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May 3, 2006 0 _ U.S. Department 400 Seventh Stree t, S. W. of Transportation Washington, D.C. 20590 Pipeline and Hazardous Materials Safety Administration DOT-SP-10904- (SEVENTH-REVISION)- - ---- ------ --- (FOR-RENEWAL,-SEE-49- CFR- §- 107.109)- 1.- GRANTEE: --In Vitr o-I nternationa l -- Ir v ine,-CA-- 2 . - PURPOSE - AND-LIMITATION: - -- a.--This-sp ecia l-permit- a uthorizes-the-use - of -a- classification-test-method-for-the-determination - o f -sk i n - corrosivity - as-an-a lte rnat i ve -t o-a-procedure -sp ecified-in - the-Ha za rdous-Mat e rials-Regulati o ns-(HMR) . - This-sp e cial- permit-pro v ides - no-relief-from-the-HMR-other-than -as - specifically-stated - herein.- b. -- The-safety-analyses-performed-in-development-of - this - special-permit - only-considered-the-hazards - and-risks - associated-with - transportation -i n-commerce. -- c . --Party-status - wil l -not - be - g r anted-to-this - speci a l - permit. - 3 . - REGUL ATORY - SYSTE M- AFFECTED: -- 4 9- CFR-Parts-10 6 ,-1 07-a nd-1 71 - 180. -- 4.- REGULATI O NS - FROM-WHICH-EXEMPTED:--The - marking-requirements- of - §§-172.203(a), - 1 7 2.301(c)-and -1 72. 302(b) -an d-(c);and---- §§-173.136(a) - and-173.137-in - that-the-use - of -a -non - animal- test-method-is-not-authorized - except-as-specified -h e rein.- 5.- BASIS: -- This -spec ial-p e rmit-is-based - on-the -appli cation - of- In Vitr o -Inte rnational-dated -Ap ril-26, - 2006,-submitted - in- ac co rdan ce-w ith-§-107.109. -

Special Permit 10904: Alternative Method for Determination ... · classification-test-method-for-the-determination-o f -ski n ... --Acids,-inorganic-and-organic. ... -inorganic-and-organic

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May 3, 2006

0 _ U.S. Department 400 Seventh Stree t, S.W.

of Transportation Washington, D.C. 20590

Pipeline and Hazardous Materials Safety Administration

DOT-SP-10904­(SEVENTH-REVISION)­

- ------------- (FOR-RENEWAL,-SEE-49-CFR- §- 107.109)­

1.- GRANTEE: --InVitro-Internationa l -­Irv ine,-CA-­

2 . - PURPOSE - AND-LIMITATION: - -­

a.--This-specia l-permit-a uthorizes-the-use- of-a­classification-test-method-for-the-determination- o f -sk i n ­corrosivity- as-an-a lternat i ve-to-a-procedure-specified-in­the-Ha za rdous-Mat e rials-Regulations-(HMR) . - This-spe cial­permit-prov ides - no-relief-from-the-HMR-other-than-as ­specifically-stated- herein.­

b. --The-safety-analyses-performed-in-development-of- this ­special-permit - only-considered-the-hazards- and-risks ­associated-with- transportation-in-commerce. -­

c . --Party-status - wil l -not - be - g r anted-to-this - speci a l - permit. ­

3 . - REGULATORY - SYSTEM-AFFECTED: -- 4 9- CFR-Parts-10 6,-1 07-and-1 71 ­180. -­

4.- REGULATI ONS - FROM-WHICH-EXEMPTED:--The - marking-requirements­of- §§-172.203(a), - 1 72.301(c)-and- 1 72. 302(b) -and-(c);and---­§§-173.136(a) - and-173.137-in- that-the-use- of - a -non- animal­test-method-is-not-authorized- except-as-specified-he rein.­

5.- BASIS: --This -spec ial-pe rmit-is-based- on-the-application- of­InVitro-International-dated-April-26, - 2006,-submitted- in­acco rdance-with-§-107.109. ­

Continuation-of- DOT-SP-10904-(7th- Rev.)-- ---- ---- Page-2 May 3, 2006

6.- HAZARDOUS - MATERIALS:­

The-following-types -of-materia ls-may- be - tested-as-spec ified­by- this-special-permit: ­

a. --Acids,-inorganic-and-organic. ­b.--Acid-derivatives-(anhydrides,-haloacids,-salts-­

---------etc.), - inorganic- and-organic.­c.--Acyl-halides.­d.--Alkylamines-and- polyalkylamines.­e.- - Bases,-inorganic-and-organi c.­f.--Chlorosilanes.­g.--Metal-halides - and-oxyhalides. ­

7.- SAFETY-CONTROL- MEASURES:­

a.--As - an-alternative-to- the-procedure-specified-in­§-173.136(a), - the-corrosivity-of-a-material-described-in­Paragraph-6-above- may - be - determined-in-accordance-with-the­test-method-specified-in-Paragraphs-4.4A-through-4.4E-of­InVitro-International's-application-dated-September-28,­19 92, -as-amended.­

b.--For-materials-that-are-determined- to- be - corrosive,­packing-groups-must-be-assigned-according-to-Paragraph-4.4C­of-the-application.­

