Federal Register / Vol. 72, No. 20 / Wednesday, January 31, 2007 / Rules and Regulations 4423 

TABLE 1.—COMPLIANCE TIMES

For airplanes on which— Inspect— And repeat the HFEC and detailed inspections thereafter at—

(1) An HFEC or a detailed inspection specified 

in Boeing Service Bulletin 737–53A1225, 

dated October 19, 2000, has not been done 

as of the effective date of this AD.

Before the accumulation of 15,000 total flight 

cycles, or within 4,500 flight cycles after the 

effective date of this AD, whichever occurs 

later.

Intervals not to exceed 6,000 flight cycles. 

(2) An HFEC or detailed inspection specified in 

Boeing Service Bulletin 737–53A1225, dated 

October 19, 2000, has been done before the 

effective date of this AD.

Within 6,000 flight cycles since the last HFEC 

inspection, within 1,200 flight cycles since 

the last detailed inspection, or within 4,500 

flight cycles after the effective date of this 

AD, whichever occurs later.

Intervals not to exceed 6,000 flight cycles. 

Corrective Actions 

(g) If any crack is detected during any 

inspection required by paragraph (f) of this 

AD, before further flight, repair or replace the 

vertical beam web and associated parts with 

a new vertical beam web, in accordance with 

the Accomplishment Instructions of Boeing 

Service Bulletin 737–53A1225, Revision 1, 

dated April 14, 2005, except as provided by 

paragraph (h) of this AD. 

(h) If any damage is beyond the scope of 

the service bulletin or structural repair 

manual, before further flight, repair the 

damaged vertical beam web in accordance 

with a method approved by the Manager, 

Seattle Aircraft Certification Office (ACO), 

FAA; or using a method approved in 

accordance with paragraph (m) of this AD. 

Terminating Preventative Modification 

(i) Before the accumulation of 50,000 total 

flight cycles, or within 25,000 flight cycles 

after the effective date of this AD, whichever 

occurs later, replace the vertical beams at 

buttock lines (BL) 5.7 and 17.0 of the BS 178 

bulkhead, in accordance with the 

Accomplishment Instructions of Boeing 

Service Bulletin 737–53A1225, Revision 1, 

dated April 14, 2005. Accomplishing the 

replacement ends the repetitive inspections 

required by paragraph (f) of this AD. 

(j) Actions done before the effective date of 

this AD in accordance with Boeing BOECOM 

M–7200–01–00546, dated March 1, 2001, are 

acceptable for compliance with the 

requirements of paragraph (i) of this AD. 

Prior to or Concurrent Requirements 

(k) For Group 1 airplanes identified in 

Boeing Service Bulletin 737–53A1225, 

Revision 1, dated April 14, 2005: Before or 

concurrently with the requirements of 

paragraph (i) of this AD, do the preventative 

modifications of the center web, vertical 

chords, and side chord areas, including the 

side chord areas at water line 207, of the 

forward pressure bulkhead, specified in 

paragraph (c) of AD 2000–05–29, amendment 

39–11639 (reference Boeing Alert Service 

Bulletin 737–53A1173, Revision 3, dated 

May 6, 1999). 

(l) For Group 2 airplanes identified in 

Boeing Service Bulletin 737–53A1225, 

Revision 1, dated April 14, 2005: Before or 

concurrently with the requirements of 

paragraph (i) of this AD, but no later than the 

time specified in AD 2001–02–01, 

amendment 39–12085, do the preventative 

modifications of the vertical and side chord 

areas of the forward pressure bulkhead 

required by paragraph (c) of AD 2001–02–01 

(reference Boeing Alert Service Bulletin 737–

53A1208, dated May 6, 1999). 

Alternative Methods of Compliance 

(AMOCs) 

(m)(1) The Manager, Seattle ACO, FAA, 

has the authority to approve AMOCs for this 

AD, if requested in accordance with the 

procedures found in 14 CFR 39.19. 

