# US Environmental Protection Agency Office of Pesticide Programs

J u ne 200 8 Reregistration Eligibility Decision for Formaldehyde and ParaformaldehydeUnite d States Preventi on, Pe sticides EPA 739-R- 08- 004 Enviro nmenta l Protection and T o xi c Substances June 20 08 Agenc y (751 0P)



# Reregistration Eligibility Decision for Formaldehyde and Paraformaldehyde (Case 0556)UNITE D S T AT ES E N VIRONME N TAL PROTECTIO N AGENCY WASHINGTON, D.C. 20460

OFFICE OF
PREVENTI ON, PESTICIDES
AND T OXI C SUB STANCES
CERTIFIED MAIL

Dear Registrant:

This is to inform you that the Environm enta l Protection Agency (her eafter referred to as EPA or the Agency) has com pleted its review of the available data and public comm e nts received related to the prelim inary risk assessm ents for the antim icrobial for m aldehyde and paraform aldehyde. The enclosed Reregistra tion Eligibility Decisi on (RED) docum ent was approved on June 30, 2008.

Based on its review, EPA is now publishing it s Reregis t ra tion Eligib ility Decision ( R ED)
and risk m a nagem e nt decision for form aldehyde and paraform aldehyde and their associated
hum an health and enviro nm ental r i sk s. A No tice of Availability will b e pu blished in th e Federal Register announcing the public ation of the RED.

The RED and supporting risk assessm e nts fo r form aldehyde and paraform aldehyde are available to the public on EP A’s Pesticide Docket at: www.regulations.gov

. The docket num ber is EPA-HQ-OPP-2008-0121.

The for m aldehyde and paraform aldehyde RED was developed through EPA’s public participation process, publis hed in the Federal Register on Septem ber 10, 2004, which provides opportunities for public involvem e nt in the Agen cy’s pesticide tolerance reassessm ent and reregistration program s. Developed in partne rship with USDA and with input from EPA’s advisory committees and others , the public participation pro cess encourages robust public
involvem e nt starting early and continuing throug hout the pesticide risk assessm ent and risk

m itigation d ecis i on m aking process. The public p a rticipation process en com p asses full, modified, and stream lined versions that enable th e Agency to tailo r the lev el of review to the
level of refinem e nt of the risk assessm e nts, as well as to the am ount of use, risk, public concern,
and com p lexity asso ciated with each pesticide. Using the pu blic particip ation p r oces s, EPA is attaining its strong com m i t m ent to both involve the public and m eet statutory deadlines.

Please note that the form aldehyde and parafo rm a l dehyde risk assessm ent and the attached RED document concern only these particular pes ticides. This RED presents the Agen cy’s conclusions on the dietary, drinki ng water, occupational, residen tial and ecological risks posed by exposure to form aldehyde and paraform aldehyde alone. T h is docum ent also identifies both generic and product-specific data that the Agency intends to require in D a ta Call-Ins (DCIs).
Note that D C Is, with all pertinent in struc tions, w ill b e sent to regis t ran t s a t a la ter d ate

. Additionally , for product-specific DCIs, the first s e t of required responses will be due 90 daysTable of Contents

Formaldeh y de and Paraforma l dehyde Reregistra t ion Team ......................

.. i Glossary of Terms and Abbreviations...................................................

.. ii
Abstract......

.................................................................. ........................ iv

I. Introduction.................................................................................

.. 1

II. Chemica l Overv iew
A. Regulatory History............................................................

.. ... 3
B. C hemical Identification

...................................................... ... 3
C. U e s Profile.................................

...................................................... 6

III. Summa ry of Formaldehyde and Para formaldehyde Risk Assessments
A. Human Health Risk Assessmen t.............................................

... 10
1. Toxicity of Formald e hy de and Paraformaldehyde ............

... 10

a. Acute Toxicity ................................................... 10
b. Toxicological Endpoints ....................................... 11

c. Carcinogenicity ................................................ 14
2. FQPA Safety Factor...................................................... 16
3. Dietary and Drinkin g Water Risk ..................................... 16
4. Residential Exposure and Risk ........................................ 16
a. Formalde hyde Residential Handler Risk.................

... 17
b. Formaldeh yde Resident ial Post application Risk......

... 18

c. Paraform aldehyde Residentia l Handler Risk ............ 19
d. Paraformaldehy de Post Application Residential Risk ... 19
5

. Aggr egate Risk............................................................. 19
6. Occupational Exposure and Risk....................................

... 19 a. Occupational Handler Exposure and Risk

................. 19
b. Occupation al Post-Application Exposure and Risk ..... 20
7

. Hum n Inc ident Data.................................................... a 20
B. E nvironmental Risk Assessment.............................................

... 22
1. Environmental Fate and Tran s p ort.................................

... 22
2. Ecological Haz ard .................................

................... 23
3. Risk to Listed Species.................................................... 23
IV. Risk M anag emen t, Reregistration, and Tolerance Rea ssessment Decision
A. D e mina tion of Reregistratio n Eligibility

.................................. et r 25
B. P ublic Comments and Respons e s...

........................................... 25
C. Regulatory Rationale............................................................

.. 26
1. Human Health Risk Management..................................... 26

a. Residential Risk Miti gation for F ormaldehyde ......

...... 26 b. Occupation al Risk Mitigation for F ormaldehyde ......

... 26

c. Occupational and Reside ntial Risk Mitigation for 27 Paraformaldehyde
2. Other Labeling Requirements..............................

............. 27
V. What Re gistrants Need to Do............................................................ 28A. Manufac turing-Use Products................................................... 30
1. Additional Generic Data Requirements.............................. 30
2. Labeling for Technical and Manufacturing-Use Products......

.. 30
B. E nd-Use Products.........................................................

......... 30
1. Additional Product-Specific Data Requirements............

......... 30
2. Labeling for End-Use Products ..............................

............. 30 a. Label Changes Summary Table..............................

.. 31

VI. Ap endic es.................................................................................. 35 p A. Table of Use Pattern s Formaldehyde ....................................

...... 36
A.1 Table of Use Patterns ParaFormaldehyde .....................

............. 42
B. Table of Generic Data Requireme nts and Studies Used to Make the Reregi stration Decision

............................................................ ... 44
C. T echnical Support Documents................................................

.. 48
D. B l ib iography Citations......................................................... 50

... E. G eneric Data Call-In............................................................

.. 70
F. Prod uct Specific Data Call-In

...... ............................................. 71
G. Batching of End-Use Products................................................

.. 72
H. L t is of A ll Registran t s Sent the Data Call-In.............................. 73

... I. Li st of Available Forms.........................................................

... 74Formaldeh yde and Paraforma l dehyde Reregistra t ion Team

Health Effects Risk Assessm ent Tim o thy F. McMahon
Jonathan Chen
Srivivas Go wda
A. Naj m Sh am i m Tim o thy C. Dole
Tim o thy Leighton

Ecological Risk Assessm e nt Richard C. Petrie

Environm ental Fate Risk Assessm ent A. Naj m Sh am i m

Registration Support
Marsha ll Swindell

Risk Managem e nt ShaRon Carlisle
Diane Isbell

iGLOSSARY OF TERMS AND ABBRE V IATIONS

a.i. Activ e Ing r ed i e n t aPAD A c u te Popu latio n Adj u sted Do se APHIS Anim al and Pl ant Health Ins p ection Se rvice
ARTF Ag ricultu ral R e -entry Task F o rce BCF Bioconcentration Factor
CDC Cen t ers for Disease Con t ro l
CDPR Califo r n i a Departm en t o f Pest icid e Regu latio n C F R C ode o f Fe de r a l R e gul at i o ns Ch EI Ch o lin esterase Inh i b ition
CMBS Carbam ate Ma rket Bas k et Survey
cPA D C h r oni c Po p u l a t i on Ad j u st ed Dose
C SFII US DA C o nt i n ui n g S u rvey s f o r

Fo o d Int a ke by I n di vi d u al s C W S Co mm u n ity Water System
DCI Data Call-In
DEEM Di et ary Ex p o s u re Eval uat i o n M odel
D L D oub le layer clo t h i ng {i.e., co v e r a lls ov er SL}
D WLOC Dri nki ng W a t e r Le vel o f C o m p ari s on EC Em ul si fi abl e C once n t r at e Fo r m

ul at i on EDSP En doc ri ne Di sr upt or Scree n i n g P r o g r am EDST AC En doc ri ne Di sr upt or Scree n i n g a n d Test i n g Ad vi so ry C o m m i tt ee EEC Esti m a ted En v i ron m en tal Co ncen tration

. The esti m a ted p e sticid e con cen tratio n in an
envi ronm ent, such as a terrest rial ecosystem

. EP End-Use P r oduct
EPA U.S. Env iro nmen tal Pro tectio n Ag en cy EXAM S Tier II Surface Water C o m puter Model
FD A Fo od an d D r u g A d m i ni st rat i on FFDC A Fed e ral Fo od

, Dru g , and Cosmetic Act
FIFR A Fede ral I n sect i c i d e, F u ngi ci d e , an d R o dent i c i d e Act
FOB Fun c tio n a l Ob serv ation Battery FQPA Foo d Qu ality Pro t ection Act
F R F e d e r a l R e g i s t e r GL W i t h glo v es GPS Glob al Po sition i ng System
HIARC Hazard Ide n tifi cation Assess ment Review Committee
IDF S Inci dent Data Sy stem IGR Insect Growth Regulator
IPM Int e grat ed Pest M a na gem e nt
RED Rereg i stration Elig ib ility Decisio n LAD D Lifetim e Avera g e Daily Do se LC 50 Med i an Let h al Co n c en tration

. Statistically d e ri ve d c once n t r ation of a subs tance expecte d to ca use deat h i n 50 % o f t e st ani m al s, usu a l l y exp r ess e d as t h e wei g ht o f s u bst a nce pe r wei g ht o r vol um e of

water

, air or fee d , e

. g., m g /l, m g /kg or ppm

. LCO Lawn Car e Oper ato r LD 50 Med i an Let h al Do se. Statistic ally d e riv e d si n g l e do se cau s i n g d eat h in 50% of th e test an im a l s whe n a d m i nistered by t h e route i ndi cat ed ( o r a l , de rm al , i nhal a t i on), ex p r e ssed as a wei g ht o f

su bstan ce p e r u n it weigh t of an im a l

, e.g., m g /kg

. LOAEC Lowest Obse rved Ad ve rse E f f ect C once n t r at i on LOAEL Lowest Obse rved Adve rse E f fect Level
LOC Level of C o nc ern LOEC Lowest Obse rved E ffect C o nc entration

m g /k g / d ay Millig ra m Per Kilo gram Per Day
MO E Mar g in of Expo sur e MP Man u f actur ing- U s e Prod uct iiMRID Master Record Identifica t i o n (n um ber). EP A’s sy st em of r ecor d i n g a n d t r acki n g st udi es

su b m itted

. M R L M a xi m u m R e si due Level
N/A No t Ap p licab le
NASS Natio n a l Ag ricu ltu ral Statistic al Serv ice NAWQA USGS Nation a l W ater Qu ality Assessm en t NG No Gl oves NMFS Natio n a l Marine Fish eries Serv ice
NOAEC No Obse rve d Adve rse E ffect Concentrati o n NO AEL No O b se rve d Ad ve rse E ffect Level
NPIC Natio n al Pesticid e In form at io n Cen t er NR No res p irat or OP Or ga no p hos p h o r u s OPP EPA Office o f Pesticid e Prog ra m s ORETF Out d oor Residential Exposure Task F o rce PA D Po pul at i o n Ad j u st ed D o se PCA Perce n t Crop Area
PDCI Product Specific Data Call-In
PDP USDA Pesticide Data Pro g ram PF10 Pr o t ection s f a cto r 10 r e sp ir at or PF5 Protection fact or 5 res p irator
PHED Pesticid e Handler’s Exp o sure Data
PHI Pre-ha rvest Interval

p pb Parts Per Billio n PPE Pers onal Pr ot e c t i v e Eq ui pm ent
PRZM Pesticid e Roo t Zon e Mod e l
RBC Red Bloo d Cell
RED Rereg i stration Elig ib ility Decisio n REI Restricted E n try Interval
RfD Referen ce Do se RPA Reaso n a b l e and Prud en t Altern ativ es R P M R easona bl e a n d P r u d e n t M e a s ures RQ Risk Quo tien t RTU ( R ead y- to -u se)
RUP Restricted Use Pesticide
SCI- GRO W Tier I G r o u n d Water C o m puter M o del
SF Safety Factor
SL Si ngl e l a y e r cl ot hi n g SLN Special L o cal Need (Re g istra t i ons U nde r Se ct i on 24C o f F I FR A)
STOR ET St ora g e a n d R e t r i e val
TEP Typical End-Use Product
TGAI Technical Gra d e Active Ingredient
TRAC Tolera nce Rea ssessm ent Advisory C o m m i ttee TTRS Transfe r able T u rf Residues
UF Unce rtainty Fa ctor US DA United States Depa rtm e nt of Ag ricultu re USFWS United States Fish a n d W i l d life Service
US GS United States Geol ogi cal S u r v ey WPS Wo r k er Pr ot ect i on St an dar d

iiiAbstract

The Environm ental Protection Agency (EPA or the Agency) has com pleted the hum an health and environm ental risk assessm ents for form aldehyde and paraform aldehyde and is issuing its risk m a nage ment decision. The ri sk as sessm ents, which are su mmarized below, are based on the review of the requi red target database supporting the use patterns of currently regis t ered products and addition a l inf o rm ation received th roug h the public docket. After consider ing the r i sks id e n tif ied in the revi sed risk assessm ents, comments received, an d

m itigation s uggestions f r om interested parties, the Agency developed its risk m a nagem e nt decision for uses of for m aldehyde and paraform a l de hyde that pose risks of concern. As a result of this review, EPA has determ ined that form aldehyde and paraform aldehyde containing products are elig ible for rereg i stratio n, provided that risk m itigation m easures are ado p ted and labels are am ended accordingly. T hat decision is discu ssed fully in th is docum ent.

ivI. Introduction

The Federal Insecticide, Fungicide, a nd Rodenticide Act (FIF RA) was a m ended in 1988 to accelerate the rereg i stratio n of produc ts with active ingred ients registered prior
to Novem be r 1, 1984 and am ended a gain by th e Pesticide Registration Improvem e nt Act
of 2003 to set tim e fra m es for the issuance of Reregistration E lig ibility Decisions. The

am ended Ac t calls for the developm ent and submission of data to support the

rereg i stratio n of an activ e ingred ient, as well as a review of all subm itted data by th e U.S.
Environm ental Protection Agency (EPA or the Agency). Reregistration involves a thorough review of the scientif ic database underlying a pe sticide’s registration. The purpose of the Agency’s review is to rea ssess the potential hazards arising from the currently registered uses of the pesticide; to determ ine the need for additional data on
health and environm ental effects; and to dete rm ine whether or not th e pesticide m eets the
“no unreaso nable advers e effects” criteria of FIFRA.

This document pres ents the Agency’s re vised hum a n health and ecological risk

assessm ents and the Reregistration Eligib ility Decision (RED) for for m aldehyde and paraform aldehyde. The for m aldehyde and pa raform aldehyde case consists of one PC
code each : 0 43001 (formaldehyde), 0 43002 (p arafor m a ldehyde). The first product containing form aldehyde was registered in 1967.

Form aldehyde as an antim i crobial pesticide is used as a fum i gant in agricultural

prem ises such as poultry and swine far m s and pr ocessing plants as well as in citrus and
mushroom houses. It is also used as a hard surface dis i nfectant in comm ercial prem ises, industrial prem ises and veterinary clinics. Form aldehyde containing products are also used in oil drilling wells for preservation of processing waters. Form aldehyde is also registered as a m a terials preservative for c onsumer products such as laundry detergents, general purpose cleaners and wall paper adhe sives. Paraform a l dehyde is used for indrawer fum i gation of hair cutting equipm ent and as a m ildewcide in closets and unoccupied vacation ho m e s. The currently registered form aldehyde prod ucts are for m ulated as liquid concentrates or liqui d ready to use solutions with formaldehyde concentrations that range from 2.28% to 54%. T he paraformaldehyde products are
for m ulated as solids with paraform alde hyde concentrations of 62.3% and 91%.This suggests there are only 2 for m ulations. Just want to ensure th is is not a range.

The Agency has determ ined that analys is of the p o tential ne e d f

o r a special
hazard

- based safety factor under th e FQPA is not needed at th is tim e. The Agency does not anticipate dietary or dr inking water exposures based on the registered use patterns
and there are no tolerances or tolerance exem ptions for the use of for m aldehyde and paraform aldehyde as an activ e ingredient. Therefore, a FQPA hazard an alysis is no t necessary at this tim e

.

This document pres ents the Agency’s decision regarding the reregistration eligibility of the registered uses of form al dehyde and paraform aldehyde. In an effort to
sim p lif y the RED, the inf o rm ation presented h ere in is summ arized f r om more detaile d
inform ation which can be found in the tech nical supporting docum e nts for form aldehyde

1 of 87and paraform aldehyde referenced in this RED. The revised risk assessm ents and related
addenda are not included in this docum e nt, but are available in the Public Docket at www.regulations.gov (Docket ID #E PA-HQ-OPP-2008-0121).

This document consists of si x sections. Section I is the Introducti on. Section II provides a chem ical overview, a profile of the use and usage of for m aldehyde and paraform aldehyde and its regulatory history. Section III, Summ ary of Form aldehyde and
Paraform aldehyde Risk Assessm ents, gives an overview of the hum an hea lth and
environm ental assessm e n ts, based on the data av ailab l e to th e Agency. Section IV, Risk Managem e nt and Reregistration, presents the reregistration e ligibility and risk

m a nage m e nt decisions. Section V, What Registrants Need to Do, summarizes the

necessa ry la bel change s based on the risk m itigation m easures outlin ed in Section IV. Finally, the Appendices list all use patterns eligible for reregistration, bibliographic
inform ation, related docum ents and how to access them , and Data Call-In (DCI)
inform ation.

2 of 87II. Chemica l Overv iew

A. Regulatory History

Form aldehyde

The first pro duct containing form aldehyde was reg i stered in the United States on January 25, 1967, for use as a fum i gant. Currentl y there are 6 active products under PC C ode
043001. The r e are no inert ingredient uses for thi s c hem ical. Form aldehy de is used prim arily
as a fum i gant in agricultural prem ises such as p oultry a nd swine farm s and processing pla nts as well as in citrus packing and m ushroom houses. It is used as a hard surfac e disinfectant in

comm ercial prem ises, industrial prem ises and veterinary clinics. Form aldehyde is also registered as a m a terials preservative for c onsumer products such as laundry detergents, general purpose cleaners and wall paper adhesives.

Paraform aldehyde

Paraform aldehy de i s a white cry s talline solid form ed by pol y m erization of
form aldehy de. In 1964, paraform aldeh y de was registered as a sa nitizer and fungicide for use
on barber an d beauty sho p equipm ent. Currentl y there are 2 ac tive products under PC C ode
043002. Steri-DriTMFum i gant (Registration #397-6 ) is used a s b acteriostat, fungicide, and sanitizer in hair/beauty sa lons and barber shop s, an d Sun Pac ( R e gistration #4972-43) i s u s ed prim arily as m i ldewcide in closets and unoccupied vacation hom es. There are no inert ingredient uses for this ch em ical. EPA issued a Regi stration Standard for para form aldehy d e in Ma y 31, 1 988.

B. Chemical Identification

Formaldeh y de Molecu lar Structu res:

Figure 1. F o rm aldehyde (Gas)

Figure 2. F o rm aldehyde (In W ater)

3 of 87Common Name: Form aldehyde (Gas) Aqueous Form aldehyde solution (in water)

Chemical N ame: Form aldehyde (Gas)
Form aldehyde m onohydrate (Aqueous solution)

Other Names: Form aldehyde
F o r m a l i n

OPP Chemical Codes: 043001

CAS Registry No.: 50-00-0

Case Number: 0556

Empirica l Formula: CH
2 O (Gas or anhydrous for m )

H
2 C(OH)
2 or C
1 H
4 O
2 (Form a ldehyde
monohydrate)

Molecula r Weight: 30.03 (Gas) 48.03 (Aqueous solution)

Manufactu rers: Cha m pion Technologies,
Hess & Clark, Inc., Baker Petrolite Corporation,

Highest P e rcent of Active Ingredient: 54%

Formulation Types Re gistered:
Technical Grade (TGAI): None. Manufacturing Use Products (MP): Soluble Con centrate End Use Pr oducts (EP): Soluble Concentrate, ready to use solution

Chemical P r operties: Form aldehyde gas is colorless with a pungent, suffocating odor; it is readily soluble in water. It has a boiling point
of -19.5oC, m e lting point of -92oC, a density of 0. 815 g/m L at 20oC with a vapor pr essure of 3,890 mm Hg @ 25oC.
Form aldehyde is gas at room tem p er ature and, therefore, has no pH. Form aldehyde gas is unstable and can polym erize quite easily. It is corrosive to m e tals and has a flashpoint of 60oC.

