RESTRICTED
WORLD TRADE G/SPS/W/6
2May1995
ORGANIZATION(95-1120)
Committee onSanitary andPhytosanitary Measures Original: English
OVERVIEW OFU.S.STANDARDS-MAKING
AND REGULATORY PROCEDURES
Development andEnforcement ofGovernment Regulations
Submission bytheUnited States attheMeeting of29-30 March 1995
Transparency andNon-Discrimination
1. IntheUnited States, thepromulgation oftechnical regulations byfederal agencies isgoverned
byvarious statutes andexecutive orders. These statutes andexecutive orders impose procedural
requirements which serve toinsure thattechnical regulations adopted bygovernment agencies are
necessary forthefulfilment ofobjectives forthepublic goodsuchasprotecting health, safety, essential
security, theenvironment, orconsumers. TheU.S.regulatory process istransparent fromproposed
ruletofinalrulemaking, andintheimplementation orapplication ofsuchrules.
2. Either theExecutive Branch ortheCongress (either theSenate orHouse ofRepresentatives)
mayinitiate newlegislation oramendments toexisting legislation. Even ifthereisanAdministration
proposal, drafting isoften donebyCongressional staff, withvarying amounts ofconsultation withthe
ExecutiveBranchagencyresponsibleforimplementingthelaw.Theprocessisaniterativeone,involving
extensive negotiation andcompromise within thelegislative bodies. Theprocess canfrequently result
inafinalstatute thatissignificantly different fromtheoriginal proposals. Allstatutes aresubject to
Congressional approval andareforwarded tothePresident oftheUnited States forenactment.
3. TheAdministrative Procedure Act(APA) setsforth thegeneral procedures forrulemaking
tobefollowed byagencies oftheUnited States Government (5U.S.C. section 551etseq.) Ata
minimum,theAPArequiresthatfortheissuanceofasubstantiverule(asdistinguishedfromaprocedural
ruleorastatement ofpolicy), anagency must:
(1) Publish anotice ofproposed rulemaking intheFederal Register. Thisnotice must
setforththetextorthesubstance oftheproposed rule,thelegalauthority fortherulemaking
proceeding, andapplicable times andplaces forpublic participation.
(2) Provide allinterested persons -nationals andnon-nationals alike -anadequate
opportunity forsubmission ofwritten comments ontheproposed rule. Thispublic comment
process serves anumber ofpurposes, including giving interested persons theopportunity to
provide theagency withinformation thatwillenhance theagency 'sknowledge ofthesubject
matter oftherulemaking. Thepublic comment process alsoprovides interested persons with
theopportunity tochallenge thefactual assumptions onwhich theagency isproceeding, and
toshow inwhatrespect suchassumptions areinerror.G/SPS/W/6
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(3) Publish anotice offinalrulemaking atleastthirty daysbefore theeffective dateof
therulewhich includes astatement ofthebasis andpurpose oftherule,andresponds toall
substantive comments received. TheAPA makes anexception from therequirement for
publication ofthefinalrulethirty daysbefore itseffective dateiftherulemakes anexemption
orrelieves arestriction, oriftheagency makes andpublishes afinding thatanearlier effective
dateisrequired "forgood cause".
4. Usually, rulemaking proceedings arecommenced byanagency atitsowninitiative. However,
theAPA provides thateachagency oftheUnited States Government shallafford interested persons
therighttopetition fortheissuance, amendment, orrepeal ofarule. According tolaw,agencies must
respond totherequest. Iftherequest ismeritorious, work willcommence ondeveloping aproposed
rule. Insome cases, Congress bystatute directs anagency tobegin arulemaking proceeding.
5. TheAPA alsocontains provisions foradvance notice ofproposed rulemaking. Thisallows
agencies toseekgeneral comments onissues prior todeveloping thespecific regulatory proposal.
Often agencies willprovide sixtydaysormore forpublic comment inanadvance notice ofrulemaking.
6. Theadjustment period allowed foraffected industries tomeetthenewregulatory requirements
willvarywiththeeconomic impact andthereasons forthenewrequirements, e.g.,theeffective date
ofnewlabelling requirements maybedelayed forayearormore topermit inventories ofexisting labels
tobedepleted.
