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Ralph
July 9, 2003
A. Simmons
(202) 434-4120
[email protected]
Via Electronic Submission and Federal Express
DocketsManagementBranch(HFA-305)
Food and Drug Administration
5630FishersLane
Room 1061
Rockville, Maryland 20852
Re:
SPI Comments on Proposed Regulations on Establishment and Maintenance
of Records Under the Public Health Security and Bioterrorism Preparedness
and ResponseAct of 2002 [Docket No. 02N-0277]
DearMadamor Sir:
The Societyof the PlasticsIndustry, Inc., (SP!)! by its attorneysandthrough its Food,
Drug, and CosmeticPackagingMaterials Committee(FDCPMC), herebyrespectfully submits
thesecommentswith regardto the regulationproposedby the Food and Drug Administration
(FDA) entitled "EstablishmentandMaintenanceof RecordsUnder the Public Health Security
and BioterrorismPreparedness
andResponseAct of 2002," which was publishedin the Federal
Registeron May 9, 2003 (68 Fed. Reg.25187). This notice requestedpublic commenton the
proposedregulationto requirethe establishmentand maintenanceof recordsby certaindomestic
and foreign personswho manufacture,process,pack, transport,distribute,receive,hold, or
import food intendedfor humanor animal consumptionin the United States. This provision is
containedin the Public Health Securityand Bioterrorism Preparedness
and ResponseAct of
2002 (the "Bioterrorism Act"). Section306, Pub. L. 107-188amendingFederalFood, Drug, and
CosmeticAct (FFDCA) (codified at 21 U.S.C. 350 etseq. (2002».
!
Foundedin 1937,TheSocietyof thePlasticsIndustry,Inc. is thetradeassociation
representingthe fourth-largestmanufacturingindustry in the United States. SPI's 1,500
membersrepresentthe entire plasticsindustry supply chain, including processors,machineryand
equipmentmanufacturers,and raw material suppliers. The U.S. plasticsindustry employs
1.5million workers and provides$330billion in annualshipments.The Food, Drug, and
CosmeticPackagingMaterialsCommitteeis composedof SPI memberswith particular interest
and expertisein packagingfor food and other FDA-relatedproducts. The Committeehasa long
history of working cooperativelywith FDA on regulatoryissuesrelating to packaging.
WASHINGTON,
D.C.
ThIs dOQJmentwas delivered electnlnically.
BRUSSELS
SAN FRANCISCO
KELLER
DocketsManagementBranch (HFA-305)
July 9, 2003
Page 2
AND
HECKMAN
LAW OFFICES
SPI and its membersfully supportCongressand FDA in implementingmeasuresto
protectthe U.S. food supply from terrorist acts. The plasticsindustry is preparedto participatein
this importanteffort. It is our view, however,that any burdensimposedon industry to prevent
terrorist actsshouldbe reasonablewhen comparedto the anticipatedprotectiveeffect. As
explainedmore fully below, the extensionof the recordkeepingprovision to suppliersand
transportersof packagingor other food-contactarticleswill unduly burdenindustry andprovide
no significant protectionagainstterrorism. Furthermore,FDA hasmisinterpretedthe language
of Section306 of the Bioterrorism Act with regardto the applicability of the provision to the
packagingindustry. Including the food packagingindustry in this requirementis in
contraventionof Congressionalintent.
Including Food-ContactMaterials in the RecordkeepingProvision Is in Contravention of
CongressionalIntent as Indicated by the Language of the Statute
SPI's FDCPMC opposesthe recordkeepingrequirementwith respectto food-contact
materials(not yet containingfood) as contraryto Congressionalintent and reflecting FDA's
misinterpretationof the statute. On the subjectof recordkeeping,the Bioterrorism Act statesthat
FDA may implementregulationsto requirerecordkeepingby persons(excludingfarms and
restaurants)who "manufacture,process,pack,transport,distribute,receive,hold, or import
food," to the extentsuchrecordsareneededto allow FDA to identify the "immediateprevious
sourcesandthe immediatesubsequentrecipientsof food, including its packaging, in orderto
addresscrediblethreatsof seriousadversehealthconsequences
or deathto humansor animals"
(emphasisadded). Basedon the languageof the statuteand our knowledgeof the underlying
Congressionalintent (throughdiscussionswith thoseinvolved in drafting the law), we are
confidentthat Congresswas using "food" accordingto the ordinary understandingof the word,
meaningedible food, not packaging.
