o 

: > 1 -

!0 RECEIVED 

U.S. Department Eastern Region 1 Aviation Plaza 

of Transportation Regional Counsel DHPT OF TBAHSffliiiullj Y 11434 

Telephone: 718 553-3267 Of iGKhiS 

Federal Aviation Facsimile: 718 995-5699 

Administration 

JAN 2 7 2010 

CERTIFIED MAIL - RETURN RECEIPT REQUESTED 

Federal Aviation Administration '-° ' 2 2010 

800 Independence Avenue, S.W. HEARING DOPK'trT 

Washington, D.C. 20591 '•^^^rKtZ I 

Attn: Hearing Docket Clerk, AGC-430 

Wilbur Wright Building - Room 2014 

ATTN: HEARING DOCKET CLERK 

Re: In the Matter of Alcon Biosciences Private Limited i 

Docket No. 2009EA700400 n?\O e f\00Ol f^^ ^ , 

Enclosed herein please find a copy of a request for hearing and the original and one copy of 

the FAA's Complaint in the above-entitled action for filing, together with proof of service 

upon the Respondent. 

The FAA requests that the hearing in this matter be held in the New York area, and expects 

that the hearing will last Iday(s). 

Please address all communications for the Federal Aviation Administration to the attention 

of Mary Madeline McCarthy, Office of the Regional Counsel, 1 Aviation Plaza Jamaica, 

NY 11434. 

Sincerely, 

Alfred R. Johnson, Jr. 

Regional Counsel 

Mary M^eline McCarthy (S 

By: 

Deputy Regional Counsel 

Enclosures 

cc: AEA-700 
Regional Counsel for the Eastern Region Date "/"' "/<>>/ I "^f • ^ 

Federal Aviation Administration 

1 Aviation Plaza 

Jamaica, NY 11434 

Alcon Biosciences Private Limited - 2009EA700400 

Subject. Final Notice of Proposed Civil Penalty 

Response Attachment 

In reply to your Final Notice of Proposed Civil Penalty Alcon Biosciences Private Limited elects to proceed as indicated by its check 

mark beside the numbered paragraph below: 

1. (_) Alcon Biosciences Private Limited hereby submits the amount of the proposed civil penalty with the understanding that an 

Order Assessing Civil Penalty will be issued in that amount. 

2. Csi''' Alcon Biosciences ftivate Limited hereby requests a formal hearing in accordance with Section 13.16 of the Federal 

Aviation Regulations. 

By sending this form to the Federal Aviation Administration, Eastern Region, Alcon 

Biosciences Private Limited also hereby certifies that a copy of this form has been filed with 

the Hearing Docket Clerk (Hearing Docket, Federal Aviation Administration, 800 

Independence Avenue, S.W., Koom 924A, Washington, DC 20591, Attention: Hearing Docket 

Clerk). 

** Please note that Alcon Biosciences Private Limited will not be entitled to a hearing if it files this form with the Federal Aviation 

Administration. Eastern Region, WITHOUT having filed this form or a written request for a hearing with the HEARING DOCKET 

CLERK. 

ATTORNEY/REPRESENTATIVE 

Name: AlCON GJOSCiS'C^^S ?MJ'M g (JA^ITFn 

Hrm: i ' c, MAniN^^ <"-'-'•'''-•-:--,-f!S, 

Address: j j i'-jrV/ f.' ' ' •'--'•" ' , -• • 

Phone NBJ ; I: •.-. -. . •" •• 
IVED 

U.S. DEPARTMENT OF TRANSPORTATION L,,. 2010 

r-fe «^« ^ r - itil C ripDERAL AVIATION ADMINISTRATION U c A D ii., ^ 

RECEiVE^O ^ OFFICE OF HEARINGS HEARfNG DOCKET 

FEB - I 2010 WASHINGTON, D.C. 