4 of 87Comm ercially form aldehyde is sold as form alin, a 37% to 55% by weight aqueous soluti on in water, usually with
0.5% to 15% m e thyl alcohol added to prevent polym erization to a solid crystalline form

. In wat e r, it
exists as form aldehyde monohydrate and its chem ical
for m ula is H
2 C(OH)
2.

A 37% Form aldehyde solution is a colorless liquid with a pungent odor. It is 100% m i scible in water and has a boiling point of 101oC. It ha s a density of 8.75 lbs/gal and sp gr. of 1.08 at 20oC. It is so luble in organic solvents such as ether, alcohol, acetone a nd benzene. It has a vapor pressure of 1.3 mm Hg at 68 oF, and 67- 88 mm Hg at 98oF.

Paraforma l dehyde Molecular Stru ctures:

Figure 1. Paraform aldehyde

Figure 2. Paraform aldehyde

Common Name: Paraform aldehyde

Chemical N ame: Paraform aldehyde

OPP Chemical Codes: 043002

CAS Registry No.: 30525-89-4

Case Number: 0556

5 of 87Empirica l Formula: HO( CH

2 O)

n H (n = 6 - 10 0 )

Molecula r Weight: (30.03)n g/mole

Manufactu rers: Protexall Pro ducts Inc
Noble Pine Products Co.

,

Highest P e rcent of Active Ingredient: 95%

Formulation Types Re gistered:
Technical Grade (TGAI): None Manufacturing Use Products (MP): None
End Use Pr oducts (EP): Crystalline

Chemical P r operties: Paraform aldehy de i s a white cry s talline solid with an irritating
odor. It is the poly m erized form of form aldehy de. It has a

m e lting point of 120 to 1 70 o C, de nsity o f 1.46 g/m l at 15oC,
bulk densit y of 750 to 850 kg/m 3, and sp gr. of 1.4. Solubility in water is p a rtial and is dependent o n pH, tem perature and

m o lecular w e ight. It is insoluble in most organic solvents and very soluble in dilute alkali and acids. It has a vapo r pressure of 1.45 m m Hg at 25 oC a nd 1 m m Hg at 30 o C. It ha s a pH of
3.5- 4.5 and is m oderately corrosive

C. Use Profile

The following inform ation is a description of the currently registered uses of for m aldehyde and paraform aldehyde products , and an overview of use sites and application m e thods. A detailed table of th e uses for for m aldehyde and paraform aldehyde that are eligible for reregistrati on can be found in Appendix A.

Formaldehyde

Type of Pesticide: Dis i n f ectant (Bacteriocide/ Germ icide), S anitizer, Microbicide/ Microbistat, Fungicide

Use Sites:

Agricultural premises and equipment Chicken and Turkey farm s Swine operations Dairy farm s Cattle f arm s Veal farm s

6 of 87Em u and ostrich farm s Federally inspected m eat and poultry establishm ents except w h ere m eat and food products are handled. Poultry and swine prem ises and confinem ent areas Hatching egg washing/fum i gating treatm e nt Citrus packing houses
Iris and daffodil bulbs in bulb farm s Mushroom houses, equipm ent and prem ises

Commerc ial, institution a l and indu strial premises and equipment Hard non-porous surfaces
Room s and Railway cars

Residential and public access premises
Zoos Veterinary clinics, kennels Pet shops

Industrial p rocesses an d water systems
Oil recov ery injec tion w ater sy stem s Drilling m u ds, work over fluids and water bas ed packer fluid s

Formulation Types: so luble con cen trate and read y to u s e

Methods and Rates of Application:

A summ a r y of the form aldehyde registered uses is given in Table 1 and a m ore detailed listing is included in Appendix A. Form a l dehyde application sites include agricultural prem ises and equipm ent, rail road car fum i gation and oil production.
Form aldehyde is also registered as an in can preservative for use in consum er products.
Form aldehyde is not register ed for use in paints.

Table 1: Form aldehyde Use Si te and Application Rates
Use Site Label # Application Rates and Instruct ions
In Container Preservative 8133-32 Us e range = 0.1 to 1000 ppm in final product. Poultry and Livestock B l dgs and Equipment. Vet Clinics
and Kennels 134-65 Spray all surfaces to satu ration using 1-3 oz product/gallon.

Wet m i st using an automatic wet fogger and 1 1⁄4 - 2 1⁄2 oz product/gallon. Poultry and swine prem ises
and confinem ent areas 8133-32 Use 20-60 oz. product/1000 ft 3

. Sprinkler ap plica tion : U se a 1:11 dilution Spray Sled : Use a 1:4 dilution Egg Hatcher/Incubator 8133-32 Use a m a xi mum of 1 fl. oz./30 ft 3

. Place in an open container and allow to evaporate.
Af ter the 19 th day of incubation, use 1⁄2 fl.

7 of 87Use Site Label # Application Rates and Instruct ions
oz/30ft 3

. Citrus packing houses 8133-32 Use 16 fl. oz product/1000 ft 3. Apply using a stationary m ounted spray m a nifold and suitable air operated foggers. Prem ises m a y be treated up to twice a year.
Mushroom houses, equipm ent and prem ises 8133-32 Non Producing areas : I n ject solutio n into

steam (1 gallon per 5,500 - 6650 ft 3 )

Room s and Railway cars 8133-32 For each 10 00 ft 3 , use 16 2 / 3 oz potassium

perm anganate and 20 oz of product.
Oil recov ery injec tion w ater system s 8133-28
10707-43 Inject 25-5000 ppm active ingredient for
continuous treatm ent or slug application. Drilling m u ds, work over fluids and water based packer
fluids Inject 100-500 ppm active ingredient for
continuous treatm ent or slug application

Paraformaldehyde

Type of Pesticide: Disinfectant, bacteriocide , algaecide, fungicide

Use Sites:

Residentia l and Public Access Pre mises
Bathroom prem ises (cabinets, drawers and closets) Kitchen prem ises (cabinet s, drawers and closets)
Hum an bedding Barber shops and beauty salons (cabinets and drawers)

Formulation Types: cr y s ta llin e

Methods and Rates of Application:

A summ a r y of the parafor m alde hyde registered uses is gi ven in Table 2 and a m or e detailed listing is included in Appendix A.

8 of 87Table 2: Paraform aldehyde Use S i te and Application Rates
Use Site Label # Use Instructions
Closets (Clothing an d Linen) 4972-43 Hang cloth bag in closet or lay on shelf or in drawer. Contents of this bag will tr eat up to 700 cubic feet.
For m usty odor in bedding, place one bag Sun Pac along
with m a ttress, quilts, blankets, sheets in sealed closet spac e no greater than 100 cubic feet . Leave articles 24 hours.
Vacation Hom e s 4972-43 When closin g hom e for vacat ion or season, place one bag
Sun Pac for each 700 cu bic feet of space. Use o nly in unoccupied room s. Room s mu st be ventilated thoroughly before reentry.
Hair/Beau ty Salons and Barber Shops 397-6 Re m ove cap, place Steri-dri in sanitizer cab inets, implem e nt drawers, ro ller trays, stu d ent im plement kits, covers or doors which are to be kept tightly closed.

9 of 87III. Summa ry of Formaldehyde and Pa raformaldehyde Risk Assessments

The purpose of this summ ary is to assist the read er by iden tif ying the key features and findings of these risk assessm ents a nd to help the reader better understand the
conclus i ons reached in the assessm ents. The hu m an health and ecologica l risk

assessm ent docum ents and supporting inform ation listed in A ppendix C were used to
for m ulate the safety finding and regu latory decision for for m a l dehyde and paraform aldehyde. W h i l e the risk assessm ents and related addenda are not included in
this docum ent, they are available fro m th e Federal Government Public Docket at www.regulations.gov

. The docket identification nu m ber is E P A-HQ-OPP-2008-0121. Hard copies of these docum ents m a y be f ound in the OPP public docket which is located
in Room S-4400, One Potom ac Yard, 2777 South Crystal Drive, Arlington, VA, and is open Monday through Friday, excluding Federal holidays, from 8:30 a.m .t o 4:00 p.m

.

The Agency’s use of hum an studies in the form aldehyde and paraform aldehyde risk as sessm ent is in accordance with the Agency' s Final Rule prom ulgated on January 26, 2006, related to P r otections for Subjects in Hum a n Research, which is codified in 40
CFR Part 26.

A. Human Health Risk Assessmen t

1. Toxicity of Formald e hy de and Paraformaldehyde

A brief overview of the toxicity studies used for determ ining endpoints in the risk

assessm ents are outlined below in Table 3. Further details on the toxicity of
for m aldehyde and paraform aldehyde can be found in the Formaldehyde: Toxicology Disciplinary Chapter for the Reregistra tion Eligibility Decision (RED) Document

, dated 3/31/2008; and Formaldehyde: Risk Assessments fo r the Reregistra tion Eligibility Decision (RED) Document , dated 4/7/2008. These docum ents are available on the U.S.
Federal Governm e nt Public Docket website at www.regulations.gov (Docket ID #EPAHQ-OPP-2008-0121).

The Agency has reviewed all toxicity studies sub m itted to su pport guid eline requirem e nts for for m aldehyde and parafo rm aldehyde and determ ined that the toxicological database is sufficient for rere gistration. Major featur es of the toxicology profile are presented below.

a. Acute Toxicity

The acute toxicity database for formalde hyde is considered com plete. Technical grade form a l dehyde (37% a.i.) has a m oderate order of acute toxic ity in experim e ntal anim als via the oral and derm al routes (Toxicity Categories II and III). Inhalation toxicity studies on form aldehyde are extensive and in clude both acute exposur es and longer term exposures. T oxicity from acute exposures is characterized by pathology of the respiratory epithelium and has been observed in rats e xposed for 4 hours to a concentration of 10

10 of 87ppm (Bhalla, 1991), while longer term exposures of rats (3 ppm for 6 hours/day for 5 days) also results in respir atory tract lesions (Buckley et al., 1984). Table 3 gives a summary of the acu te tox i city data.

Table 3. Acute Toxicity data for Formaldehyde technical a.i.

Guideline
Number Study Type / Test substance ( % a.i.) MRID
Number/
Citation Results Toxicity Category

87 0. 1 10 0 ( §81 -1 ) Acute Oral – Guinea Pig
Puri t y 37 .3%

- Form al dehy de 0 005 805 4 LD 50 = 26 0 m g /k g II

87 0. 1 20 0 ( §81 -2 ) Acute De rm al
– Rat Puri t y 3 7

. 3 % - Fo rm al dehy de 0 005 805 4 LD 50 = 30 0 m g /k g II

87 0. 1 20 0 ( §81 -2 ) Acut e De rm al
– R a bbi t Puri t y 3 7

. 3 % - Fo rm al dehy de 0 005 805 4 LD 50 = 24 0 m g /k g II

87 0. 1 20 0 ( §81 -2 ) Acute De rm al – Do g Puri t y 3 7

. 3 % - Fo rm al dehy de 0 005 805 4 LD 50 = 55 0 m g /k g II

87 0. 1 30 0 ( §81 -3 ) Acut e I nhal a t i o n – M o use a n d R a t See Op en Literatu re st u d i es in Tox i city Profi l e for
Form al dehy de

87 0. 2 40 0 ( §81 -4 ) Prim ary Eye Irritatio n - Puri t y 3 7

. 3 % - Fo rm al dehy de 0 005 805 4 Sev e re eye irritan t I

87 0. 2 50 0 ( §81 -5 ) Prim ary Dermal Irritatio n Puri t y 3 7

. 3 % - Fo rm al dehy de 0 005 805 4 Form at i on of v e si cl es with sup e rficial n ecro s is

or

n o dul es. I

87 0. 2 60 0 ( §81 -6 ) Derm al Sensi t i zat i on – Gui n e a pi g s Puri t y 40 .0%

- Form al dehy de 4 016 110 3 Extrem e Sensitizer NA

b. Toxicological Endpoints

On June 12, 2008, m e m b ers of the Antim icrobials Division' s Toxicity endpoint Selection Comm ittee (ADTC) m e t to discuss the n on-cancer in halation tox i city endpoint for for m aldehyde that h a d been prev io usly selected by the co mmittee for use in conducting inhalation toxicity risk assessm ents for the form aldehyde reregistration elig ibility d e cision (RED) docum ent.

11 of 87The original endpoint of 100 ppb was se lected from the published report of Horvath et. al., [JAMA 259, no. 5: 701-707, 1988] , who reported nasal and respiratory effects in 109 workers occupationally e xposed to for m aldehyde. The value of 100 ppb
was selected as a NOAE L for use in occupational risk assessm e nts, while for the general population; a value of 10 ppb was selected. Th is value was derived by application of a 10-fold uncertainty facto r to th e NOAEL value of 100 ppb to account for intraspecies variation in response in acco rdan ce with Agency policy.

During the public comment phase of th e form aldehyde risk assessm ent, the
Form aldehyde Council responded to the select ion of the 100 ppb endpoint. They stated that the Agency should consider the resu lts of a 2007 publication by Noisel et al. (Regulatory Toxicology and Pharm a cology 48: 118-127), which reviewed som e of the
available scientific literature. This st udy, in the Council' s opinion, "is based on hum a n exposure rather than controlled hum an cham ber studies and can be used for deriving a No-Observed-Adverse-Effect-Level ( NOAE L) fo r the non-cancer endpoint for
for m aldehyde."

The ADTC noted both observational hum a n exposure data as well as data

com p iled from exposure of hum a n subjects under controlled conditions in the Noisel et. al., publication. Notwithstanding the need for in tentional exposure da ta to be presented to the Agency' s Human Studies Review Boar d, the ADTC not ed that irritant effects of
for m aldehyde have been reported in other studies below the 0.75 ppm concentration

recomm ended by Noisel et. al., as a s a fe le vel. Further, this recommendation is for worker populations only.

The irritant effects of form aldehyde, incl uding both eye and nasal irritation as well as respiratory sym p tom s (irritation, changes in pulm onary function), can be
considered from a toxicological perspectiv e to be com posed of both physiological and adverse responses. Based on the available data , the ADTC was not com pelled to select a value higher than that alrea dy proposed. W ith respect to th e 10-fold uncertainty factor
used for risk assessm ent to the general population, the ADTC concluded that a reduction
in this factor is not warranted at this tim e

. Contrary to the Form aldehyde Council' s
statem ent that "the nature of the health eff ect does not suggest that there are particularly susceptible subpopulations which would warrant application of the 10x intraspecies UF," the 1999 ATSDR Toxicological Review of for m a l dehyde (AT S DR, 1999) noted two studies "...providing sug g estiv e evid ence that children m ay be m o re sensitive to the
irritant effects of for m aldehyde." T hese studie s were not intentional exposure studies. It
is also no ted in the ATSDR review that "add itio nal res earch is n eces sary to confirm or discard the hypothesis that chil dren m a y be more susceptible than adults to the irritant
effects of form aldehyde..."

The ADTC concluded that, based on the ava ilab l e data, it is appropriate to rem ain with the NOAEL value selected from the 1988 Horvath et. al., publication and with the 10-fold uncertainty factor for risk assessm ents to the general population. The ADTC i s also aware, however, of ongoing efforts by ORD/NCEA to develop an inhalation
reference co ncentration, or RfC for form alde hyde. OPP will continue to coordinate its

12 of 87efforts with ORD and ot her program offi ces to refine the non-cancer inhalation

assessm ent as necessary

. The toxico logical endp oints selected for various exposur e scenarios are sum m arized below in Ta ble 4.

Table 4. Toxicology En dpoint Selection for Formaldehyde

Exposure
Scenario Dose Used in Risk
Assessment (mg/kg/day ) Target MOE, UF, Special FQPA SF*
for Risk Assessmen t Study and Toxicological
Effects

Dietary Risk Assessments

Acute Di etar y (general populati on includin g infa nts and children) An acute dietary assess me nt is not needed for the registered anti m i crobial uses of formaldehy de

.

Chronic Diet ary (all populatio ns) A chronic dietary assess ment is not nee d ed for the re gistered antimicrobial use s of formaldehy de

.

Non-Dietary Risk As ses s m ents

Incidental Oral An incidental oral risk assess ment is not required for the registered antim i c robial uses of formaldehy de

.

Der m al (all durations) A der m al risk asse ss ment is not required for the registered anti m i cr obial uses of formaldehy de

.

Inhalation (all durations ) NOA E L (human) = 0.1 p pm Occupational UF = 1

Residential UF = 10 ( 10x intraspecies) ACGIH 2001 pu blication on formaldehy de

Horvath, E.P. et. al., (1986): JAMA 259(5): 701-707. Based on

co m p laints of ey e, nose, and throat irritation in particle board workers
at concentrations of form aldeh y de
from 0.4 – 1. 0 ppm

.

Redden, J. (2 005): Section 18
Em ergency Exem ption for the use
of Paraform aldeh y de: U.S. Arm y Medical Research Institute of
Infectious Diseas es.

Cancer Formaldehy de is currently classifi ed as a B1 (probable hum an car ci nogen) i n EPA’ s IRIS
assessment. IARC has cl assified formal dehy de as “carcinogenic to hum ans.” Th e Agency has decided to present the formaldehy de cancer risks f o r the pesticidal uses using both the existing 19 91 IRIS cancer unit risk of 1. 3 E-5 per (μ g / m 3 ) and the CIIT BBDR m odel until

any new canc e r esti m ates a re fully peer reviewed.

13 of 87c. Carcinogenicity

The Agency is currently reevaluating th e carcinogenic potential of form al dehyde. The historical and ongoing developm ent of an i nhalation unit risk value to assess the carcinogenic potential of for m aldehyde is briefly summ arized below. Contributors to this summary included scientists from se veral EPA program offices (Office of Pesticide Program s [OPP], Office of Pollution, Preventio n, and Toxics [OPPT], Office of Rese arch and Developm ent /National Center for Envi ronm ental Assessm e nt [ORD/NCEA], Office of Research and Developm ent/National Heal th Effects Exposure Research Laboratory [ORD/NHEERL], and Office of Air and Radiation [OAR]).

• In 1991 IRIS published a weight-of-eviden ce characterization fo r carcinogenicity
of for m aldehyde, classifying form al de hyde as a B1 probable hum a n carcinogen with a potency factor of 1.3 E-5 per ( μ g/m 3 ) ) on the basis of squam ous c e ll nasal

tum ors observed in a two-year study in rats (Kerns et al., 1983).

• In 1999 the Che m ical Industry Institute of Toxicology (CIIT ) developed a health
risk assessm ent for formaldehyde based upon the anim al toxicology data (CIIT, 1999). This docum ent presented the dose-re sponse m odeling of these data in two distinct parts: 1) based upon a biologically-based dos e response (BBDR) model, and 2) benchm ark dose models that we re based upon point of departures at various response levels of the tum or and precursor data. Both these approaches

m a de extensive use of the available ti m e-to-tum o r and m echanistic inform ation.
The 1999 assessm ent was subsequently publis hed in various ar ticles in peerreviewed journals (2001, 2002, 2003, and 2004).

• In 1999, the U.S. EPA’s Office of Air and Radiation and Offi ce of Research and Developm ent, in conjunction with Health Canada, conducted an external peer review workshop for the CIIT BDDR m odel as well as an external written peer review and public com m ent period for th eir ass essm ents. W h ile the rev i ew was largely positive on the overall approach in th e as sessm ent, reviewers also pointed to the po tential f o r s i gnif i cant un cer tain ty due to model m i s-specification and uncertainties in key param e ters involved in the B B DR model.

• Based on the peer review of the CIIT m odel, OAR determ i ned in 2004 that the
CIIT m odel was the m os t appropriate tool for risk assessm ent for for m aldehyde. OAR has subsequently used the formaldehyde cancer potency derived using the
CIIT m odel for a num ber of risk asse ssm ents involving formaldehyde em issions
to the atm os phere such as the Plyw ood and Composite W ood Products N a tional
Em ission Standard for Hazardous Air Pollu tants (final ru le 2 004, reconsidered final rule 2006, rem a nded to EPA by c ourt 2007); Control of Hazardous Air
Pollutants from Mobile Sources (Final Rule 2007); and Proposed Rule for
National Em ission Standard for Combusti on Turbines (2004). Health Canada, Australia, the W orld Health Orga nization, and the Germ an Ma xim a le Arbeitsplatzkonzentrationen (MAK) Comm issi on have also used the CIIT m odel.