The referenceto packagingdoesnot mandaterecordkeepingby packagingsuppliersor
transporters.Indeed,the referenceto "packaging,"in addition to "food," indicatesa distinction
betweenthe two terms in the view of the drafters. The law and Congressionalintent would be
satisfiedby a food processormaintainingrecordsidentifying the sourceof the finished
packagingfor the food product. In the unlikely eventthat food packagingis the targetof
terrorists,recordsin the handsof food processorsregardingtheir packagingsupplierswill allow
FDA to follow the history of the packagingand its components.The regulationasproposedby
FDA extendsfar beyondwhat was intendedby Congress.To follow Congressionalintent, the
proposedregulationneedsto be revisedto provide only that food processorshaverecords
identifying the suppliersof their packaging.
WASHINGTON,
D.C.
This dOQJment was delivered electronically.
BRUSSELS
SAN FRANCISCO
LLP
KELLER
DocketsManagementBranch (HFA-305)
July 9,2003
Page 3
AND
HECKMAN
LAW OFFICES
The Burden on the Food Packaging Materials Industry Is Disproportionateto Any Reduction
in Risk
Including food-contactmaterialsin the regulationbeyondthe limited extent described
abovewill imposeburdenson manufacturers(and transporters)of suchmaterialsthat are
disproportionateto any minimal reductionin risk and that will provide no significant protection
againstterrorism. Regardlessof whetheror not the recordkeepingrequirementwould apply only
to finished food packaging(as indicatedby FDA in meetingsbut not so limited in the language
of the proposedregulation),it would imposean ongoing, significant burdenon the companies
involved. Someof the information to be requiredby FDA unquestionablyis alreadymaintained
by industry. The proposedregulation,however,would apply to domesticand foreign firms
dealingwith packagingmaterialswho arenot accustomedto having a recordkeeping
responsibilitywith respectto FDA. The fmns would needto educatethemselveson the new
requirementsand establishsystemsnot only to keep the recordsrequiredby FDA, but alsoto
haveall of the requiredinformation availablefor FDA within 4 hoursof a requestmadeby the
Agency between8 a.m. and 6 p.m., Mondaythrough Friday, or within 8 hoursif requestedat any
othertime.
Oneassumesthat the times are meantto be the local times of the facilities that must
respond,but the proposaldoesnot addressthis point. If the times areinterpretedto be when the
requestis madeby FDA, then multinational siteswould be requiredto hire additional staff (with
the associatedincreasedcosts)to be availableon a 24 hour, 7 daysa week schedule.For
example,a requestfrom FDA that is madeon Friday at l:OOpm EasternStandardTime, will be
receivedin Tokyo at 2:00 pm on Saturday. Likewise, a requestfrom FDA that is madeat 4:00
pm, will not be receivedin Europeuntill 0:00 pm. Furthermore,evenif the information is
availablefrom existing records,the 4 - 8 hour window for responsecertainly will requiremany
companiesto establisha procedurededicatedto the recordsrequiredby FDA, as opposedto
relying on existing systems.
In addition, requiring suppliersof food-contactmaterialsto keeptheserecordswould
havelimited usefulnessin satisfyingthe purposeof the Bioterrorism Act, which is to "expand
FDA's powersto preventand respondeffectively to terrorist threatsagainstthe food supply."
FDA doesnot explain how recordkeepingrelating to food-contactmaterialswould deterthe
intentionalcontaminationof food or assistthe Agency in determiningthe sourceand causeof
contamination.In estimatingthe benefitsof the proposedregulation,FDA discussesfive
outbreaksof foodbomeillness from accidentaland intentional contaminationof edible food, but
thereis no mentionof food-contactarticlesbeing relatedto any suchoccurrences.It seems
unlikely that terroristswould take suchan indirect approachto contaminatingthe food supply.At
the least,this prospectseemssufficiently remoteso asnot to justify the additional burdenthat
would be imposedon suppliersand transportersof food-contactmaterials.
WASHINGTON,
D.C.
TNsdocumentwasdeliveredaecr lcalJy.