HEARING DOCKET 

In the Matter of Alcon Biosciences Private Limited 

2009EA700400 

Judge Not Assigned 

COMPLAINT 

The Federal Aviation Administration (FAA), by counsel, hereby files its Complaint, 

pursuant to Rule 208 of the Rules of Practice (14 C.F.R. 13.208), and states as follows: 

I 

Respondent, Alcon Biosciences Private Limited, was advised through a Final Notice of 

Proposed Civil Penalty that the FAA proposed to assess a civil penalty in the amount of 

$78,000. On January 22, 2010, Respondent submitted a written demand for a hearing. 

II 

1. On or about May 16, 2009, Alcon Biosciences Private Limited (hereinafter 

"Alcon") offered an undeclared shipment of hazardous materials for 

transportation in air commerce (hereinafter, "the shipment"). 

2. The above-mentioned shipment comprised three (3) cartons with six (6) 

metal cans, each containing 1.0kg of white powder packaged in a clear 

plastic bag. 

3. The Federal Aviation Administration determined that the white powder 

comprising the shipment described is a substance named Colchincine. 

4. Colchincine is a substance regulated by the Department of Transportation 

(DOT) Hazardous Materials Regulations (HMR) 49 C.F.R. §§ 171-177), 

listed in the DOT HMR Hazardous Materials Table (49 C.F.R. §172.101) as 

"'Alkaloid, solid, n.o.s., UN 1544, PGII, Class 6.1, Poisonous material". 
'•wT^^w^^r^rn^fT^'^lfn^ 

5. The shipment was transported into the United States on Air India Flight 191 

from Mumbai, India to Newark Liberty International Airport, Newark, NJ, 

under Airway Bill (AWB) 098-8930 0326, on or about May 17, 2009. 

6. At all times mentioned herein, the Department of Transportation (DOT) 

Hazardous Materials Regulations (HMR) (49 C.F.R. §§171-177) required 

Alcon, as a hazmat employer, to ensure that each of its hazmat employees 

was trained in accordance with the requirements of the HMR, was tested by 

appropriate means on the training subjects covered in §172.704 (49 

C.F.R.§172.704), and was precluded from performing any ftinction subject 

to the requirements of the DOT HMR without first being instructed in the 

requirements of the HMR that apply to that ftinction. 

7. At all times herein, Alcon did not ensure that each of its hazmat employees 

is trained in accordance with the requirements prescribed by the applicable 

DOT HMR. 

8. At all times herein, Alcon did not ensure that each of its hazmat employees 

had been provided general awareness/familiarization training designed to 

provide familiarity with the requirements of the DOT HMR. 

9. At all times herein, Alcon did not ensure that the above-referenced shipment 

meet all applicable requirements of the DOT HMR. 

10. At all times herein, Alcon did not ensure that the above-referenced 

shipment meet the requirements of the applicable international standards or 

regulations and that it was offered for transportation or transported in 

conformance with those applicable standards or regulations. 

11. At all times herein, Alcon did not describe the hazardous material on the 

associated shipping paper in the manner required by the DOT HMR. 

12. Alcon did not ensure that the package or containment device in which it 

offered the above-referenced hazardous materials shipment was labeled with 

labels specified for the material in the §172.101 Table and other applicable 

parts ofthe DOT HMR. 

13. At all times herein, Alcon did not ensure that the associated shipping paper 

contain an emergency response telephone number, as prescribed in subpart G 

of DOT HMR. 
Ill 

By reason of the foregoing facts and circumstances. Respondent violated the following 

section(s) ofthe Department of Transportation Hazardous Materials Regulations: 

a. Section 171.2(a), which states that each person who performs a ftinction 

covered by this subchapter must perform that ftinction in accordance with this 

subchapter. 

b. Section 171.22(b), which states that limitations on the use of intemational 

standards and regulations. A hazardous material that is offered for 

transportation or transported in accordance with the intemational standards 

and regulations authorized in paragraph (a) of this section~(l) Is subject to 

the requirements of the applicable intemational standard or regulation and 

must be offered for transportation or transported in conformance with the 

applicable standard or regulation; and (2) Must conform to all applicable 

requirements of this subpart. 

