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Wednesday,

November 30, 2005

Part II

Department ofHealth and HumanServices42 CFR Parts 70 and 71

Control of Communicable Diseases;Proposed Rule

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71892 Federal Register / Vol. 70, No. 229/ Wednesday, November 30, 2005 / Proposed Rules

DEPARTMENT OF HEALTH ANDHUMAN SERVICES

42 CFR Parts 70 and 71

RIN 0920AA03

Control of Communicable Diseases

AGENCY: Centers for Disease Control and

Prevention (CDC), Department of Healthand Human Services (HHS).ACTION: Notice of proposed rulemaking.

SUMMARY: CDC is committed toprotecting the health and safety of theAmerican public by preventing theintroduction of communicable diseaseinto the United States. Having updatedregulations in place is an importantmeasure to ensure swift response topublic health threats. CDC proposes toupdate existing regulations related topreventing the introduction,transmission, or spread ofcommunicable diseases from foreign

countries into the U.S. and from oneState or possession into another.DATES: Written comments must bereceived on or before January 30, 2006.Written comments on the proposedinformation collection requirementsshould also be submitted on or before

January 30, 2006. Comments receivedafter January 30, 2006 will beconsidered to the extent practicable.ADDRESSES: You may submit writtencomments to the following address:Centers for Disease Control andPrevention, Division of Global Migrationand Quarantine, ATTN: Q Rule

Comments, 1600 Clifton Road, NE.,(E03), Atlanta, GA 30333. Commentswill be available for public inspectionMonday through Friday, except for legalholidays, from 9 a.m. until 5 p.m. at1600 Clifton Road, NE., Atlanta, GA30333. Please call ahead to 18666944867 and ask for a representative in theDivision of Global Migration andQuarantine to schedule your visit.Comments also may be viewed at http://www.cdc.gov/ncidod/dq.You maysubmit written comments electronicallyvia the Internet at http://www.regulations.gov or via e-mail [email protected] an electronic version of therule, you may access http://www.regulations.gov.

Mail written comments on theproposed information collectionrequirements to the following address:Office of Information and RegulatoryAffairs, OMB, New Executive OfficeBuilding, 725 17th Street, NW., rm.10235, Washington, DC 20503, Attn:Desk Officer for CDC.FOR FURTHER INFORMATION CONTACT:

Jennifer Brooks, Centers for Disease

Control and Prevention, Division ofGlobal Migration and Quarantine,1600Clifton Road, NE., (E03), Atlanta, GA30333; telephone (404) 4982395.SUPPLEMENTARY INFORMATION: ThePreamble to this notice of proposedrulemaking is organized as follows:

I. Legal AuthorityII. Background and PurposeIII. Legal Basis of Federal Quarantine

AuthorityIV. Summary of Proposed Changes to 42 CFR

Part 70V. Summary of Proposed Changes to 42 CFR

Part 71VI. Required Regulatory Analyses Under

Executive Order 12866, the UnfundedMandates Reform Act, and theRegulatory Flexibility Act

A. Objectives and Basis for the ProposedRegulation

B. The Nature of the ImpactsC. Need for the RuleD. BaselineE. AlternativesF. Cost Analysis of Proposed Option and

AlternativesG. Impacts on IndustryH. BenefitsI. Comparison of Costs and Benefits

J. Regulatory Flexibility AnalysisK. References for Part VI

VII. Other Administrative RequirementsA. Executive Order 13045: Protection of

Children from Environmental Health andSafety Risks

B. Paperwork Reduction Act of 1995C. Environmental AssessmentD. Executive Order 13175: Consultation

and Coordination With Indian TribalGovernments

E. Executive Order 12630: GovernmentalActions and Interference With

Constitutionally Protected PropertyRights

F. Executive Order 13132: FederalismG. Executive Order 13211: Energy EffectsH. National Technology Transfer and

Advancement ActI. Family Policy Analysis

J. Executive Order 12988: Civil JusticeReform

K. Plain LanguageVIII. Solicitation of Comments

I. Legal Authority

These regulations are proposed underthe authority of 25 U.S.C. 198, 231, and1661; 42 U.S.C. 243, 248, 249, 264272,

and 2001.II. Background and Purpose

The primary authorities supportingthis rulemaking are 361368 of thePublic Health Service Act (42 U.S.C.264271). Section 361 authorizes theSecretary to make and enforceregulations as are necessary to preventthe introduction, transmission or spreadof communicable diseases from foreigncountries into the United States andfrom one State or possession intoanother.

Recent experiences with emerginginfectious diseases such as West NileVirus, SARS, and monkeypox haveillustrated the rapidity with whichdisease may spread throughout theworld and the impact communicablediseases, when left unchecked, mayhave on the global economy. As noted

by the Institute of Medicine, National

Academy of Sciences in a recent study,Whether naturally occurring orintentionally inflicted, infections cancause illness, disability, and death inpersons while disrupting wholepopulations, economies, andgovernments. And because national

borders offer trivial impediment to suchthreats, especially in the highlyinterconnected and readily traversedglobal village of our time, onenations problem soon becomes everynations problem. (Microbial Threats toHealth: Emergence, Detection andResponse, Institute of Medicine,

March, 2003). As diseases evolvenaturally or as a result of humanintervention, it is important to ensurethat containment procedures reflect newthreats and uniform ways to respond tothem.

Stopping an outbreakwhether it isnaturally occurring or intentionallycausedrequires the use of the mostrapid and effective public health toolsavailable. These tools include basicpublic health practices such as diseasereporting requirements andidentification and notification ofcontacts who may have been exposed toa communicable disease so that they

may receive preventive measures.Quarantine is defined as the restrictionof the movement of persons exposed toinfection to prevent them from infectingothers, including family members,friends, and neighbors. Quarantine ofexposed persons may be the best initialway to prevent the uncontrolled spreadof highly dangerous biologic agents suchas smallpox, plague, and Ebola feverespecially when combined with otherhealth strategies such as vaccination,prophylactic drug treatment, patientisolation, and other appropriateinfection control measures. Quarantine

may be particularly important if abiologic agent has been renderedcontagious, drug-resistant, or vaccine-resistant through bioengineering,making other disease control measuresless effective.

The Secretarys authority toquarantine persons is limited to thosecommunicable diseases published in anExecutive Order of the President. Thislist currently includes cholera,diphtheria, infectious tuberculosis,plague, smallpox, yellow fever, andviral hemorrhagic fevers, such as

http://www.cdc.gov/ncidod/dqhttp://www.cdc.gov/ncidod/dqhttp://www.regulations.gov/http://www.regulations.gov/http://www.regulations.gov/mailto:[email protected]://www.regulations.gov/http://www.regulations.gov/http://www.regulations.gov/http://www.regulations.gov/mailto:[email protected]://www.regulations.gov/http://www.regulations.gov/http://www.cdc.gov/ncidod/dqhttp://www.cdc.gov/ncidod/dq


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71893Federal Register / Vol. 70, No. 229/ Wednesday, November 30, 2005 / Proposed Rules

1The Office of the Surgeon General was abolishedby section 3 of the 1966 reorganization plan,effective June 25, 1966, 31 FR 8855. Accordingly,statutory references to the Surgeon General shouldbe understood as referring to the Secretary.

Marburg, Ebola and Congo-Crimean,Severe Acute Respiratory Syndrome,and influenza caused by novel orreemergent influenza viruses that arecausing or have the potential to cause apandemic (see Executive Order 13295,as amended by Executive Order 13375on April 1, 2005).

Regulations that implement federalquarantine authority are currentlypromulgated in 42 CFR parts 70 and 71.Part 71 deals with foreign arrivals andpart 70 deals with interstate matters.The Secretary has delegated to theDirector of the Centers for DiseaseControl and Prevention the authority forimplementing 42 CFR part 71, whichwas last substantively updated in 1985.On August 16, 2000, the Secretarytransferred the authority for interstatequarantine over persons from FDA toCDC, which became 42 CFR part 70.FDA retained, pursuant to 21 CFR part1240, regulatory authority over animals

and other products that may transmit orspread communicable diseases. TheSecretary took this action in order toconsolidate regulations designed tocontrol the spread of communicablediseases, thereby increasing theagenciesefficiency and effectiveness.This proposed rule is not intended tohave any effect upon FDAs authority in21 CFR part 1240. In 2003, in responseto the emergence of Severe AcuteRespiratory Syndrome (SARS), Healthand Human Services (HHS) amended 42CFR 70.6 and 71.3 to incorporate byreference the Executive Order listing the

communicable diseases subject toquarantine, thereby eliminating theadministrative delay involved inseparately publishing the list of diseasesthrough rulemaking. Also in 2003, CDCpublished an interim final rule thatadded 71.56 African rodents and otheranimals that may carry the monkeypoxvirus. Finally, on January 25, 2005, theSecretary added section 70.9 to establishvaccination clinics and a user fee inconnection with administration ofvaccine services and vaccine.