8.- SPECIAL- PROVISIONS: ­

a.--This-special - permit - author i zes - the - use - of- an - a l ternative­test-method- for - the - determinat i on-of-skin-corrosivity- by- any­person- or-class-of-persons,-in-addition-to-the-holder-of­this-special-permit,-subject-to-the-terms-specified-herein.­-However,-no-person-may-app ly-the-test-method-authorized-by­this-special - permit - unless-that-person-maintains-a-current ­copy-of-this-special-permit-and- the- t est - method- identified­in-Paragraph- 7-above-at-each-facility-where-the-tests-are­performed-for-the-purpose- of - determining-the-hazard-class­and-packing- group-of-a-materia l -for-its-transportation-in­commerce. ­

b. --A- current-copy-of-this-special-permit-must-be-retained­by- each- person-initially-offer i ng-a-hazardous-material-for­transportation-under-this - special - permit. ­

Continuation- of-DOT-SP - 10904-(7th- Rev.)-- --------Page-3 May 3, 2006

c. --Packages - containing- corrosive-materials,-classed-and­assigned-packing-groups-as - authorized-by- this-special­permit,-may- be-offered-and- reoffered-for- transportation-and­transported-in-the-same- manner-as - required-for-corrosive ­materials-classed- according-to-§-1 73.136(a) .­

d. - - The-marking- requirements-of-49- CFR,-§§-172.203(a),­172.301(c)-and- 1 72.302(b)-and- (c) - are-waived-unless-another­special - permit-is-involved- r e quiring-the-display- of - an ­special-permit-number. - ­

9.- MODES-OF - TRANSPORTATION-AUTHORIZED: - - Motor-vehicle,-rail­freight,-cargo-vessel,-cargo - aircraft-only,-passenger­carrying- aircraft.­

10.- MODAL-REQUIREMENTS:-None-as-a-condition- of- this - spe cial ­p e rmit.­

11.- COMPL I ANCE:-Failure-by-a-person-to-comply-with-any-of-the­following- may-result-in-suspension-or-revocation-of-this­spe cial-permit-and-penalties-prescribed-by-the-Federal­hazardous-materials-transportation-law-49-U.S.C.-5101-et­seq.: ­

o- All-terms-and-condit i ons-prescribed-in-this ­special - permit. ­

o- Persons-operating-under-the-terms-of-this - special­permit - must - comply-wi th-the-security-plan­requirement-in-Subpart - I - of- Part - 172-of-the-HMR, ­when - applicable. ­

o- Registration-required-by-§-107.601-~t - seq.,when---

appropriate . ­

Each-"Hazmat-employee", - as - de fined- in - §-171.8-who-performs - a­function-subject-to-this-special-permit-must-receive­training- on - the- r e quire ments - and- conditions-of-this-special­permit-in-addition-to-the-training-required-by-§§-17 2 .700­through-172.704.­

No-person-may-use-or-apply-this-special-permit-when- it - has­expired-or - is - otherwise- no - longer-in-effect.­

Cont inuation- of-DOT-SP -10 904-(7th-Rev .)-- ------ - - Page- 4 May 3, 2006

Under-Tit1e-VII-of-the-Safe,-Accountable,-Flexible ,­Efficient-Transportation-Equity-Act:-A-Legacy-for- Users­(SAFETEA- LU)--'The-Hazardous-Materials-Safety- and- Security­Reauthorization-Act-of-2005' - (Pub.-L.-109-59),-119- Stat . ­1144-(August - 10 ,-2005) , - arnended- the-Federal - hazardous­rnaterials-transportation-law-by-changing- the-term­'exemption' - t o- ' spec ial-permit ' -and-authorizes-a-spec i al­permit - to-be-granted-up- to-two - years -fo r - new-special-permits­and- up-to-four-years-for-renewals.­

12 .- REP ORTING-REQUIREMENTS :--Shipments - o r-operations-conducted­under-this-special-permit-are-sub j ect - to-the-Hazardous­Materials-Incident - Report ing-requi rements - spec ified- i n -49­CFR-§§- 171 .1 5---Immediate - notice-of-certain-hazardous ­mater i a ls- inc idents ,-and-1 71.16- - - Detailed-hazardous­mater i a ls - incident - repo rts . - -In- addit i on,-the- grantee(s)-of­this - spec i a l-permi t -must - not ify - the - Assoc i ate-Administrator­f or-Hazardous-Mate r ials-Safety, -in-wr iting,-of- any-incident­involving-a-package,-shiprnent-or-operation- conducted-under­terms-of - th is-special-permit. ­

I ssued- in- Washington,-D.C. : ---­

-----;::::__--:._-fl­---.

-/s/

f o r - Robert - A. -McGuire ­Associate-Admi ni s tr a tor­- - - -for -Hazardous-Mater ial s-Safety-

Address -all - inqui ries-to: --Assoc iate-Administrator- f o r - Hazardous­Materials-Safety,-Pipeline-and-Hazardous-Materials-Safety­Administration, -Department-of-Transportation,-Washingt on ,-D.C . - ­20590 . - Attent i on: --PHH-31 . ­

Copies-of-this-special-permit-may-be-obtained-by-accessing-the­Hazardous-Material s-Safety-Homepage-at­http : //ha zma t . dot . gov/sp app/sp ecial_permits/spec pe r m i ndex.htm­Photo-reproductions-and-legible-reductions-of-this-special-permit ­are - permitted . - - Any- al t eration- of-this-special -permit-is­prohib i ted. ­

PO:-GEC/sln­