14 of 87Model stren g ths inc l ude consider atio n of the m ode of action data for
for m aldehyde and a conservative appro ach to account for potential direct DNA
interaction and m utation i nduction. Model uncertainties include variability for

som e of the param e ters of the m odel (e .g., cell proliferation) which can affect predictions of risk (Subram ania n et. al., 2007; 2008 [in press]).

• In 2004, NCEA convened a panel of experts, including scientists from CIIT, to provide advice on these and other critical biological and statistic al uncertainties. The strength of the CIIT model is it s consideration of m ode of action and
extensive mechanistic infor m ation.

• Although current OAR assessm ents still us e the CIIT m odel, these assessm e nts now acknowledge previously unknown uncer tainties with the CIIT m ode l when characterizing the risk results.

• In 2004, the International Agency for Res earch on Cancer (IARC) characterized
for m aldehyde as a hum an carcinogen base d on their review of the current literature (IARC, 2004) , including data in hum ans on nasopharyngeal cancer, cancer of the nasal cavity and paranasal sinu ses, and leukem i a. It should be noted
that som e epidem iology studies did no t find a reported association between
for m aldehyde exposure and carcinogenic ity. For exam ple, Coggon et. al., 2003 studied over 14,000 workers exposed to form aldehyde in industrial workplaces and reported no excesses of either leukem ia or nasal and nasopharyngeal cancer.

• In 2005, the Scientific Review Panel (SRP) of the California Office of
Environm ental Health H azard Assessm e nt responded to the CA Air Resources Board request to reevaluate the carci nogenic potential of form aldehyde. The
Panel noted in this 2005 re view that California’s Offi ce of Environm ental Health (OEHHA)’s Nove m ber 2002 evaluation of a petition had included the 1999 report
on the CIIT model and other inform a ti on, and that OEHHA h a d concluded that

“ the evidence...(1) did not change the de termination that formaldehyde is a carcinogen; (2) presented information t hat considered the possibility of nonlinear dose response relationships, but pres ented no clear grounds to review the original “no threshold” determina tion; and (3) did not provide any new epidemiology or bioassays supporting a change in potency. In addition, there was insufficient in formation to fu lly e v aluate the CIIT model; issues su ch as model uncertainty were not adequately addressed.... ” The Scientific Review Panel’s overall conclusion in 2005 was, “The Panel concluded that there was not sufficien t new data to su pport the p e tition to review the [ O EHHA’s earlier 1992 ] formaldehyde risk assessment. In addition, the newly published studies represented relevant new information, but they did not allow determination of a causal relationship betw een formaldehyde exposure and leukemia. These studies deserve further evalua t ion over time given their potential im portance.” (Froines, 2005).

15 of 87• EPA is currently com pleting a new IRIS assessment and unit risk value for
for m aldehyde; the reassessm ent is scheduled to start internal p eer review in May 2008 and begin independent external peer review in January 2009 (http ://cfpub.epa.gov/ncea/iristrac/ind e x.cfm ? f useaction =view Che m ical.sh o wChe

m i cal&sw_id=1031). EPA anticipates that the peer review of the for m aldehyde

assessm ent will be a lon g er proc ess then that of EPA’s rereg i str a tion pro cess scheduled to conclude in Septem ber 2008.

Based on the on going developm ent of the science to predict carcinogenic potential of for m aldehyde, OPP has decided to present the form aldehyde cancer risks f o r the pesticidal uses using both the existing 1991 IR IS cance r unit risk of 1.3 E-5 per (μg/m 3 ) and the CIIT BBDR m odel until any new cancer estim ates are f u lly pee r reviewed. OPP also acknowledges the wide ra nge in cancer risks using these approaches
and will coo r dina te with other of f i ces in EPA on the outcom e of the upcom ing peer review process on the carcinogenicity of for m aldehyde. Because form aldehyde air
concentratio ns approach those asso ciated w ith ocular and respir a t ory trac t ir ritation

, the
risk m itigation m easures to be im plem ented in the m eantim e f o r the pesticidal u ses will
be based on m itigating the non-cancer effects at a lim it of 0.01 ppm

. It is believed th at this level will r educe ex posures suf f i cien tly su ch that the cancer risks would not be of

concern. The EPA process of regulating pesticid es allows for reevaluation at any tim e if
new infor m ation from the peer review pr ocess of the carcino genic potential of
for m aldehyde warrants.

2. FQPA Safety Factor
There are no tolerances f o r form alde hyde or parafor m aldehyde and the use patterns considered for the reregistration e ligibility decision do not involve dietary

exposure. A s a result, an FQPA safet y finding is not applicable.

3. Dietary and Drinking Water Risk

Form aldehyde is used to treat m u shroom houses, equipm ent and prem ises and
citrus facilities as a disinfectant treatm ent when food is not present. The Agency believes that the dietary exposure from citrus packing and m u shroom houses will be neglig ible. In addition, form aldehyde is used as a m aterial s preservative in dish washing detergent.
Form aldehyde is a gas at room te m p e r ature a nd it is dissolved in water. H owever, for m aldehyde is not stable in water and has a tendency to escape from sol ution. Half lives in air and water are short, so it is un likely form aldehyde persists on pots, pans, and
dishes. In addition, it is not expected to contam inate ground wa ter. Therefore, there are no dietary or drinking water concerns from the antim i crobial uses of for m a l dehyde.

4. Residential Exposure and Risk

The resid ential expo sure assessm ent cons iders all potential pesticide exposure, other than exposure due to residues in food or in drinking water. Each route of exposure (oral, derm al, inhalation) is assessed, where a ppropriate, and risk is expressed as an MO E (Margin of Exposure) w hich is the ratio of estimated exposure to an appropriate NOAEL

16 of 87(No Observed Adverse Effect Level). Estim at ed MOEs are then com pared to the Target MOE, which repres ents the dose selected for risk assessm ent and uncertainty factors (UF) applied to that dose. The standard UF is 100x, which includes 10x for interspecies extrapo l atio n (to accoun t for differences between laboratory anim als and hum a ns) and 10x for intraspecies variation (to account for differences within th e sam e species).

There is one product containing formaldehyde that is labeled for use as in can preservative of consum e r products such as laundry detergents, ge neral purpose cleaners and wall paper adhesives. Use of these products can result in residential handler

exposure. In addition, there is one paraform aldehyde m ildewcide product that is labeled
for treatm ent of closets and vacation hom es. Use of this prod uct could res u lt in residential postapplication exposure to pa raform a l dehyde. The exposure scenarios for
residen t ial exposure are provided in Table 5. Addition a l info rm ation on the resid ential exposures to for m aldehyde and paraf orm aldehyde can be found in the Formaldehyde: Revised Occupational and Residential Expos ure Assessment for the Reregistration Eligib ility D ecis i on ( RED) Document

, dated 4/15/2008; and Formaldehyde: Risk Assessments for the Reregistra tion Eligibility Decision (RED) Document , dated 4/7/2008.
These docum ents are available on the Federal Governm e nt Public Docket website at www.regulations.gov (Docket ID #E PA-HQ-OPP-2008-0121). No updated risk

assessm ents to referen c e?

Table 5. Exposure Scenarios for Formaldehyde and Paraformaldehyde

Use Expos ure Sce n ario App licatio n Rate (pp m ) Residential Handler Inhalation Expo sures fro m Formald e hyde Uses

Material Preservation of
Laun dr y D e terg en t H a nd ler Expo su r e W h ile U s i ng Tr eated
Laun dr y D e terg en t 10 0 0 ppm pr o d u ct

Material Preservation of
Flo o r and Fu rnitu re Po lish

an d D e ter g en t Pr odu cts H a nd ler Expo su r e W h ile U s i ng Tr eated
Gene ral Purpose Cleaners 1 50 pp m p r oduct

Material Preserv atio n of Wall Pape r Ad hesi v e H a nd ler Expo su r e W h ile U s i ng Tr eated Wallpaper Adhesive 1 00 pp m p r oduct

Residential Postapplication Inhalation Exposures from Paraformaldehyde Uses

Mildewcide for clot hing a n d
linen in closets Po st App licatio n Ex po su re 4 ou nce o f pr o duct pe r 75 0 ft 3

Mildewcide for Vacation
Hom e s Po st App licatio n Ex po su re 4 ou nce o f pr o duct pe r 75 0 ft 3

Material Preserv atio n of Wall Pape r Ad hesi v e Po st App licatio n Ex po su re fro m W a llp ap er Ad hesi ve 1 00 pp m p r oduct

a. Formaldehyde Residential Handler Risk

Residential handler inhalation expos ures were assessed for handlers of
for m aldehyde treated laundry detergent, general purpose cleaners and wall paper

17 of 87adhesives. The EPA’s Consum er Exposur e Module (CEM) was used to estim ate air concentrations resulting from the use of laundry detergent and general purpose cleaner preserved with form aldehyde. The EPA’s W a ll Paint Exposure Model (W PEM) was
used to estim a te handler inhalation as well as post application exposures resulting from the use of wall paper adhesive preserved with form aldehyde.

A summ ary of the residential risks for form aldehyde is included in Table 6. The
non-cancer risks are of concern for three of th e scenarios because the MO Es are less than the target MOE of 10. The non-cancer ri sk estimates are based upon EPA exposure models which are generally belie ved to be conservative. The fact that the vapor pressure of 1.0 mm Hg, which is based on form aldehyde as for m alin, was used in these m odels rather than the vapor pressure of pure for m alde hyde, which exists only as gas, is a source of uncertainty. There are also uncertainti es regarding the use of the W P EM m odel because it is based on test data for paint so lvents that hav e different physical/chem i cal properties than for m aldehyde.

The estim ated cancer ris k s range fro m <3 x 10 -9 when using the CIIT m o del to 8 x
10 -6 when using the IRIS unit risk. T h e IR IS cancer risk estim a tes provide an upperbound on risk. Based on the on going reevaluationf the potential can cer and non-cancer
risks of form aldehyde through the ORD Inte grated Risk Infor m ation System (IRIS)

program , a reevaluation m a y need to be done at a later date. The EPA process of regulating pesticides allows fo r reevaluation at any tim e if new infor m ation from the peer review process of the carcinogenic potential of form aldehyde warrants.

Table 6 – Residential Risk Summary fo r Biocidal Uses of Formaldeh yde
Scenario Peak Air
Concentration MOE (Target MOE =10) LADC Cancer Risk
IRIS CIIT

Laundry Detergent
Handler 240 ppb 0.4 0.5 ppb 8 x 10 -6 <3 x 10 -9

General Purpose
Cleaner Han d ler 21 ppb 4.8 0.12 ppb 2 x 10 -6 <3 x 10 -9

Wall Paper Adhesive
Handler 15 ppb 6.7 0.044 ppb 7 x 10 -7 <3 x 10 -9

Wall Paper Adhesive Post Application 4.9 ppb 20 0.038 ppb 6 x 10 -7 <3 x 10 -9

b. Form aldehyde Residential Post Application Risk

The EPA’s Wall Paint E xposure Model (W PEM ) was used to estim ate post application exposures resulting from the us e of wall pap e r ad hesive preserved with
for m aldehyde. The MOE for peak exposure is 20 and is not of concern. The estim ated cancer risk ranges from <3 x 10 -9 when using the CIIT m odel to 6 x 10 -7 when using the
IRIS unit risk.

18 of 87c. Paraformaldehyde Handler Residential Risk

Based on current use patterns, there are no residential handler exposures anticipated from the use of paraformaldehyde.

d. Paraformaldehyde Post App licatio n Residential Risk

The EPA’s Consum er Exposure Module (CEM) was used to estim ate post application inhalation exposures resulting from the use of parafor m aldehyde m ildewcide in closets of occupied hom e s. The M O E for the m ildewcide use is less than 0.1, which is below the target MOE of a10 and is of concern. The estim ated cancer risk ranges from
<8 x 10 -7 when using the CIIT m odel to 3 x 10 -3 when using the IRIS unit risk.

Conversations with the regist rant of this product have i ndicated that it is prim arily intended to be used in unoccupied hom e s. Although these products are used in unoccupied hom e s, the risks for the closet s cenario are of concern because of potential difficulty providing thourough ventilation before reentry. For this reason, use in closets and other confined spaces presen t ris k concerns.

5. Aggregate Risk

The Food Quality Protection Act am endm ents to the Federal Food, Drug, and
Cos m etic Act (FFDCA, Section 408(b)(2)(A )(ii)) require “th a t there is reasonable certainty that no harm will result from aggreg ate exposure to pesticide ch em ical resid u e, including all anticipated di etary exposures and other exposures for which there are
reliable inform ation.” Aggregate exposure is the total exposure to a single chem ical (or its residues) that m ay occur from dietary (i .e., food and drinking wate r), residential, and other non-occupational sources, and from all known or plausible expos ure routes (oral,
derm al, and inhalation). Acute and chroni c d i etary aggregate assessm ents were not conducted f o r form aldehyde because there are n o uses for form aldehyde attributable to the dietary route of exposure.

6. Occupational Exposure and Risk

a. Occupational Handler Exposure and Risk

Workers can be exposed to form alde hyde through m i xing, loading, applying a pesticide or re-entering treated sites. Form aldehyde is used as a fum i gant for agricultural

prem ises, in preservation, in production, and in wall paper adhesive. The Agency has very little infor m ation c oncerning exposure from biocid al uses for formaldehyde.
Because form aldehyde has a high v a por pressure (1.0 mm Hg in form alin), the inhalation unit surrogate exposure data that are often used to estim ate risks associated with pesticide use are generally not applicable. Alt hough there are m a ny studies of for m aldehyde occupational exposures reported in the litera ture, these studies i nvolved the non-biocidal

uses. Therefore, it was not possible to qua ntitatively assess the for m aldehyde exposures

19 of 87that result from biocide uses ; a qualitative assessm e nt was completed based upon work practices listed on the labels.

In general, it was determ ined for the biocid e application scena r ios th at if the labe l requirem e nts such as closed system loading, rem ote application and adequate ventilation are followed, exposures would be reduced to levels that are not of concern. There are several occupational handler exposure scen arios that involve form aldehyde products.
These scenarios are listed below:

• Mechanical Fum i gation

• Evaporative Fum i gation

• Catalyzed E v aporative F u m i gation

• Hard Surface Disinfection of Ani m al Housing Areas and Eq uipm ent

• Material Preservation

• Oil Production

• Wall Paper Adhesive Application

The wall paper adhesive application was assessed using the WPEM model. The
MOE for non-cancer risk is 1.6 which is above the target MO E of 1 and is thus not of

concern. Th e estim a ted cancer risk ranges from <1 x 10 -8 when using the CIIT m odel to
6 x 10 -5 when using the IRIS unit risk. Fo r additional information, please see the Formaldehyde: Revised Occupational and Re sidential Exposure Assessm ent for the Reregis t ration Eligib ility Decision ( RED) Document

, dated 4/15/2008; located on the
Federal Governm e nt Public Docket website at www.regulations.gov (Docket ID #EPAHQ-OPP-2008-0121).

b. Occupational Post Application Exposure and Risk

Form aldehyde is used for fum i gating pou ltry and swine containm ent buildings and post app lication exp o sure can o c cur when the workers re-enter the fum i gated areas. These exposures were assessed using the sing le cham ber decay for m ula fromthe MultiCha m ber Concentration and Exposure Model (M CCEM) and a ventilation rate of 4 air changes per hour. This assessm ent was based upon the application param e ters listed in
the Cham pi on Technologies Form aldehyde Solution 37 Label (EPA Reg #8133-32). The ventilation rate is based upon poultry and an im al housing design criteria; given these conditions, the for m aldehyde air concentration d eclines to a level that is not of concern
after 3 hours. For additional information, please see the Formaldehyde: Revised Occupational and Residential Exposure Assessm ent for the R e registration Eligibility Decision (RED) Document

, dated 4/15/2008; located on the Federal Governm e nt Public
Docket website at www. regulations.gov (Docket ID #EPA-HQ-OPP-2008-0121).

7. Human Incident Data

There are many reported incidents associ ated with for m aldehyde exposure, but only a lim ited few are associated with its use as an antim icrob i al ag ent (b iocide).
Form aldehyde is a dermal irrita nt and a derm al sensitizer. The prim ary derm al effects

20 of 87that have been reported are rash, burni ng sensation, itching, dry scaling irritation, cracking and thickened skin, itching, and blisters and rash on hands. Symptom s associated w ith eyes are the prim ary reported il lness in all asso ciated incidents. Nausea, dizzin ess, headache, and sore th roat are the p r im ary system ic effects that have been reported. Allergic reactions and asthm a

- like symptom s also have been reported following occupational exposures. O n ly lim ite d acute cases w ith oral exposure to
for m aldehyde have been published in scientif ic literature. For additional infor m ation on the repo rted inciden t s, r e f er to the Incidents Report Associated with Formaldehyde

, dated 1/30/2008; located on the Federal Govern m e nt Public Docket website at www.regulations.gov (Docket ID #E PA-HQ-OPP-2008-0121).

21 of 87B. Environmental Risk Assessment

A summ ary of the Agency’s environ m enta l risk assessm ent is presented below. The following risk characterization is intended to describe the m a gnitude of the estim ated ecological h azards and environm ental risk s for form aldehyde and paraform aldehyde. Based on the registered antim icrobial use patterns, for m aldehyde and parafor m aldehyde have low potential for terrestrial or aqua tic environm ental exposure. Therefore, a quanitatiave risk assess m e nt was not conducted.

For detailed discussions of all aspects of the environm ental risk assessm ent, see the Environ m ental Fate Assessment of Fo rmaldehyde for the Issuance of the Reregistration Eligibility Decision Document , dated January 23, 2008, and the Ecological Hazard and Environmental Risk Assessment of Formaldehyde and Paraformaldehyde for the Rereg i stration Eligibility Decision ( RED) Document, dated January 29, 2008.

1. Environmental Fate an d Transport

The Agency has no environm ental fate and transport data for form aldehyde or paraform aldehyde and relied on open literature fo r fate and transport studies. Available
literature in dicates that there are m u ltiple degrad ation pathways for for m aldehyde.
Paraform aldehyde off-gasses as formaldehyde from a for m aldehyde/paraform a ldehyde
solution ; th erefore, the A g ency has as sum e d that paraform aldehyde will have fate and transport behavior sim ilar to form aldehyde.

a. Water

The half-life of for m aldehyde has been reported between 24-168 hours (1-7 days)
in surface w a ter and 48-336 hours (2 - 14 da ys) in groundwater, based on estim ated aqueous aerobic biodegradation half lives. Form aldehyde, therefore, is not likely to persis t in n atural waters. The Agency for Toxic Substances an d Disease R e gistry (ATSDR) notes that when for m aldehyde is re leased into water it biodegrades to low levels in a few days.

b. Soil

A Koc value of 1.567 wa s estim ated for form alde hyde based on open literature (ATDSR, 1999 1 ) therefore, it is not expected to adsorb to soils and is likely to be m obi le
in soils. Compounds with a Koc value of less than <100 are considered to be m odera tely
mobile in soils and m a y contam inate groundwat er. Octanol/Water partition is low (log Kow = 0.65). Therefore for m aldehyde is not lik ely bioaccum u late in aquatic o r ganism s.

1 ATS D R (A ge ncy f o r

T oxi c Su bst a nces an d Di sease R e gi s t ry ). To xi col o gi cal Pr ofi l e fo r F o rm al dehy d e

. U.S

. Depa rt m e nt o f Heal t h a n d Hum a n Se rvi ces. 1 9 9 9

.

22 of 87c. Air

The half life of for m aldehyde in air has been found to depend on intensity of natural light, tem perature, and location. Ba sed on its reaction with hydroxy radical using hydroxyl radical rate constant, th e half life of form aldehyde in air varies between 7 to 70
hours. One study even estim ated the air half life to vary betw een 0.3 to 250 hours. This study, however, assum e d there was hydroxyl or hydr operoxyl radicals present. It is not likely to persistent in air. Degradation produc ts from this interaction likely are: water,
for m ic acid, carbon m o noxide and an interm ediate adduct likely hydroperoxyl/form a ldehyde. Air ph otolytic half life of for m a l dehyde has been estim a ted
between 1.6 to 6 hours.