The intent of the proposed updates to42 CFR parts 70 and 71 is to clarify and

strengthen existing procedures to enableCDC to respond more effectively tocurrent and potential communicabledisease threats.

III. Legal Basis of Federal QuarantineAuthority

The primary statutory authority toenact regulations for the purpose ofcommunicable disease control is foundat section 361 (42 U.S.C. 264) of thePublic Health Service Act. Section 361is divided into four subsections.

Subsection (a) authorizes the Secretary 1to make and enforce such regulationsas in his judgment are necessary toprevent the introduction, transmission,and spread of communicable diseasesfrom foreign countries and from onestate or possession into any other stateor possession. Subsection (a) alsoauthorizes a variety of public health

measures, including destruction ofarticles determined to be sources ofcommunicable disease. Subsection (b)authorizes the apprehension,detention, or conditional releaseofindividuals to prevent the spread ofcommunicable diseases as specified inExecutive Orders of the President.Subsection (c) provides the basis forforeign quarantine of persons, whilesubsection (d) provides the basis forinterstate quarantine of persons.

As prescribed in 42 U.S.C. 271 and 18U.S.C. 3559 and 3571(c), criminalsanctions exist for violating regulations

enacted under section 361. Specifically,individuals in violation of suchregulations are subject to a fine of nomore than $250,000 or one year in jail,or both. Violations by organizations arecurrently subject to a fine no greaterthan $500,000 per event. Federal districtcourts also have jurisdiction to enjoinindividuals and organizations fromviolating regulations implementedunder section 361. See 28 U.S.C. 1331.Furthermore, section 311 (42 U.S.C.243) of the PHSA, authorizes theSecretary to accept state and localassistance in the enforcement of

quarantine regulations and to assiststates and their political subdivisions inthe control of communicable diseases.

Prevention of communicable diseaseshas long been the subject of federalregulation. In 1796, Congress enactedthe first federal quarantine law inresponse to a yellow fever epidemic,which gave federal officials theauthority to assist states in theenforcement of quarantine laws. In1799, Congress repealed the 1796 Actand replaced it with one establishingthe first federal inspection system formaritime quarantines. In 1878, Congressamended the Quarantine Act to assignresponsibilities to the Marine HospitalService, which had been established in1798 to provide for the health needs ofmerchant seaman. The 1878 QuarantineAct, however, was extremely limitedand provided that federal quarantineregulations could not conflict with thoseof state or municipal authorities.

In 1893, Congress expanded the roleof the Marine Hospital Service byenacting An Act Granting AdditionalQuarantine Powers and ImposingAdditional Duties upon the MarineHospital Service.See CompagnieFrancaise de Navigation a Vapeur v.State Board of Health, Louisiana, 186U.S. 380, 39596 (1902). While the 1893

Act did not abrogate the role of thestates, it nonetheless granted theSecretary of the Treasury the authorityto enact additional rules and regulationsto prevent the introduction of diseases,

both foreign and interstate, where stateand municipal ordinances were deemedinsufficient. Id. at 396. The Act alsoauthorized direct federal enforcement ofcommunicable disease regulationswhere state and municipal authoritiesrefused to act. Id. Section 361 wasenacted in 1944, and last amended in2002.

Acknowledging the critical

importance of protecting the publicshealth, long-standing court decisionsuphold the ability of Congress and theStates to enact quarantine and otherpublic health laws, and to have themexecuted by public health officials.United States v. Shinnick, 219F.Supp.789 E.D.N.Y. (1963). Kroplin v.Truax, 165 N.E. 498 (1929);Jacobson v.Massachusetts, 197 U.S. 11 (1905);North American Cold Storage Co. v. Cityof Chicago, 211 U.S. 306 (1908);Compagnie Francaise de Navigation aVapeur v. Board of Health, 186 U.S. 380(1902). Whereas the States derive publichealth authorities from the police power

reserved to them by the 10thAmendment to the U.S. Constitution,the authority of the federal governmentto enact quarantine rules andregulations is based on the CommerceClause, which grants to Congress theexclusive authority to regulate foreignand interstate commerce. See U.S.Const. Art. I, section 8, cl.3 (granting toCongress the power to regulateCommerce with foreign Nations, andamong the several States, and with theIndian Tribes.).

In addition to Congressauthority toregulate foreign commerce, the U.S.

Supreme Court has identified threebroad categories of interstate activitythat Congress may regulate under itsCommerce Clause authority: (1) The useof the channels of interstate commerce(e.g., prohibitions on the shipment ininterstate commerce of noxious articlesor kidnapped persons); (2) theinstrumentalities of interstatecommerce, or persons or things ininterstate commerce, even though thethreat to interstate commerce may comeonly from intrastate activities (e.g.,regulations on railway rates); and (3)



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activities that substantially affectinterstate commerce (e.g., laborstandards). United States v. Lopez, 514U.S. 549, 558559 (1995). The proposedregulation is consistent with the scopeof the federal governments commercepower because it seeks to regulate theuses of the channels of foreign andinterstate commerce (i.e., by protecting

against the introduction, transmission,and spread of communicable diseases)and the instrumentalities of foreign andinterstate commerce (e.g., airlines withflights arriving into the U.S. or travelingfrom one state or possession intoanother).

The proposed regulation also isconsistent with the search and seizurerequirements of the Fourth Amendment.Authority to search and seizein theform of inspections, detentions, andquarantine has long existed under thePublic Health Service Act and thecurrent regulations. The Fourth

Amendment to the U.S. constitutionprovides that [t]he right of the peopleto be secure in their persons, houses,papers, and effects, shall not beviolated, and no warrants shall issue,

but upon probable cause. * * *Courtshave held, however, that not all types ofsearches and seizures necessarilyrequire probable cause and a warrant.Searches and seizures conducted withthe consent of an authorized person andthose searches and seizures that areconducted to avert an imminent threatto health or safety do not run afoul ofthe Fourth Amendment even when

conducted without probable cause anda warrant. See Lenz v. Winburn, 51 F.3d1540, 1548 (11th Cir. 1995) (Anyonewho possesses common authority overor other sufficient relationship to thepremises or effects sought to beinspected may consent to the search ofanothers property.) (internalquotations marks omitted); NorthAmerican Cold Storage, 211 U.S. at 315(upholding seizure of food unfit forhuman consumption). Similarly,individuals at points of entry and whoare in transit have a substantiallyreduced expectation of privacy

concerning their persons and effects andthus courts have not required thatsearches and seizures be conductedpursuant to probable cause and awarrant. See United States v. McDonald,100 F.3d 1320, 132425 (7th Cir. 1996)(noting that it is generally recognizedthat people who are in transit oncommon thoroughfares, i.e., on a bus,train, or airplane, have a substantiallyreduced expectation of privacycompared to persons in a fixeddwelling); United States v. Berisha, 925F.2d 791, 795 (5th Cir. 1991) (noting

that both incoming and outgoing bordersearches have features in commonincluding the need to protect U.S.citizens, the likelihood of smugglingcontraband, and the fact thatindividuals are placed on notice thattheir privacy may be invaded when theycross the border).

The U.S. Supreme Court has also

recognized a reduced expectation ofprivacy concerning commercialindustries that are closely regulatedand thus searches and seizures of suchcommercial industries do not requireprobable cause and a warrant. See NewYork v. Burger, 482 U.S. 691, 702 (1987)(noting that the warrant and probable-cause requirements of the FourthAmendment have lessened applicationin this context); Lesser v. Espy, 34 F.3d1301, 1308 (1994) (upholdingwarrantless inspections of rabbit farms

by the Animal Plant Health InspectionProgram pursuant to the Animal Welfare

Act). Specifically, warrantlessinspections of closely regulatedbusinesses are deemed reasonableprovided that (1) there is a substantialgovernment interest that informs theregulatory scheme pursuant to whichthe inspection is made; (2) thewarrantless inspection is necessary tofurther the regulatory scheme; and (3)the inspection program, in terms of thecertainty and regularity of itsapplication, provides an adequatesubstitute for a warrant. Burger, 482U.S. at 702703.

Section 361(a) of the PHS Act (42U.S.C. 264(a)) provides that regulations

enacted by the Secretary may providefor inspection, fumigation, disinfection,sanitation, pest extermination,destruction of animals or articles foundto be so infected or contaminated to besources of dangerous infection to human

beings, and other measures that in theSecretarys judgment may be necessaryto prevent the introduction,transmission, or spread ofcommunicable diseases from foreigncountries into the United States or fromone state or possession into another.The statute also authorizes theapprehension, detention, and

conditional release of personsreasonably believed to be infected withspecified communicable diseases andarriving into the United States ortraveling from one state into another. Incarrying out this statutory authority, theproposed regulations authorize theDirector to detain and inspect carriersand articles on board carriers forpurposes of determining whether theymay require the application of sanitarymeasures to prevent the introduction,transmission, or spread ofcommunicable diseases.