c. Section 172.200(a), which states that, except as otherwise provided in this 

subpart, each person who offers a hazardous material for transportation shall 
describe the hazardous material on the shipping paper in the manner required 

by this subpart. 

d. Section 172.201(d), which states that, except as provided in §172.604(c), a 

shipping paper must contain an emergency response telephone number, as 

prescribed in subpart G of this part. 

e. Section 172.300(a), which states that each person who offers a hazardous 

material for transportation shall mark each package, freight container, and 

transport vehicle containing the hazardous material in the manner required by 

this subpart. 

f. Section 172.400(a), which states that except as specified in § 172.400a, each 

person who offers for transportation or transports a hazardous material in any 

of the following packages or containment devices, shall label the package or 

containment device with labels specified for the material in the §172.101 

Table and in this subpart. (1) A non-bulk package; (2) A bulk packaging, 

other than a cargo tank, portable tank, or tank car, with a volumetric capacity 

of less than 18 m3 (640 cubic feet), unless placarded in accordance with 

subpart F of this part; (3) A portable tank of less than 3785 L (1000 gallons) 
capacity, unless placarded in accordance with subpart F of this part; (4) A 

DOT Specification 106 or 110 multi-unit tank car tank, unless placarded in 

accordance with subpart F of this part; and (5) An overpack, freight 

container or unit load device, of less than 18 m3 (640 cubic feet), which 

contains a package for which labels are required, unless placarded or marked 

in accordance with §172.512 of this part. 

g. Section 172.604(a), which states that a person who offers a hazardous 

material for transportation must provide a 24-hour emergency response 

telephone number (including the area code or intemational access code) for 

use in the event of an emergency involving the hazardous material. The 

telephone number must be (1) Monitored at all times the hazardous material 

is in transportation, including storage incidental to transportation; (2) The 

number of a person who is either knowledgeable of the hazardous material 

being shipped and has comprehensive emergency response and incident 

mitigation information for that material, or has immediate access to a person 

who possesses such knowledge and information and (3) Entered on a 

shipping paper, as follows: (i) Immediately following the description ofthe 

hazardous material required by subpart C of this part; or (ii) Entered once on 

the shipping paper in a clearly visible location. This provision may be used 
only if the telephone number applies to each hazardous material entered on 

the shipping paper, and if it is indicated that the telephone number is for 

emergency response information (for example: EMERGENCY 

CONTACT:***). 

h. Section 172.702(a), which states that a hazmat employer shall ensure that 

each of its hazmat employees is frained in accordance with the requirements 

prescribed in this subpart. 

i. Section 172.704(a)(1), which states that hazmat employee training shall 

include the following: Each hazmat employee shall be provided general 

awareness/familiarization training designed to provide familiarity with the 

requirements of this subchapter, and to enable the employee to recognize and 

identify hazardous materials consistent with the hazard communication 

standards of this subchapter. 

IV 

1. Pursuant to 49 U.S.C. §5123(a) of Chapter 51, Title 49 ofthe United States Code of 

Transportation, 49 U.S.C.§5123 Respondent is liable for a civil penalty of not less than 

$250 ($450 for training violations), nor greater than $50,000 ($100,000 if death, serious 
^^^^^^^^ 

illness, severe injury, or substantial property damage results), for each of the violations 

alleged. 

2. Under the facts and circumstances of this case, a civil penalty of $78,000 is appropriate. 

WHEREFORE, the FAA, by counsel, respectftilly requests that the Administrative 

Law Judge enter an order that Respondent be assessed a civil penalty in the amount of 

$78,000. 

Respectftilly submitted, 

Alfred R. Johnson, Jr. 