2. Ecological Haz a rd

Form aldehyde and paraf o rm aldehyde labeled uses including oil field uses such as

treatm ents of drilling m u ds and waterfloods are considered by the Agency to pose little adverse risk to non-target organi sm s or listed species. Antim i cr obial pesticides used in oil fields are ty pically m i nor use chem icals, di luted and greatly redu ced before discharge into water, and are often regul ated by other Federal or EPA offices (OW

, Office of Solid Waste, OPPTS, state NPDES per m its). In th e ca se of oil fields, the US Departm e nt of the Interior, Minerals Managem e nt Service (M MS) had jurisdiction over the environm ental
im pacts of synthetic drilling fluids in terrestrial and aquatic areas.

Terres t rial o il field s typically u se berm s and catch basins to prevent surface runoff
of

oil drillin g m uds and wastes f r om oil dr illing a r eas. Estu ar ine and m arine aquatic organism s m a y be te mporarily exposed duri ng m a rine drilling; however, im pacts are lim ited to a defined area around the oil well (Neff, 2000). If the pesticid e is to be used in
estuarine o r m arine environm ents, three additi onal acute estuarine/m a rine toxicity studies are required. The ecolog i cal h azard assessm ent has determ ined that form aldehyde product labels m u st state: “This product is toxic to oysters.”

3. Risk to Listed Species

Section 7 of the Endangered Species Ac t (ESA), 16 U.S.C. Section 1536(a)(2), requires that federal agencies consult with th e Nationa l Ma rine Fisher ies Service (NMFS)
for m a rine and andronomus listed species, or with the Unite d States F i sh and W ildlif e Services (F WS) for listed wildlife and freshwat er organisms, if proposing an "action" that

m a y a ffect listed species or their designated habitat. Each federal agency is required
under the A c t to insure that a ny action they authorize, fund, or carry out is not likely to jeopard ize the continu e d existence of a liste d sp ecies o r resu lt in the destruction or
adverse m odification of designated critical ha bita t. To jeopa r d ize th e continued existence
of

a listed sp ecies is to "to engage in an action that r easonably would be expected, directly or indirectly, to reduce appreciably the likeli hood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of the species." 50 C.F.R. §402.02.

23 of 87To com ply with subsection (a)(2) of the ESA, EPA’s Office of Pesticide Program s has established procedures to eval uate whether a proposed registration action

m a y directly or indirectly appreciably re duce the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of any listed speci es (U.S. EPA 2004). If any of the Lis t ed S pecies LOC
Criteria are exceeded fo r either d i rect or ind i rect effects in th e Ag ency’s screen ing-level
risk as sessm ent, the Agency identifies any listed or candidate sp ecies that m ay occur spatially and tem porally in the f ootprint of the proposed use. F urther biological

assessm ent is undertaken to refine the risk. The extent to which any species m a y be at
risk de term ines the ne ed to develop a m o re comprehens ive consultation package as required by the ESA.

For certain use categories, incl uding all current form aldehyde and paraform aldehyde uses, the Agency assum e s there will be m i nim al environm ental exposure, and only a m i nim a l toxicity data set is required (Overv iew of the Ecological
Risk Assessm e nt Process in the Office of Pesticide Program s U.S. Environm ental
Protection A gency - Endangered and Threat en ed Species Effects Determ inations, 1/23/04, Appendix A, Section IIB, p 81). Uses in these categories do not undergo a full

screen ing-level risk assessm ent and are cons id ered to generally fall under a “no effect”
determ ination, however, an endangered species effect determ i nation will not be m a de at
this tim e

.

24 of 87IV. Risk Management, Reregistratio n, and Tolerance Reassessment Decision

A. Determination of Rere gistra tion Eligib ility

Section 4(g)(2)(A) of FIFRA calls for th e Agenc y to dete rm ine, af ter sub m ission of relevant data concerning an active ingred ient, whether or not products containing the active ingredient are eligible for reregistrati on. The Agency has previously identified and required the subm ission of the generic (i.e., act ive ingredient-specifi c) data required to support reregistration of products containing form aldehyde and paraformaldehyde as an active ingredient. The A g ency has com p leted its review of these generic data and has determ ined that the data are sufficient to s upport reregistration of virtually all supported products containing form aldehyde and paraformaldehyde.

The Agency has com p leted its assess m ent of the residential, occupational and ecological risks associated with the use of pesticide products containing the active ingredient f o rm aldehyde and paraform alde hyde. The Agency has determined that virtually all for m aldehyde and paraform alde hyde containing products are eligible for

rereg i stratio n provided that: 1 ) all ris k m itig ation m easures ar e im plem ented; 2) cu rren t data gaps and confirm a tory data needs are ad dressed; and 3) label am endm ents are made
as described in Section V. Use in confined spaces such as closets is not elig ible for regis t ration because of the difficulty associ ated with ventilation of these spaces. Appendix A summarizes the uses of form aldehyde and paraform aldehyde that are eligible for reregistration. Appendix B identifies the generic data requirem ents that the Agency reviewed as part of its dete rm ination of reregistration e ligibility of for m aldehyde and paraform aldehyde and lists the submitted studie s that the Agency found acceptable. Data gaps are identified as generic data require m e nts that have not been satisfied with acceptable d ata.

Based on its evaluation of for m aldehyde and paraform aldehyde, the Agency has determ ined that form aldehyde and paraform al dehyde products, unless labeled and used as specified in this docum ent, would present ri sks inconsistent with FIFRA. Accordingly, should a reg i strant fail to im ple m ent the risk m itig ation m easures, subm it confirm atory data as well as m a ke the label changes identi fied in this docum ent, the Agency m a y take regulatory action to address the risk concerns from the use of for m aldehyde and paraform aldehyde. If all changes outlined in this docum ent are fully com p lied with, then no risks of concern exist for the registered uses of for m aldehyde and paraform aldehyde and the purposes of this determ ination. Once an endangered species assessm ent is

com p leted, further chang es to th ese registra tions m a y be necessary as explained in Section III o f this document.

B. Public Comments and Respons e s

Through the Agency’s public participation process, EPA worked with stakeholders and the public to reach th e regulatory decision for form aldehyde and paraform aldehyde. EPA released its prelim inary risk assessm ent for formaldehyde and paraform aldehyde for public comm e nt on April 23, 2008. The Agency received a
comment from the registrant, as well as the Form aldeyde Council, during the 60-day

25 of 87public com m e nt period, which closed on March 23, 2008. The comm ent s included suggestions to refine the endpoint selection.

C. Regulatory Rationale

The Agency has determ ined that form aldehyde and paraformaldehyde are eligible
f o r rereg i str ation p r ovid ed that risk m itigati on m easures ar e im plem ented as outline d in
this docum ent, additional required data conf irm this decision and label changes are made
accord ingly. W h ere labeling revision s are warr an ted, specific language is set forth in the summary tables of Section V of this docum ent.

1. Human Health Risk Management

a. Residential Risk Mitiga tion for Formaldehyde

In order to address the ri sks of concern identified fo r the laundry detergent, general purpose cleaner and wall paper adhe sive uses, m a xi mum allowable application
rates need to be reduced. The non-cancer risks (i.e., MOEs ) would require product rate reductions to 40 ppm

, 72 ppm and 67 ppm fo r the laundry detergent, general purpose cleaner and wall paper adhesive handler scen arios, respectiv ely to achiev e the target MOE of 10. However, the registrant has re quested voluntary cancellation of the laundry detergent use. The non-cancer risk f or the wa ll paper post application scenario does not require a product rate reduction. In term s of potential cancer risks, the Agency believes
that the m itigation required f o r the n on-cance r r i sks will ad e quately addr ess thes e ris k s as well regardless of which of the cu rrent cancer ap proaches are used.

b. Occupational Risk Mi tigation for Formaldehyde

In order to reduce poten tial occupational ha ndler exposures the following m itigation is required:

• For industrial uses of form aldehyde cl osed system s with dry couplers (or equivilant) are required

• Structures that m ay be fum i gated are lim ite d to anim al prem is es such as poultry houses and swine houses, m u shroom houses, ci trus packing houses, egg facilities and rail cars (not in-transit).

• All fum ugiated uses m u st be done in such a way that the operator is outside the structure undergoing fum i ga tion when applying the fog.

• The labels must be updated to elim in ate cloth or m op applications of
for m aldehyde.

• Manual spray applications of for m al dehyde solutions requ ire the use of a full face respirato r

.

• After fum i gating poultry/swine containm ent buildings, re-entry by unprotected persons should be allowed only after a total 12 air change s. (e.g., 3 hours of
ventilation at a rate of 4 air changes per hour (A CH))

26 of 87e. Occupational and Resident ial Ris k Mitiga tio n for Paraformaldehyde

To m itigate the occupational risks from paraform aldehyde use in beauty salon s and barber shops, it is necessary that these ar eas have general ventilation that m eets the
Am erican Society of Heating, Refrigerat ing and Air-conditioning Engineers (ASHRAE)

recomm endations and/or local exhaust ve ntilation that m eets ACGIH recommendations.

To m itigate the residen t ial risks from par a for m aldehyde use in vacation hom es,

use m u st be lim ited to unoccupied structur e that can be thorou ghly ventilated six (6) hours prior to re-occupancy.

2. Other Labeling Requirements

In order to b e elig ible f o r

rereg i stratio n, various us e and saf ety inf o rm ation will be included in the labeling of all end-us e products containing form aldehyde and paraform aldehyde. For the specific labeling statem ents and a list of outstanding data,
refer to Section V of this RED docum ent.

27 of 87V. What Registrants Need to Do

The Agency has determ ined that form aldehyde and paraformaldehyde are eligible f o r rereg i str ation p r ovid ed that: ( i ) a ddition al da ta that the A g ency inten d s to requ ire conf irm this decis i on; ( i i) the r i sk m itigation m easures outline d in this d o c u m ent are adopted; and (iii) label am endm ents are m ade to reflect these m easures. To im ple m e nt the risk m itigation m easures, the reg i stra nts m u st am end their product lab eling to incorporate the label statem ents set forth in the L a bel Changes Summ ary Table in Section B below (Table 8). The additional data requi rements th at th e Agen cy intends to obtain will in clude, am ong othe r things, sub m ission of the following :

For for m aldehyde and paraform aldehyde technical grade active ingredient products , th e regis t r ant needs to sub m it the f o llowing item s:

Within 90 d ays from receipt of the generic data call-in (D CI):

1. Com p leted response for m s to the ge neric DCI (i.e., DCI response form and requirem e nts status and regist rant’s response form ); and

2. Subm it any tim e extension and/o r waiver r equ ests with a f u ll written justif ication.

Within the time limit s p eci fied in the generic DCI:

1. Cite any existing generic data which address data requirem e nts or subm it new generic data responding to the DCI.

Please contact ShaRon Carlisle at (703) 308-6427 with questions regarding generic

rereg i stratio n.

By US mail: By express o r courier service:

Docum e nt Processing Desk Docum e nt Processing Desk
ShaRon Carlisle ShaRon Carlisle
Off i ce of Pestic ide Prog r am s Office of Pesticide Program s (7510P) (7510P)
U.S. Environm ental Protection Agency U.S. Environm ental Protection Agency 1200 Pennsylvania Ave., NW One Potom ac Yard, Room S-4900 Washington, DC 20460-0001 2777 South Crystal Drive Arlington, V A 22202

28 of 87For end-use products containing the active ingredient form aldehyde and paraform aldehyde , the registrant n e eds to subm it the followin g item s for each product.

Within 90 d ays from the receipt of th e product-specific da ta call-in (PDCI) :

1. Com p leted response for m s to the PDCI (i.e., PDCI response form and requirem e nts status and regist rant’s response form ); and

2. Subm it any tim e extension or waiver re quests with a full w r itten justification.

Within eight months fr om the re ce ipt of the P DCI:

1. Two copies of the confidential st atem ent of formula (EPA Form 8570- 4);

2. A com pleted original application for reregistration (EPA Form 8570- 1). Indica te on the f o rm that it is an “app lica tion f o r r eregis t r ation ”;

3. Five copies of the dra f t label incor porating all label am endm ents outlin ed in Table 26 of this docum ent;

4. A com p leted form certifying com p liance with data com p ensation requ irem ents (EPA For m 8570-34);

5. If applicable, a com p leted form cer tif ying com p lianc e with cost sha r e o f f er requirem e nts (EPA Form 8570-32); and

6. The product-specific data responding to the PDCI.

Please contact Marshall Swindell at (703) 308-6341 with que stions regarding product reregistration an d/or th e PDCI. All m a terials subm itted in respo n se to th e PDCI should be addressed as follows:

By US mail: By express o r courier service:

Docum e nt Processing Desk Docum e nt Processing Desk
Marshall Swindell Marshall Swindell Office of Pesticide Program s (7510P) Office of Pesticide Program s (7510P)
U.S. Environm ental Protection Agency U.S. Environm ental Protection Agency 1200 Pennsylvania Ave., NW Room S-4900, One Potom ac Yard Washington, DC 20460-0001 2777 South Crystal Drive Arlington, V A 22202

29 of 87A. Manufacturing Use Products

1. Additional Generic Data Requirements

The generic database supporting th e reregistration of for m aldehyde and paraform aldehyde has been reviewed and dete rm ined to be substantially com plete. However, the following additional data require ments have been identified by the Agency as conf irm atory data req u irem ents a nd are in clu d ed in the g eneric data -call-in (DCI) for this RED. Table 8 provides an outline of the requested confirm a tory data for for m aldehyde and paraform aldehyde.

Table 8. Con f irmatory and Condition al Da ta for F o rmaldeyde and Parafor m aldehyde

Guideline Study Name New OPPT S Guideline Number

Huma n Hea lth Co nf irmatory D a ta

90 -D ay De rm al To xicity 87 0. 3 25 0

Devel opm ent a l To xi ci t y i n N o n-R ode nt s 87 0. 3 70 0

Environmental F a te & Ecol ogic a l Expos u re Confirmatory Data

Acute Da phn ia ma gna usi n g TGA I fo rm al dehy de 85 0.101 0

2. Labeling for Manufacturing Use Products

To ensure c o m pliance with FIFRA, technical an d m a nufact uring-use product (MP) labeling should be revise d to comply with all curren t EP A regulations, PR Notices and applicable policies. The Technical and MP labeling should bear the labeling contained in Table 9, Labe l Changes Summ ary Table.

B. End-Use Products

1. Additional Product-Sp ecific Data Requirements

Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed productspecific data regarding the pest icide a f ter a determination of eligibility has been m a de. The Registrant m u st review previous data s ubm issions to ensure th at they m eet curren t EPA acceptance criteria and if not, comm it to conduct new studies. If a registrant believ es that previous ly s u bm itted data m eet current tes ting s t andards, then the study MRID numbers should be cited according to the instructions in the Requirem ent Status and Registrants Response Form provided for each product. A product-specific data call-in will be issue d at a late r d ate.

2. Labeling for Technical and End-Us e Products

Labeling changes are necessary to implem e nt measures outlined in Section IV above. Specific language to incorporate th ese changes is specified in Table 9 Label Changes Summary Table.

Registrants m a y generally distribute and sell products bearing old labels/labeling f o r 26 m onths f r om the date of the issuance of this Rereg i str a tion Eligib ility Dec i sio n

30 of 8731 of 87 docum ent. Persons other than the registra nt m a y generally distribute or sell such products for 52 m onths from the approval of la bels reflecting the m itigatio n describ e d in this RED. However, exis ting sto cks tim e f r am es will be e stab lished case

- by-case, depending on the num be r of products involved, the num ber of label changes, and other factors. Refer to “Existing Stocks of Pesticide Products; Statem ent of Pol i cy,” Federal Register , Volum e 56, No. 123, June 26, 1991.

a. Label Changes Summary Table

In order to be eligible for reregistrati on, all product labels m u st be am ended to incorporate the risk m itig ation m easure outlin ed in Section IV of the for m aldehyde an d paraform aldehyde RED. The following tabl e describes how language on the labels should be am ended.Table 9 Labeling Changes Summary TableFORMALDEHYDEDescriptionAmended Labeling LanguagePlacement onLabelAllEnd Use ProductsEnvironmental HazardsStatements Required by theRED and Agency Label Policies"Thispesticideistoxic tooysters.Donotdischarge effluentcontainingthisproductintolakes,streams, ponds, estuaries,oceans, orotherwaters unless inaccordancewiththerequirementsofa National Pollution Discharge EliminationSystem(NPDES)permit andthepermittingauthority has beennotifiedinwritingprior todischarge.Do not dischargeeffluentcontainingthis product tosewer systemswithoutpreviously notifyingthe localsewage treatmentplantauthority.ForguidancecontactyourStateWater BoardorRegionalOffice oftheEPA."PrecautionaryStatementsDirections For UseEndUse ProductsIntendedforPoultry/SwineContainmentBuildings“A minimumre-entrytime of3hours intothe fumigated area isrequired”Directions for UseEndUse ProductsIntendedforOccupationalDisinfectantuseALLLabelsmustbeupdatedtoeliminatemopand clothorspongeapplicationsDirections for UseEndUse ProductsIntendedforLaundry DetergentThisuse has been voluntarilycancelledEndUse ProductsIntendedforGeneral Purpose CleanerProduct applicationrate MUSTbereducedto72ppmEndUse ProductsIntendedforWallPaperAdhesiveProduct applicationrate MUSTbereducedto67ppm32 of 87FORMALDEHYDEDescriptionAmended Labeling LanguagePlacement onLabelEndUse ProductsIntendedforOccupational useIn order to reduce potential occupational handler exposures the followingmitigation isrequired:•For industrial uses of formaldehydeclose systems with dry couplers (orequivilant) are required•Structures that may be fumigated arelimited to animal premises such aspoultry houses and swine houses, mushroomhouses, citrus packinghouses, egg facilities and railcars (not in-transit).•All fumugiated uses must be done insuch a way that the operator isoutside the structure undergoing fumigation when applying the fog.•The labels must be updated to eliminate cloth or mop applications offormaldehyde.•Manual spray applicationsof formaldehyde solutions require the use ofa full face respirator.•After fumigation poultry/swine containment building, re-entry byunprotected persons should be allowed only after a total 12 air changes.(e.g. 3 hoursof ventilation at a rate of4 air changes per hour ( ACH))Directions for UsePARAFORMALDEHYDEDescriptionAmended Labeling LanguagePlacement onLabelAllEnd Use ProductsEnd-Use Products forVacationHomesALL labelsmust limit the use to an UNOCCUPIEDstructure that can bethoroughly ventilated six (6) hours prior to re-occupancy.Directions for Use33 of 8734 of 87FORMALDEHYDEDescriptionAmended Labeling LanguagePlacement onLabelEnd-Use Products for BeautySalons and Barber ShopsThis product must be used in areaswith general ventilation that meetsASHRAE recommendations and/or local exhaust ventilation that meets ACGIHrecommendations.Directions for Use35 of 87 