The Directors delegated authorityunder section 361 is distinct from legalauthority afforded to other federalagencies, such as USDA, which, amongother things, includes the legal authorityto prohibit or restrict the importation orentry of any animal, article, or means ofconveyance, or the use of any means ofconveyance or facility, if the USDA

Secretary determines that theprohibition or restriction is necessary toprevent the introduction into ordissemination within the United Statesof any pest or disease of livestock. See7 U.S.C. 8303. In implementingmeasures necessary to prevent theintroduction, transmission, and spreadof communicable diseases that affect

both human and livestock health, e.g.,avian influenza, CDC would workcollaboratively with USDA.

As previously noted, there arecircumstances where courts have heldthat the Fourth Amendment does not

require probable cause and a warrant,including searches conducted upon theconsent of the individual and thosenecessary to avert an imminent threat tohuman health or safety. Inspectionsconducted by quarantine officers atports of entry and other locations willmost often fall into one of these twocategories. In addition, under theproposed regulations, the Director maycompel inspections of carriers and theapplication of sanitary measuresthrough written order. Furthermore, theproposed regulations provide theowners with an opportunity for awritten appeal in the event that the

Director orders the detention of a carrieror the destruction of animals, articles, orthings, on board the carrier. Regardingindividuals, the proposed regulationauthorizes the provisional quarantine ofpersons arriving into the United Statesreasonably believed to be infected withor exposed to a quarantinable diseaseand persons who the Directorreasonably believes to be in thequalifying stage of a quarantinabledisease and traveling from one state intoanother or who are a probable source ofinfection to others who may be travelingfrom one state into another.

The routine inspection of persons orproperty for purposes of determiningthe presence of communicable disease isauthorized by statute and does not runafoul of the Fourth Amendment becauseof the reduced expectation of privacyinherent in travel and at bordercrossings. See United States v. Flores-Montano, 541 U.S. 149, 152 (2004)(noting that the Governments interest inpreventing the entry of unwantedpersons and effects is at its zenith at theinternational border and that bordersearches conducted pursuant to the



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longstanding right of the sovereign toprotect itself by stopping and examiningpersons and property crossing into thiscountry are reasonable simply by virtueof the fact that they occur at the border);McDonald, 100 F.3d at 1324 n.5 (Thisdiminished interest derives from, amongother factors, the myriad legitimatesafety concerns that pertain to those

who travel by common carrier.). Airtravel and shipping are also closelyregulated industries in the United States

because these industries must complywith myriad regulatory requirementsrelating to safety, immigration, andhomeland security. See United States v.Dominguez-Prieto, 923 F.2d 464, 468(6th Cir. 1991) (holding that commoncarriers in the trucking industry arepervasively regulated industries forpurposes of warrantless inspections

because of extensive federal and stateregulations). Courts have also longrecognized a substantial government

interest in preventing the introduction,transmission, and spread ofcommunicable diseases. See Jacobson,197 U.S. at 11. Unsanitary carriers, aswell as contaminated goods, may posea threat to human health or safety, aswell as lead to further contamination ofother articles, if not immediatelyinspected and sanitized. The issuance ofa written order by the Director, whennecessary to compel compliance,accompanied by an opportunity for awritten appeal, in the case of carriersordered detained or animals, articles, orthings ordered destroyed, also provides

protections analogous to those of awarrant. See Burger, 482 U.S. at 711(ruling that the administrativeinspection program provided anadequate substitute for a warrant

because it placed appropriate restraintson the discretion of the inspectingofficers).

It is well recognized that freedomfrom physical restraint is a libertyinterest protected by the Due ProcessClause of the 14th Amendment to theU.S. Constitution. See Kansas v.Hendricks, 521 U.S. 346, 356 (1997)(noting that while freedom from

physical restraint is at the core of theliberty protected by the Due ProcessClause, that liberty interest is notabsolute). In circumstances where dueprocess is required, courts determinethe process that is due by balancing theprivate interest affected by the officialaction against the governments assertedinterest and the burdens that thegovernment would face in providinggreater process. See Hamdi v. Rumsfeld,124 S.Ct. 2633, 2646 (2004) (relying onMathews v. Eldridge, 424 U.S. 319, 335(1976)). Due process is a flexible

concept requiring that the level ofprocess granted be commensurate withthe degree of deprivation and thecircumstances of the event. See Parhamv.J.R., 442 U.S. 584, 608 (1979) (Whatprocess is constitutionally due cannot

be divorced from the nature of theultimate decision that is being made.).Furthermore, due process does not

always require judicial-type hearings orquasi-criminal proceedings beforecurtailing an individuals physicalliberty for public health purposes. Seeid. at 609 (Although we acknowledgethe fallibility of medical and psychiatricdiagnosis, we do not accept the notionthat the shortcomings of specialists canalways be avoided by shifting thedecision from a trained specialist usingthe traditional tools of medical scienceto an untrained judge or administrativehearing officer after a judicial-typehearing.) (internal citation omitted);Addington v. Texas, 441 U.S. 418, 431

(1979) (holding that states need notapply the strict criminal standard ofproof beyond a reasonable doubt beforecommitting the mentally ill); Morales v.Turman, 562 F.2d 993, 998 (5th Cir.1977) (noting in dicta that [a] stateshould not be required to provide theprocedural safeguards of a criminal trialwhen imposing a quarantine to protectthe public against a highlycommunicable disease.). The basicelements of due process include:Reasonable and adequate notice of theaction that the government is purportingto take (typically through a written

order); an opportunity to be heard in areasonable time and manner; access tolegal counsel; and review of thegovernments actions by an impartialdecision-maker. See Goldberg v. Kelly,397 U.S. 254, 267268 (1970)(discussing due process in the context ofterminating welfare benefits). Becausequarantine implicates an individualsliberty interest to remain free fromphysical restraint, CDC in carrying outquarantine actions is obliged to act in amanner consistent with these basicelements of due process.

The proposed regulation establishes

administrative procedures that affordindividuals with due processcommensurate with the degree ofdeprivation and the circumstances ofcontrolling the spread of communicabledisease. CDC quarantine officers aretypically the first line of defense inpreventing the importation ofcommunicable diseases into the UnitedStates. Quarantine officers routinelyconduct rapid assessments of illpassengers at airports and other ports ofentry to assess the presence ofcommunicable disease. Such

assessments generally occur on avoluntary basis with the consent of theill passenger. Where the quarantineofficer reasonably believes that an illpassenger has a quarantinable disease,and the passenger is otherwise non-compliant, the quarantine officer mayorder the provisional quarantine of thepassenger by serving the passenger with

a written order, verbally ordering thatthe passenger be provisionallyquarantined, or by ordering that actualrestrictions be placed on a non-compliant passenger. The quarantineofficers reasonable belief would beinformed by objective scientificevidence such as clinical criteriaindicative of one of the specifiedquarantinable diseases, e.g., high fever,respiratory distress, and/or chills,accompanied by epidemiologic criteriasuch as travel to or from an affected areaand/or contact with known cases.Provisionally quarantined individuals

are provided with a written order insupport of the agencys determination atthe time that provisional quarantinecommences or as soon thereafter as thecircumstances reasonably permit. Thewritten provisional quarantine orderprovides the individual with noticeregarding the legal and scientific basisfor their provisional quarantine, thelocation of detention, and the suspectedquarantinable disease. Under theproposed regulations, CDC mayprovisionally quarantine an individualfor up to three business days unless theDirector determines that the individual

should be released or served with aquarantine order. CDC does not intendto provide individuals withadministrative hearings during thisinitial three-day period of provisionalquarantine, but rather will afford anopportunity for a full administrativehearing in the event that the individualor group of individuals is served with aquarantine order, which potentiallywould involve a longer period ofdetention.

While there are no federal casesestablishing a specific time period forholding persons in quarantine-type

detentions, there are several analogousfederal cases dealing with alimentarycanalsmugglers, i.e., persons whosmuggle drugs in their intestines byswallowing balloons. In United States v.Montoya de Hernandez, 473 U.S. 531(1985), the U.S Supreme Courtanalogized holding a suspectedalimentary canal smuggler to detainingsomeone for suspected tuberculosis,noting that both are detained untiltheir bodily processes dispel thesuspicion that they will introduce aharmful agent into this country.



