56916 Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Proposed Rules 

by land to Mexico or Canada, shall be 

exported through said ports or through 

ports designated in special cases under 

paragraph (b) of this section. 

(b) In special cases, other ports may 

be designated as ports of embarkation by 

the Administrator, with the concurrence 

of the Commissioner of the Bureau of 

Customs and Border Protection, when 

the exporter can show to the satisfaction 

of the Administrator that the animals to 

be exported would suffer undue 

hardship if they are required to be 

moved to a port listed as a designated 

port of embarkation in accordance with 

paragraph (a) of this section. Ports shall 

be designated in special cases as ports 

of embarkation only if the inspection 

facilities are approved as meeting the 

requirements of paragraph (c) of this 

section. 

* * * * * 

(d) Approval and denial or revocation 

of approval. Approval of each export 

inspection facility for designation under 

paragraph (a) of this section, and in 

special cases under paragraph (b) of this 

section, shall be obtained from the 

Administrator. Approval of an export 

inspection facility under paragraph (a) 

or (b) will be denied or revoked for 

failure to meet the standards in 

paragraph (c) of this section. Designated 

ports of embarkation and export 

facilities shall be reevaluated annually, 

by means of an APHIS site inspection, 

for continued compliance with the 

standards contained in paragraph (c) of 

this section. If the port or facility fails 

to pass the annual inspection, its 

designation will be revoked, and it will 

be removed from the list of designated 

ports and facilities. A written notice of 

any proposed denial or revocation shall 

be given to the operator of the facility, 

and he will be given an opportunity to 

present his views thereon. Such notice 

shall list in detail the deficiencies 

concerned. After remedying the 

deficiencies, an operator may request 

another inspection. Approval of a port 

of embarkation in connection with the 

designation of an export inspection 

facility in special cases shall be limited 

to the special case for which the 

designation was made. 

* * * * * 

■ 3. In § 91.15, paragraph (a) is revised 

to read as follows: 

§ 91.15 Inspection of animals for export. 

(a) All animals offered for exportation 

to any foreign country, except by land 

to Mexico or Canada, shall be inspected 

within 24 hours of embarkation by an 

APHIS veterinarian at an export 

inspection facility at a port listed as a 

designated port of embarkation in 

accordance with § 91.14(a), or at a port 

or inspection facility designated by the 

Administrator in a special case under 

§ 91.14(b). 

* * * * * 

Done in Washington, DC, this 13th day 

of September 2010. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2010–23245 Filed 9–16–10: 8:45 am] 

BILLING CODE 3410–34–S 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

9 CFR Parts 101 and 114 

[Docket No. APHIS-2009-0028] 

RIN 0579-AD06 

Viruses, Serums, Toxins, and 

Analogous Products; Expiration Date 

Required for Serials and Subserials 

and Determination of Expiration Date 

of Product 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Proposed rule; withdrawal and 

reproposal. 

SUMMARY: We are proposing to amend 

the Virus-Serum-Toxin Act regulations 

concerning expiration dating to clarify 

that the expiration date of a serial or 

subserial of a veterinary biologic should 

be computed from the date of the 

initiation of the first potency test. We 

also propose to require the expiration 

dating period (stability) of a product to 

be confirmed by conducting a real-time 

stability study with a stabilityindicating assay; require stability 

monitoring of products after licensing; 

and specify a single standard for 

determining the expiration date for 

veterinary biologics in place of the 

current standard that specifies different 

procedures for products contingent 

upon whether they consist of viable or 

nonviable organisms. These 

amendments would update and clarify 

the regulations concerning expiration 

dating and establish a single uniform 

standard for determining the stability of 

veterinary biological products. This 

proposed rule replaces a previously 

published proposed rule, which we are 

withdrawing as part of this document. 

DATES: We will consider all comments 

that we receive on or before November 

16, 2010. 

ADDRESSES: You may submit comments 

by either of the following methods: 

∑ Federal eRulemaking Portal: Go to 

(http://www.regulations.gov/ 

fdmspublic/component/ 

main?main=DocketDetail&d=APHIS2009-0028) to submit or view comments 

and to view supporting and related 

materials available electronically. 

