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XML US Government Publishing Office Kansasjudicialcouncil Demand Assistance

welcome to this presentation on.regulatory research here are some of the.goals on our regulatory roadmap at the.conclusion of this module.you will know how to locate the official.text of federal regulations update.regulatory research evaluate free.government resources for accuracy.authenticity and currency and use these.resources efficiently and effectively.regulatory law is an increasingly.important source of law in our legal.system in order to do effective and.efficient regulatory research it is.important to know your turf that means.understanding where regulations come.from namely the administrative agencies.within the federal government before.researching regulatory law let's review.what you have already learned about.federal government agencies as displayed.in this organizational chart our.government is composed of three branches.executive judicial and legislative under.the US Constitution only the legislative.branch is empowered to make law agencies.have sometimes been called a fourth.branch of government agencies possess.powers which are a hybrid of the other.three branches quasi-legislative because.they make regulations which are a source.of law and quasi-judicial because they.decide certain cases as required by law.in addition most agencies fall within.the executive branch of government and.are empowered to enforce the laws they.create agencies are therefore very.powerful entities but only within their.limited sphere of authority according to.this chart there are 15 departments.within the executive branch and over 50.independent agencies and government.corporations note that the Food and Drug.Administration is an agency which falls.within the Department of Health and.Human Services we'll take a look at FDA.regulations in just a moment.so how did all these agencies come into.being and how did they become so.powerful if under the Constitution only.the legislative branch can make laws how.is it that agencies have been able to.take on this lawmaking role without.violating the Constitution the answer.stems from industrialization and the.Great Depression those events brought.about major economic and social changes.as a result of these changes Congress.found it increasingly necessary to.delegate some of its lawmaking authority.to existing agencies or to create new.agencies to implement the laws it.enacted for example how many million.particles of talc per cubic foot of air.is acceptable in a factory as a.practical matter Congress does not have.the expertise to implement safety.standards and factories but if you look.up the regulations of the Occupational.Health and Safety Administration or OSHA.you will find limits for talc and other.air contaminants agencies are indeed.very powerful but they may only act.within their statutory authority in.addition agencies must follow the.procedures set forth in the.Administrative Procedure Act when making.regulations these procedures may include.giving notice to the public and an.opportunity for the public to submit.comments to the agency publication in.the Federal Register is considered.official notice to the public lawyers.who work in heavily regulated industries.regularly monitor agency notices and.actions in the Federal Register and.sometimes participate in the regulatory.process by making comments about.proposed regulations this notice and.comment making process has gotten much.easier with regulations gov it is now.possible to review regulations that have.comments due soon and even see the.comments that others have made via this.amazing website we won't explore the.regulations gov and a tale in this.but keep it in mind if you ever need to.track proposed regulations or.participate in the regulatory process.what are regulations regulations or.rules are basically law created by an.agency an agency promulgates regulations.pursuant to enabling legislation enacted.by Congress also known as statutory.authority regulations have the force and.effect of law but they are considered.subordinate to legislation for these.reasons agency regulations are sometimes.called delegated or subordinate.legislation whereas statutes tend to be.broad in general agency regulations are.detailed and specific also note that.regulations are updated more frequently.than statutes there for updating your.regulatory research is extremely.important regulations are published.initially in chronological order in the.Federal Register.they are then codified or put into a.subject arrangement in the Code of.Federal Regulations or CFR the CFR has.50 subject titles which usually but not.always correspond to the 50 subject.titles of the United States Code when.citing to regulations these are the.major divisions title part and section.when citing to the wage and hours.regulations under Title 29 on labor for.example you will often see a citation to.a part such as part 7 7 8 on overtime.compensation or a specific section such.as 29 CFR section 7 7 8 . 107 section.107 of part 7 7 8 explains the general.standard for overtime pay one of the.benefits of the information age is the.improved accessibility to government.agency information via the Internet.every federal agency now has its own.website which gives each agency an.online presence and a new way to convey.information to the public here are just.a few agencies.may be familiar to you these agency home.pages provide a great introduction to.the activities of the agencies as well.as the laws and regulations that they.implement how my agency regulations be.relevant to you or your client consider.the safety of products that we consume.like food and drugs a federal agency the.Food and Drug Administration is charged.with keeping our food and drugs safe.acai berries have been touted as a super.food which can address many health.concerns like arthritis and cancer.suppose your client has created a new.acai berry drink which promises.fantastic health benefits the label.claims that this special juice supports.joint heart and immune health providing.the nutrition you need for a healthy and.active lifestyle each serving delivers a.wide array of antioxidants vitamins and.phytonutrients and is as efficacious as.it is delicious does this label comply.with FDA regulations let's explore the.FDA website and see if we can obtain.some background information about the.FDA and the types of products it.regulates the FDA website is.particularly useful because it has an.excellent search mechanism for browsing.and locating relevant regulations.remember that every agency website is.different in terms of ease of use.note that the FDA website is designed.for different audiences including.consumers and patients health.professionals scientists and researchers.and Industry if we scroll down we will.see a box of regulatory information.including a link to the CFR and to the.laws the FDA enforces let's start with.the laws that the FDA enforces note that.the federal Food Drug and Cosmetic Act.of 1938 or FDC Act is the major.legislation which overhauled the public.health system and created the modern FDA.the FDC Act is therefore the