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Federal courts have upheld detentionperiods ranging from 16 hours to 20days based on reasonable suspicionfor suspected alimentary canalsmugglers. CDC believes that theprovisional quarantine of individualsfor up to three business days without anadministrative hearing is reasonable

because such a time frame is necessary

to determine whether the individual hasone of the specified quarantinablediseases. A provisional quarantine orderis likely to be premised on the need toinvestigate based on reasonablesuspicion of exposure or infection,whereas a quarantine order is morelikely to be premised on a medicaldetermination that the individualactually has one of the quarantinablediseases. Thus, during this initial three

business day period, there may be verylittle for a hearing officer to review interms of factual and scientific evidenceof exposure or infection. Three business

days may be necessary to collectmedical samples, transport suchsamples to laboratories, and conductdiagnostic testing, all of which wouldhelp inform the Directors determinationthat the individual is infected with aquarantinable disease and that furtherquarantine is necessary. In addition,

because provisional quarantine may lastno more than three business days,allowing for a full hearing, withwitnesses, almost guarantees that nodecision on the provisional quarantinewill actually be reached until after theprovisional period has ended, thus

making such a hearing virtuallymeaningless in terms of granting releasefrom the provisional quarantine. In theevent that further quarantine orisolation is necessary, the Directorwould issue an additional order basedon scientific principles such as clinicalmanifestations, diagnostic or othermedical tests, epidemiologicinformation, laboratory tests, physicalexamination, or other available evidenceof exposure or infection. The length ofquarantine or isolation would notexceed the period of incubation andcommunicability for the communicabledisease as determined by the Director.

Under 28 U.S.C. 2241, an opportunityfor judicial review of the agencysdecision exists via the filing of apetition for a writ of habeas corpus. Thisjudicial review mechanism affordsindividuals under quarantine with thefull panoply of due process rightstypical of a court hearing. A petition fora writ of habeas corpus is the traditionalmechanism by which individuals maycontest their detention by the federalgovernment. See Hamdi, 124 S.Ct. at2644 (noting that absent suspension, the

writ of habeas corpus remains availableto all individuals detained within theUnited States); United States v.Shinnick, 219 F.Supp.789 (E.D.N.Y.1963) (upholding the U.S. Public HealthServices medical isolation of anarriving passenger because she had beenin Stockholm, Sweden, a city declared

by the World Health Organization to be

a smallpox infected local area and couldnot show proof of vaccination).

In addition to this judicial reviewmechanism, as previously mentioned,the proposed regulations establish aprocedure for individuals underquarantine to request an administrativehearing. The purpose of theadministrative hearing is not to reviewany legal or constitutional issues thatmay exist, but rather only to review thefactual and scientific evidenceconcerning the agencys decision, e.g.,whether the individual has beenexposed to or infected with a

quarantinable disease. Such anadministrative hearing would comportwith the basic elements of due process.Under the proposed regulations, theDirector would notice the hearing anddesignate a hearing officer to review theavailable evidence of exposure orinfection and make findings as towhether the individual should bereleased or remain in quarantine. Theproposed regulations authorize theDirector to take such measures as theDirector determines to be reasonablynecessary to allow an individual inquarantine to communicate with their

authorized representative to participatein the hearing.In addition to section 361 of the PHS

Act (42 U.S.C. 264), HHS also relies onthe following legal authorities withrespect to this notice of proposedrulemaking: 25 U.S.C. 198, 231, and1661; 42 U.S.C. 243, 248, 249, 265272,and 2001. 25 U.S.C. 198, 231, 1661 and42 U.S.C. 2001 contain legal authoritiesprimarily relevant to public healthmeasures taken with respect to Indiancountry. 42 U.S.C. 265272 containlegal authorities primary relevant toHHS operations and activities with

respect to quarantine and other publichealth measures. These authorities arediscussed in depth in Section IV.

IV. Summary of Proposed Changes to42 CFR Part 70

Several new sections have been addedto 42 CFR Part 70. Most of these sectionsare provided to update and streamlinepractices to reflect modern quarantinepractice. Imposition of quarantine needsto be based on clear legal authoritiesand applied safely and effectively whileaccording respect to the individual.

The following is a section-by-sectionanalysis:

Section 70.1 Scope and Definitions

Section 70.1 is renamed scope anddefinitions. Section 70.1 explains that,except where otherwise stated,regulations to prevent the spread ofdisease among possessions or from a

possession to a State are contained in 42CFR Part 71.

A number of terms have been addedor modified to be consistent withmodern quarantine concepts andcurrent medical principles and practice.Specifically, definitions for aircraftcommander,airline,airline agent,business day,carrier,detention,emergency contact information,flight information,hearing officer,Indian country,Indian tribe,infectious agent,interstate traffic,medical monitoring,militaryservice,possession,provisionalquarantine, public healthemergency,qualifying stage,quarantine,quarantinable disease,sanitary measure,Secretary,Stateand vectorhave been addedor modified. The definition of an illperson has been modified to include thesigns or symptoms commonlyassociated with diseases for whichprovisional quarantine or quarantinemay be necessary. This definition is ofparticular importance because itdetermines the scope of the reportingrequirement specified in 70.2. Becausereporting is dependent on recognition ofan ill passenger by non-medical

personnel and without the benefit of amedical examination, such as by theflight crew, this definition relies ondescriptive terms that are overt andcommonly understood by lay persons.The definition is broad by design fortwo reasons: (1) To ensure that allsituations for which the Director musttake action in order to prevent theintroduction and spread ofcommunicable diseases are reported,and (2) the reporting of ill passengersrelies on personnel without medicaltraining. While a narrower definitionmight reduce the number of situations

reported for which action by theDirector is unnecessary, such adefinition would necessarily includefindings or terms that cannot beaccurately assessed by those withoutmedical training. Moreover, a narrowerdefinition would likely excludesituations of public health significancethus circumventing the very purpose forwhich the reporting requirement isdesigned. Therefore, the more prudentcourse has been chosen, wherebyreporting is required for a broad rangeof signs and symptoms, allowing the



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Director to use her professionaljudgment to determine which situationsrequire additional action.

Section 70.2 Report of Death or Illnesson Board Flights

As noted previously, the Director hasa responsibility to prevent the spread ofcommunicable diseases between states.

The purpose of the disease reportingrequirement is to ensure that CDC canmobilize appropriate personnel torespond efficiently to the arrival of anill person with a communicable disease.This response may require evaluation ofthe ill passenger by trained medicalpersonnel, evaluation of otherpassengers who may have been exposedto the disease en route, and securetransport of individuals to a designatedisolation facility where they may receiveappropriate care while minimizing therisk of transmission to others. Becausethe entire panel of responders may not

be onsite at the airport it is imperativethat notification be received by CDC assoon as the illness is identified and,whenever possible, at least one hourprior to arrival.

Under current regulations ( 70.4), theperson in charge of any carrier engagedin interstate traffic on which a case orsuspected case of a communicabledisease develops, as soon as practicable,is required to notify the local healthauthorities at the next port of call,station, or stop and take such measuresas the local health authority directs.Paragraph (a) of 70.2 in the proposedrevision eliminates the requirement that

carriers report to local healthauthorities, requiring instead thatreports be made to the Director. Byproviding a single point of contact fordisease reports, the burden on carriersto identify and maintain points ofcontact with local health authorities issignificantly reduced. The Directorwould assume responsibility fornotifying local health authorities asindicated. It is common, but notuniversal, that FAA officials (e.g., airtraffic control) are included amongthose notified by the airline of an illpassenger. Current CDC procedure

dictates that FAA personnel and otheremergency response personnel arenotified by Quarantine Station staff ofthe impending arrival of a planecarrying a passenger with other thanroutine illness. However, thisnotification is contingent on CDCawareness of the situation prior to flightarrival, as this provision requires.

The regulation was drafted to affordthe carrier maximum flexibility inestablishing a system to ensure that theadvance reporting requirement is met.We do not intend to mandate a

particular pathway of communication aslong as a report is made by thedesignated airline official within thespecified time frames. Individualstypically involved in the notificationprocess include the crew, including thepilot or captain, flight operations on theground, air traffic controllers, otherground personnel, and other airlinerepresentatives.

Paragraph (b) of this section enablesthe Director to order airlines engaged ininterstate traffic to distribute topassengers and crew, at a time specified

by the Director, public health noticesand other materials that describerecommended measures for preventingspread of communicable diseases.During SARS and in the time since theoutbreak was controlled, CDC hasdistributed Health Alert Notices toadvise passengers on internationalflights who may have been exposed to

a communicable disease as to how tomonitor their health and how to proceedshould certain symptoms develop.These notices were an importantcomponent of the CDC response toSARS. The effectiveness of thismeasure, however, was limited byCDCs inability to ensure that allpassengers received the notices, a goalthat was particularly difficult ifdistribution occurred after passengersalready had entered the terminal andwere focused on getting to distant gatesor their final destinations. The routinedelay in passenger dispersal followingdisembarkation that accompaniesinternational arrivals (i.e., while theyundergo immigration and customsprocessing) is absent from interstatearrivals, thereby making distribution ofthis information post-disembarkationeven more challenging. By requiringairline staff to distribute these materialsprior to disembarkation, for example,Director can better ensure thatpotentially exposed passengers haveaccess to information critical tomaintaining their own health and topreventing spread in the community.