(2) Before using any AMOC approved in 

accordance with § 39.19 on any airplane to 

which the AMOC applies, notify the 

appropriate principal inspector in the FAA 

Flight Standards Certificate Holding District 

Office. 

(3) An AMOC that provides an acceptable 

level of safety may be used for any 

replacement or repair required by this AD, if 

it is approved by an Authorized 

Representative for the Boeing Commercial 

Airplanes Delegation Option Authorization 

Organization who has been authorized by the 

Manager, Seattle ACO, to make those 

findings. For a replacement or repair method 

to be approved, the replacement or repair 

must meet the certification basis of the 

airplane, and the approval must specifically 

refer to this AD. 

(4) Approved AMOCs to paragraph (c) of 

AD 2000–05–29 done before or concurrently 

with the requirements of paragraph (i) of this 

AD are approved as AMOCs for the 

corresponding provisions of paragraph (k) of 

this AD. 

(5) Approved AMOCs to paragraph (c) of 

AD 2001–02–01 done before or concurrently 

with the requirements of paragraph (i) of this 

AD are approved as AMOCs for the 

corresponding provisions of paragraph (l) of 

this AD. 

Material Incorporated by Reference 

(n) You must use Boeing Service Bulletin 

737–53A1225, Revision 1, dated April 14, 

2005, to perform the actions that are required 

by this AD, unless the AD specifies 

otherwise. The Director of the Federal 

Register approved the incorporation by 

reference of this document in accordance 

with 5 U.S.C. 552(a) and 1 CFR part 51. 

Contact Boeing Commercial Airplanes, P.O. 

Box 3707, Seattle, Washington 98124–2207, 

for a copy of this service information. You 

may review copies at the Docket Management 

Facility, U.S. Department of Transportation, 

400 Seventh Street SW., Room PL–401, 

Nassif Building, Washington, DC; on the 

Internet at http://dms.dot.gov; or at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at the NARA, 

call (202) 741–6030, or go to http:// 

www.archives.gov/federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

Issued in Renton, Washington, on 

January 19, 2007. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. E7–1396 Filed 1–30–07; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Bureau of Customs and Border 

Protection 

DEPARTMENT OF THE TREASURY 

19 CFR Parts 113, 141, and 151 

[CBP Dec. 07–02] 

RIN 1505–AB57 

Conditional Release Period and CBP 

Bond Obligations for Food, Drugs, 

Devices, and Cosmetics 

AGENCIES: Customs and Border 

Protection, Department of Homeland 

Security; Department of the Treasury. 

ACTION: Final rule. 

SUMMARY: This document amends the 

Customs and Border Protection (CBP) 

regulations to clarify the responsibilities 

of importers of food, drugs, devices, and 

cosmetics under the basic CBP 

importation bond and to provide a 

reasonable period of time to allow the 

Food and Drug Administration (FDA) to 

perform its enforcement functions with 

respect to these covered articles. The 

amendments include a provision for a 

specific conditional release period of 30 

days for any food, drug, device, or 

cosmetic which has been released under 

bond and for which admissibility is to 

be determined under the provisions of 

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4424 Federal Register / Vol. 72, No. 20 / Wednesday, January 31, 2007 / Rules and Regulations 

the Federal Food, Drug, and Cosmetic 

Act (the Act). The amendments also 

clarify the amount of liquidated 

damages that may be assessed when 

there is a breach of the terms and 

conditions of the bond and authorize 

any representative of FDA to obtain a 

sample of any imported article subject 

to section 801 of the Act, as amended. 

DATES: Effective Date: The amendments 

set forth in this document are effective 

on May 1, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Wende Schuster, Office of International 

Trade, (202–572–8761). 

