What are &quot;inactive ingredients when a safety factor&quot; in the context of vaccines? I was reading Title 21 of the Code of Federal Regulations when I came upon the following sentence (n) The inactive ingredients when a safety factor, or reference to an enclosed circular containing appropriate information; How is it determined if an inactive ingredient is a safety factor?
A partial answer (for a manufacturer) is "look it up" – that may tell you if a determination has been made by the FDA. If so, it is not new and may require a less extensive review the next time it is included in a new drug product. For example, if a particular inactive ingredient has been approved in a certain dosage form at a certain potency, a sponsor could consider it safe for use in a similar manner for a similar type of product (the FDA says). The legal part doesn't explain how it is scientifically determine that an inactive ingredient raises safety concerns but to take on example, wheat gluten is in the Inactive Ingredient Guide. This article gives a bit of analysis of the factors that sponsors have to consider in shouldering their burden of proof. If you want to manufacture a new vaccine, you have to show (the FDA) that it is safe. If you dilute the vaccine with water, that ingredient is not a "safety factor". Benzalkonium chloride could be (you would have to show that it isn't), and if it is, that regulation requires you to list it. What's not specified clearly is how many adverse reactions per million doses constitute being a safety factor.
the first two highlighted parts seem to contradict each other. No, in this case they do not. The first highlighted portion refers to works or items produced "for or under the direction of the Company", whereas the second highlight refers to your creations that satisfy conditions (a) and (b). Where contradictions actually exist, the doctrine of contra proferentem entitles you (the non-draftsman of the contract) to adopt the portion or reasonable interpretation that favors your legal position. Also wondering how valid those statements actually are They are valid and become enforceable as soon as you sign the contract or your subsequent conduct reflects your acceptance thereof. it's a matter of privacy. So the question is what I can do or what the reality is of the situation The reality is that you are asked to sign a contract that is abusive and ridiculous. One vulnerability from describing your inventions (presumably in Appendix A) is that the employer gets "irrevocable, worldwide, etc" rights on them as soon as you "use or disclose any [items listed in Appendix A] when acting within the scope of [your] employment". This means that if instead of reinventing the wheel you share or apply any portion of your prior creations so as to enhance your productivity, you knowingly and irreversibly grant to the employer perpetual rights to those items. Legal disputes regarding APIs can become extremely intricate. And, since judges usually have no decent background on IT, even those few judges with integrity are unlikely to grasp the key subtleties that would lead to a correct ruling. "not useful with or related to any Company Interest" is very vague. The company could be interested in literally anything these days. Clauses which are too vague or excessively wide-encompassing are supposedly stricken as unconscionable, unenforceable, etc. However, I personally would foreclose upfront the risk of judicial hassle and decline the abusive contract. Legal issues aside, keep in mind that you are offering your expertise (in terms of supply &amp; demand, you are on the supply side). This fact has a less derogatory connotation than "asking for a job". Accordingly, the relation between the parties should be more leveled.
It may be discrimination; not all discrimination is illegal. Details vary by jurisdiction, for example discrimination on the following bases is illegal in Australia: race colour sex sexual preference age physical or mental disability marital status family or carer’s responsibilities pregnancy religion political opinion national extraction social origin A medical condition like an allergy is not necessarily a physical disability. The school is arguably fulfilling its obligations under WHS legislation by banning nut products if that is what a risk assessment indicates. It may also be necessary to ban milk products if that is required for your daughter's safety. If (and I do not know) nuts pose a greater risk than milk then banning the former and not the latter may be perfectly justified. Ask to see the risk assessment.
Note, Washington State Senate Bill 5061 seeks to block certain "untracable" firearms without a serial number. This relates in part to "3D printable" guns, but the act of milling of a 80% lower (in Washington) could be a violation, if and when it passes. But it appears the bill hasn't been made a law yet... Is Washington specific news this issue what drives the question? Federally, the ATF web site says: Receiver blanks that do not meet the definition of a "firearm" are not subject to regulation under the GCA. The ATF has long held that items such as receiver blanks, "castings" or "machined bodies" in which the fire-control cavity area is completely solid and un-machined have not reached the "stage of manufacture" which would result in the classification of a firearm per the GCA. But this gets a bit technical. For further risk mitigation, the Texan could mitigate any risk related to both Federal and Washington state law by shipping it to a federal firearms licensee (FFL) in Washington as if it were a firearm, per ATM instructions which say (in part): Generally, for a person to lawfully transfer a firearm to an unlicensed person who resides out of State, the firearm must be shipped to a Federal Firearms Licensee (FFL) within the recipient’s State of residence. He or she may then receive the firearm from the FFL upon completion of an ATF Form 4473 and a NICS background check. That FFL is then responsible for ensuring the transaction properly conducted in the state of Washington, including federal and state requirements. The FFL I contacted only charged $25.00 (plus collecting the state sales tax). Form 4473 was easy enough; only about one page for me to fill out. Of course, I've got a clean record, so going through channels isn't a problem for me, it took less than an hour. The FFL confirmed for me that it wasn't necessary for something like an antique musket, which legally isn't a firearm by the federal defeinitions. In my case the sender was a nervous "trust" lawyer who wasn't sure, hired yet another lawyer to advise him. The FFL didn't charge me anything for receiving that musket.