CDC expects to exercise thisrequirement in situations where asignificant outbreak of a quarantinabledisease is detected abroad and there isthe potential for exposure amonginterstate travelers. CDC might alsorequire airlines to distribute notices inthe period between the outbreak of anew communicable disease and theaddition of the disease to the list ofquarantinable diseases.

Section 70.3 Written Plan forReporting of Deaths or Illness on BoardFlights and Designation of an AirlineAgent

In order to ensure that all parties areaware of the appropriate lines ofcommunication between airlines andCDC for reporting, and that policies andprocedures are in place to facilitate suchcommunication, this section requiresairlines engaged in interstate travel todevelop a written plan sufficient toensure the reporting of ill passengersand deaths on board flights and submitit to the Director within 90 days of thefinal publication of this rule. Airlinesthat intend to commence operation offlights in interstate traffic after thiseffective date shall submit a writtenplan to the Director before commencingoperations.

The plan may be submittedelectronically to an e-mail address orpermanent address that will be provided

in the final rule. This plan wouldidentify the designated airline point ofcontactor agentfor issues related toreporting of any deaths or ill passengers.In addition, the plan would identify themembers of the flight team (e.g., cabincrew, captain, airline flight operations,flight controllers, or other airline-designated agent for reporting) who will

be responsible for making the requiredreport to the Director.

The plan must be implementedwithin 180 days of the final publicationof the rule. CDC believes that a 90-daytime frame for development of a written

plan and an additional 90 days forimplementation to be appropriatebecause airlines should already havesuch procedures in place to satisfy theexisting ill passenger reportingrequirement currently contained in 42CFR 70.4. Airlines commencingoperations after the rule is in effect mustimplement their written plans by thelater of the following: 180 days after thefinal publication of the rule or uponcommencement of operations. CDCsolicits comment on whether thesetimeframe are appropriate. During thephase-in period established in this

section, airlines are still expected tocomply with the reporting requirementscontained in current 70.4.

Airlines are required to review theplan one year after implementation andannually thereafter and make revisionsas necessary. Airlines that have notreported ill passengers or deaths on

board a flight under the requirements in70.2 in the prior 365 days are requiredto conduct drills or exercises to test andevaluate the effectiveness of the plan.Any revisions as a result of the annualreview or the drills or exercises must be



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submitted to the Director within 60days.

Section 70.4 Passenger Information

Among the fundamental componentsof the public health response to thereport of a person with a communicabledisease is the identification andevaluation of those who may have been

exposed. Public health authorities maythen offer these individuals treatment,vaccination, or other preventivemeasures as may be available. Thesetreatments, by preventing thedevelopment or progress of the disease,serve the dual purpose of providingdirect benefit to those exposed alongwith benefit to the community at large

by preventing further person-to-personspread. Thus, in order to carry out herdelegated responsibility to controlspread of communicable diseases

between states, the Director must, for alimited time, be able to efficientlyidentify and locate persons who mayhave been exposed to a communicabledisease during travel. The identificationand notification of those exposed is anessential first step in providing theexposed access to potentially life-savingmedical follow-up and diseaseprevention measures, includingvaccination. Preventing secondary casesamong contacts, in turn, helps preventfurther propagation and spread ofdisease within the community. As such,travelers and the public at large derivedirect benefit from a system, such as isproposed, that ensures that, if anexposure has occurred, affected

passengers can be identified, located,and notified within the incubationperiod of the disease. If notificationdoes not occur by the conclusion of theincubation period, the effectiveness ofmedical follow-up and diseaseprevention measures and, therefore, the

benefit to the public is severely reduced.The worldwide outbreak of SARS, an

illness that was originally reported inAsia in late 2002 and quickly spread toNorth America and Europe, provided aclear example of the rapidity withwhich an infectious disease may spreadthrough air travel, while exposing clear

limitations in the current system ofidentifying and notifying those whomay have been exposed during travel.During this outbreak, CDC attempted togather contact information on personsexposed and received significantcooperation from the airlines. CDC metflights containing suspected contagiouspassengers and obtained location andcontact data from both passengers andcrew members before disembarkation.Ill passengers on planes from affectedareas were met by CDC staff membersfor evaluation and referred for medical

care when appropriate. However, if asuspected case of SARS was identifiedafter disembarkation, CDC staff had tomanually gather, compile, and processdata from flight manifests, customsdeclarations, and any other availablesources relevant to the case.

Utilizing this manual process, CDCstaff encountered the following

difficulties: Manifests provided by carriers

contained only the name and the seatnumber.

Custom declarations werecompleted by the passenger by handand were often illegible.

Names on the customs declarationsdid not necessarily match those on themanifests.

Phone numbers were not includedon customs forms, and only onecustoms form was filled out per family.

Since the data gathered frommanifests and customs declarations

were only available in hard copy, itoften took several days to obtain.Photocopies were sent by express mailto CDC where the data were keyed intoa database. Entering the data andverifying the addresses usually tookseveral more days. The time required totrack passengers was routinely longerthan the incubation period of the SARSvirus.

While CDC received good cooperationfrom the industry, the primaryresponsibility for locating passengersrests with public health authorities asrecognized by International AirTransport Association (IATA)

Recommended Practices 1788, as shownin the following excerpts:

When a Member is advised by a healthauthority that it may have transported apassenger with an infectious disease, it shallco-operate with such health authority, withthe understanding that it is not the Membersresponsibility to trace and notify otherpassengers who may have been exposed tothe infectious disease.

If the health authority requests a list ofother passengers who may have beenexposed to the infectious disease, the healthauthority should be advised to first utilizeimmigration records of the arrivingpassengers, such as landing cards, in order to

determine the names and addresses of suchpassengers. If the health authority advises theMember that it was unable to determine fromimmigration records, the names of otherpassengers who may have been exposed tothe infectious disease, the Member shouldask the health authority to make a formalrequest for a list of passengers.

In the aftermath of SARS, CDC hascontinued to enjoy good overallcooperation from airline industrypartners. However, citing informationprivacy concerns, some airlines haveincreasingly required that CDC

accompany its request for passengerinformation with a written orderexplaining CDCs legal authority forrequesting such information.

In November 2003, the University ofLouisville School of Medicine prepareda report entitled Quarantine andIsolation: Lessons Learned from SARS,that recommended:

In the event that an international travelerdevelops an infectious disease, there is anurgent need to be able to locate crewmembers and other passengers from the sameflight or ship. Public health officials musthave immediate access to passengermanifests or be able to require all arrivingpassengers to complete a public health formcontaining, for example, the individualshealth status, seat number, countries visited,and contact information. This informationmust be in electronic form.

Collection of this information findsstrong support in public opinion. Whilea significant number of air passengersexpressed concerns with increased

reservation or check-in time, a HarvardSchool of Public Health study, Projecton the Public and Biological Security,finds that 94% of air travelers wouldwant public health authorities to contactthem if they might have been exposedto a serious contagious disease on anairplane. In addition, 93% of domesticair travelers and 89% of internationalair travelers expressed a willingness toprovide some type of contactinformation.

In its April 2004 report on EmergingDiseases, GAO04564, the U.S.Government Accountability Office

concluded:The Centers for Disease Control and

Prevention * * * tried to contact passengersfrom flights and ships on which a travelerwas diagnosed with SARS after arriving inthe United States. However, these effortswere hampered by airline concerns andprocedural issues.

On the basis of that conclusion, theGAO recommended that the

Secretary of HHS complete steps to ensurethat the agency can obtain passenger contactinformation in a timely manner, including, ifnecessary, the promulgation of specificregulations.

This provision seeks to address thisrecommendation by GAO.As stated previously, under 42 U.S.C.