SUPPLEMENTARY INFORMATION: 

Background 

Federal Food, Drug, and Cosmetic Act 

Section 801 of the Federal Food, Drug, 

and Cosmetic Act, as amended (21 

U.S.C. 381 referred to herein as section 

381), and the regulations promulgated 

under that statute, provide the basic 

legal framework governing the 

importation of food, drugs, devices, and 

cosmetics into the United States. Under 

21 U.S.C. 381(a), the Secretary of the 

Treasury shall deliver to the Secretary of 

Health and Human Services, upon 

request, samples of food, drugs, devices, 

and cosmetics which are being imported 

or offered for import. The Secretary of 

Health and Human Services is 

authorized under section 381(a) to 

refuse admission of, among other things, 

any article that appears from the 

examination or otherwise to be 

adulterated or misbranded or to have 

been manufactured, processed, or 

packed under insanitary conditions. In 

addition, the Secretary of the Treasury 

is required by section 381(a) to cause 

the destruction of any article refused 

admission unless the article is exported, 

under regulations prescribed by the 

Secretary of the Treasury, within 90 

days of the date of notice of the refusal 

or within such additional time as may 

be permitted pursuant to those 

regulations. 

Under 21 U.S.C. 381(b), pending 

decision (by FDA) as to the admission 

of an article being imported or offered 

for import, the Secretary of the Treasury 

may authorize delivery of that article to 

the owner or consignee upon the 

execution by him of a good and 

sufficient bond providing for the 

payment of liquidated damages in the 

event of default, as may be required 

pursuant to regulation. In addition, 

section 381(b) allows the owner or 

consignee in certain circumstances to 

take action to bring an imported article 

into compliance for admission purposes 

under such bonding requirements as the 

Secretary of the Treasury may prescribe 

by regulation. 

Authority Delegation 

On November 25, 2002, the President 

signed into law the Homeland Security 

Act of 2002, Public Law 107–296, 116 

Stat. 2135 (referred to in this document 

as ‘‘the HS Act’’), which involved, 

among other things, the creation of a 

new cabinet-level department, the 

Department of Homeland Security 

(DHS), and the transfer or reorganization 

of a number of executive branch 

agencies and offices within existing 

cabinet-level departments. This 

legislation and subsequent 

reorganization plans affected the 

organization and operation of the 

Customs Service. 

Section 402 of the HS Act provides 

that the Secretary of Homeland Security 

shall be responsible for administering 

the customs laws of the United States. 

With regard to the Customs Service, 

section 403(1) of the HS Act transferred 

the functions, personnel, assets, and 

liabilities of the Customs Service, 

including the functions of the Secretary 

of the Treasury relating to the Customs 

Service, to the Secretary of Homeland 

Security. However, notwithstanding the 

transfer of the Customs Service to DHS, 

section 412 of the HS Act provides that 

the legal authority vested in the 

Secretary of the Treasury over customs 

revenue functions is to be retained by 

the Secretary of the Treasury. Section 

412 also authorizes the Secretary of the 

Treasury to delegate any of the retained 

legal authorities over the customs 

revenue functions to the Secretary of 

Homeland Security. 

By Treasury Order 100–16, dated May 

15, 2003, the Secretary of the Treasury, 

by virtue of authority vested in him/her 

by 31 U.S.C. 321(b) and section 412 of 

the Homeland Security Act of 2002, 

delegated to the Secretary of Homeland 

Security authority for customs revenue 

functions with certain exceptions, 

including that contained in paragraph 

(1)(a)(i) of the Order by which the 

Secretary of the Treasury retains the 

sole authority to approve regulations 

concerning import quotas or trade bans, 

user fees, marking, labeling, copyright 

and trademark enforcement, and the 

completion of entry or substance of 

entry summary including duty 

assessment and collection, 

classification, valuation, application of 

the U.S. Harmonized Tariff Schedules, 

eligibility or requirements for 

preferential trade programs, and 

establishment of related recordkeeping 

requirements. As this final rule 

concerns activities involving both the 

completion of entry and the substance 

of the entry summary focusing on bond 

obligations and consequences that might 

arise as a result of post-entry and postsummary determinations of 

admissibility of merchandise, its subject 

matter is excepted from the delegation 

of authority to the Secretary of 

Homeland Security. Thus, the 

responsibility for this regulation rests 

with the Secretary of the Treasury. 