∑ Postal Mail/Commercial Delivery: 

Please send one copy of your comment 

to Docket No. APHIS-2009-0028, 

Regulatory Analysis and Development, 

PPD, APHIS, Station 3A-03.8, 4700 

River Road Unit 118, Riverdale, MD 

20737-1238. Please state that your 

comment refers to Docket No. APHIS2009-0028. 

Reading Room: You may read any 

comments that we receive on 

Regulations.gov (see the link above) or 

in our reading room. The reading room 

is located in room 1141 of the USDA 

South Building, 14th Street and 

Independence Avenue, SW., 

Washington, DC. Normal reading room 

hours are 8 a.m. to 4:30 p.m., Monday 

through Friday, except holidays. To be 

sure someone is there to help you, 

please call (202) 690-2817 before 

coming. 

Other Information: Additional 

information about APHIS and its 

programs is available on the Internet at 

(http://www.aphis.usda.gov). 

FOR FURTHER INFORMATION CONTACT: Dr. 

Albert P. Morgan, Chief of Operational 

Support, Center for Veterinary 

Biologics, Licensing and Policy 

Development, VS, APHIS, 4700 River 

Road Unit 148, Riverdale, MD 20737- 

1231; (301) 734-8245. 

SUPPLEMENTARY INFORMATION: 

Background 

The Virus-Serum-Toxin Act 

regulations in 9 CFR part 114, 

‘‘Production Requirements for Biological 

Products’’ (referred to below as the 

regulations), include requirements 

applicable to computing expiration 

dates and determining expiration dating 

periods (stability) for veterinary 

biologics. Currently, § 114.12 of the 

regulations requires each serial or 

subserial of veterinary biological 

product prepared in a licensed 

establishment to be given an expiration 

date, and § 114.13 provides that the 

expiration date for each product shall be 

computed from the date of the initiation 

of the potency test. 

The computed expiration date of a 

serial or subserial of biological product 

is inextricably linked to the stability of 

such product. The expiration date of a 

veterinary biologic designates the end of 

the period during which such product, 

when properly stored and handled, can 

be expected with reasonable certainty to 


wwoods2 on DSKDVH8Z91PROD with PROPOSALS-1
Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Proposed Rules 56917 

1 To view the proposed rule and the comments 

we received, go to (http://www.regulations.gov/ 

fdmspublic/component/ 

main?main=DocketDetail&d=APHIS-2005-0041). 

be efficacious. The most precise 

determination of the stability of a 

veterinary biologic occurs when the 

potency of such product is measured at 

the end of its predicted shelf life 

(expiration date). Typically, however, 

products are licensed and serials or 

subserials are released for marketing 

before the first production serials reach 

the end of their predicted shelf life. 

Thus, prior to licensure, licensees and 

permittees must submit preliminary 

stability data that provides a level of 

confidence that the product will remain 

efficacious throughout the dating period 

shown on its labeling. Typically, such 

data is obtained by subjecting the 

product to extreme temperatures for a 

specified time period and measuring the 

relative strength of each fraction by 

conducting a potency test. Products that 

pass the potency test are licensed with 

the provision that the dating period 

must be confirmed by real-time stability 

testing at the end of the predicted shelf 

life. Currently, the requirement 

prescribed under § 114.13 of the 

regulations for confirming stability is 

contingent upon whether a product 

consists of viable or nonviable 

organisms. For products consisting of 

viable organisms, each serial must be 

tested for potency at release and at the 

approximate expiration date until a 

statistically valid stability record has 

been established; for nonviable 

biological products, each serial 

presented in support of licensure 

(prelicensing serials) must be tested for 

potency at release and at or after the 

dating requested. Products with 

satisfactory potency tests at the 

beginning and end of dating are 

considered to be efficacious throughout 

the requested dating period. Current 

science, however, considers stability 

estimates based on potency tests 

conducted at the beginning and end of 

dating (a two-point profile) to be 

inaccurate and imprecise. 