statutory.authority for the FDA.the FDA is charged with making.regulations to carry out the aims of the.FTC act and also this later legislation.which relates to food and drug safety as.we take a look at the act itself not the.caveat at the FDA website about FD sis.which warrants those using it for legal.research to verify their results against.the print version of the u.s. code we.will talk further about FD sis in a.later part of this module but please.note that FD sis provides access to an.authentic official digital version of.the u.s. code so it should no longer be.necessary to verify one's results.against the print version.despite the caveat at this agency.website however if this agency website.refers to the 2006 edition of the u.s..code as supplemented through January.2010 later versions are available at FD.sis so you may wish to make sure to.update your legislative research and FD.sis instead of relying on the agency.links to the code sections read the.information at every agency website.closely to make sure you understand just.how reliable and up-to-date it really is.given its importance you may want to.take a look at the FTC act the law.itself is quite large and complex it is.made up of ten chapters by clicking on.Chapter four for example we can see the.provisions relating to food lawyers who.specialized in food and drug law know.the relevant statutes and regulations.like the back of their hand.in fact they often refer to a law by its.original chapters and section numbers.rather than its u.s. code citation that.is why this cross-reference chart is a.great convenience it shows us that the.FTC Act was codified in title 21 of the.u.s. code in addition we can see that a.specific section like section 403 on.misbranded food was codified at 21 USC.Section 3 for 3 let's navigate back to.the regulatory information and the rules.and regulations the.sells here we see another statement.about the mission of the FDA as well as.a link to title 21 of the CFR or Code of.Federal Regulations where the.regulations are codified at this next.webpage.this search template allows one to.search only the regulations in title 21.of the CFR if one has a citation to the.part and/or section one can enter it in.this box alternatively one can use this.menu to browse the parts within title 21.then select the part that seems most.relevant note that there are more than.1400 parts in this one title it is also.possible to do a full-text search of all.of title 21 using this search box but.remember how long this title is with.over 1400 parts regulations tend to be.voluminous and may contain language that.is not familiar to you it is usually.wise to get familiar with regulations by.first browsing them before attempting to.search them full text we are interested.in whether the label of our clients acai.berry drink complies with FDA food.labeling requirements specifically the.statements about health benefits if we.are lucky we will see a part that is.relevant such as part 101 on food.labeling let's browse part 101 browsing.is generally the most effective and.efficient way to find and navigate.regulations when you browse the.regulations you see them in context and.you understand how they are organized.note at the bottom of part 101 the.reference to statutory authority these.are some of the provisions of the FTC.Act which we looked at earlier including.section 3 4 3 on misbranded food in.addition this source information.indicates when part 101 first appeared.in the Federal Register March 15 1977.unless otherwise noted this means that.there may be different dates after.specific sections which were amended or.to part 101 later this source.information may be important if you are.researching the development of a.particular section or trying to find out.what the law was at an earlier time note.that part 101 on food labeling is.further divided into sub parts including.subpart a general provisions subpart B.specific food labeling requirements and.subpart E specific requirements for.health claims as we browse we can often.determine which regulations supply to.our client situation and which do not.pay special attention to general.provisions that could be applicable and.especially to the scope and definition.provisions let's take a quick look at.the general labeling provisions.specifically section 101 dot 14 which.relates to health claims here we see a.note which says revised as of April 1.2011 that means that the text of this.regulation is current as of that date.the CFR is updated annually but the.updating process is staggered throughout.the year so different titles are grouped.together and updated each quarter title.17 through 27 for example are updated.each April this updating schedule will.be more evident when we look more.closely at the CFR later in this module.note that section 101 dot 14 contains.definitions of terms like health claim.or nutritive value these are terms of.art that we probably did not know when.we first started our research if we.wanted to explore these terms further we.could return to the search template and.use them as search terms this can be.more efficient than starting out with a.keyword search and then guessing what.terms to use this search for the term.health claims in part 101 further.narrows our search results to only those.sections which contain this term of.course section 101 dot 14 appears again.always read definitions of key terms.closely as they can often determine if a.regulation applies to a particular.situation.not the references at the end of the.regulatory text this first reference is.to the section as it originally appeared.in the Federal Register on January 6.1993 as you may recall part 101 was.promulgated on March 15 1977 so this.specific section was added much later.these subsequent citations to the.Federal Register referred to later.amendments including this most recent.amendment on March 30 2001 can we rely.on the text of section 101 . 14 as.displayed at the FDA website.unfortunately the answer is no even.though the agency is charged with.creating these regulations enforcing.them and posting them to its website.there is no guarantee that the text is.authentic or up-to-date as we recall.from this note the text of this.regulation is current as of April 1 2011.that may sound very current but as.mentioned earlier regulations can change.much more quickly than statutes it is.possible that there have been revisions.since that time therefore updating your.regulatory research is extremely.important the FDA website is an.excellent place to start research on our.clients acai berry juice drink label.remember however that every agency.website is different not all are as easy.to navigate or search as the FDA website.this concludes part 1 of this module on.regulatory research in parts 2 and 3 we.will examine two more free government.resources that can be used to access the.most current version of the regulation.as well as the authentic text before.moving on to the next two parts of this.module please refer to your ls1 course.website and answer the brief questions.relating to what you have learned thus.far about regulatory research.you.

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