Applicable Regulations 

Based upon the above Federal Food, 

Drug, and Cosmetic Act statutory 

provisions, imported foods, drugs, 

devices, and cosmetics are conditionally 

released under bond while 

determinations as to admissibility are 

made; see 19 CFR 12.3. Under current 

19 CFR 141.113(c), CBP may demand 

the return to CBP custody of most types 

of merchandise that fail to comply with 

the laws or regulations governing their 

admission into the United States (also 

referred to as the redelivery procedure). 

The condition of the basic 

importation and entry bond contained 

in 19 CFR 113.62(d) sets forth the 

obligation of the importer of record to 

timely redeliver released merchandise 

to CBP on demand and provides that a 

demand for redelivery will be made no 

later than 30 days after the date of 

release of the merchandise or 30 days 

after the end of the conditional release 

period, whichever is later. Under 

current procedures, when imported 

merchandise is refused admission by 

the Food and Drug Administration 

(FDA), CBP issues a notice of redelivery 

in order to establish a claim for 

liquidated damages if the importer of 

record fails to export, destroy, or 

redeliver the refused merchandise in the 

time period prescribed in that notice of 

redelivery. 

CBP has taken the position in C.S.D. 

86–21 that the term ‘‘end of the 

conditional release period’’ in 19 CFR 

113.62(d) has reference to a set time 

limitation that is either established by 

regulation (see, for example, 19 CFR 

141.113(b) which prescribes a 180-day 

conditional release period for purposes 

of determining the correct country of 

origin of imported textiles and textile 

products) or by express notification to 

the importer of record. The end of the 

conditional release period does not refer 

to the liquidation of the entry covering 

the imported merchandise. 

Proposed Regulatory Changes 

On June 7, 2002, a Notice of Proposed 

Rulemaking was published in the 

Federal Register (67 FR 39322; the 

NPRM) that proposed to amend the 

regulations to provide for a specific 

conditional release period for 

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Federal Register / Vol. 72, No. 20 / Wednesday, January 31, 2007 / Rules and Regulations 4425 

merchandise for which the FDA is 

authorized to determine admissibility. 

The changes proposed were intended to 

clarify importers’ responsibilities under 

the bond, provide a defined period of 

time to allow the FDA to perform its 

enforcement functions, and provide 

finality to the process. 

The NPRM proposed to make the 

following specific changes to what were 

then referred to as the Customs 

regulations (now the CBP regulations): 

1. To redesignate some paragraphs in 

19 CFR 141.113 due to the addition of 

a new paragraph (c), which provided for 

a specific conditional release period of 

180 days for any food, drug, device, or 

cosmetic. The FDA would have this 

time period to make its determination of 

admissibility. Similar to the case of 

textiles and textile products mentioned 

above, the proposed amendment 

specified a 180-day conditional release 

period but also provided for a shorter 

period if FDA made a determination of 

inadmissibility before the expiration of 

that 180-day period. It is noted that 

under the proposed regulatory text, a 

demand for redelivery under 19 CFR 

113.62(d) could be made up to 210 days 

(that is, 180 days plus 30 days) after the 

date of release of the merchandise. (The 

standard CBP bond condition states that 

redelivery may be demanded within 30 

days after release or 30 days after the 

end of any applicable conditional 

release period, whichever is later.) The 

proposed regulation also made clear that 

the failure to redeliver merchandise 

would result in the assessment of 

liquidated damages equal to three times 

the value of the merchandise or equal to 

the domestic value of the merchandise 

in those instances where the port 

director has required a bond equal to the 

domestic value as permitted by current 

19 CFR 12.3. 

2. To amend 19 CFR 151.11 to 

authorize a representative of the FDA to 

obtain samples of food, drugs, devices, 

and cosmetic products covered by the 

Federal Food, Drug, and Cosmetic Act. 

Comments 

One hundred and forty (140) 

comments were received from 

importers, brokers, sureties, freight 

forwarders, express consignment 

operators, and trade associations. All 

commenters were opposed to the length 

of time of the proposed conditional 

release period. An analysis of those 

comments follows. 