Regional Counsel 

By: {Ihno^POadnhMLmcfhh^ 

Mary Marin e McCarthy 

Deputy Regional Counsel 

Federal Aviation Administration 

1 Aviation Plaza 

Jamaica, NY 11434 

718 553-3267 

718 995-5699 
NOTE; 

The Rules of Practice for this proceeding are set forth in Part 13, Subpart G, of 

the Federal Aviation Regulations (14 C.F.R Part 13). 

The Rules of Practice provide that Respondent must file a written answer to 

this Complaint, or a written Motion to Dismiss if appropriate, not later than 30 days 

after the date shown on the Certificate of Service. A general denial is deemed a failure 

to file an answer (Section 13.209(e)). 
CERTIFICATE OF SERVICE 

I hereby certify that the foregoing Complaint has been placed this date in the United States 

mail, postage prepaid, by Certified Mail - Retum Receipt Requested addressed as follows: 

Alcon Biosciences Private Limited 

112 Marine Chambers 

II New Marine Lines 

Mumbai India, 40002 

Federal Aviation Administration (Original and one copy) 

800 Independence Avenue, S.W. 

Washington, D.C. 20591 

Attn: Hearing Docket Clerk, AGC-430 

Wilbur Wright Building - Room 2014 

IF FILING BY FEDERAL EXPRESS 

Federal Aviation Administration (Original and one copy) 

600 Independence Avenue, SW 

Wilbur Wright Building - Room 2014 

Washington, DC 20591 

Attn: Hearing Docket Clerk, AGC-430 

Date: JAN 2 7 2010 

Carolyn M. O^eefe 

Legal Technician 

Federal Aviation Administration 

Office of Regional Counsel 
U.S. DEPARTMENT OF TRANSPORTATION 

FEDERAL AVIATION ADMINISTRATION 

OFFICE OF HEARINGS 

WASHINGTON, D.C. 

In the Matter of Alcon Biosciences Private Limited 

2009EA700400 

Judge Not Assigned 

NOTICE OF APPEARANCE 

Complainant, Federal Aviation Administration, hereby notifies the United States 

Department of Transportation, Office of Hearings, and the Respondent, pursuant to 14 

C.F.R. §13.204(b), that it shall be represented in the above-stated action by the following 

attomey: 

Mary Madeline McCarthy 

Federal Aviation Administration 

Office of Regional Counsel 

1 Aviation Plaza 

Jamaica, NY 11434 

Telephone: 718 553-3267 

Facsimile: 718 995-5699 
All communications, notices, pleadings or documents are respectfully requested to be 

forwarded as follows: 

Mary Madeline McCarthy 

Federal Aviation Administration 

Office of Regional Counsel 

1 Aviation Plaza 

Jamaica, NY 11434 

Telephone: 718 553-3267 

Facsimile: 718 995-5699 

Respectfully submitted, 

Alfred R. Johnson, Jr. 

Regional Counsel 

Mary M^jieline McCarthy (j 

Deputy Regional Counsel 
CERTIFICATE OF SERVICE 

I hereby certify that on this day copies ofthe foregoing Notice of Appearance were placed 

in the United States mail, postage prepaid. Certified Mail - Retum Receipt Requested 

addressed as follows: 

Alcon Biosciences Private Limited 

112 Marine Chambers 

II New Marine Lines 

Mumbai India, 40002 

Federal Aviation Administration (Original and one copy) 

800 Independence Avenue, S.W. 

Washington, D.C. 20591 

Attn: Hearing Docket Clerk, AGC-430 

Wilbur Wright Building - Room 2014 

IF FILING BY FEDERAL EXPRESS 

Federal Aviation Administration (Original and one copy) 

600 Independence Avenue, SW 

Wilbur Wright Building - Room 2014 

Washington, DC 20591 

Attn: Hearing Docket Clerk, AGC-430 

Date: JAN 2 7 201Q 

Carolyn M. "QXeefe 

Legal Technician 

Federal Aviation Administration 

Office of Regional Counsel 

1 Aviation Plaza 

Jamaica, NY 11434