# VI. APPENDICESAppendix A:Use Patterns Eligible for Reregistration for Formaldehyde (Case 0556)Use SiteFormulationMethod ofApplicationApplicationRate/ No. ofapplicationsUse LimitationsAgriculturalpremises and equipmentPoultry and Turkeyfarms, Swine operations,Dairy farms, Cattlefarms, Veal farms, Emuand ostrich farmsSolubleconcentrate:Reg: 134-65Reg: 8133-33Spray or soakor fog1 - 3 oz of product pergallon of water. ONLYFOUND directions using3 oz for canine and feline(not those listed to the leftunder use site) Precleanall surfaces. Spray allsurfaces to saturation. 10minute contact time.Ventilate closed spaces.Do not houselivestock until treatment has absorbedor dried and all surfaces have beenscrubbed with soap or detergent andrinsed with potable water.Reentry restrictions:Entry into treatedareas by other than correctly equippedhandler is prohibited until the airconcentration level of formaldehyde isLESS than 0.75 ppm.1 1⁄4 - 2 1⁄2 oz of productper gallon of water.Wetmist until the area is moistusing an approvedautomatic wet fogger.Federally inspected meatand poultryestablishmentsexceptwhere meat and foodproducts are handled.Solubleconcentrate:Reg: 134-65Reg: 8133-33Spray or soakor fog1 - 3 oz of product pergallon of water. ONLYFOUND directions using3 oz for canine and feline(not those listed to the leftunder use site) Precleanall surfaces. Spray allsurfaces to saturation. 10minute contact time.Ventilate closed spaces.Do not houselivestock until treatment has absorbedor dried and all surfaces have beenscrubbed with soap or detergent andrinsed with potable water.Reentry restrictions:Entry into treatedareas by other than correctly equippedhandler is prohibited until the airconcentration level of formaldehyde isLESS than 0.75 ppm.36 of 87Use SiteFormulationMethod ofApplicationApplicationRate/ No. ofapplicationsUse Limitations1 1⁄4 - 2 1⁄2 oz of productper gallon of water.Wetmist until the area is moistusing an approvedautomatic wet fogger.Poultry and swinepremises andconfinementareasSolubleconcentrate:Reg: 8133-32Reg: 8133-33Mechanicalsprayer orsprinklerRemove all animals.Preclean and sanitize thepremises. Use 20-60 oz.of product for each 1000ft3of building volume.Sprinkler application:Use a 1:11 dilution in anapproved sprinklersystem. Follow approvedapplication methods.Spray Sled:Use a 1:4dilution in an approvedportable spray sled.Follow approvedapplication methods.For effectiveness, relative humidityshould be at least 70% and ambienttemperature at least 70F or higher.Reentry restrictions:Treated buildingsmust be left closed, locked and securedagainst unauthorized entry for aminimum of 24 hours.Entry into treated areas by other thancorrectly equipped handler is prohibiteduntil the air concentration level offormaldehyde is LESS than 0.75 ppm.Hatching eggwashing/fumigatingtreatmentReady toUse: Reg:8133-32Reg: 8133-33Fog,fumigationMaximumof 2 fl. oz. per1,000 eggs in a 24-hourperiod. Product is to beplace in an open containerand allowed to evaporateor in a slight vacuum. Donot use potassiumpermanganate as acatalyst. Repeated at aIncubators must be vented directly(“directly” has been removed fromthelabel) to outside air. Fumigation may beperformed on both empty incubatorsand incubators containing eggs.Eggsto be fumigated should be held on cleanracks or eggflats which permit aircirculation.Eggfumigation shouldNOT be done between 24 hours and37 of 87Use SiteFormulationMethod ofApplicationApplicationRate/ No. ofapplicationsUse Limitationsmaximum rate of 2 fl. oz.of Formaldehyde Solution37 per 1,000 eggs in a 24-hour period.five days incubation because embryodamage may occur.Last treatmentshould be added at least 12 hoursbefore chicks are pulled. Reentryrestrictions:Entryinto treated areas byother than correctly equipped handler isprohibited until the air concentrationlevel of formaldehyde is LESS than0.75 ppm.Citrus packing housesSolubleconcentrate:Reg: 8133-32Reg: 8133-33Fog,fumigationUse 16 fl. Oz. of productper 1000 ft3of space to betreated. Product may bediluted at a rate of up toone part solution to 10parts water.Roomto betreated should be tightlyclosed and humidityintroduced for at least 24hours. Do not wet downwith hose. Apply using anapproved stationarymounted spray manifoldand suitable air operatedfoggers. Premises may betreated up to twice a year.Worker buffer zone:Establish aworker buffer zone of 25 feet and aresidential buffer zone surrounding thetreated building during treatment andaeration.See buffer zone tables fromdistributor.Bufferzones should bemaintained for 24 hours.Reentry restrictions:Treated buildingsmust be left closed, locked and securedagainst unauthorized entry for aminimum of 24 hours.Entry into treated areas by other thancorrectly equipped handler is prohibiteduntil the air concentration level offormaldehyde is LESS than 0.75 ppm.Formaldehyde is phytotoxic to citrus.Remove all fruit fromspaces to betreated.Allow formaldehyde residue todissipate from storage boxes beforefilling with fruit.38 of 87Use SiteFormulationMethod ofApplicationApplicationRate/ No. ofapplicationsUse LimitationsIris and daffodil bulbs inbulb farmsSolubleconcentrate:Reg: 8133-33None listedon labelNone listed on labelNoneMushroomhouses,equipment and premisesReady toUse: Reg:8133-32Reg: 8133-33Fog,fumigationNon Producing areas:Empty mushroomhouseof all growing media.Broomclean.Wet outgrowing boards. Closeand seal up area to betreated.Inject steamintohouse until interiortemperature reads 140-150F.Inject solution intosteam(4 gallons forhouses up to 26,600 ft3, 5gallons in houses up to33,300 ft3and 8 gallonsfor houses up to 44,400ft3) and continue steamingfor 12 hours.Turn onexhaust fan for 12 hours,then ventilate for 24hours.Reentry restrictions:Entry into treatedareas by other than correctly equippedhandler is prohibited until the airconcentration level of formaldehyde isLESS than 0.75 ppm.Reentry restrictions:Treated buildingsmust be left closed, locked and securedagainst unauthorized entry for aminimum of 24 hours.Entry into treated areas by other thancorrectly equipped handler is prohibiteduntil the air concentration level offormaldehyde is LESS than 0.75 ppm.Commercial, institutional and industrial premises and equipment39 of 87Use SiteFormulationMethod ofApplicationApplicationRate/ No. ofapplicationsUse LimitationsHard non-porous surfacesSolubleconcentrate:Reg: 134-65Reg: 8133-33Spray or soakor fog1 - 3 oz of product pergallon of water. Precleanall surfaces. Spray allsurfaces to saturation. 10minute contact time.Ventilate closed spaces.Do not houselivestock until treatment has absorbedor dried and all surfaces have beenscrubbed with soap or detergent andrinsed with potable water.Reentry restrictions:Entry into treatedareas by other than correctly equippedhandler is prohibited until the airconcentration level of formaldehyde isLESS than 0.75 ppm.1 1⁄4 - 2 1⁄2 oz of productper gallon of water.Wetmist until the area is moistusing an approvedautomatic wet fogger.Rooms and Railway carsReady toUse: Reg:8133-32Reg: 8133-33Fog,fumigationFor each 1000 cubic feetof space, use 162/3ozpotassiumpermanganateand 20 oz of product.Place large dishpan onfloor in which a smallerpan is set.Put Kpermanganate in thesmaller pan and pourproduct over it.Leaveroomimmediately.Closeall windows and doors.Ventilate after 5 hours.Reentry restrictions:Entry into treatedareas by other than correctly equippedhandler is prohibited until the airconcentration level of formaldehyde isLESS than 0.75 ppm.Residential and public access premises40 of 87Use SiteFormulationMethod ofApplicationApplicationRate/ No. ofapplicationsUse LimitationsZoosSolubleconcentrate:Reg: 134-65Spray, soak,mop orsponge1 oz of product per gallonof water. Preclean allsurfaces. Spray allsurfaces to saturation. 10minute contact time.Use at 3 oz per gallon todisinfect against canineparvovirus and felinepanleukopenia.Ventilate closed spaces.Do not houselivestock until treatment has absorbedor dried and all surfaces have beenscrubbed with soap or detergent andrinsed with potable water.Reentry restrictions:Entry into treatedareas by other than correctly equippedhandler is prohibited until the airconcentration level of formaldehyde isLESS than 0.75 ppm.Veterinary clinics,kennelsSolubleconcentrate:Reg: 134-65Spray, soak,mop orsponge1 oz of product per gallonof water. Preclean allsurfaces. Spray allsurfaces to saturation. 10minute contact time.Use at 3 oz per gallon todisinfect against canineparvovirus and felinepanleukopenia.Ventilate closed spaces.Do not houselivestock until treatment has absorbedor dried and all surfaces have beenscrubbed with soap or detergent andrinsed with potable water.Reentry restrictions:Entry into treatedareas by other than correctly equippedhandler is prohibited until the airconcentration level of formaldehyde isLESS than 0.75 ppm.Pet shopsSolubleSpray, soak,1 oz of product per gallonVentilate closed spaces.Do not house41 of 87Use SiteFormulationMethod ofApplicationApplicationRate/ No. ofapplicationsUse Limitationsconcentrate:Reg: 134-65mop orspongeof water. Preclean allsurfaces. Spray allsurfaces to saturation. 10minute contact time.Use at 3 oz per gallon todisinfect against canineparvovirus and felinepanleukopenialivestock until treatment has absorbedor dried and all surfaces have beenscrubbed with soap or detergent andrinsed with potable water.Reentry restrictions:Entry into treated areas by other thancorrectly equipped handler is prohibiteduntil the air concentration level offormaldehyde is LESS than 0.75 ppm.Industrial processes and water systemsOil recoveryinjectionwater systemsReady toUse: Reg:8133-28Reg: 8133-30Reg: 10707-43InjectionInjectin either acontinuous treatment orslug application toproduce between 25-5000ppmof active ingredient.For use with closeddelivery systemsonlyDrilling muds, work overfluids and water basedpacker fluidsReady toUse:Reg: 8133-28Reg: 8133-30Reg: 10707-43InjectionInjectin either acontinuous treatment orslug application toproduce between 100-500ppmof active ingredient.For use with closeddelivery systemsonlyMaterials preservativePolishes for floors andfurniture, surfactants andsilicone emulsionsReady to use:8133-32IncorporationUse range = 0.10 to 1000ppmin final productSolution may not be used in productscoming in direct contact with food and/ or drinking water42 of 87Appendix A:Use Patterns Eligible for ReregistrationParaformaldahyde case number:(0556)Use SiteFormulationMethod ofApplicationApplicationRate/ No. ofapplicationsUse LimitationsResidential and public access premisesSanitizerHair/beautysalons, andbarbershops, sanitizer,cabinets,implement drawers,rollertrays,student implementkits, coversordoors of whichare tobe kepttightlyclosed.Ready touseReg 397-6FumigantRemovecapplace insanitizercabinetsWhen fungicidal actionis requiredkeepclosedfor24 hours. For use inhair. beautysalons and barbershopsNone mentioned43 of 87`APPENDIXB: Formaldahyde / Paraformaldahyde (case 0556)Appendix B lists thegeneric(not product specific) datarequirements which support the re-registration of Formaldahyde /Paraformaldahyde.These requirements applyto Formaldahyde / Paraformaldahyde in allproducts, including data requirements forwhich a technical grade active ingredient is the test substance.DATA REQUIREMENTCITATION(S)New GuidelineNumberOld GuidelineNumberStudy TitleUse PatternMRIDNumberPRODUCT CHEMISTRY830.155061-1Product identity and composition43987201,43983801830.1600830.1620830.165061-2aStarting Materials and ManufacturingProcess42724601, 43987201, 43983801830.167061-2bFormationofImpurities42724601, 43987201, 43983801830.170062-1Preliminary Analysis42724601, 43987201, 43983802,43983801830.175062-2CertificationofLimits42724601, 43987201830.180062-3Analytical Method42724601, 43987201, 43983801830.630263-2Color42724601, 43987201, 43983801,57014, 57022, 57024, 7642830.630363-3Physical State42724601, 43987201, 43983801,57014, 57022, 76242830.630463-4Odor42724601, 43987201, 43983801,57014, 57022, 7642830.720063-5Meltingpoint43987201, 43983801, 57014, 57024,76242830.730063-7Density orSpecificGravity43987201, 43983801, 124869,57014,57024, 76242830.7840830.786063-8Solubility42724601, 57014, 57024, 7624244 of 87DATA REQUIREMENTCITATION(S)New GuidelineNumberOld GuidelineNumberStudy TitleUse PatternMRIDNumber830.795063-9Vaporpressure42724601, 43987201, 43983801,124869, 57014, 57024, 76242830.737063-10DissociationConstant42930901, 43987201, 43983801830.755063-11Oct/WaterpartitionCoef42930901, 43987201, 43983801830.700063-12pH42930901, 43987201, 43983801830.631363-13Stability42930901, 43987201, 43983801,57014, 57024, 124869830.631563-15Flammability43987201, 43983801, 57022, 124869830.631663-16Explodability43987201,43983801830.631563-17Storage Stability43987201, 43983801830.710063-18Viscosity43987201,43983801830.710063-19Miscibilty43987201,43983801830.632063-20CorrosionCharacteristic43987201,43983801830.632163-21Dielectric Breakdown Voltage43987201,43983801830.631463-14Oxidation/Reduction:ChemicalIncompatibility43987201, 43983801, 57022, 124869870.110081-1AcuteOral- Rat00058054, 00065508870.120081-2Acute Dermal-Rabbit00058054, 00065508, 00159395870.130081-3AcuteInhalation - RatOpenLiterature, 43170601870.250081-5Primary Dermal Irritation-Rabbit00058054,00065514,00159392870.260081-6DermalSensitization40161103,Open Literature870.310082-1a90-DayFeeding-Rodent00124677, 00134114, OpenLiterature870-315082-190Dayoral toxicity innorodentsOpenLiterature45 of 87DATA REQUIREMENTCITATION(S)New GuidelineNumberOld GuidelineNumberStudy TitleUse PatternMRIDNumber870.325082-390-DayDermalToxicity-RodentDataGap870-346582-490Dayinhalation toxicity00082134.Open Literature870.346582-46weekinhalationtoxcity00149755870.370083-3aDevelopmentalToxicity-Rat00082136, 00123770, 00123769,00164652, OpenLiterature870.370083-3bDevelopmentalToxicity–NonrodentDataGap870.380083-4Reproductionand fertility effects00143291,OpenLiterature870.410083-1aChronic Toxicity-RatOpenLiterature870.420083-2aCarcinogenicity-Rat00143288, OpenLiterature870.420083-2bCarcinogenicity-MouseOpenLiterature870.430083-5Combinedchronic toxicity/ Carcinogenicity00143289870.510084-2BacterialReverseMutationAssay00132156, 00138157, OpenLiterature870-520084-2Mousevisiblespecific locustestOpenLiterature870-5275Sex-linkedrecessive lethaltestinDorosophliamelanogasterOpenLiterature870.537584-2In Vitromammalianchromosomeaberrationtest00132168,OpenLiterature870.538084-2Mammalian spermatogonialchromosomeaberration testOpenLiterature870-545084-2RodentdominantlethalassayOpenLiterature870.555084-2UnscheduledDNA synthesisinmammaliancellculture00132169870.590084-2In VitrosisterchromatidexchangeassayOpenLiterature870.591584-2In VitrosisterchromatidexchangeassayOpenLiterature870.620082-7Neurotoxicity screening batteryOpenliterature46 of 8747 of 87DATA REQUIREMENTCITATION(S)New GuidelineNumberOld GuidelineNumberStudy TitleUse PatternMRIDNumber870.650085-5Schedule-controlled operantbehaviorOpenLiterature870.748585-1GeneralmetabolismOpenLiteratureAppendix C. Technical Support Documents

Additional docum e ntation in support of this RED is m a intained in the OPP docket, located in Room 119, Crystal Mall #2, 18 01 Bell Street, Arlington, VA. It is open Monday through Friday, excluding legal holidays, from 8:30 am to 4 pm

.
OPP public docket is located in Room S-4400, One Potom ac Yard (South Building), 2777 South Crystal Drive, Arlington, VA, 22202 and is open Monday through Friday, excluding F e deral holidays, from 8: 30 a.m . to 4:00 p.m

.

The docket initially contai ned th e (d ate) p r elim inary risk ass essm ent and the
related docum ents. EPA then considered comm ents on thes e risk as sessm ents (which are posted to the e-docket) and revised the risk assessm e nts. The revised risk assessm ents will be pos te d in the doc ket at the sa m e tim e as the RED.

All docum e nts, in hard copy for m , m a y be viewed in the OP P docket room or
downloaded or viewed v i a the Intern et at www.r e gulations.gov

These docu m ents include:

• Form aldehyde Prelim inary Risk Assessm ent; Notice of Availability, (date).

• Form aldehyde Summ ary, (date).

• Overview of the Form aldehyde Prelim inary Risk Assessm ent, (date).

Prelim inary Risk Assessm e nt a nd Supporting Science Documents:

• Form aldehyde: Prelim inary Risk Assessm en t for the Reregist ration Eligibility Decision, P C Code 043001, Case 0556, An tim i c robials Division, 4/7/08,
Tim othy F. McMahon, Ph.D., Jonathan Che n, Ph.D., Srivivas Gowda, Ph.D., A. Najm Sha m im, Ph.D., Richard C. Petrie , Agronom i st, Ti m othy C. Dole, CIH, Industrial Hygienist.

• Product Chem istry Science Chapter on Form aldehyde. PC Code 043001, Case 0556, Antimicrobials Division, 1/24/08, Srivivas Gowda, Ph.D.

• Product Chem istry Science Chapter on Paraform a l dehyde. PC Code 043002, Case 0556,
Antim icrobials Di vision, 1/24/08, Srivivas Gowda, Ph.D.

• Form aldehyde: Toxicology Disciplinary Chap ter for the Reregistration Eligibility
Decision Docum e nt, PC Code 043001, Ca se 0556, Antim icrobials Division, 3/31/08, Timothy F. McMahon, Ph.D.

• Form aldehyde Dietary Exposure Assessm ents for the Reregistration Eligibility
Decision. P C Code 043001, Case 0556, An tim i c robials Division, 1/29/08, A. Najm Sha m im, Ph.D.

• Form aldehyde Occupational/Residential Exposure Assessm ent. PC Code 043001, Case 0556, Antim icrobials Division, 4/15/ 08, Timothy C. Dole, CIH, Industrial Hygienist.

• Health Effects of Form al dehyde in Hum a ns. PC Code 043001, Case 0556,
Antim icrobials Division, 1/30/08.

48 of 87• Environm ental Fate Assessm ent of Form aldehyde for the Reregistration Eligibility Decision (RED). PC Code 043001, Case 0556, Antim icrobials Division, 1/23/08, A. Najm Sha m i m , Ph.D.

• Ecological Hazard and Environm ental Risk Assessm ent: Form aldehyde. PC Code 043001, Case 0556, Antim i crobials Division, Richard C. Petrie, Agronom i st.

• Drinking Water Assessm e nt for For m alde hyde Reregistration Eligibility Decision (RED). PC Code 043001, Case 0556, Antim ic robials Division, 1/30/08 A. Najm
Sha m i m , Ph.D.

• Form aldehyde/Paraform a dehyde - R e port of the Antim icrobials Division Toxicity Endpoint Selection Comm ittee (ADT C). PC Code 043001; 043002, Case 0556,
Antim icrobials Division, Tim othy F. McMahon, Ph.D.

49 of 87Appendix D. Citations C onsidered to be Part of the Data Base Supporting the Reregistration Decision (Bibliogra phy)

GUIDE TO APPE NDI X D

1. CONTENTS OF BIBLI OGRAPHY. This bi bliography contains citations of all studies considered relevant by EPA in arriving at the posit ions and conclusions stated elsewher e in the Chlor i n e Dioxide R eregis t r ation Eligib ility Docum ent. Prim ary sources for studies in this bib lio graphy have been the bo dy of data subm itted to EPA and its predecessor agencies in support of past regu latory decisions. Se lections from other sources including the published literature, in tho se instances where they have been considered, are in cluded

.

2. UNITS OF ENTRY. The unit of entry in this bibliography is called a “study.” In the case of published m a terials, this corresponds closely to an article. In the case of unpublished m aterials su bm itted to th e Agen cy, th e Agency has sought to identify docum ents at a lev el pa r alle l to the p ublishe d article f r om within the typic ally large r volum es in which they were subm itted. The re s u lting “stud i es” gene rally have a dis t inct title (o r at le ast a s i ngle s ubject), can stand alone for pur poses of review and can be described with a conventional bibliographic ci tation. The Agency has also attem pted to unite basic docum e nts and commentaries upon them , treating them as a single study.

3. IDENTIFICATION OF ENTRIE S. The entries in this bibliography are sorted

num e rically by Master Record Id entifier, or “MR I D” num ber. This num ber is unique to the citation, and should be used whenever a sp ecif i c reference is required. It is not rela ted to th e six-d i git “ A ccession N u m b er” whic h has been used to identify volum es of subm itted studies (s ee p aragr aph 4(d )(4) be low f o r f u rther ex planation). In a f ew cases, entries added to the b i bliogra phy late in the review m a y be preceded by a nine character

tem porary identifier. These en tries are listed afte r all MRID entries. This tem porary identifying num ber is also to be used whenever specific reference is needed.

4. FORM OF ENTRY. In addition to the Master Record Id entifier (MRID), each entry consists of a cita tion containing standard elem ents f o llowed, in the c ase of m ater i al subm itted to EPA, by a descrip tion of the earliest known subm ission. Bibliographic convention s used reflect the standard of the Am erican National Standards Institu te (ANSI), expanded to provide for certain special needs.

a. Author. W h enever the author cou l d conf idently be identif i ed , the Agency has chosen to show a personal author. W h en no individual was identified, the Agency has shown an identifiable laboratory or testing facility as the author. W h en no author or labora t ory c ould be iden tif ied, th e Agency has sh own the f i rst subm itter as the autho r

.

b. Docum e nt date. The date of the study is taken directly from t he docum ent. When the date is followed by a question m a rk, the bibliographer has deduced the date from the evidence contained in the docum ent. W h en the da te appears as (1999), the Agency was unable to determ ine or estim a te the date of the docum ent.