7. There areonlylimited exceptions torequirements fornotice andcomment onrulemaking.
Forexample, agencies arenotrequired topublish inadvance forpublic comment theirgeneral statements
ofpolicy, orrules concerning theiragency 'sorganization, procedure orpractice.
8. From starttofinish, asimple orhighpriority rulemaking maytakeasmuch asayearto
complete. Regulations forcontroversial andcomplicated issues willtakemuch longer. Everyone has
anequal opportunity tocomment onproposed rulesduring thespecified comment period. Thisincludes
commercialrepresentativesandEmbassiesofforeigncountries.AccordingtoU.S.law,publiccomments
havetobereviewed andassessed, andthenaddressed inthefinalrule.
9. Inaddition toproviding forpublic participation intherulemaking process, theAPA subjects
allfinalrulestojudicial review (e.g., United States District Court). Inparticular, areviewing court
mustsetaside aruleifthecourt finds thattheagency 'sactions were"arbitrary, capricious, anabuse
ofdiscretion, orotherwise notinaccordance withlaw". Incertain cases, acourt must invalidate a
ruleifitsprovisions are"unsupported bysubstantial evidence" (5U.S.C. section 706(2)). Thus, at
aminimum, technical regulations promulgated byaU.S.Government agency mustmeetoneofthe
twoaforementioned legalstandards.
10. TheOfficeofManagementandBudget(OMB)publishesaUnifiedAgendaofFederalRegulations
intheFederal Register eachApril andOctober. Thispublication contains abriefdescription ofeach
activity ofeachagency thatislikely toresult intheissuance ofaproposed orfinalrulewithin the
nexttwelve months. Thispublication isinaddition tothenotices published byagencies intheFederal
Register toinitiate arulemaking proceeding.
11. Specificadministrativeandproceduralrequirementsand,insomeinstances,differentprocedures
andamore stringent standard forjudicial review, maybeincorporated intoaparticular agency 's
authorizing statutes inaddition totheAPArequirements. These additional requirements provide further
assurance thattechnical regulations arenecessary tofulfilgovernment objectives forthepublic good.
Forexample, provisions oftheConsumer Product Safety Act[15U.S.C. section 2058(a)], theFederal
Hazardous Substances Act[15U.S.C.section 1262(f)], andtheFlammable Fabrics Act[15U.S.C.G/SPS/W/6
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section 1193(g)], require thepublication ofanadvance notice ofproposed rulemaking asthefirststep
inaproceeding fortheissuance ofcertain kinds ofstandards andbanning rules. Allthree ofthese
statutes require theConsumer Product Safety Commission toprovide opportunity fororalpresentations
concerning certain types ofproposed rulesatapublic hearing, andtheseactsprovide forjudicial review
ofcertain rules byaUnited States Court ofAppeals rather thanbyaUnited States District Court.
Additionally, theConsumer Product Safety Actprovides thatinreviewing aconsumer product safety
standard orbanning rule,thecourt shallnotsustain theruleunless itsprovisions aresupported by
"substantial evidence ontherecord taken asawhole".
12. Specific regulations andenforcement responsibilities forallproducts, neworused, arecodified
intheCode ofFederal Regulations (CFR). Itisdivided into50titleswhich represent broad sectoral
areas subject tofederal regulation. Eachtitleisfurther divided intochapters, which usually bearthe
name oftheissuing agency. Eachchapter issubdivided intopartscovering specific regulatory areas.
Theindex refers users totheappropriate titles andchapters affecting specific areas. TheCFR also
contains Federal requirements forpackaging andshipping. TheCFRisupdated annually, usually in
theSpring. Individual states orlocaljurisdictions (cities orcounties) mayimpose additional special
requirements forspecific products (e.g., building andconstruction products andmaterials, automobiles)
entering theirstateboundaries. AllU.S. agencies maintain thesame regulations fordomestic and
imported merchandise andagricultural products. Thus, products made intheUnited States aresubject
tothesame requirements asimported products.
13. Statutes andregulations maybesubject tointerpretation byagency-developed policies or
guidelines. Within theframework ofthestatute orregulation anagency hastheadministrative flexibility
tomodify policies andguidelines toreflect current conditions, e.g.newscientific information, advances
inprocessing technologies, orlessfrequently tobring policies intoalignment withbroader USGpolicy
positions. Guidelines alsoareusedinternally toensure thatregulations areinterpreted andapplied
uniformly byanagency 'semployees throughout thecountry.