264, the Secretary of HHS is authorizedto make and enforce regulationsnecessary to prevent the introduction,transmission, and spread ofcommunicable diseases from foreigncountries into the United States andfrom one state or possession intoanother. The Director has beendelegated the responsibility for carryingout these regulations. The Directorsauthority to investigate suspected cases



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and potential spread of communicabledisease among foreign and interstatetravelers is thus not limited to thoseknown or suspected of having aquarantinable disease (any of thecommunicable diseases listed in anExecutive Order, as provided underSection 361 of the Public Health ServiceAct (42 U.S.C. 264). Executive Order

13295, of April 4, 2003, as amended byExecutive Order 13375 of April 1, 2005,contains the current revised list ofquarantinable diseases, and may beobtained at http://www.cdc.gov andhttp://www.archives.gov/

federal_register). Rather, theauthorityencompasses all communicable diseasesthat may necessitate a public healthresponse. An order for transmission ofpassenger information is more likely tofollow exposure to a non-quarantinablecommunicable disease than to one listedas quarantinable under the currentExecutive Order as the former occur

much more commonly. Examples ofsituations where manifest data may be

requested for communicable diseaseswould be following exposure to anindividual with suspected measles or

bacterial meningitis. When to ordertransmission of data from airlineswould, by necessity, have to be decidedon a case-by-case basis depending onthe facts and circumstances of theparticular disease occurrence. However,

any order to transmit passengerinformation to CDC would be done sowhen necessary for the protection of thevital interests of an individual or otherpersons, in regard to significant healthrisks.

The proposed regulation requires thatairlines operating interstate flightsarriving in or departing from any of theairports listed in Appendix A to requestcertain information from passengers,maintain it in an electronic database for60 days from the end of the flight, andtransmit the information to CDC within12 hours of a request. This information

includes, as specified in paragraph (e),full name (first, last, middle initial,

suffix); current home address (street,apartment number, city, state/province,postal code); at least one of thefollowing current phone numbers inorder of preference: (mobile, home,pager, or work ); e-mail address;passport or travel document, includingthe issuing country or organization;traveling companions or group; flight

information; returning flight (date,airline number, and flight number); andemergency contact information asdefined in 70.1. The following tablesummarizes the data elements thatwould be collected under the proposedNPRM, those items currently collected

by airlines and the frequency ofcollection, and items which theDepartment of Homeland Securitycollects under its Advanced PassengerInformation System (APIS). Based onCDCs experience with previous contacttracing efforts using passenger data, thedata elements are ordered according to

the relative utility of each piece of datawith respect to contract tracing.

Data elements required by CDC NPRM Currently collected by airlines

Required byDHS/APIS forinternational

flights

Name ........................................................................................... Yes ............................................................................................ Yes.Emergency contact ..................................................................... Intermittent to rarely for domestic flights, more frequently for

international flights.No.

Flight information ........................................................................ Yes ............................................................................................ Yes.Phone number ............................................................................ Intermittent ................................................................................ No.Email address ............................................................................. Intermittentusually only for Internet, phone, or travel agent

reservations.No.

Current home address ................................................................ Intermittentusually only for Internet or travel agent reserva-tions.

No.

Passport or travel document number and country (for foreignnationals for domestic and international flights). Only for international flights ...................................................... Yes.

Traveling companions ................................................................. No .............................................................................................. No.Returning flight information ......................................................... Usually only if booked at same time or with same airline ........ No.

The data are to be collected from eachcrewmember and passenger or head ofhousehold if the passenger is a minorand must be maintained by the airlinefor 60 days from the end of the voyage.Upon request of the Director, the dataare to be transmitted to CDC within 12hours. This time period is consideredlonger than will actually be necessary

once the plan for data transmissiondeveloped pursuant to 70.5 has beenimplemented. In addition, paragraph (f)enables the Director to compel, throughorder, transmittal of additionalinformation in the airlines possessionthat may be necessary to prevent theintroduction, transmission, or spread ofcommunicable diseases. For example,information regarding the airlines foodservice provider may be relevant to aninvestigation of a foodborne outbreak on

board an airline.

The provision does not requireairlines to verify the accuracy of theinformation collected from passengers.Airlines, however, are expected toaccurately transmit informationcollected from passengers. Based in parton data from a public opinion survey, itis believed likely that passengers willvoluntarily provide this information sothat CDC could contact the passenger inthe case of that passengers exposure toa communicable disease. However,passengers who decline to providecontact information will not beprohibited from traveling.

CDC invites comments on any and allaspects of this data collection.Specifically, CDC solicits comments onthe following subjects:

Although we assume travelers willbe willing to provide accurateinformation in the interest of beingcontacted for public health reasons, we

are interested in further strategies thatmay increase the likelihood of receivingaccurate information from travelers

Whether a shorter list of contactdata would improve the willingness toprovide information or the accuracy ofthe information provided.

The degree to which airlines andshiplines currently collect eachproposed data element, the feasibilityand cost of collecting each data element,and the extent that the additional datacollection would require changes in ITsystems or operating procedures.

The utility of each proposed dataelement for the purposes of contacttracing.

Information and records provided toCDC will be maintained and stored inaccordance with HHS and CDC policiesand in accordance with Privacy Act (5U.S.C. 552a) and its implementingregulations (45 CFR Part 5b), which

http://www.cdc.gov/http://www.cdc.gov/http://www.archives.gov/federal_registerhttp://www.archives.gov/federal_registerhttp://www.archives.gov/federal_registerhttp://www.archives.gov/federal_registerhttp://www.archives.gov/federal_registerhttp://www.archives.gov/federal_registerhttp://www.cdc.gov/


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require that the records only be used forauthorized purposes by authorizedpersonnel. Paper records will be kept inlocked storage containers and accesswill only be allowed for authorizedpersonnel; electronic records will beinaccessible to all CDC employeesexcept those that are authorized to usethem in accordance with Federal law.

After the legal retention period for theserecords has expired, they will bedestroyed (shredding or maceration forpaper files; wiping of electronic files) toensure that the information is notrecoverable and to ensure the privacyand confidentiality of those involved.CDC has a long history of managingsensitive data in a manner that protectsthe confidentiality and privacy of thepublic. This positive track record willcontinue with the management of theserecords.

The Federal Records Managementretention guidelines require that we

develop a specific approved recordscontrol schedule through theestablished records disposition process.CDC intends to propose a recordscontrol schedule for these records thatwould establish a legal retention periodof one year. This would allow CDC toproperly respond to outbreaks, and toensure the health of airline passengersand the American public. The reviewprocess (as defined in 36 CFR part 1228)will involve significant internal CDCreview (including substantive legalreview), a review by HHS and theNational Archives and RecordsAdministration (NARA), and finally the

publishing of a proposed retentionschedule for these records in theFederal Register for public comment.CDC anticipates that this process willtake 1218 months. We are confidentthat after this process all relevantinterests and concerns from health,privacy and legal perspectives, andthose representing the interests ofpassengers, the airline industry, and thegeneral public will be taken intoconsideration. Current standard recordsretention policy requires that we keepdata for 10 years. Until we can create anew records schedule for these data,

CDC will follow this policy.Airlines are expected to safeguard theconfidentiality of the informationcollected. Under the proposedregulation, information collected solelyin order to comply with this rule mayonly be used for the purposes for whichit is collected. Airlines shall ensure thatpassengers are informed of the purposesof this information collection at the timepassengers arrange their travel. CDCsolicits comments on the privacyaspects of collecting information to beused solely in order to comply with this

rule, including the practicality ofinforming passengers of the purposes ofthe information collection and thesafeguarding of passenger information.

The airports listed in Appendix A arederived from a list that the FederalAviation Administration uses toapportion its Airport ImprovementProgram grants base. As part of this

program, FAA assigns the status ofairport hubs based upon that airportspassenger boardings as a percent of totalU.S. passenger boardings. CDC haslisted in Appendix A the 67 large andmedium hubs assigned by FAA in 2004,which is the latest list published byFAA. CDC is focusing upon the 67 largeand medium hubs because this capturesa majority (approximately 90%) ofannual passenger boardings without

burdening airlines that operate only insmall hubs where passenger boardingsare considerably lighter. CDC may revisethis list in the future through notice and

comment rulemaking.Section 70.5 Written Plan forPassenger Information and Designationof an Airline Agent

This provision as outlined inparagraph (a) requires airlines engagedin interstate commerce to designate anagent as a CDC single point of contactfor communications related to passengermanifests. In addition, airlines mustdevelop, within six months of the finalpublication of this rule, a written plansufficient to ensure the electronictransmission to the Director of data thatare collected from passengers and crew

pursuant to 70.4. Paragraph (f)explains that airlines meeting theprovisions in (a) that intend tocommence operations after the effectivedate in (a) shall submit a written planto the Director prior to commencingoperations.

The plan may be submittedelectronically to an e-mail address orpermanent address that will be providedin the final rule. The written plan mustinclude policies and procedures for thetransmission of the data in an electronicformat available to both the airline andthe Director using industry standards for

data encoding, transmission, andsecurity. Airlines are required to submittheir written plans for transmission ofpassenger manifest information to theDirector and implement the plan within2 years of the final publication of thisrule. Airlines commencing operationsafter the effective date in (a) are requiredto implement the plan on the later ofthese two dates: 2 years after the finalpublication of this rule or uponcommencement of operations. CDC issoliciting comments specifically inregard to these timeframes.