To address this situation, on April 28, 

2005, we published in the Federal 

Register (70 FR 21985-21987, Docket 

No. 04-064-1) a proposed rule1 to amend 

the regulations concerning expiration 

dating to require veterinary biologics 

licensees and permittees to confirm the 

proposed expiration dating period of 

products by potency testing serials on 

multiple occasions throughout the 

proposed dating period. The proposed 

rule also would have required stability 

data to be submitted to the Animal and 

Plant Health Inspection Service (APHIS) 

for review and filing; the stability data 

approved for filing date to be specified 

in the filed Outline of Production; and 

a plan for monitoring the stability of the 

product and the suitability of its 

proposed dating period. 

We solicited comments on our 

proposal for 60 days ending on June 27, 

2005. We received six comments by that 

date. The comments were from three 

licensed manufacturers, two national 

trade associations representing 

manufacturers of animal health 

products, and a professional association. 

All of the commenters agreed with the 

need to establish a uniform standard for 

determining expiration dating; however, 

most expressed concern that the 

proposed rule lacked detail, and 

suggested that such detail be added and 

the rule reproposed. 

In response to these comments, we 

have provided specifics that we believe 

address the perceived ambiguity in the 

proposed rule. Therefore, we are 

withdrawing the April 22, 2005, 

proposed rule referenced above and 

replacing it with the proposed changes 

described in this document. The 

proposed requirements for determining 

expiration dating that would apply to 

each licensee and permittee that 

prepares and distributes veterinary 

biologics are described below. 

Definitions 

The regulations in 9 CFR part 101 

contain the definitions of terms used in 

the regulations concerning veterinary 

biologics. The proposed changes to part 

114 of the regulations would make it 

necessary for us to add a definition in 

§ 101.5 for a term used in the proposed 

regulations: Stability-indicating assay. 

We would define stability-indicating 

assay as a validated quantitative 

analytical procedure (in vitro or live 

animal test) that can detect changes over 

time in the pertinent properties of a 

veterinary biologic. 

Expiration Date Required for a Serial 

We are proposing to change the title 

of § 114.12 from ‘‘Expiration date 

required’’ to ‘‘Expiration date required 

for a serial.’’ In addition, we propose to 

amend this section by adding the 

wording ‘‘computed from the date of the 

initiation of the first potency test.’’ 

These changes are intended to clarify 

the fact that the requirements in this 

section pertain to serials or subserials of 

product, and that APHIS interprets the 

‘‘date of the initiation of the potency 

test’’ to mean the on-test date of the first 

potency test conducted on a serial or 

subserial. This interpretation is 

consistent with the APHIS policy in that 

regard. 

Determination of the Expiration Dating 

Period of a Product 

We are proposing to change the title 

of § 114.13 from ‘‘Expiration date 

determination’’ to ‘‘Determination of the 

expiration dating period of a product.’’ 

This change would clarify the fact that 

the requirements in that section pertain 

to determining the stability of a product 

rather than the expiration date of a 

serial or subserial of such product. The 

proposed revision of this section would: 

∑ Prescribe a single, uniform standard 

for determining the stability of 

veterinary biologics in place of the 

current standards, which prescribe 

different procedures for products 

consisting of viable and nonviable 

organisms; 

∑ Remove the wording ‘‘computed 

from the date of the initiation of the 

potency test’’ and providing that the 

expiration dating period of a product 

would be based on the testing of 

production serials beginning on the day 

of filling into final containers or the date 

final formulation of the product if such 

date is specified in the filed Outline of 

Production; 

∑ Require testing of serials or 

subserials using a stability-indicating 

assay on multiple occasions throughout 

the predicted dating period in place of 

the current requirement, which only 

requires potency testing at the beginning 

and end of the dating period in order to 

confirm stability; 

∑ Require the stability data to be 

submitted to APHIS for review and 

filing and the approved for filing date to 

be specified in section VI of the filed 

Outline of Production; and 

∑ Require the periodic testing of 

serials or subserials to monitor the 

stability and suitability of the approved 

dating period. 

APHIS is proposing these 

amendments because it has been shown 

that the potency of most veterinary 

biologics degrade in a nonlinear fashion, 

which may cause potency to degrade 

more quickly than previously estimated. 