50 of 87c. Title. In so m e cases, it has been ne c essary f o r th e Agency bibliogr aphers

to cre ate o r enhance a d o cum ent title. A ny such edito ria l ins ertions ar e c ontained between squ a re brackets.

d. Trailing par entheses. F o r studies su bm itted to th e Agency in the pas t , the trailing parentheses include (in addition to any self-explanatory text) the following elem ents describing the earliest known subm ission:

(1) Subm ission date. The date of the ea rliest known subm ission appears imm e diately following the word “received.”

(2) Adm i nistrative num ber. The next elem ent i m m e diately follow i ng the word “under” is the registration nu m b er, experim ental use perm it num b er, petition num b er, or other adm i nistrative num ber associated with the earliest known subm ission.

(3) Subm itter. The third ele m ent is the s u bm itter. W h en authors h ip is def aulted to the subm itte r, this elem ent is om itted

.

(4) Volum e Identif ica tion ( A ccession N u m b ers). The f i nal ele m ent in the trailing parenth eses identifies th e EPA acces sion num ber of the volu m e in which the original subm ission of the study appears. Th e six- d i git accession nu mber follows the sym bol “CDL,” whi c h stands for “Com pany Data Libr ary.” This accession num ber is in turn followed by an alphabetic suffix which shows th e relative position of the study w ithin the volum e.

51 of 87

### 1. MRID Studies

MRID # Citation

00065640 Birdsong, C. L. and J.W

. Avalt, Jr . (1971). Toxicity of Certain Che m icals
to Juvenile Pom pano. Progressi ve F i sh Culturist.33:76-80.

00101857 Bentley

, R

. E. (1 975). Acute Tox i city of Ten Bar o id Compounds to Blu e gill (Lep omis macrochiru s )
and Rainbow Tr out (Salmo gaird n eri ). Unpublish e d stud y

. Condu cted b y Bionomics, EG&G for Baroid, Division , N.L. Industries

, Houston, TX.

00126394 Heitm uller, T. (1975). Acute Toxici ty of Surflo-B17 to Larvae of the Eastern Oyster ..., Pink Shrim p ..., and Fiddler Crabs (Uca pugilator ). Unpublished study. Conducted by Bionom ics, EG&G for Baroid Division, N. L. Industries, Houston, TX.

00126395 Heitmuller

, T. (1 975). Acute Tox i city of Ald a cide to Larv ae of th e Eastern O y ster .., Pink Shrimp ..., and Fiddler Crabs (Uca pugilator) . Unpublished stud y

. Cond ucte d b y Biono mics, EG&G for
Baroid Div i sion, N. L. Industries

, Houston, TX.

00126396 Heitmuller

, T. (1 975). Acute Tox i city of Surfl o -B19 to Larv ae of the Eastern O y ster ..., Pink
S h rim p ..., and F i ddler Cr abs (U ca pug ila tor ). Un published stud y

. Conducted b y Bionomics,
EG&G for B a roid Division, N. L. Industries, Houston, TX.

00128086 Heitmuller

, T. (1 975). Acute Tox i city of Surflo

- B16 to Larv ae of the Eastern O y ster ..., Pink shrimp ..., and Fiddler Crabs (Uca pugilator )

. Un published stud y

. Conducted b y Bionomics,
EG&G for B a roid Division, N. L. Industries, Houston TX.

00132485 Bills, T.D

. , Mar k ing, L.L., and J

. H. Ch andler . (1 977). Form alin: Its Toxi cit y to Nontarget Aquatic Organisms, Persistence, and Cou n tera ction

. U.S

. Fish & W ildl i fe Service

, Inv e st. Fish Control
73:1-7.

00134123 McCann, J

. and F. Pitch e r. (1973 ). Russell’ s Incu bator Fumigant: Bluegill: Test No. 577

. Unpublished stu d y . Prepared b y Pesticides Regula tion Division, Animal Biolog y Laborator y , U.S.
Environmental P rotection Agency , Beltsville, M D

.

00134124 McCann, J

. , and F. Pitch e r. (1973 ). Russell’s Incu bator Fumigant: Rainbow Trou t: Test No. 560. Unpublished stu d y . Prepared b y Pesticides Regula tion Division, Animal Biolog y Laborator y , U.S.
Environmental P rotection Agency , Beltsville, M D

.

00134126 McCann, J

. and F. Pitch e r. (1973 ). Parson’s Form aldeh y d e : B l uegi ll: Test No. 594

. Unpublished
stud y

. Prepa r ed b y Pestic ides Re gulation Divisio n , Animal Biolo g y Labor ator y , U.S.
Environmental P r otection Agency , Beltsville MD.

00148770 Lem on, K.A. (1985). Acute Toxicolo gical Evaluations of Estuarine Organism s to Support Registrati on Action 44797-RL. Conducted by EnviroSystem s, Inc. for N.L. Trea ting Che m ical Com pany, Houston, TX. .

00148772 Sm ith, E.H. (1985). Acute Toxicity of For m alin on Daphnia m a gna to Support Registration Action 44797-RL. Unpublished study. Conducted by
ANAT EC L a boratories, Inc. for N.L. Testing Chem icals, Houston TX.

52 of 8700148773 Fletcher, D.W. (1983). Report to N L Treating Che m icals/NL Industries, Inc., Eight-day Dietary LC 50 Study with Surflo-B315 in Bobwhite Quail: BLAL No.83 QC 39. Unpublishe d study. Conducted by Bio-L i fe Associates Ltd. For NL Treating Ch em icals/NL Industries, Inc.

00148774 Fletcher, D.W. (1983). Report to N L Treating Che m icals, NL Industries, Inc., Acute Toxicity S t udy with Su rflo-B315 in Bobwhite Quail: BLAL No.83 QD 38. Unpublished study Conducted by Bio-Life Associates Ltd. For NL Treating Chem icals/NL Indu stries, Inc.

00148775 Fletcher, D.W. (1984). Report to N L Treating Che m icals, NL Industries, Inc., Eight-day Dietary LC 50 Study with Surflo-B 315 in Mallard Ducklings: BLAL No.83 DC 40. Unpublished study. Conducted by BioLife Associates Ltd. For NL Treatin g Che m icals/NL Industries, Inc.

00058054 Celanese Che m ical Com p any (1976?) Toxico logical Data and Health
Hazards: Fo rm aldehyde. (Unpublish e d study received Nov 4, 1977 under 11558-8; CDL: 232282-K)

00065508 3T1522: Laboratory Nos. 5E-6921, 5E-6923, 5E-6924, 5E- 6922. (Unpublished study received Jan 11, 1977 under 10000-4; su bm itted by
Hallem ite Lehn & Fink, Montvale, N.J.; CDL: 229296-A)

00065514 St. Pierre, F.; Parke, G.S.E. (1976) Report on Prim ary Der m a l Irritation Study in Rabbits: L a boratory No. 6E-4231. (Unpublished study received Jan 11, 1977 under 10000-4; prepared by Cannon Laboratories, Inc.,
subm itted by Hallem ite Lehn & Fin k, Mont- vale, N.J.; CDL:229296-G)

00082134 Coon, R.A. et al. (1970) Ani m al Inha lation Studies on Amm o nia, Ethylene Glycol, Form aldehyde, Di m e thylamin e, and Ethanol. Toxicology and Applied Pharm acology 16: 646-655.

00082136 Schnurer, L.B. (1963) Maternal and f o etal responses to chronic stress in pregnancy: A study in al bino rats. A c ta Endocrinologica, Supplem e nt 80 ?:3-96. (Also in unpublished subm ission received Oct 15, 1973 under 4G1438; subm itted by Chevron Chem ical Co., Richm ond, Calif.; CDL:095383-A)

00123769 Ranstrom , S. and Schrurer, L. (1956) Stress and Pregnanc y. Acta Pathol.
Microb iol. S candinav i a. Supplem ent III, 113 -114.

00123770 Schnurer, L. (1963) Maternal and foet al responses to chronic stress in pregnancy. Acta Endocrinologica (80):3-96. (Also In unpublished
subm ission received 196 3 under 4G1438; subm itted by Chevron Che m ical Co., Richm o nd, CA; CDL:093832-T )

53 of 8700124677 Driedger, A.; W a lker, J.; Galloway, F. (1973) Letter sent to C. Sm art dated Oct 1, 1973: “Rat tolerance to Dietary Form aldehyde: Reference No. AD-114-73, JRW

- 341-73.” (Unpublished study; subm itted by Celanese
Che m ical Co., Dallas, T X ; CDL:094622-H)

00132156 Jagannath, D. (1978) Mutagenicity Evaluation of Dantoin DMDMH-55
40-697 737543 in the A m es Sal m onella /Microsom e Plate Test: LBI Project No. 20838. Final rept. (Unpub lished study received May 9, 1983
under 38906 -5; prep ared by Litton Bione tics, Inc., sub- m itted by Glyco, Inc., Greenwich, CT; CDL:250313-A)

00132157 Haworth, S.; Lawlor, T.; Burke, P.; et al. (1982). Salm onella/Mamm a lianm i crosom e Preincubation Mutagenicity Assay (A m e s Test): Test Article
447:34-3: S t udy No. T1804.502. (Unpublished study received May 9, 1983 under 38906-5; prepared by M i crob iological Assoc., su bm itted by Glyco, Inc., Greenwic h, CT; CDL:250313-B).

00132168 Thilagar, A.; Kum a roo, P.; Pant, K. (1982) Cytogenicity Study: Chinese
Ha m s ter Ovary (CHO) Cells in vitr o: Test Article 447:34-1: Study No. T1802.338. (Unpublished study received May 9, 1983 under 38906-5;

prepar ed by Microb iolog i cal Assoc ., subm itted by Glyco, Inc ., Greenwic h, CT; CDL:250313-M)

00132169 Thilagar, A.; Pant, K. (1982) Un scheduled DNA Synthesis in Rat Hepatocytes: Test Article 447:34-1: Study No. T1802.380002. (Unpublished study received May 9, 1983 under 38906-5; prepared by
Microb iolog i cal Assoc., subm itted by Glyco, Inc ., Greenwic h, CT; CDL:250313-N)

00134114 Viguera, C.; Kundzins, M. (1960) “ 28-Day Oral Adm i nistration--Rats: U.F. Concentrate-85|.” (Unpublis hed study; prepared by Hazleton Laboratories, Inc.; CDL: 105284-C)

00143288 Watanabe, F., et al. (1954) Study on the Carcinogenicity of Aldehyde. 1st Report. E xperim e nt ally Produced Rat Sarcomas by Repeated Injections of Aqueous Solution of Formaldehyde. T w o unpublished translations of Japanese article published in Gann 45(2- 3):451-452.

00143289 Kerns, W

. D. et al. (1983) Carcinoge nicity of Form aldehyde in Rats and Mice after Long-Term Inhalation Exposure. Cancer Research 43:
4382-4392.

00143291 Hurni, H. and H. Odher (1972) Reproduction Study with Formaldehyde
and Hexam e thylenetetr-am i ne in Beagle Dogs. Fd. Cos m et. Toxicol. 11:
459-462.

54 of 8700149755 Rusch, G.; Rinehart, W . (1980) A 26 W eek Inhalation Toxicity Study of
Form aldehyde in Monkey, Rat, and Ha m s ter: Project No. 79- 7259. Unpublished study prepared by Bio/dynam i cs Inc. 184 p.

00159392 Liggett, M.; W ilson, J. (1980) Irritant Effects of Acticide BG on Rabbit Skin: 79648D/THR 2. Unpublished study prepared by Huntingdon Research Centre. 5 p.

00159393 Liggett, M.; W ilson, J. (1980) Irri tant Effects of Acticide BG on Rabbit Eye Mucosa: 8088D/THR 3. Unpublished study prepared by Huntingdon Research Centre. 5 p.

00159395 Kynoch, S.; Charnley, B.; Ginty, J. (1980) Acute Percutaneous Toxicity to
Rats of Acticide BG: 79625D/THR 4. Unpublished study prepared by Huntingdon Research Centre. 5 p.

00164652 Marks, Thom as A. et al. (1980) Infl uence of Form aldehyde and Sonacide (Potentiated Acid Glutaraldehyde) on Em bryo and Fetal Developm ent in
Mice. Teratology 22: 51-58.

40161103 Spiers, J. (1987) Form aldehyde: Skin Sensitisation Study to the Guinea Pig: (Positive Control): La boratory P r oject ID: CTL/P/ 1211A. Unpublished study prepared by ICI C e ntral Toxicology Laboratory. 28 p.

43167201 Burleigh- Flayer, H. D. and W .J. Kintigh (1992) Glut araldehyde and
Form aldehyde: Vapor P u lm onary Hype rsensitivity Study in Guinea Pigs. Bushy Run Research Center (Export , PA), Union Carbide. Study ID 92U1123, dated February 28, 1992, Unpublished.

43170601 Werley et al. (1994). Glutar dehyde and Form aldehyde: Sensory Irritation Study in Swiss-W e bster Mice. Union Carbide Lab P r oject No.
91U0123.

00146665 Celanese Chem ical Co., Inc. (1985) [ P roduct Chem istry: Form aldehyde 45%]. Unpublished compilation. 19 p.

41926001 Sibinovic, K . (1991) Reichold Form aldehyde/ Methanol: Product
Chem istry: Accelerated Storage Stab ility: Lab Project Num b er: C80- PCRI-1991. Unpublished study prepared by Shaldra, Inc. 38 p.

42596708 Stupp, S. (1992) Product Chem istries and 30-Day Storage Stability of
Methaform 55A: (Product renam e d Form aldehyde Solution 54): Lab Project Number: CHAMP-01A-92. U npublished study prepared by A & S
Environm ental Testing, Inc. 65 p.

55 of 8742656801 Petrolite Corp. (1993) F orm al dehyde: Physical and Che m ical Characteristics. Unpublished study. 4 p.

42724601 Stupp, S. (1992) Product Chem istries and 30-Day Storage Stability of
Methaform 55A: (Product renam e d Form aldehyde Solution 54): Lab Project Number: CHAMP-01A-92. U npublished study prepared by A & S
Environm ental Testing, Inc. 65 p.

42859001 Stupp, S. (1991) Product Chem istry and 30-Day Storage Stability of
Bactron K-55W Microbiocide: Lab P r oject Num b er: C80-BACT55-PC1990: C80-ASST-PC-1991. Unpublis hed study prepared by A & S
Environm ental Testing, Inc. 75 p.

42995401 Stupp, S. (1993) Product Chem istries and 30 Day Storage Stability of
Form aldehyde Solution 54: Lab Project Num ber: CHAMP-01A-92. Unpublished study prepared by A&S E nvironm ental Testing, Inc. 172 p.

42930901 Stupp, S. (1992) Product Chem istries and 30 Day Storage Stability of
Form aldehyde Solution 54: Lab Project Num ber: CHAMP-01A-92. Unpublished study prepared by A & S E nvironmental Testing, Inc. 65 p.

43051601 Douglas, C. (1993) Formaldehyde-P roduct Identity Analysis and Certification of Product Ingredie nts. Unpublished study prepared by Borden Packaging and Industrial Products. 51 p.

43745001 Sibinovic, K .; Tenhaeff, S. (1995) Product Chemistry--Form a ldehyde Solution 37: Lab Project Num ber: BORDEN-FS97-95. Unpublished study prepared by Shaldra, In c. and Bo rden Che m ical & Plastics. 35 p.

44952301 Sibinovic, K

. (1999) Product Chem is try--Form a ldehyde Solution 37F: Lab Project Number: CTI-99-PC-01. Unpub lished study prepared by Shaldra, Inc. 31 p.



### 2.Open Literature

Citation Neff, J.M., S. McKelvie and R.C. Ayers, Jr. (2000). “Environm ental Im pacts of Synthetic Based Drilling Fluids. Report prepared for MMS by Robert Ayers & Associates, Inc. August 2000. U.S. Departm e nt of the In terior, Minerals m a nagem ent Service,
Gulf of Mexico OCS Re gion, New Or leans, L.A. OCS Study MMS 2000-064. 118pp.

Chenier, R. (2003). An Ecological Risk A ssessm e nt of Form aldehyde. Hum a n and Ecological Risk Assessm ent. Vol. 9, No. 26 pgs.

56 of 87Canadian E nvironm ental Protection Act (1999) . Priority Substances L i st Assessm ent Report. Form aldehyde. Health Canada. 102 pgs.

ATSDR (Agency for Toxic Substances and Dis ease Registry). Toxicological Profile for
Form aldehyde. U.S. De partm e nt of Health and Hum a n Services. 1999.

Concise International Chem ical Assessm ent Doc u m e nt 40 (CICADS) on Form aldehyde
Published U nder IPCS (The Internat ional Programme on Che m ical Safety, Geneva, 2002. 116 pgs. ACGIH (Am e rican Conference of Governm e nt al Industrial Hygienists). (2001). Acrolein
in Docum e ntation of the Threshold L i m it Values and Biological Exposure Indices,
7th Ed. Cincinnati, OH: Am erican C onference of Governm e ntal Industrial Hygienists.

Alexandersson, R. and Hedenstierna, G. ( 1988). Respiratory H azards Asso ciated with Exposure to Form aldehyde and Solvents in Acid-Curing Paints. Arch. E nv. Health. 43: 222-227.

Alexandersson, Rolf, M.D. and Hedenstierna, Goran, M.D. (1989). Pulm onary Function
in W ood Workers Exposed to Formalde hyde: A Prospective Study. Arch. Env. Health. Vol. 44, No. 1. p. 5-11.

ATSDR (Agency for Toxic Substances and Disease Registry). (1999). Toxicological
Profile for Form aldehyde. U.S. Departm e nt of He alth and Hum a n Services, Public
Health Serv ices, Agency for Toxic Substa nces an d Disease R e gistry, Atla nta, GA. July 1999.

BEST (The Board on Environm ental Studies and Toxicology). (2007). Form aldehyde.
Em ergency and Continuous Exposure Guidance Levels for Selected Subm arine
Contam inants Vol. 1. Page 103-138. The National Academ ies Press.

Blair, A., R. Saracci, P.A. Stewart, R. B. Hayes, and C. Shy. (1990). Epidem iologic evidence on the relationship between fo r m aldehyde exposure and cancer. S cand.
J. W o rk Environ. Heal th 16(6):381-393.

Burkhart K K , Kulig KW, McMartin KE. (1990). Form ate levels follow i ng a form alin ingestion. Vet Hum Toxi col 32:135-137.

Collins, J.J., J.F. Acquavella, and N.A. Esm e n. (1997). An updated m e ta-analys i s of
for m aldehyde exposure and upper respirat ory tract cancers. J. Occup. Environ. Med. 39(7):639-651.

Dally, K. A., Eckam nn, A. D., Hanr ahan, L. P, Anderson, H.A., and Kanarek, M. S. (1981). A follow-up study of indoor air quali ty in W i sconsin hom e s. International Sym posium on Indoor Air Pollution, Hea lth and Energy Conservation, October 13-16,

57 of 87Dally, K. A., Hanrahan, L. P, W oodbury, M. A., and Kavarek, M. S. Formaldehyde exposure in non-occupational environm en ts. Arch. Environ. Health 36: 277-284 (1981).

Edling, C.; Odkvist, L.; Hellqui st, H. (1985): Form aldehyde and the Nasal Mucosa. Br. J.
Ind. Med. 42: 570-571.

Eells JT, McMartin KE, Black K, et al. (1981). F orm aldehyde poisoning: Rapid

m e tabolism to form ic acid. JAMA, J Am Med As soc 246:1237-1238.

Engel, H.O. and Calnan, C.D. (1966). Resin de rm atitis in a Car Factory. B r it. J. Ind. Med.
23: 62-66.

Feinm an SE, edito r. (19 88). Form aldehyde sens itiv ity and to xicity. Boca Raton (FL): CRC Press Inc;.

Fleischer, J.M. (1987). Medical student' s exposure to form aldehyde in gross anatomy laboratories, NY State J. Med., 87: 385–388.

Flyvholm

, M.A.; Hall, B.M.; Agner, T.; Tied emann, E.; Greenhill, P.; Vanderveken, W.; Freeberg, F.E.; and Menne, T. (1997). Threshold for occluded for m aldehyde patch test in for m aldehyde-s ensitive patients: Relati onship to repeated open application test with a product cont aining form al dehyde releaser. Contact
Derm atitis 3 6 :26-33.