Comment 

The vast majority of commenters 

stated that, as importers of food and 

health and beauty aid products, having 

a conditional release period of 180 days 

would effectively put them out of 

business. The costs involved in 

warehousing the goods would make 

their businesses unmanageable. 

Additionally, the long waiting period 

could cause products to fall out of 

specification, lose effectiveness, or 

become obsolete or unusable. These 

comments assume that any FDAregulated merchandise must be held 

intact for 180 days after entry. Other 

commenters who stated that the 180-day 

period is too long recognize that the 

intent of the regulation was not to 

require that all this merchandise be held 

during the pendency of the conditional 

release period, but rather that it only 

apply to merchandise for which an 

admissibility decision by FDA is not 

made. Many of these commenters 

specifically recommended that the 

conditional release period end upon 

issuance of a notice from FDA providing 

that the goods may proceed (a may 

proceed notice) or issuance of a notice 

of refusal if those acts occur before the 

end of the 180-day conditional release 

period. Various other commenters noted 

that under FDA’s own Regulatory 

Procedures Manual, articles which have 

been released by FDA are no longer 

considered to be in import status by that 

agency. 

Response 

After review of all the comments, CBP 

concurs that the 180-day conditional 

release period is too long. Thus, the 

regulatory text of this final rule is 

amended to provide that the conditional 

release period ends upon the soonest 

occurring of the following events: 

issuance by the FDA that the 

merchandise may proceed, issuance of a 

notice of refusal of admission, or 

expiration of the 30-day period after 

release of the goods. 

It was not the intention of the 

proposed regulation to require that all 

goods regulated by the FDA be 

warehoused for 6 months while the 

conditional release period runs its 

course. When FDA issues a notice that 

the merchandise may proceed (which is 

the case on the vast majority of entries 

that come under FDA scrutiny), that act 

will serve to end the conditional release 

period. Accordingly, we concur with the 

commenter who recommended 

amendment of the proposed rule to 

indicate that the conditional release 

period ends upon issuance of the notice 

by FDA that the merchandise may 

proceed. In addition, the issuance of a 

notice of refusal of admission would 

end the conditional release period. 

There may be some situations where 

FDA will need additional time to 

determine admissibility. Accordingly, 

the final rule also includes regulatory 

language that would permit FDA to 

extend the general 30-day conditional 

release period through express 

notification to the importer identifying 

the necessary testing requiring this 

extension. 

Comment 

Many commenters opposed the 180- 

day conditional release period for the 

reason that it extends the current 

conditional release period of 30 days. 

Response 

Under the conditions of the basic 

importation bond, in order to establish 

a valid claim for liquidated damages for 

failure to redeliver merchandise into 

CBP custody, CBP must issue a notice 

of redelivery within 30 days of CBP 

release of merchandise or within 30 

days after the end of the conditional 

release period, whichever is later. As 

stated in the notice of proposed 

rulemaking, there currently exists no 

conditional release period created by 

regulation for merchandise the 

admissibility of which is determined by 

the FDA. Therefore, neither the 

proposed rulemaking nor this final rule 

extends the conditional release period 

from 30 to 180 days because no express 

conditional release period for FDA 

contexts has ever been created by 

regulation. The commenters were 

apparently confusing the conditional 

release period with the 30-day period, 

after the conditional release period, 

during which CBP may still demand 

redelivery. 

Comment 

One commenter suggested that the 

proposed sampling procedures would 

result in the compromising of its 

packaging between manufacturing sites 

and customers’ facilities. The 

commenter proposed a process whereby 

it and other manufacturers could 

provide dedicated samples of present 

and proposed imported products, and 

CBP could maintain a data bank of 

importers and known imported 

products covered by these regulations. 