Testing on only two occasions would be 

reasonable only if potency loss has a 

strictly linear pattern, and this is 

usually not the case. Thus, when 

confirming the dating period, APHIS is 

proposing to require the stability of a 

product to be evaluated as a function of 

time by requiring serials to be tested on 

multiple occasions with a stabilityindicating assay. 

The changes and test procedures 

prescribed in this proposal would 

update and standardize expiration date 

determination for veterinary biologics in 

§§ 114.12 and 114.13 by establishing a 

single, uniform standard for all products 


wwoods2 on DSKDVH8Z91PROD with PROPOSALS-1
56918 Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Proposed Rules 

based on testing and monitoring with a 

stability-indicating assay. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This proposed rule has been 

determined to be significant for the 

purposes of Executive Order 12866 and, 

therefore, has been reviewed by the 

Office of Management and Budget. 

This proposed rule would amend the 

Virus-Serum-Toxin Act regulations in 

§§ 114.12 and 114.13 concerning 

expiration dates and the determination 

of the stability of veterinary biologics to: 

Change the title of the sections; clarify 

that the ‘‘date of the initiation of the 

potency test’’ is the on-test date of the 

first potency test conducted on a serial 

or subserial; require veterinary biologics 

licensees and permittees to evaluate the 

stability of veterinary biologics as a 

function of time by testing serials for 

potency on multiple occasions with a 

stability-indicating assay throughout 

and after their proposed dating period; 

require the stability data approved for 

filing date to be specified in the filed 

Outline of Production; and require 

monitoring of the stability of the 

product and the suitability of its dating 

period. In addition, the proposed 

changes to the regulations are consistent 

with the recommendations of the 

collaborative initiative by regulatory 

authorities and industry associations 

known as International Cooperation on 

Harmonization of Technical 

Requirements for the Registration of 

Veterinary Medicinal Products (VICH). 

VICH is concerned with harmonization 

of technical requirements for the 

registration of veterinary medicinal 

products among three regions: The 

European Union, Japan, and the United 

States. The proposed stability testing 

guidelines are consistent with those 

adopted by VICH as an international 

standard for the generation and 

submission of stability data for 

veterinary medicinal products. The 

overall benefit of these proposed 

amendments would be to reduce the 

differences in technical requirements for 

veterinary biologics among regulatory 

agencies in different countries. 

This proposed rule would affect all 

licensed manufacturers of veterinary 

biologics. Currently, there are 

approximately 125 veterinary biologics 

manufacturers, including permittees. 

According to the standards of the Small 

Business Administration, most 

veterinary biologics establishments are 

small entities. Relative to the baseline of 

the existing regulations in §§ 114.12 and 

114.13, we do not believe that the 

changes we are proposing would result 

in new or additional effects on small 

entities subject to the regulations, as the 

current testing protocols would not 

change; we are simply clarifying those 

existing protocols. All veterinary 

biologics manufacturers are currently 

required to confirm the expiration 

dating of the products that they produce 

and to submit the data to APHIS for 

review and filing. In addition, the 

proposed requirements to test serials of 

product on multiple occasions when 

confirming expiration dating, and to 

monitor stability post-licensing are not 

expected to have a significant economic 

impact because most veterinary 

biologics manufacturers routinely test 

and monitor the stability of products 

throughout their dating period. 

Under the changes to the regulations 

described in this proposed rule, 

veterinary biologics with a 2-year dating 

period would require 7 test occasions, 

for a total of 21 tests of 3 serials. To 

confirm expiration dating under current 

regulations, many licensees may be 

required to test 10 serials twice, a total 

of 20 tests. This is about the same 

number of tests. The most recent data 

compiled by APHIS show that over one 

3-year period, 101 veterinary biologics 

manufacturers submitted 105 stability 

studies to the Center for Veterinary 

Biologics, an average per manufacturer 

of 1 every 3 years. The proposed 

amendment to the regulations would 

not necessitate an increase in the 

number of stability studies required to 

be performed, or an increase in 

associated testing costs, as these 

proposed changes will primarily apply 

to newly licensed products. 

Under these circumstances, the 

Administrator of the Animal and Plant 

Health Inspection Service has 

determined that this action would not 

have a significant economic impact on 

a substantial number of small entities. 

