Brak, a religious suburb of Tel Aviv, because they are not Jewish. Rubin says she has written to the minister of education about the matter. She is still waiting for a response.And then there are those who are illegally denied medical care. Rubin remarks: “This morning I got news from [our field worker] in Eilat that a pregnant woman was sitting at a medical clinic and the doctor came out and said ‘I’m not taking care of Sudanese’ and they asked her to leave.”Rubin adds that the doctor’s refusal of treatment was even more shocking because the woman had insurance, something many asylum seekers lack.The same day I interview Rubin, I meet an Ethiopian asylum seeker in Ashkelon who tells me that he recently sought medical help after he was attacked on the street by a Jewish Israeli. He was bleeding when he arrived at the hospital. And he was turned away.Testing the waterIt might seem sensationalist to draw conclusions about violence and discrimination from such examples. But it is important to recognise these trends early on and act on them, before they have a chance to lay root.Yohannes Bayu, the founder and director of the ARDC, points out that the Israeli rabbis’ edict against renting and selling property to Arabs came months after a similar letter was posted in south Tel Aviv.“It started there, with the refugees,” Bayu says. “And nobody responded. And then it was, ‘Let’s expand that’ and [the rabbis] came up with [the edict against] the Arabs.”So if there is not a strong response to what is happening in south Tel Aviv now, Bayu says: “It’s obvious that [things] can go to another level. This is what happened in Germany and many other places.”When asked if he hopes that the government will step in and help prevent an escalation, Bayu answers: “They’re the ones who started it.”He points towards the remarks of Eli Yishai, the interior minister, that migrants bring “a profusion” of diseases and drugs to Israel – claims that fly in the face of ministry of health data proving that migrants have low rates of illness.Other government employees, including a Tel Aviv city council member, have blamed foreigners for increasing crime even though a recent Knesset report proves that asylum seekers are actually much less likely to be involved in criminal activities than Israelis.And both migrant workers and asylum seekers were targeted by a government campaign of advertisements depicting “real Israelis” (read: paid actors) who did not have work because of “foreigners”.“First, they [the government] try to create this fear among the public, to create this discrimination, and then the result is always violence,” Bayu says. “That’s my biggest fear.”Fear of the unknownRubin agrees that the problem is rooted in the government. But she also adds that it says something about society.“I think that some of it is not just Israel. It’s human nature to fear what you don’t know, to fear what is different.”Rubin pauses.“Me, personally,” she continues, “I was brought up in a home of Holocaust survivors and I was always taught that Israelis are different … that they have learned from experience and will be weary before they slide into racism. But, you know, it’s not like that.“Part of it is that we forgot what happened in the Second World War was human. Humans were doing it – not beasts, not monsters, but humans.”Reflection of the WestIt is too easy to demonise Israel, in part because the government, the army and some of the people do things that make it so easy.But one of the ugliest truths about Israel – a truth that must be faced in both the US and Europe, where xenophobic and anti-Islamic sentiments are also on the rise – is that Israel offers the Western world a reflection of itself.Of course, it is an exaggerated, hyperbolic image. But it is a picture of nationalism gone wrong. It is a picture of what can happen when a state believes that its very survival depends on maintaining a certain demographic balance. It is a picture of what happens when any country believes that those who change these numbers are an existential threat.And it is getting more and more frightening here by the day.Mya Guarnieri is a Tel Aviv-based journalist and writer. A regular contributor to Al Jazeera English, her work has also appeared in The Guardian and The Huffington Post, as well as other international media outlets.The views expressed in this article are the author’s own and do not necessarily reflect Al Jazeera’s editorial policy.