Response 

The commenter’s suggestion is 

outside the scope of the regulation 

because it proposes an examination 

procedure that is not done on a 

shipment-by-shipment basis. Under the 

provisions of 21 U.S.C. 381, CBP 

delivers to the Secretary of Health and 

Human Services such samples of food, 

drugs, devices, and cosmetics that are 

being imported or offered for import 

into the United States. Through these 

regulations, this sampling authority is 

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4426 Federal Register / Vol. 72, No. 20 / Wednesday, January 31, 2007 / Rules and Regulations 

delegated to the FDA in recognition of 

the practicalities of merchandise 

inspection. This will clarify that FDA 

inspectors may, under section 381(a), 

pull samples of imports of food, drugs, 

devices, and cosmetics. 

Comment 

One commenter asked whether CBP 

contemplates changing line release 

(otherwise known as Border Release 

Advanced Screening and Selectivity 

(BRASS)) procedures to accommodate 

the exchange of information necessary 

for providing notices of sampling. 

Response 

Contemplated changes to line release 

(otherwise known as BRASS release) 

systems are operational in nature and 

are, thus, outside the scope of this 

rulemaking. 

Comment 

One commenter suggested that the 

rule must be rescinded in order to 

comply with Executive Order (E.O.) 

12866. The commenter stated that given 

the huge volume of imports involved, 

the storage costs alone would almost 

certainly exceed the $100 million 

threshold or would, at the very least, 

adversely affect in a material way the 

economy, a sector of the economy, 

productivity, competition, or jobs. 

Response 

The commenter did not provide detail 

or justification for these comments, but 

CBP does not believe that storage costs 

of this magnitude would be incurred as 

a result of the rule now being 

promulgated. As noted above, CBP does 

believe that the 180-day conditional 

release period originally proposed is too 

long and realizes that this time period 

could negatively affect importers. To 

that end, CBP has modified the 

conditional release period from 180 

days to 30 days in the final rule to 

reduce potential negative impacts to 

imports and corresponding storage 

costs. 

Comment 

Various commenters state that CBP 

has failed to comply with the Regulatory 

Flexibility Act, disagreeing with the 

statement in the proposed rulemaking 

that the proposed amendments, if 

adopted, will not have a significant 

impact on a substantial number of small 

entities. The commenters claim that, 

contrary to the assertion in the notice of 

proposed rulemaking, assessment of 

liquidated damages of three times the 

value of imported merchandise could 

have a devastating impact upon the 

many thousands of small companies 

engaged in the importation of FDAregulated products. It is also stated that 

the proposed rulemaking represents a 

radical departure from current CBP 

policy with regard to redelivery of FDAregulated products. 

Response 

CBP does not agree because the rule 

is not a radical departure from current 

CBP policy. Additionally, in response to 

the comments to the proposed rule, the 

final rule reduces the conditional 

release period time from 180 days to 30 

days, and potential costs that could be 

incurred should now be substantially 

less. The rule should not affect small 

entities that are compliant with 

redelivery requirements, and the rule 

does not impose further entry 

requirements or additional paperwork 

burden. 

Comment 

Various commenters suggested that 

CBP rescind or place a stay on 

consideration of the proposed 

rulemaking until the implications of 

recently passed legislation governing 

port security can be considered in 

relation to FDA’s inspection protocol 

and CBP’s release procedures. The 

commenters indicated that the new law 

requires that importers provide CBP and 

FDA with advance notice of their intent 

to import food products—a procedure 

that should enhance FDA’s ability to 

promptly identify shipments that pose a 

safety concern. Those commenters also 

stated that the proposed rule should be 

rescinded in order to allow CBP and 

FDA to examine and discuss 

standardization of FDA notifications to 

importers and to take into account the 

commercial needs of the importing 

community. 

Response 

CBP disagrees. We are unaware of 

legislation governing port security that 

impinges upon or supplants FDA’s 

authority to refuse merchandise 

pursuant to the provisions of 21 U.S.C. 

381(a). That provision allows for the 

release of merchandise under bond 

while the determination as to 

admissibility is made. This rulemaking 

simply provides for the creation of a 

conditional release period for FDA 

contexts that is more clearly defined 

than the practice that currently exists. 