BRUSSELS
SAN
Fa.ANCISCO
LLP
KELLER
DocketsManagementBranch (HFA-305)
July 9,2003
Page 4
AND
HECKMAN
LAW OFFICES
The ProposedRegulation Must Be Revisedto Follow FDA's Own ExpressedIntent
Suppliersof food packagingand other food-contactmaterialsare broughtwithin the
reachof the proposedregulationby virtue of the proposal'sdefinition of ,'food," which, as in the
previousproposedbioterrorismregulations,is coextensivewith the definition of ,'food" in the
FederalFood, Drug, and CosmeticAct (FFDCA). As SPI hasdiscussedin commentson the
previousproposedbioterrorismregulations,the definition of "food" under Section201(f) of the
FFDCA includesboth articlesusedfor food by man or animalsand components(emphasis
added)of sucharticles. A "food additive" is defined in Section201(s)of the FFDCA as any
substance"that is reasonablyexpectedto becomea component of food" (emphasisadded).
Therefore,any food-contactsubstancethat meetsthe definition of a "food additive" also comes
within the definition of "food," which FDA hasincorporatedby referencein the proposed
regulationon recordkeepingandthe other proposedbioterrorismregulations. In fact, court
decisionsindicatethat a food-contactarticle or material comeswithin FDA's authority over
"food" evenif it is exemptfrom the needfor premarketclearanceas a "food additive" (by being
a "houseware,"for example). In the languageof the proposedregulationitself, FDA indicates
that the Agency intends"food" to be interpretedas extendingto the full breadthof the term's
definition underthe FFDCA, offering as an exampleof "food" "substancesthat migrateinto food
from food packagingand other articlesthat contactfood." 68 Fed. Reg.25238.
The way the proposedrecordkeepingregulationis drafted,then, it would apply, at a
minimum, to all food-contactsubstances
that meetthe definition of "food additive," and,
possibly,to literally all food-contactarticles and materials. The preambleto the proposed
regulationand FDA's public statements,however,suggestthat suchbroad coverageis not really
the Agency's intent. Specifically,the preamblestatesas follows with respectto food packaging.
FDA interpretspackagingin section306 of the Bioterrorism Act
[the recordkeepingprovision] to meanthe outer packagingof food
that bearsthe label. FDA is not interpretingpackagingto include
food contactsubstances,
which are included in the definition of
"food." Outerpackagingwould include, for example,the outer
cardboardcerealbox that bearsthe label of the cereal,but would
not include the inner lining that holds the cereal. Outerpackaging
would alsonot includethe outer shippingbox in which the cereal
boxesare shipped.
FDA hastentatively concludedthat the risk to humanand animal
health from contaminationof outer food packagingis relatively
small comparedto the risk from contaminationof the immediate
packagingthat comesin direct contactwith food. Therefore,FDA
is proposingnot to requirecoveredpersonsto keeprecords
regardingouter food packaging. However,the agencyalso
recognizesthat theremay be instanceswhereit may be necessary
for FDA to be ableto investigateagentsthat could laceouter
WASHINGTON,
D.C.
This document was delivered electronically.
BRUSSELS
SAN 'SANCrSCO
LLP
KELLER
DocketsManagementBranch (HFA-305)
July 9, 2003
Page 5
LAW
AND
HECKMAN
OFFICES
packagingand could therebycontaminatea food for which the
immediatefood contactmay not provide an adequatebarrier. In
addition, outerpackagingcould be intentionally diverted and used
to packagefood that hasbeentamperedwith. FDA seekscomment
on whetherthe level of risk to humanand animalhealth from
potential contaminationof outer packagingis high enoughto
warrant inclusion of outer packagingin the final regulations.
68 Federal Register25190.
SPI appreciatesFDA's statementin the preamblethat the Agency "is not interpreting
packagingto include food contactsubstances,which are includedin the definition of 'food' [in
the FFDCA]." This statedintent, however,is not implementedby the wording of the proposed
regulation,which encompasses
the full breadthof the statutorydefinition of "food," explicitly
"including substancesthat migrateinto food from food packagingand other articlesthat contact
food." The proposedregulationmust be revisedto follow FDA's own expressedintent not to
requirerecordkeepingby suppliersof "food contactsubstances."To accomplishthis, we
recommendthat the phrase"including substancesthat migrateinto food from food packaging
and other articlesthat contactfood" be removedfrom Section1.328of the proposedrule, and
that the following languagebe insertedinto this section:"for purposesof this provision, "food"
doesnot include food-contactmaterialsnot yet containingfood."