Upon implementation of the plan,airlines are required to conduct drills orexercises to test and evaluate theeffectiveness of the plan. Airlines arerequired to review the plan one yearafter implementation and annuallythereafter. The review shall includedrills or exercises to test and evaluatethe effectiveness of the written plan

unless the airline has transmittedpassenger and crewmember informationunder 70. 4 in the prior 365 days.Airlines shall make revisions asnecessary as result of the review andsubmit them to the Director within 60days.

Section 70.6 Travel Permits

This provision requires any personwho knows that he or she is in thequalifying stage, as defined in 70.1, ofany quarantinable disease to obtain atravel permit from the Director if he/sheintends to travel in interstate traffic orfrom one state or possession into anyother state or possession.

Section 70.6 prohibits interstatecarriers from knowingly transporting oraccepting for transport any person in thequalifying stage of a quarantinabledisease without a travel permit issued

by the Director. If a person possesses atravel permit, the carrier is required totake all steps necessary to preventspread of the disease during transport.

Persons who know that they are in thequalifying stage of a quarantinabledisease are prohibited from traveling ininterstate traffic or from one state orpossession into another without a

permit issued by the Director. Theperson issued a permit is required tomaintain possession of the permit at alltimes during travel, and to comply withits conditions. Persons whoseapplication for a travel permit has beendenied may submit a written appealwithin two business days in accordancewith 70.31.

An order of the CDC Director is notnecessary for travel permits to berequired under this section, rather theseare ongoing requirements. CDC expectsthat the need to issue a travel permitwill arise infrequently. CDC envisions

that the circumstances under which theuse of travel permits would be necessaryinclude (1) to prevent spread ofquarantinable disease in interstatetraffic or from one state or possessioninto any other state or possession; (2)upon request of a health authority; and(3) in the event of inadequate localcontrol. The requirement of travelpermits pertains to individuals whoknow they are in the qualifying stage ofquarantinable disease and thus requiresactual knowledge of ones condition.Similarly, section 70.6 provides that a



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carrier may not knowingly transport atraveler in the qualifying stage of aquarantinable disease without a permit.

The Director may additionally applythe provisions of this section to personsand carriers traveling entirely within the

boundaries of a state or possession uponthe request of a cognizant healthauthority or in the event of inadequate

local control if the Director determinesthat such personstravel or theoperations of the carrier have an effecton interstate commerce. In such cases,the Director will issue an order advisingpersons of the application of thisprovision to intrastate traffic that affectsinterstate commerce. CDC believes thattravel permits may be an importantpublic health tool in the event of apublic health emergency thatnecessitates the control of intrastatemovement or the orderly evacuation ofinfected individuals to other locationswithin a state or possession.

Section 70.7 Responsibility WithRespect to Minors, Wards, and Patients

This section clarifies that parents,guardians, physicians, nurses, and otherpersons may not procure transportationfor children, wards, or patients whomthey know to be in the qualifying stageof a quarantinable disease withoutobtaining a travel permit from theDirector if such a permit is requiredunder this part. Because minor children,wards, and hospitalized persons maynot be able to procure transportation ontheir own, the responsibility forobtaining the travel permit falls to their

guardians and/or other persons inwhom their care is entrusted. Thisprovision is a carryover from existing 70.7, with the exception that theprovision has been changed tospecifically reference travel permits.Persons whose application for a travelpermit has been denied may submit awritten appeal within two business daysin accordance with 70.31.

Section 70.8 Military Services

Under section 361 of the PHS Act (42U.S.C. 264), the HHS Secretary has

broad authority to enact regulations to

prevent the introduction, transmission,and spread of communicable diseases.This is a statute of general applicabilityand thus applies to the military and itsservice members traveling on militarycarriers. Section 70.8, however, exemptsthe military services and their memberstraveling on military carriers fromcertain provisions of Part 70.Specifically, the military services andtheir members traveling on militarycarriers are exempt from the followingprovisions: 70.6(a) (travel permitsrequirements relating to carriers),

70.11 (sanitary measures), and 70.12(detention of carriers affecting interstatecommerce). A limited exemption is alsocreated with respect to 70.6(c) (travelpermit requirements relating to personswho know that they are in thequalifying stage of a quarantinabledisease) and 70.7 (Responsibility withrespect to minors, wards, and patients),provided that the person authorizing theservice members travel on a militarycarrier takes measures consistent withthose prescribed by the Director toprevent the possible transmission ofinfection to others during travel. Thissection is largely carried over fromexisting 70.8. Furthermore, while notspecifically exempt, carriers belongingto the military services are not subjectto requirements relating to reporting ofdeaths or illness on board flights ( 70.2& 70.3) and passenger information( 70.4 & 70.5) because aircraft

operated by the military services do notoperate commercially.Theseexemptions exist because the U.S.military has established mechanisms toprevent disease spread on board itscarriers and among its personnel. HHSalso wishes to minimize any potentialdisruption of military activities.

Section 70.9 Vaccination Clinics

This provision replaces current 70.9,recently promulgated as an interim finalrule. The current section authorizes theDirector to establish vaccination clinicsand to charge persons not enrolled in

Medicare Part B a user fee to cover costsassociated with administration ofvaccine. The proposed regulationcontains similar authority, andadditionally requires vaccination clinicsto comply with recordkeeping and otherinstructions issued by the Director toensure safe administration, handling,monitoring and storage of vaccines.These requirements include collectionand maintenance of information onvaccine recipients including age,gender, date of vaccination, vaccine lotnumber, prior vaccination, concurrentvaccinations, Vaccine Adverse Events

Reporting System Report/Adverse EventReport Number (if applicable), andverification that the vaccinationconferred immunity. In addition, thereason for vaccination (e.g. postexposure, pre-exposure prophylaxis,military, administrative requirement[pre-employment, school entry],member of high risk group, pre-travel,general vaccination, or other reason)must be stated. The Director may waiveor modify these requirements in theevent of a public health emergency.

Section 70.10 Establishment ofInstitutions, Hospitals and Stations

This provision authorizes the Directorto enter into voluntary agreements withpublic or private institutions for thepurpose of establishing places for careand treatment. This provision is basedupon legal authority provided in 42

U.S.C. 267. With the approval of theSecretary, the Director may selectsuitable sites for the establishment ofquarantine stations and places for careand treatment. Additional legalauthorities relevant to the control,management, and control of institutions,hospitals, and stations established bythe Secretary are also contained in 42U.S.C. 248.

Section 70.11 Sanitary Measures

Section 361(a) of the PHS Act (42U.S.C. 264(a)) provides that in carryingout regulations, the Secretary

may provide for such inspection, fumigation,disinfection, sanitation, pest extermination,destruction of animals or articles found to beso infected or contaminated as to be sourcesof dangerous infection to human beings, andother measures, as in his judgment may benecessary.

Section 70.11 implements thisstatutory provision by authorizing theDirector, in consultation with otherFederal agencies as appropriate, toinspect and order the application ofsuch sanitary measures (as that term isdefined) to any carrier affectinginterstate commerce or to things on

board the carrier that the Director

reasonably believes to be infected orcontaminated by a communicabledisease.

Paragraph (a) updates, consolidatesand makes applicable to interstatesituations the disinfection,disinfestations,disinsection,andother provisions contained in current 42CFR Part 71. It explains that theDirector, in consultation with otherfederal agencies as appropriate, mayinspect and order the carrier, or otherentity specified in the order, as the partyresponsible for applying such measuresas the Director deems necessary to

prevent the introduction, transmission,or spread of communicable diseases.Paragraph (b) explains that CDC shall

not bear the expense of applying thesanitary measure or, expenses related tothings on board. While the precedingparagraph states that CDC shall not bearrelated expenses, paragraph (c) indicatesthat CDC does not intend to prevent anentity conducting sanitary measuresrequired by the Director from seekingreimbursement through contractualarrangements or other available meansfrom entities other than the CDC.



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A written order to the carrier operatoror owner of the cargo would be onemethod that CDC could use for orderingthe application of sanitary measures, butwould not be the exclusive method.Depending on the circumstances of thedisease, CDC, for example, could notifycarrier operators through publication inthe Federal Register when the

occurrence of a communicable diseaseoutbreak in a foreign country increasesthe likelihood of the importation ofinfected persons or goods into theUnited States, and thus may affectinterstate travel. In time-sensitivesituations that present an imminentthreat to human health and require theimmediate application of sanitarymeasures, a CDC quarantine officercould also verbally order that suchmeasures be carried out. Typically, anorder to carry out sanitary measureswould explain the risk to human healthposed by the infected or contaminated

carrier or article and containinstructions on which measures shouldbe employed to abate the human healthrisk. Which sanitary measures should beemployed in a given circumstancewould be determined based on scientificand public health principles applicableto the threat to human health.