Executive Order 12372 

This program/activity is listed in the 

category of Federal Domestic Assistance 

under No. 10.025 and is subject to 

Executive Order 12372, which requires 

intergovernmental consultation with 

State and local officials. (See 7 CFR part 

3015, subpart V.) 

Executive Order 12988 

This proposed rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. It is not intended to 

have retroactive effect. This rule would 

not preempt any State or local laws, 

regulations, or policies where they are 

necessary to address local disease 

conditions or eradication programs. 

However, where safety, efficacy, purity, 

and potency of biological products are 

concerned, it is the Agency’s intent to 

occupy the field. This includes, but is 

not limited to, the regulation of labeling. 

Under the Act, Congress clearly 

intended that there be national 

uniformity in the regulation of these 

products. There are no administrative 

proceedings which must be exhausted 

prior to a judicial challenge to the 

regulations under this rule. 

Paperwork Reduction Act 

This proposed rule contains no new 

information collection or recordkeeping 

requirements under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501- 

3520). 

List of Subjects 

9 CFR Part 101 

Animal biologics. 

9 CFR Part 114 

Animal biologics, Reporting and 

recordkeeping requirements. 

■ Accordingly, we propose to amend 9 

CFR parts 101 and 114 as follows: 

PART 101—DEFINITIONS 

■ 1. The authority citation for part 101 

continues to read as follows: 

Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 

2.80, and 371.4. 

■ 2. Section 101.5 is amended by adding 

new paragraph (s) to read as follows: 

§ 101.5 Testing terminology. 

* * * * * 

(s) Stability-indicating assay. A 

stability-indicating assay is a validated 

quantitative analytical procedure that 

can detect changes over time in the 

pertinent properties of the product. 

PART 114—PRODUCTION 

REQUIREMENTS FOR BIOLOGICAL 

PRODUCTS 

■ 3. The authority citation for part 114 

continues to read as follows: 

Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 

2.80, and 371.4. 

■ 4. Section 114.12 is revised to read as 

follows: 

§ 114.12 Expiration date required for a 

serial. 

Unless otherwise provided for in a 

Standard Requirement or filed Outline 

of Production, each serial or subserial of 

biological product prepared in a 

licensed establishment shall be given an 

expiration date computed from the date 

of the initiation of the first potency test. 

A licensed biological product shall be 

considered worthless under the VirusSerum-Toxin Act after the expiration 

date appearing on the label. 


wwoods2 on DSKDVH8Z91PROD with PROPOSALS-1
Federal Register / Vol. 75, No. 180 / Friday, September 17, 2010 / Proposed Rules 56919 

■ 5. Section 114.13 is revised to read as 

follows: 

§ 114.13 Determination of the expiration 

dating period of a product. 

An expiration dating period 

determined by the stability of each of its 

fractions shall be assigned to each 

product. Stability shall be determined 

with a stability-indicating assay that can 

detect changes over time in the 

pertinent properties of the product. 

Stability criteria include the 

specifications for potency at release, 

potency throughout the dating period, 

and the length of the dating period. 

When tested at any time during the 

dating period, the potency of the 

product shall not be less than the 

minimum specified in the filed Outline 

of Production. Prior to licensure, the 

licensee shall propose an expiration 

dating period for the product based on 

preliminary data available about the 

stability of each of its fractions. If the 

preliminary stability data are 

acceptable, the product may be licensed 

with the provision that the proposed 

expiration dating period must be 

confirmed by conducting a real-time 

stability study with a stabilityindicating assay as follows: 

(a) In the case of a newly licensed 

product with acceptable preliminary 

stability data and the real-time stability 

study is not conducted in animals, at 

least three production serials of the 

product shall be selected and tested 

during the proposed dating period. Each 

serial shall be tested beginning on the 

day of filling into final containers or the 

date of final formulation specified in the 

filed Outline of Production, and at the 

following intervals: 

(1) Every 3 months during the first 

year of storage, 

(2) Every 6 months during the second 

year of storage, and 

(3) Annually thereafter throughout the 

proposed dating period. 