Hanrahan, L . P, Anderson, H. A., Da lly, K. A., Eckam nn, A. D., and Kanarek, M. S. (1981). An investigation of the off gassi ng decay function in aging m obile hom es with clim ate corrected form aldehyde r eadings. International S y m posium on Indoor Air P ollution, Health and Ener gy Conservation, October 13-16 1981.

Hanrahan, L P ; Dally, KA.; Anderson, HA.; Kanarek, MS. And Rankin, J.(1984).
Form aldehyde vapor in mobile homes: a cro ss sectional survey of concentrations
and irritant effects. Am J Public Health. 74: 1026–1027.

Hauptm a nn, M., J.H. Lubin, P.A. Stewart, R.B. Hayes, and A. Blair. (2003). Mortal- ity
from lym p hohem atopoietic m alignancies am ong workers in f o rm aldehyde industries. J. Natl. Cancer Inst. 95(21):1615-1623.

Hauptm a nn, M., J.H. Lubin, P.A. Stewart, R.B. Hayes, and A. Blair. (2004). Mortality
from solid cancers am ong workers in for m aldehyde industries. Am . J. Epi dem iol. 159(12):1117-1130.

Hol m strom et al. (1989) Histological Cha nges in the Nasal Mucosa in Persons Occupationally Exposed to Form aldehyde Alone and in Combination with W ood
Dust. Acta Otolaryngo l (Stockh) 107:120-129.

58 of 87Horvath EP, Anderson H, Pierce W E , Hanrahan L , W e ndlick J. (1985). The effects of
for m aldehyde on the m u cus m e m bra nes and lungs in an industrial population.
Subm itted to US Departm e nt of Labor for propo sed rulem a king for exposure to
for m aldehyde (50 FR 50412, December 10, 1985 ).

Horvath Jr., E.P., H. Anderson Jr., W .E. Pier ce, L. Hanrahan, and J.D. W endlick. (1988).
Effects of form aldehyde on the m u cous m e mbranes and lungs: A study of an industrial population. JAMA 259(5):701-707.

Horvath, E. P. Jr.et al. (1988). Effects of For m aldehyde on the Mucous Membranes and Lungs: A Study of an Industrial Population. JAMA, Vol. 259, No.5. p. 701-707.

IARC (International Agency for Research on Cancer). (1995). Form aldehyde. Pp. 217-
362 in W ood Dust and Form aldehyde. IARC Monographs on the Evaluation of Carcinogenic Risks to H u m a ns, Vol. 62. Lyon, France: W orld Health Organization, Internat io nal Agency for Research on Cancer.

IARC (International Agency for Research on Cancer). (2004). Form aldehyde (Group 1). IARC Monographs Programm e on the Eval uation of Carcinogenic Risks to
Hum a ns, Vol. 88. International Agency for Research on Cancer, W orld Health Organization, Lyon

Japanese Contact Derm a titis Research Group (1982). [Standard patch test allergens for 1981 in Japan.] Skin Re s. (Hif u), 24: 514-525 (in Japanese).

Kochhar R, Nanda V, Nagi B, et al. ( 1986). Form aldehyde-induced corrosive gastric cicatrization: Case repo rt. Hum Toxicol 5:381-382.

Kriebel D, S a m a SR, Cocanour B. (1993) . Reversible pulm onary responses to for m aldehyde: A study of clinical anat om y students. Am Rev Respir Dis
148:1509-1515.

Kulle JT, Sauder LR, Hebel JR, Green D, Chatham MD. (1987). Form aldehyde doseresponse in healthy nonsmokers. J Ai r Pollution Control Assoc 37:919-924.

Liteplo, R.G ., and M.E. Meek. (2003). Inhaled form aldehyde: Exposure estim ation,
hazard ch aracterization, and exposure-respon se analysis. J. Toxicol. Env. Health.
Part B. 6:85-114.

Main, DM and Hogan, TJ. (1983). H ealth eff ects of low-level exposure to for m aldehyde, J. Occup. Med. 25:896–900

Malaka T, K odam a AM. (1990). Respiratory health of plywood workers occupationally exposed to form aldehyde. Arch Environ Health 45:288-294

59 of 87Marzulli F.N., Maibach H.J. (1973). Antim icrobial s: experim e ntal contact sensitization in

m a n. J Soc Cos m et Chem 24:399-421.

NAC (National Advisory Comm ittee). ( 2003). Acute Exposure Guideline Levels (AEGLs) for Form aldehyde. Draft1:02/2003. National Advisory
Comm ittee/AEGL, U.S. Environm e ntal Pr otection Agency, Washington, DC.

NAC (National Advisory Comm ittee). ( 2003). Acute Exposure Guideline Levels (AEGLs) for Form aldehyde. Draft1:02/2003. National Advisory
Comm ittee/AEGL, U.S. Environm e ntal Pr otection Agency, Washington, DC.

OEHHA (Office of Envi ronm ental Health Hazard Assessm ent). (1999). D e term ination of Acute Reference Exposure Levels fo r Airborne Toxicants: Acute Toxicity
Summ ary - Form aldehyde. CalEPA

Partanen, T. (1993). Form aldehyde exposure and respiratory cancer - A meta analysis of the epidem i o logic evidence. Scand. J. W ork Environ. Health 19(1):8-15.

Paustenbach, D., Y. Alarie, T. Kulle, N. Sch achter, R. Sm ith, J. Swenberg, H. W itschi, and S.B. Horowitz. (1997). A recomm ended occ upational exposure lim it for
for m aldehyde based on irritation. J. Toxi col. Environ. Health 50(3): 217-263.

Porter JAH. (1975). Acute re spiratory distress following for m alin inhalation. Lancet
1:603-604.

Rudzki E, Rebandel P, Grzywa Z. (1989). Pa tch tests with occupa tional contactants in nurses, doctors and dentists . Contact Derm atitis 20:247-259.

Sneddon, I.B. (1968). Derm atitis in an interm ittent haem odialys i s unit. Br. m e d. J., 1:
183-184.

Solom ons K, Cochrane JWC. (1984). Form aldehyde toxicity: Pa rt 1. Occupational exposure and a report of 5 cases. S Afr Med J 66:101-102.

Solom ons K, Cochrane JWC. (1984). Form aldehyde toxicity: Pa rt 1. Occupational exposure and a report of 5 cas es. S Afr Med J, 66:101-102.

Uba, G., et al. (1989). Prospective Study of Respiratory Effects of For m aldehyde am ong Healthy and Asthm a tic Medical Studen ts. Am . J . Ind. Med. 15: 91-101.

Weber-Tschopp A, Fisher T, Granjean E. (1977). Irritating ef fects of form aldehyde on

m e n. Int Oc cup Environ Health. 39:207-218.

WHO ( W orld Health Organization). (1989). Form aldehyde WHO Environm ental Health Criteria , 89 (1989) 219 p

60 of 87WHO ( W orld Health Organization). (2002) . Form aldehyde, Concise International
Che m ical Assessm ent Docum e nt 40. Ge neva: World Health Organization

W ilson, JT J r ., M.D. (1987). Form aldehyde Exposure Following Urea Form aldehyde
Insulation. Environm ental Health and Sa fety News, University of W a shington,
v.26 IUC L ID Dat e set . ( 2 00 0 ) . E u ro pea n C o m m i ssi on – E u ro pea n C h em i cal s B u rea u

. Ye ar 20 0 0
CD-ROM ed itio n.

Agency for Toxic Substances and D i sease Re gistry (1999): Toxico logical Profile for
Form aldehyde. U.S. De partm e nt of Health and Hum an Services.

Ada m s, D.O. et al. (1987). The Effect of Form a l dehyde Exposure upon the Mononuclear Phagocyte S ystem of Mi ce. Toxicology and Applied Pharm acology 88: 165-174. (NCEA)

Appelm an, L.M. et al. (1988). One-year In halation Toxicity Study of Form aldehyde in
Male Rats with a Dam a ged or Undam a ged Nasal Mucosa. Journal of Applied Toxicology, 8(2): 85-90.

Arts, JH., Droge, S,C., Spanhaak, S. et al. (1997). Local lym ph node activation and IgE responses in brown Norway and W i star rats after derm al applic ation of sensitizing and non-sensitizing chem icals. Toxicology 117:229-234.

Bartnik, F.G., Gloxhuber Chr and Zimmer m ann, V. (1985), Percutaneous Absorption of
Form aldehyde in Rats. T oxicology L e tters. v. 25. p. 167 - 172.

Basler, A., W. v. d. Hude and M. Scheut winkel-Reich. (1985). “Form a ldehyde-Induced
Sister Chrom a tid Exchanges in vitro and the Influence of the Exogenous Metabolizing System s S9 Mix and P r im ar y Rat Hepatocytes.” Arch Toxicol 58:
10-13.

Battelle, Pacific Northwest Laboratories. ( 1980). "Tracor Jitco I nhalation Carcinogenesis Bioassay: R e peated Dose Study Report on Formaldehyde."

Blackburn, G.R., Doole y, J, III., Schreiner, C.A. et al. (1991 ). Specific identification of
for m aldehyde-m ediated mutagenicity us ing the mouse lym p hom a L5178Y TK positiv e neg ative assay s upplem ented w ith formaldehyde dehydrogenase. In Vitro Toxicology 4:121-132.

Biagini, R.E ., Moorm a n, W .J., Knec ht, E.A. et al. (1989). Acute airway narrowing in monkeys from challenge with 2.5 ppm fo r m aldehyde generated from form alin.
Arch Environ Health 44:12-17.

Boja , J.W ., Nielsen, J.A ., Foldvary, E. et al. (1985). Acute L o w-Level Form aldehyde
Behavioural and Neurochem i cal T oxicity in the Rat. Prog NeuroPsychopharm acol Biol Psychiat 9:671-674.

61 of 87Buckley, L.A., Jiang, X.Z., Jam e s, R.A. et al . (1984). Respiratory tract lesions induced by sensory irritants at the R D 50 concentrat ion. Toxicol Appl Pharm acol 74:417-429.

Casanova-S chm itz, Mercedes., Thom as B. Starr and Henry D'A. Heck. (1984).
Dif f erentiation between Metabo lic I n cor poration and Covalent Binding in the Labeling of Macrom olecules in the R a t Nasal Mucosa and Bone Marrow by Inhaled (14C)- and (3H ) Form aldehyde. Toxicology and Applied Pharmacology
76: 26-44.

Casanova, Mercedes., Donald F. Deyom and Henry D' A. Heck. (1989). Covalent Binding
of Inhaled Form aldehyde to DNA in the Nasal Mucosa of Fischer 344 R a ts: Analysis of Form aldehyde and DNA by High-Perform a nce Liquid
Chrom a tography and Provisional Pharm ac okinetic Interpreta tion. Fundam e ntal and Applied Toxicology 12: 397-417.

Casanova, Mercedes. et al. (1991). Covalent Binding of Inhaled Form aldehyde to DNA in the Respiratory Tract of Rhesus M onkeys: Pharm acokinetics, Rat- to-Monkey Interspecies Scaling, and Extrapolat ion to Man. Funda m e ntal and Applied Toxicology 17: 409-428.

Casanova, Mercedes. et al. (1994). DNA-Protein Cross-link s and Cell R e plication at Specific Sites in the Nose of F344 Rats Exposed Subchronically to Form aldehyde.
Funda m e ntal and Applied Toxicology 23: 525-536.

Cassee, F.R., Arts, J.H., Groten, J.P. et al . (1996). Sensory irritation to m i xtures of
for m aldehyde, acro l ein, and acetaldeh yde in rats. Arch Toxico l 70:329-33 7.

Cassidy, S.L., K.M. Dix and T. Jenkins. (1983) . Evaluation of a testicular sperm head counting technique using rats exposed to dim e thoxyethyl phthalate (DMEP), glycerol a-m onochlorohydrin (GMC H), epichlorohydrin (EC H ), for m aldehyde (FA), or m e thyl m e thanesulphonate (MMS). Arch. Toxicol. 53:71-78

Chang, J.C.F., W .H. Steinhagen, and S. Barro w. (1981). Effect of Single or Repeated
Form aldehyde Exposure on Minute Volum e of B6C3F1 Mice and F-344 Rats. Toxicology and Applied Pharm a lcology. 61: 451-459.

Chang, J.C.F. et al. (1983). Nasal Cavity Deposition, Histopathology, and Cell Proliferation after Single or Repeated 18.59 m g/ m 3 for m aldehyde for 6 epithelial cells, necrobiotic cells with Form alde hyde Exposures in B6C3F1 Mice and F-344
Rats. Toxicology and Applied Pharm acology, v. 68, p. 161-176.

Chang, J.C. and Barrow, C.S. (1984). Sensory irritation tolerance a nd cross-tolerance in F-344 rats exposed to chlorine or form aldehyde gas. Toxicol Appl Pharm a col
76:319-327.

62 of 87Conolly R.B. et al. (2002): Dose response fo r form aldehyde- induced cytotoxicity in the
hum a n respiratory tract. Regul Toxicol Pharm acol. Feb; 35 ( 1 ): 32-43

.

Conolly, R.B. et al. (2003). Biologically Motivated Com put ational Modeling of
Form aldehyde Carcinogenicity in th e F344 Rat. Toxicol. Sci.75: 432–447.

Conolly, R.B. et al. (2004): Hum a n resp irato r y tract cancer risks of inhaled
for m aldehyde:dose-response predictions derived from biologically-m otivated

com putational m odeling of a com b ined r odent and hum a n dataset Toxicol Sci. Nov; 82 ( 1 ): 279-96

.

Connor, TH; Barrie, MD ; Theiss, JC ; et al. (1983) Mutagenicity of for m alin in the Ames

assay. Mutat Res 119:145–149.

Connor, TH; Theiss, JC; Hanna, HA; et al. (1985) Genotoxicity of organic chem icals frequently f ound in the air of m obile hom es. Toxicol Lett 25:33–40.

Craft, T.R., E. Berm ude z, and T.R. S kopek. (1987). Form aldehyde m ut a genesis and
for m ation of DNA-protein crosslinks in hum an lymphoblasts in vitro. Mutation
Research 176: 147-155.

Dalbey, W

. E. (1982). Form aldehyde and tum o rs in ham ster respiratory tract. Toxicology.
24: 9-14.

Dean et al. (1984). Studies of Immune F unction and Host Resistance in B 6C3F1 Mice Exposed to Form aldehyde. Toxicology and Applied Pharm acology, v.72, p. 519-
529.

Donovan, SM; Krahn, DF; Stewart, JA; et al. (1983) Mutagenic activities of
for m aldehyde (HCHO) and hexam e thylphosphoram ide (HM P A) in reverse and
forward S almonella typ h imurium mutation assays. Environ Mutagen 5:476.

Dubreuil, A., G. Bouley, J. Godin, and C. Boudène. (1976). C ontinuous inhalation of
low-level doses of for m a l dehyde: Experim e nt al study on the rat. Eur. J. T oxicol.
9:245-250.

DuPont, 7/28/80, Haskell Laboratory Re port No. 581-80. Mouse Lym phom a L5178Y Cell TK Locus Assay for Mutagenicity; A Study with Form aldehyde.

Fontignie-Houbrechts, N . (1981). Genetic E ffects of For m aldehyde in the Mouse. Mutation Research, v. 88, p. 109-114.

Frei, E; Pool, BL; Plesch, W ; et al. (1984) Biochem i cal and biological properties of prospective N-nitrod ialk ylam ine m etabolit es and their derivatives. IARC Sci
Publ 57:491–497.

63 of 87Gardner, R.J., Burgess, B.A. and Ke nnedy, G. L., Jr. (1985). Sensory irritation potential
of selected nasal tum o rigens in th e rat. Food Chem Toxicol 23:87-92.

Graves, R.J., Truem a n, P., Jones, S. et al . (1996). DNA seque nce anal ysis of m e thylene
chloride-induced HPRT mutations in Chinese ham ster ovary cells: Com p arison
with the m utation spectrum obtained fo r 1,2-dibrom oethane and for m aldehyde. Mutagenesis 11:229-233.

Fujim aki, H., Kurokawa, Y., Kunugita, N. et al. (2004). Diffe re ntial immunogenic and neurogenic inflammatory responses in an allergic m ouse m o del exposed to low
levels of form aldehyde. Toxicology 197:1-13.

Hauptm a nn, M; Lubin, JH; Stewart, PA ; et al. (2003) Mortality from lym phohe matopoietic m a lignancies am ong work ers in form aldehyde industries. J Natl Cancer Inst 95:1615-1623.

Hauptm a nn, M; Lubin, JH; Stew art, PA; et al. (2004) Mo rtality from solid cancers

am ong workers in form aldehyde industries. Am e r J Epidem iology 159:1117-
1130.

Heck, D.A., Henry, and Merccedes Casa nova. (1987). Isotope Effects and Their
Im plications for the Covalent Binding of Inhaled (3H) and (14C) Form al dehyde
in the Rat N a sal Mucosa. Toxicology and Applied Pharm a cology 89: 122-134.

.

Hester, et al. (2003). Form aldehyde-Induced Gene Expression in F344 Rat Nasal Respiratory Epithelium

. Toxicology 187: 13-24.

Hilton et al. (1996). Experim e ntal Assessm ent of the Sensitizing Properties of
Form aldehyde. Food and Che m ical Toxicology 34: 571-578.

Iversen, Olav Hilm ar. (1986). Form a l dehyde and Skin Carcinogenesis. Environ Int
12:541-544.

Iversen, Olav Hilm ar. (1988). Form a l dehyde a nd Skin Tum origenesis. Environ Int 14:23-
27.

Jakab, GJ. (1992). Relationship between car bon black particulate-bound for m aldehyde, pulm onary antibacterial defenses, and al veolar macrophage phagocytosis. Inhal
Toxicol 4:325-342.

Jeffcoat, A.R., Chasalow, F., Feldman, DB ., Marr, H. (1983): Disposition of 14-C
Form aldehyde after Topical Exposure to Rats, G uinea Pigs, and Monkeys. In: Gibson JE, ed. Form aldehyde Toxic ity. W a shington, D.C.: He m i sphere Publishing Corporation, 38-50.

Johannsen, F.R., Levinskas, G.J., Tegris, A.S. (1986). Effects of For m aldehyde in the Rat and Dog following Oral Exposure. Toxicology L e tters 30:1-6.

64 of 87Ka m a ta, Eiichi. et al. (1997). Results of a 28- m o nth Chronic Inhalation T oxicity Study of
Form aldehyde in Male F i scher-344 Rats. Th e Journal of Toxicological S c iences 22(3): 239-254.

Kane, Laurel E. and Alarie, Yves. (19 77). Sensory Irritation to Form aldehyde and Acrolein During Single and Repeated E xposures in Mice. American Industrial Hygiene Association Journal, v.38, p. 509-522.

Ki m bell JS, Overton JH, Subram aniam RP, Schlosser PM, Morgan KT, Conolly RB, Miller FJ. (2001): Dosimetry m odeling of inhaled for m aldehyde: binning nasal
flux predictions for quantitative ri sk assessm ent. Toxicol Sci. Nov; 64 ( 1 ): 111-21

.

Kligerm a n, A.D., Phelps, M.C., Erexson, G.L. (1984). Cytogenetic analysis of lym phocytes from rats following form aldehyde inhalation. T oxicol Lett 21:241-
246.

.

Krivanek, N.D., Chrom e y, N.C. and McAlack, J.W. (1983)."Skin initiation- prom otion study with form aldehyde in CD-1 mice", E.I. du Pont de Nemours & Company,
Inc. In: Form aldehyde: Toxicology, Epidem iology, and Mechanism s, Clary, J.J., J.E. Gibson, and R.S. Waritz, Eds., N.Y., Marcel Dekker, Inc.

Kulle, T.J. and Cooper, G.P. (1975). Effects of form aldehyde and ozone on the trigem inal nasal sensory system . Ar ch Environ Health 30:237-243.

Lee, Hye Kyung., Alarie, Yves and Karol, M.H. (1984). Induction of Form aldehyde
Sensitiv ity in Guinea Pigs. Toxicolo gy and Applied Pharm acology, v. 75, p.147-
155.

Liber, H.L., Benforado, K.. Crosby, R.M. et al. (1989). Formaldehyde-induced and spontaneous alterations in hu m a n hprt DNA sequence and mRNA expression.
Mutat Res 226:31-37.

Malek, F.A., Moritz, K.U. and Fanghanel, J. (2003a). Form a l dehyde inhalation and open
field behaviour in rats. Ind J Med R e s 118:90-96.

Malek, F.A., Moritz, K-U. and Fanghaenel, J. (2003b). A study on specific behavioral
effects of form aldehyde in the ra t. J Exp Ani m Sci 42:160-170.