Under paragraph (c), the Director mayapply sanitary measures to persons whoare not in the qualifying stage of aquarantinable disease. Provisionsspecifically dealing with respect topersons who may be in the qualifyingstage of a quarantinable disease may be

found in 70.6, and 70.14 through70.24. When applied to a person orgroup of persons, a sanitary measureinvolves the application or directexposure to such chemical, physical, orother processes that are designed todestroy the presence of infectious agentsthat may be outside the body. Underparagraph (c), such procedures may becarried out only with the consent of theperson. Sanitary measures applied to aperson or group of persons are intendedto kill agents (or vectors capable ofconveying infectious agents) outside the

body by direct exposure to a chemical,

physical or other process designed todestroy such infectious agents orvectors. During an outbreak of avianinfluenza, for example, persons exitinga farm containing infected birds wouldhave all visible organic matter removedfrom their shoes with disposable towels.Those persons would then transitthrough a foot bath containing aneffective virucidal solution. As anadditional example, persons infectedwith body lice during an outbreak ofepidemic typhus would be treated withappropriate antibiotics and an effective

topical pediculocidal agent, and wouldhave their clothing washed in hot waterand detergent. The sanitary measuresapplicable to carriers, animals or thingsinclude detention, destruction, seizure,disinfection, disinfestations,disinsection and any other measuresdeemed necessary to prevent theintroduction, transmission or spread of

communicable diseases. If the Directororders the destruction or export ofanimals, articles, or things inaccordance with this section, the ownerof such animals, articles, or things mayappeal the measure, within two

business days, in accordance withSection 70.31.

CDC invites comments on any and allaspects of the proposed process forissuing orders to conduct sanitarymeasures and the appeals process.

Section 70.12 Detention of CarriersAffecting Interstate Commerce

In addition to the provisions listed inSection 70.11, this provision furtherauthorizes the Director, in consultationwith such other federal agencies asappropriate, to detain a carrier until thenecessary measures outlined in Section70.11 have been completed. Theexpense of applying sanitary measuresand detention shall not be borne byCDC. If the Director orders the detentionof a carrier in accordance with thissection, the carrier owner may appealthe detention, within two business days,in accordance with Section 70.31.

CDC invites comments on any and allaspects of the proposed process for

issuing orders to conduct sanitarymeasures and the appeals process.

Section 70.13 Screenings to Detect IllPersons

This section authorizes the Director atairports and other locations to conductscreenings to detect the presence of illpersons. The definition of ill personsappears in the definitions section.Methods of screening may includevisual inspection, electronictemperature monitors, and othermethods determined appropriate by theDirector to detect the presence of ill

persons.Section 70.14 Provisional Quarantine

Quarantine officers routinely conductshort term examinations of illpassengers at airports and other ports ofentry to assess the presence of disease.Such examinations generally occur on avoluntary basis with the consent of theill passenger. In situations where apassenger withholds his or her consentthough those situations are few innumber, the Director may neverthelessneed to detain that person to determine

whether the person may be in thequalifying stage of a quarantinabledisease. This section is primarilyintended to deal with those situations.

Section 361(b) of the Public HealthService Act (42 U.S.C. 264(b))authorizes the apprehension,detention, or conditional releaseofpersons to prevent the introduction,

transmission, and spread of specifiedcommunicable diseases from foreigncountries into the United States andfrom one State or possession intoanother. Section 70.1 3(a) authorizes theDirector to provisionally quarantine aperson or group of persons believed to

be in the qualifying stage of aquarantinable disease. Ordinarily,provisional quarantine will be ordered

by the quarantine officer at the port ofentry, but may also be ordered by otherauthorized agents of the Director. Inaccordance with sections 311 and 365 ofthe PHS Act (42 U.S.C. 243 and 268),

the Director may seek the assistance ofstate and local authorities and of U.S.Customs and Coast Guard officials,respectively, in the enforcement ofquarantine rules and regulations.

Under 70.14, paragraph (b),provisional quarantine commences onthe occurrence of any one of threeevents: (i) Service of a writtenprovisional quarantine order on theperson or group of persons; (ii) a verbalorder from an authorized party(typically the quarantine officer at theport of entry) that the person or groupof persons are being provisionallyquarantined; or (iii) placement of actual

movement restrictions on the person orgroup of persons. Actual movementrestrictionsoccur when, as determined

by the Director, a person under the samecircumstances would understand thathe or she is being detained and thus isnot free to leave. In most circumstances,provisional quarantine is a briefdetention lasting only as long asnecessary for the quarantine officer (orother authorized agent) to ascertainwhether the person or groups of personsare a possible carrier of disease. Underparagraph (c), however, provisionalquarantine may continue for up to three

business days, provided that personssubject to provisional quarantine may bereleased sooner if the Directordetermines that detention is no longernecessary. In the event it is necessary toquarantine an individual beyond three

business days, the Director will servethe individual with a quarantine order.

A time frame of up to three businessdays for provisional quarantine isnecessary to confirm whether certaindisease-causing microorganisms arepresent in samples that may be obtainedfrom ill or deceased persons.



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Confirmation generally requires in vitrocultivation of the organism followed byidentification, direct visualization of theorganism in tissue samples,amplification of organism-specificnucleic acid sequences (e.g. PCRconfirmation), or detection of organism-specific antibodies generated inresponse to the infection. Before these

tests can be performed, samples must becollected and shipped to CDC, a processlikely to take 24 hours. Once received,completion of culture and identificationof bacteria requires a minimum of 2448 hours. Direct visualization in tissuesamples typically requires 1224 hours.Quicker methods (amplification orantibody detection) may be available forsome diseases. Even under optimalcircumstances, however, the mostmodern testing methods require aminimum of 12 hours. In addition to thetime required for sample collection,shipping and testing, the Director may

need up to an additional 24 hours toassimilate test results with the findingsof other investigations before arriving ata well-informed determination on theneed for a quarantine order.

A time frame of up to three businessdays comports with the requirements ofdue process. While there are no federalcases establishing a bright line forquarantine-type detentions, there areseveral federal cases dealing withalimentary canalsmugglers, i.e.,persons who smuggle drugs in theirintestines by swallowing balloons. InUnited States v. Montoya de Hernandez,473 U.S. 531 (1985), the U.S Supreme

Court analogized holding a suspectedalimentary canal smuggler to detainingsomeone for suspected tuberculosis,noting that both are detained untiltheir bodily processes dispel thesuspicion that they will introduce aharmful agent into this country.Federal courts have upheld detentionperiods ranging from 16 hours to 20days based on reasonable suspicionfor suspected alimentary canalsmugglers. Accordingly, provisionallyquarantining a person suspected ofcarrying a specified communicabledisease and affording that individual an

opportunity for an administrativehearing during that period is consistentwith due process requirements. Underparagraph (d), in the event that theDirector determines that it is necessaryto continue to detain such persons

beyond three business days, the Directormay serve the person or group ofpersons with a quarantine order inaccordance with 70.1670.18.

Under paragraph (e), persons subjectto provisional quarantine may be offeredmedical treatment, prophylaxis, orvaccination as the Director deems

necessary to prevent the transmission orspread of disease. Medical treatment,prophylaxis, or vaccination willtypically occur in a hospital setting, butmay occur in other settings as theDirector deems necessary. Medicaltreatment, prophylaxis, or vaccinationshall occur on a voluntary basis,provided that persons who refuse

remain subject to provisionalquarantine. Medical treatment,prophylaxis, or vaccination may beprovided in accordance with theprovisions set forth in 70.21.

Paragraph (f) explains that nothing in 70.14 shall be construed to limit theDirectors ability to detain a person orgroup of persons on a voluntary basis oroffer such persons medical treatment,prophylaxis, or vaccination on avoluntary basis.

Section 70.15 Provisional QuarantineOrders

This section explains the content of aprovisional quarantine order issued inaccordance with 70.11 and the processfor serving an order on a person orgroup of persons. Paragraph (a) explainsthat the provisional quarantine ordershall be served by the Director at thetime that provisional quarantinecommences or as soon thereafter as theDirector determines that thecircumstances reasonably permit.Service will typically occur throughpersonal service, for example, by thequarantine officer or another authorizedrepresentative serving the person orgroup of persons with a copy of the

provisional quarantine order at the portof entry or hospital facility, but may alsooccur through other methods ofpersonal service. Due process requiresthat the method of serving the order inany case be reasonably designed toaccomplish actual service. Becausepersonal service may be impracticableor undesirable in certain circumstances

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70 Fed. Reg. 71892-71948, “Control of Communicable Diseases,” RIN 0920-AA03

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