Basedon the remainderof the preamble,it appearsthat FDA intendsto apply the
recordkeepingrequirementonly to suppliersof fmishedpackagingfor direct contactwith food.
While FDA hasinterpretedthe recordkeepingprovision of the Bioterrorism Act to include socalled"outer packaging,"the Agency hasproposedin the preambleto exemptsuch"outer
packaging"from the regulationon recordkeeping.SPI certainly agreesthat suppliersof "outer
packaging"shouldbe exemptfrom this proposedregulation,along with all other packaging
suppliers. Onceagain,however,the languageof the proposedregulationdoesnot follow FDA's
statedintent. Under the proposedregulation,suppliersof "outer packaging"would be subjectto
the recordkeepingmandatealongwith all other packagingmaterialsuppliers.
If FDA intendsthis proposedregulationto apply to finished packagingfor direct contact
with food, the regulationmust so state. As SPI has indicatedin prior commentson the first two
regulationsproposedunderthe Bioterrorism Act, the following revisionswould be neededto
havethe recordkeepingregulationapply only to finishedpackagingfor direct contactwith food.
SPI is not recommendingthis definition becauseCongressdid not intend for the recordkeeping
requirementto apply to manufacturersand transportersof food packagingmaterials. We simply
point out that clarification of the proposedregulationwould be neededto implementFDA's
statedintent properly. The proposedregulationshouldbe revisedto implementthe intent of the
Congress,which was not to extendthe Bioterrorism Act to any packagingor packagingmaterials
not yet containingfood.
WASHINGTON,
D.C.
TNs document was delivered eIectrvnlcally.
BRUSSELS
SAN FRANCISCO
LLP
KELLER
DocketsManagementBranch(HFA-305)
July 9, 2003
Page 6
LAW
AND
HECKMAN
OFFICES
FDA's Estimate of the Burden is Low
In attemptingto estimatethe numberof food packagingcompaniesaffectedby the
proposal,FDA usedcountsof facilities found in the County BusinessPatterns(CBP), which was
createdby the U.S. CensusBureau. Data in the CBP is tabulatedby industry as defmedin the
North American Industry ClassificationSystem(NAICS) Codes. A particularNAICS Code
correspondsto a specific industry or subsetof industry.
In the discussionof the estimateof flrInS affected,FDA referencestwenty NAICS Codes
for the food packagingindustry. See68 Fed Reg.25201. Thesecodescorrespondto general
categoriesof finished packagingmanufacturers,suchas "PlasticsBottle Manufacturing,"
"PaperboardContainerManufacturing," and "Glass and GlassProductManufacturing." Thus,
many manufacturersof the materialsusedin the productionof food packagingarenot included
in the estimate. As a result, FDA's estimateof the burdenis unrealistically low if the regulation
remainsas drafted,meaningthat it appliesto all domesticand foreign manufacturersand
domestictransportersof food-contactmaterials.
Further,FDA hasnot identified the transporters(of food-contactmaterials,as opposedto
food products). In addition, FDA againhasusedits proprietaryOperationaland Administrative
Systemfor Import Support(OASIS) databaseto identify foreign companiesthat would be
subjectto the proposedregulation. Although SPI cannotobtain information on the precise
coverageof the OASIS database,we arereasonablycertainthat it doesnot cover imports of all
food-contactmaterials
.
.
.
In summary,the burdenof recordkeepingrelating to all food-contactmaterialsis contrary
to the languageand intent of the Bioterrorism Act. In addition, suchrecordkeepingwill not
provide any significant assistanceto FDA in deterringor respondingto terrorism directedagainst
the food supply. If FDA neverthelesscontinuesto proposeinclusion of somefood-contact
materialswithin this proposedregulation,the scopeof the productsto be coveredmust be
clarified.
SPI's FDCPMC appreciatesthis opportunityto commenton FDA's recordkeeping
proposal. SPI alsoreiteratesthe commitmentof the plasticsindustry to work with FDA and
other agenciesto combatthe threatof terrorism.
Sincerely,
~}
,
~.
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Ralph A. Simmons
Legal Counselfor
The Societyof the PlasticsIndustry,Inc
WASHINGTON,
D.C.
BRUSSELS
SAN FRANCISCO
ThIsdOQl~t wasdeliveredelectronically.
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