(b) In the case of a newly licensed 

product with acceptable preliminary 

stability data and the real-time stability 

study is conducted in animals, at least 

three production serials shall be tested 

as follows: 

(1) One test per serial shall be 

conducted beginning on the day of 

filling into final containers or the date 

of final formulation specified in the 

filed Outline of Production. 

(2) One test per serial shall be 

conducted at thebe end of the proposed 

dating period. 

(3) One test per serial shall be 

conducted between the initial and final 

test, but at a different interval for each 

serial. 

(c) In the case of a newly licensed 

product, and licensed products whose 

stability studies were completed prior to 

[Effective date of final rule], a real-time 

stability study conducted with a 

stability-indicating assay in accordance 

with paragraphs (a) or (b) of this section 

shall be completed in support of 

changes to one of the stability criteria or 

for major changes to the potency test. 

(d) In the case of a licensed product 

with an unconfirmed expiration dating 

period that is tested in animals with a 

test that is not a stability-indicating 

assay, the following shall apply: 

(1) Testing involving the use of a nonstability-indicating assay specified in 

the filed Outline of Production to 

confirm the expiration dating period for 

such product shall be completed by 

[Date 42 months after effective date of 

the final rule], or 

(2) Subsequent to [Date 42 months 

after effective date of the final rule], 

such testing to confirm expiration 

dating shall be completed with a 

stability-indicating assay. Products not 

meeting the requirement to confirm the 

expiration dating with a stabilityindicating assay shall be withheld from 

the market. 

(e) At the completion of the real-time 

stability study to confirm or change 

expiration dating, the data shall be 

submitted to Animal and Plant Health 

Inspection Service for approval for filing 

and the approved for filing date shall be 

specified in section VI of the filed 

Outline of Production at the next 

revision. 

(f) For products licensed subsequent 

to [Effective date of the final rule], the 

licensee or permittee shall submit a plan 

to monitor the stability of the product 

and the suitability of its dating period 

that includes regularly testing serials for 

potency with a stability-indicating assay 

during and at the end of dating. 

Done in Washington, DC, this 3rd day 

of September 2010. 

John Ferrell, 

Deputy Under Secretary for Marketing and 

Regulatory Programs. 

[FR Doc. 2010–23186 Filed 9–16–10: 10:57 am] 

BILLING CODE 3410–34–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 167 

[Docket No. USCG–2010–0785] 

Port Access Route Study: The 

Approaches to San Francisco 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of public meetings; 

request for comments. 

SUMMARY: The Coast Guard announces a 

public meeting to receive comments on 

the study entitled ‘‘Port Access Route 

Study: Off San Francisco’’ that was 

published in the Federal Register on 

Thursday, December 10, 2009. As stated 

in that document, the Coast Guard is 

conducting a Port Access Route Study 

(PARS) to evaluate the continued 

applicability of and the potential need 

for modifications to the current vessel 

routing in the approaches to San 

Francisco. 

DATES: A Public meeting will be held on 

Wednesday, October 20, 2010 from 6:30 

p.m. to 8:30 p.m. to provide an 

opportunity for oral comments. Written 

comments and related material may also 

be submitted to Coast Guard personnel 

specified at the meetings. 

ADDRESSES: The October 20, 2010 public 

meeting will be held at the Executive 

Inn and Suites at 1755 Embarcadero, 

Oakland, California. Visitor parking is 

available in the lots outside the hotel. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions concerning the 

meeting or the study, please call or email LTJG Lucas Mancini, Coast Guard; 

telephone 510–437–3801, e-mail 

Lucas.W.Mancini@uscg.mil. If you have 

questions on viewing the docket call 

Ms. Renee V. Wright, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: 

Background and Purpose 

We published a notice of study in the 

Federal Register on December 10, 2009 

(74 FR 65543), entitled ‘‘Port Access 

Route Study: Off San Francisco’’ in 

which we did not state a plan to hold 

a public meeting. We have decided to 

hold a meeting in order to give the 

public and waterway users a chance to 

comment in person. 

In the notice of PARS, we discussed 

our intent to help reduce the risk of 

marine casualties and increase the 

efficiency of vessel traffic in the study 

region. Our goal is to assess whether the 

current vessel routing system is effective 


wwoods2 on DSKDVH8Z91PROD with PROPOSALS-1