Marnett, LJ; Hurd, HK; Hollstein, MC; et al. (1985) Naturall y occurring carbonyl

com pounds are m u tagens in salm onella te ster strain TA104. Mutat Res 148(1– 2):25–34.

Monticello et al. (1991). Regi onal Increases in R a t Nasal Ep ithelial Cell Proliferation following Acute and Subchronic Inhala tion of Form aldehyde. Toxicology and Applied Pharm acology 111: 409-421.

65 of 87Morgan, K. et al. (1986). Res ponses of the Nasal Mucociliary Apparatus of F-344 Rats to
Form aldehyde Gas. Toxicology and Applied Pharm a cology 82: 1-13.

Muller, W ; Engelhart, G; Herbold, B ; et al . (1993) Evaluation of m u tagenicity testing
with Salmonella typhimurium TA102 in three different laboratories. Environ Health Perspect 101(Suppl. 3):33–36.

Natarajan, A.T. et al. (1983). Evaluation of the mutagenicity of for m aldehyde in

m a mmalian cytogenics assays in vivo and vitro. Mutation Research 122: 355-360.

Odeigah, P.G.C. (1997). “Sperm He ad Abnorm a lities and Dom i nant Lethal Effects of
Form aldehyde in Albino Rats.” Mutation Research 389: 141-148.

O’Donovan, MR; Mee, CD. (1993) Form aldehyde is a bacterial m utagen in a range of
salm onella and escherichia indicator strains. Mutagenesis 8:577–581.

Oerstavik, D ; Hongslo, JK. (1985) Mutagenic ity of endodontic sealers. Biom aterials
6:129–132.

Ohtsuka, R., Shuto, Y., Fujie, H. et al. (1997). Response of respirator y epithelium of BN
and F344 rats to form aldehyde inhalation. Exp Anim 46:279-286.

Ohtsuka, R., Shutoh, Y., Fujie, H. et al. ( 2003). R a t strain difference in histology and expression of Th1- and Th2-related cytoki nes in nasal m u cosa af ter sho r t- term for m aldehyde inhalation. Exp Toxicol Pathol 54:287-291.

Overm a n, D.O. (1984). Absence of Em br yotoxic Effects of Form aldehyde after Percutaneous Exposure in Ha m s ters . Toxicology Letters 24: 107-110.

Pitten, F.A., Kram er, A., Herrm ann, K. et al . (20 00). Form aldehyde neurotoxicity in
anim al experim e nts. Pathol Res Pract 196:193-198.

Riedel, F. et al. C.H.L. (1996). Formaldehyde Exposure Enhances Sensitization in the Guinea Pig. Allergy 51: 94–99.

Ross, W E ; Shipley, N. (1980) Relationship between DNA da m a ge and su rvival in
for m aldehyde-treated m o use cells. Mutat Res 79:277–283.

Ryden, E; Ekstrom

, C; Hellm er, L; et al. (2000) Com p arison of th e sensitivities of Salmonella typhimurium strains TA102 and TA2638A to 16 mutagens. Mutagenesis 15:495–502.

Saillenfait, A.M. et al (1989). The effect s of m a t e rnally inhaled for m aldehyde on

em bryonal and foetal developm ent in ra ts. Fd. Che m . Toxic. 27(8): 545-548.

66 of 87Schlosser P M, Lilly PD, Conolly RB, Janszen D B , Ki m bell JS: Benchm a r k dose risk

assessm ent for form aldehyde using airflow m ode ling and a single-com p artm ent, DNA-protein cross-link dosim etry model to estim a te hu m a n equivalent doses. Risk Anal. 2003 Jun; 23 ( 3 ): 473-87

.

Schm id, E., Goggelm ann, W

. and Bauchi nger, M. (1986). F orm aldehyde-induced Cytotoxic, Genotoxic, and Mutagenic Response in Hum a n Lymphocytes and
Salm onella typhim u rium. Mutagenesis vol. 1 no. 6 p. 427-431.

Spangler, F. and W a rd, J.M. (1983). "Skin initiation/prom otion study with for m aldehyde
in Sencar m i ce". Study location: Microbiol ogical Associates (Bethesda, MD) in conjunction with NCI. In: Form al dehyde: Toxicology, Epidem iology, and
Mechanism s, Clary, J.J., J.E. Gibson, a nd R.S. Waritz, Eds., N.Y., Marcel Dekker, Inc.

Subram aniam, R., Chen, C., Crum p, K., Fox, J., Schlosser, P M ., and W hi t e, P. (2007).
Uncertainties in the CIIT 2-stage m odel for formaldehyde-indu ced nasal cancer in
the F344 rat: a lim ited se nsitiv ity analysis - I. Risk Anal . 27, 1237-54.

Steinhagen, W.H. and Barrow, C.S. (1984). Sens ory irritation struct ure-activity study of inhaled aldehydes in B6C3F1 and Swiss- W ebster m i ce. Toxicol Appl Pharm acol
72:495-503.

Takahashi et al. (1986). Effects of Et hanol, Potassium Metabisulfate, Form aldehyde, and Hydrogen Peroxide on Gastri c Carcinogenesis in Rats after Initiation with Nm ethyl-N' n itro-N' nitrosoguanidine. Jap. J. Cancer Res. 77: 118-124.

Tarkowski, M. and Gorski, P. (1995). Increase d IgE antiovalbum in le vel in m i ce exposed
to form aldehyde. Int. Arch. Allergy Immunol. 106: 422–424.

Tem c haroen, P., Thilly, W.G. (1983). Toxic a nd mutagenic effects of for m aldehyde in
Salm onella typhim u rium. Mutat Res 119:89-93.

Til, H.P. et al. (1988). Evaluation of the Oral Toxicity of Acetaldehyde and
Form aldehyde in a 4-week Drinking Wate r Study in Rats. Fd. Che m . Toxic. 26(5): 447-452.

Tobe, M., Kaneko, T., Uchida, Y. et al. (1985) . S t udies of the inhalation toxicity of
for m aldehyde. National Sanitary and Medi cal Laboratory Serv ice (Japan). p. 1-
94.

Tsubone, H. and Kawata, M. (1991). Stim ulation to the trigeminal a fferent nerve of the nose by form aldehyde, acrolein, an d acetaldehy de gases. In hal Toxico l 3:211-
222.

67 of 87Valencia, R., Mason, J.M. and Zimm ering, S. (1989). Chem ical Mutagenesis Testing in Drosophila. VI. Interlaboratory Com par ison of Mutagenicity Tests After
Treatm ent of Larvae. Environm ental and Molecular Mutagenesis, v. 14, p. 238-
244.

Vargova, M., W a gnerova, J., Lis kova, A. et al. (1993). Subacute imm unotoxicity study of
for m aldehyde in m a le rats. Drug Chem Toxicol 16:255-275.

Woutersen, R.A. et al. (1987). Subchronic (13-week) Inhalation Toxicity Study of
Form aldehyde in Rats. Journal of Applied Toxicology, 7(1): 43-49.

Xu, B., Aoyam a , K., Takeuchi, M. et al. ( 2002). Expression of cytokine mRNAs in m i ce cutaneously exposed to form al dehyde. Imm unol Lett 84:49-55.

Zielenska, M; Guttenplan, JB. (1988) Muta genic activity and sp ecificity of Nnitrosom ethylaniline and N-nitrosodi phenylam ine in salm one lla. Mutat R es 2 02( 1) :26 9–2 76

.



### 2. Website Referen ces

Citation

Assessm ents of the reproductive and deve lopm ental toxicity of for m aldehyde conducted by the Australian governm e nt ( www.nicnas.gov.au ) as well as the Agency for Toxic Substances and Disease Regist ry (ATSDR, 1999)support this conclusion.

EPA is currently com pleting a new IRIS asse ssment that will include a cancer unit
risk value for form aldehyde; the reassessm en t is scheduled to st art internal peer review in May 2008 and begin independent external peer review in January 2009 ( http ://cfpub.epa.gov/ncea/iristrac/ind e x.cfm ? f useaction =view
Che m ical.showChe m i cal&sw_id=1031). EPA an ticipates th at the p eer review of the
for m aldehyde assessm ent will no t be finished before EPA completes th e reregistration process for form aldehyde pest icidal uses, scheduled to conclude in Septem ber 2008.

The EPA’s Consum er Exposure Module (CEM) was used to estim ate air concentrations resulting from the us e of laundry detergent preserved with
for m aldehyde. Detailed inform ation and the executable m odel can be downloaded
fro m http://www.epa.go v/opptintr/exposure.



### 3. Other Supporting Documents

Citation ASHRAE, 1989. Ventilation for Acceptable In door Air Quality, Am erican Society of Heating Refrigerating and Ai r Conditioning Engineers, 1989.

68 of 87ASRC, 2005. Form aldehyde Sm art Meeting, August 9, 2005, Minutes P r epared by Eric Brewer of ASRC Aerospace.

Jacobson, L a rry. 2005. Professor and Extension Engineer at University of Minnesota.

Kline, 2000. Specialty Biocide Nort h Am erica 2000, Kline and Com p any, Inc.

NIOSH, 1990. Health Hazard Evaluatio n of Buckeye Hills Career Center (H ETA 88-153- 2072), NIOSH, October 1990.

NIOSH, 199 7. Pocket Guide to Chem ical Hazards, DHHS ( N IOSH Pub lication No. 97- 140)

Olcrest, 1999. Paraform aldehyde Steril ant Use in Vocational High School Program, Robert Olcrest, Brujos S c ientific Inc.

, Baltim ore, Maryland. Published in Applied Occupational and Environm ental Hygiene, Volum e 14: 391-396, 1999

USDA, 1999. Crop Profile for Poultr y (Broilers) in California

USDA, 2000. Crop Profile for Eggs in California

USDA, 2002. Crop Profile for Poultry in Florida

US EPA, 1997a. Exposure Facto r s Handbook. Volum e I-II. Office of Research and Developm ent. W ashington, D.C. EPA/600/P-95/002Fa.

US EPA, 1999. Evaluation of Che m i cal Manufacturers Association Antimicrobial Exposure Assessm ent Study. Mem o randum from Siroos Mostaghim i , Ph.D., US EPA, to
Julie Fa irf ax ,

US EPA, 2008. Incident Reports Associated with Form aldehyde. Jonathen Chen Ph.D.,

US EPA, 2008. Form aldehyde - Report of th e Antim icrobials Division T oxicity Endpoint
Selection Comm ittee (A DTC),

69 of 87Appendix E. Generic Data Call-In

The Agency intends to issue a Generic Data Ca ll-In at a later date. See the Form aldahyde
/ Paraform aldahyde RED for a list of studies that the Agency plans to require.

70 of 87Appendix F . Product Specific Data Call-In

The Agency intends to issue a Product Speci fic D a ta Call-In at a later date for:

Form aldahyde / Paraform aldahyde ( 0556 )

71 of 87Appendix G. Batching of Formaldahyde / Paraforma l dahydeProducts for Meeting Acute Toxicity Data R e quirements for Rereg istration

The Agency intends to c o m p lete a B atching Me mo at a later date

72 of 87Appendix H. List of All Regi strants Sent the Data Call-In

The Agency intends to is sue a Data C all-In a t a later date to the following registrants:

Baker Petrolite Corporation
12645 W e st Port Airport Blvd Sugarland, Texas 77478

Cha m pion Technologies, Inc. 3185 Madison Highway, PO Box 5126 Valdosta Georgia 316035126

Protexall Products, Inc. 402 Integrated Court Debary, Florida 32713

Noble Pine Products Co. PO Box 41 Centuck Stat Yonkers, New York, 10710

Hess & Clark Inc. 110 Hopkins Drive Randolph, W i sconsin 539561316

73 of 87Appendix I. List of Available Relate d Documents and Electronically Available
Forms

Pesticide Reg i stration Forms ar e availa bl e at the foll owing EPA i n ternet site: http://www.epa.gov/ oppr d001/form s/

.
Pesticide Reg i stration Forms (Thes e forms ar e in PDF format and require the Acrobat reader)

Instructions

1. Print out and co m p lete the forms. (Not e : Form nu m b ers that are b o lded can be filled out on your com puter then printed.)

2. The com p let e d form (s) sho u ld be s ubm itted in hardcopy in accord with the existing polic y.

3. Mail the forms, along with any additio nal docum ents necessary to co m p ly with EPA regulations covering your request, to the address below for the Docu m e nt Processing D esk.

DO NOT f a x or e- m a il any form containing ‘Confidential Business I n form ation’ or ‘Sensitive Information.’

If you have any problem s accessing these for m s, pl ease contact Ni cole William s at (703) 308- 5551 or b y e-mail at williams.nicole@epam ail.epa.g o v

.
The following Agency Pesticide Registr a tion Form s a re currently a v ailable via the internet at the following locations:

8 570 -1 Ap p lication for Pesticid e Registratio n / Am en d m en t h ttp ://w ww .epa.go v / o pprd001 /fo r m s /8 5 7 0

- 1

. p d f

8 570 -4 Co nfid en tial State m en t o f Form u la h ttp ://w ww .epa.go v / o pprd001 /fo r m s /8 5 7 0

- 4

. p d f

85 7 0

- 5 Not i ce of S u p p l em ent a l R e gi st rat i on of Di st r i but i o n of a Reg i stered Pesticid e Pro d u c t h ttp ://w ww .epa.go v / o pprd001 /fo r m s /8 5 7 0

- 5

. p d f

85 7 0

- 1 7 A ppl i cat i o n f o r a n E xpe ri m e nt al Use Perm it h ttp ://w ww .epa.go v / o pprd001 /fo r m s /8 5 7 0

- 1 7 .pdf

85 7 0

- 2 5 A ppl i cat i o n f o r/ N o t i f i cat i on of St at e R e gi st rat i o n o f a Pesticide T o M eet a Special L o cal Nee d h ttp ://w ww .epa.go v / o pprd001 /fo r m s /8 5 7 0

- 2 5 .pdf

85 7 0

- 2 7 Fo rm ul at or’s Exem pt i on St a t em ent h ttp ://w ww .epa.go v / o pprd001 /fo r m s /8 5 7 0

- 2 7 .pdf

8 570 -28 Certificatio n of Co m p lia nce with Data Ga p Procedure s h ttp ://w ww .epa.go v / o pprd001 /fo r m s /8 5 7 0

- 2 8 .pdf

8 570 -30 Pesticid e Reg i stratio n Mai n ten a n c e Fee Filin g h ttp ://w ww .epa.go v / o pprd001 /fo r m s /8 5 7 0

- 3 0 .pdf

8 570 -32 Certificatio n of Attem p t to En ter i n to an Agreem en t wi t h ot he r R e g i st rant s f o r De vel o pm ent of Dat a h ttp ://w ww .epa.go v / o pprd001 /fo r m s /8 5 7 0

- 3 2 .pdf

8 570 -34 Certificatio n with Resp ect t o Citatio n s of Data (i n PR Notice 98-5) h ttp ://www.epa.go v / o ppp m s d 1 / PR_No tices/p r98

- 5. pd f

8 570 -35 Data Matrix (i n PR No tice 98-5) h ttp ://www.epa.go v / o ppp m s d 1 / PR_No tices/p r98

- 5. pd f

85 7 0

- 3 6 Sum m ary of t h e Phy s i cal / C he m i cal Prope rt i e s (i n PR Notice 98-1) h ttp ://www.epa.go v / o ppp m s d 1 / PR_No tices/p r98

- 1. pd f

8 570 -37 Self-Certificatio n State m en t fo r th e Ph ysical/Ch e mical Prop erties (i n PR No tice 98 -1 ) h ttp ://www.epa.go v / o ppp m s d 1 / PR_No tices/p r98

- 1. pd f

74 of 87Pestic ide Registra tion Kit

www.epa.go v/pesticid es/registrationkit/

.
Dear Registrant:

For your convenience, we have assem bled an online registration kit that contains the following pertinent f o rm s and inform ation needed to register a pesticide product with the U.S. Environm ental Protection A g en cy’s Office of Pesticide Program s (OPP):

1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIF RA) and the Federal Food, Drug and Cos m etic Act (FFDCA) as Am ended by the Food Quality Pro t ection Act (FQPA) of 1996.

2. Pesticide Registration (P R) Notices

a. 83-3 Label Improvem e nt Pr ogram —Storage and Disposal Statem ents

b. 84-1 Clarification of Label Im provem e nt Program

c. 86-5 Standard Form at for Data Submitted under F I FRA

d. 87-1 Label Improvem e nt Program for Pesticides Applied through Irrigation System s (Chem i gation)

e. 87-6 Inert Ingredients in Pe sticide Products Policy Statem ent

f. 90-1 Inert Ingredients in Pe sticide Products; Revised Policy Statem ent

g. 95-2 Notifications, Non-notific ations, and Minor Form ulation Am endm ent s

h. 98-1 Self Certification of Product Chem istry Data with Attachm e nts (This docum ent is in PDF for m at a nd requires the Acrobat reader.)

Other PR Notices can be found at http://www.epa.gov/opppm s d1/PR_Notices

.

3. Pesticide Product Registration Appli cation Forms (These form s are in PDF f o rm at and will req u ire the Acr obat re ader. )

a. EPA For m No. 8570-1, Application for Pesticide Registr a tion /Am endm ent

b. EPA For m No. 8570-4, Confidential Statem ent of For m ula

c. EPA For m No. 8570-27, Form ulator’s Exem ption Statem ent

d. EPA For m No. 8570-34, Certificatio n with Respect to Citations of D a t a

e. EPA For m No. 8570-35, Data Matrix

75 of 874. General Pesticide Information (Som e of these form s are in PDF for m at and will req u ire the Acr obat re ader. )

a. Registration Division Personnel Contact L i st

b. Biopesticides and Pollution Prev ention Division (BPPD) Cont acts

c. Antim icrobials Division Organi zatio nal Stru cture/ Contact List

d. 53 F.R. 15952, Pesticide Registra tion Procedures; Pesticide Data Requirem e nts (PDF form at)

e. 40 CFR Part 156, Labeling Requirem e nts for Pe sticides and Devices (PD F for m at)

f. 40 CFR Part 158,Data Requirem e nts for Registration (PDF form at)

g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (Novem b er 27, 1985)

Before subm itting your application for regi stration, you m a y wish to con s ult som e additional sources of inform ation. These include:

1. The Office of Pesticide P r ogram s’ Web Site

2. The booklet “General Inform ation on Applying for Registration of Pesticides in the United States ”, PB92-221811, available through the National Technical Inform ation Service (NTIS) at the foll owing address:

National Technical Inform ation Service (NTIS) 5285 Port Royal Road Springfield, VA 22161

The telephone num ber for NTIS is (703) 605-6000. Please note that EPA is currently in the process of upda ting this booklet to reflect th e changes in the registration

program resulting from the passage of the FQ PA and the reorganization of the Office of Pesticide Program s. W e anticip ate that this publication will becom e available during the Fall of 1998.

3. The National Pesticide Infor m ation Re trieval System (NPIRS) of Purdue University’s Center for Environm ental and Regu lato ry Inf o r

m ation System s. This serv ice d o es charg e a fee for subscrip tions an d custom searches. You can contact NPIR S by telephone at (765) 494-6614 or through their W e b site.

4. The National Pesticide T e lecomm uni ca tions Network (NPTN) can provide inf o rm ation on activ e in gredien t s, us es, toxicology, and chemistry of pesticides. You can contact NPTN by telephone at (800) 858-7378 or through their W eb site: http://np i c.o r st.edu

.

76 of 87The Agency will return a notic e of receip t of an applic ation f or registration or

am ended registration, experim e ntal use perm it, or am endm e n t to a petition if the applic ant or petitione r encloses with his subm ission a stam ped, self-addressed postcard. The postcard m ust contain the follow i ng entries to be com pleted by OPP:

Date of rece ipt
EPA identifying num ber Product Manager assignm e nt

Other identifying information m a y be included by the applicant to link the acknowledg m ent of receipt to the sp ecific app lication subm itted. EPA will stam p the date of receipt and provide the EPA identifyi ng F ile Sym bol or petition number for the new subm ission. The identifying number s hould be used whenever you contact the Agency concerning an applicati on for registration, experim e ntal use perm it, or tolerance petition.

To assist u s in ensuring that all da ta you have su bm itted for the chem ical are properly coded and assigned to your com p any, pl ease include a list of all synonym s, common and trade n ames, com p any experim ent al codes, and other nam e s which identify
the chem ical (inc luding “ b lind” cod es used when a sam p le was subm itted f o r testing b y commercial or academ ic facilities )

. P l ease p r ovid e a CAS number if one has been assigned.

77 of 87