I should have done my research properly, hopefully this will be indexed and be helpful to someone else in the future. The specific legislation is The Road Vehicles (Construction and Use) Regulations 1986 regulation 98: Stopping of engine when stationary 98.—(1) Save as provided in paragraph (2), the driver of a vehicle shall, when the vehicle is stationary, stop the action of any machinery attached to or forming part of the vehicle so far as may be necessary for the prevention of noise. (2) The provisions of paragraph (1) do not apply— (a) when the vehicle is stationary owing to the necessities of traffic; (b) so as to prevent the examination or working of the machinery where the examination is necessitated by any failure or derangement of the machinery or where the machinery is required to be worked for a purpose other than driving the vehicle; or (c) in respect of a vehicle propelled by gas produced in plant carried on the vehicle, to such plant.
Summary from comments. (Hat tip @jqning) Daniel Nathan Ballard writes here: [It] is not only improper it is UNLAWFUL and may result in serious repercussions... Such a misuse may constitute false advertising... (“It is no doubt true” that affixing the ‘Trade Mark Registered U.S. Patent Office” notice on goods that are not protected by a federally registered trademark creates “a prima facie case of fraud against the public… .”). ... Such use is also a form of “unclean hands” that can bar the user’s registration of the mark. ... Such a use may also bar the maintenance of an infringement case. ... And the fraudulent use of the trademark registration symbol DOES provide other marketplace participants with standing to oppose the user’s registration of the mark. http://www.avvo.com/legal-answers/use-of---symbol-but-not-federally-registered-1125746.html
This ATF page quotes from 26 USCA §5845(f)(2) as follows: (f) Destructive device.--The term “destructive device” means * * * (2) any type of weapon by whatever name known which will, or which may be readily converted to, expel a projectile by the action of an explosive or other propellant, the barrel or barrels of which have a bore of more than one-half inch in diameter, except a shotgun or shotgun shell which the Secretary or his delegate finds is generally recognized as particularly suitable for sporting purposes; . . .” The hypothetical device you describe has a bore of > ½", and when fired would cause a projectile (the rocket) to exit the barrel. The rocket's firing is clearly caused by firing the blank shotgun shell, and would, I think, be seen as "expelling" the projectile. The objection that "the rocket fired and expelled itself" would not be persuasive. Thus, I think the device you describe meets the statutory definition of "destructive device." To avoid breaking this law, do not either a) insert a projectile (here, the rocket) in the shotgun bore, or b) set up any external mount or mechanism to ignite the rocket as a result of igniting a shotgun shell (blank or not blank) in the shotgun barrel.
If the requirement is imposed by an employer, then the basis for an exemption, if any, would be whatever the employer choose to allow, unless some applicable law required some particular exemption. Such mandates are not common. Indeed I do not recall hearing of any such absolute mandates. But an employer could choose to impose one, and I have heard (and read) discussions of hospitals, for example, requiring COVID-19 vaccinations to be taken by employees when available. If an employer mandates a vaccination, it is up to the employer to decide when, and if, an exemption is warranted. It is up to the employee to decide whether to comply by accepting the vaccination or refuse at the risk of being fired. I do not know of any law which would specifically require an employer to grant exemptions in particular circumstances. A law might exist, or be passed, requiring such exemptions. If the employee had a particular medical condition which makes a vaccination si9gnificantly more risky for that employee than for an average person, and if that condition was considered to be a disability (not all or even most medical conditions are so considered) then the Americans with Disabilities Act (ADA) would require the employer to offer a &quot;reasonable accommodation&quot; to the employee, if one is available. Exactly what accommodation is &quot;reasonable&quot; is a fact-based determination, and would depend on the reason for the mandate, the cost and burden of the accommodation on the employer, and the degree if risk to the employee with and without the accommodation. In some cases no accommodation is found to be &quot;reasonable&quot;, and in such cases the ADA does not mandate any accommodation at all. The ADA generally specifies whet must be done when an employee has \ a disability, but dopes not specify exactly how a disability must be proved. A medical certificate is common, but njot invariable, iof an employer questions the existence o a disability. The ADA would not require an exemption for a &quot;Religious/Philosophical&quot; objection. Soem state laws protect religious scruples in various particular employment situations. In some but not all states objections on such grounds for vaccinations otherwise required for school attendance are honored. The exact grounds accepted vary from state to state. A specific state would need to be listed for a more specific answer to be given, and I am not aware of any state that has such a requirement for exemption from a private employer's vaccine mandate. Addition: It seems from comments that some employers, such as hospitals and the military, already require vaccinations for some diseases. This seems reasonable to me, and does not change my answer otehrwise.