Furthermore, the Bioterrorism Act 

creates a new section 21 U.S.C. 381(m), 

which specifically indicates that FDAregulated food and food products for 

which prior notice of arrival is not 

received shall not be released under a 

bond authorized by section 381(b). As 

set out in implementing regulations 

issued by FDA and CBP (see 68 FR 

58974), decisions regarding compliance 

with new prior notice requirements are 

different from, and may precede, 

determinations of admissibility under 

other sections of the Federal Food, Drug, 

and Cosmetic Act or other laws. (See 21 

CFR 1.283(g).) While CBP believes that 

the Bioterrorism Act will affect the 

importation of FDA-regulated products, 

it does not serve to overrule regulations 

concerning longstanding FDA and CBP 

authorities. Effect must be given to all 

of the substantive provisions of 21 

U.S.C. 381, not part of them. Further, 

since the FDA-regulated food or food 

products for which prior notice of 

arrival is not received will not be 

released under a bond authorized by 

section 381(b), any issues arising 

concerning a conditional release period 

for merchandise released under bond 

are moot. 

Comment 

One commenter suggested that the 

time period to comment on the 

proposed rule be extended because of 

the complex underlying issues involved. 

Response 

CBP disagrees that the comment 

period needed to be extended. CBP 

received 140 comments to the proposed 

rule, and a wide variety of issues were 

presented in these comments. The 

primary concern, which was raised by 

all commenters to the proposed rule, 

was the length of the conditional release 

period. In response to this concern CBP 

has reduced the conditional release 

period from 180 to 30 days. 

Comment 

Many commenters conceded that it 

may be appropriate to clearly define a 

conditional release period, but they also 

suggested that 30 days would be a 

reasonable conditional release period 

for these products. Those same 

commenters also stated that CBP must 

further clarify and limit the scope of the 

proposed rule. Clarification is needed 

that clearly exempts from the 

conditional release period shipments 

that have been issued a may proceed 

notice. The commenters also suggested 

that FDA should notify importers when 

an entry is deemed conditional. As 

proposed, the commenters claimed that 

the rule represents a radical departure 

from current practices when the release 

of imported product is only rendered 

conditional through FDA’s timely 

notification of its intent to examine or 

sample the product. 

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Federal Register / Vol. 72, No. 20 / Wednesday, January 31, 2007 / Rules and Regulations 4427 

Response 

CBP agrees that the rule should make 

clear that a conditional release period 

ends when FDA provides a may proceed 

notice. The final rule has been amended 

accordingly. CBP also agrees that a 

conditional release period shorter than 

180 days is appropriate and has 

amended the rule to provide for a 

conditional release period of 30 days 

after the release of the merchandise 

unless FDA issues a may proceed notice 

or a notice of refusal which would 

immediately end the conditional period 

as provided for in the final rule. 

However, shipments that have been 

issued a may proceed notice are still 

subject to demands for redelivery for 30 

days from the issuance of the may 

proceed notice. The regulation confirms 

that all FDA-regulated products under 

the Federal Food, Drug, and Cosmetic 

Act are conditionally released pending 

FDA’s determination of admissibility. In 

the vast majority of cases the 

conditional release period will end 

when the may proceed notice is 

provided before the end of the time 

provided in the regulation. 

Comment 

Various commenters contended that 

CBP seeks to modify its regulations in 

order to reverse the result of the court 

decision in United States v. So’s USA 

Company, Inc., 23 CIT 605 (1999). These 

commenters stated that the So’s court 

indicated that an importer must have 

affirmative notice that goods are 

released conditionally in order to 

extend the redelivery period beyond the 

30 days from the date of release. 

Another stated that under the proposed 

regulation, FDA would no longer be 

required to advise an importer why its 

product is on hold, or even that it is on 

hold, within the first 30 days of entry. 

Response 

CBP disagrees. The final rule is 

entirely consistent with the So’s opinion 

and it does not conflict with that 

opinion in any respect. Further, this 

regulation does not affect any notice 

that FDA provides to an importer under 

its authorities. 

Comment 

One commenter stated that the 

proposal is arbitrary because the 

Government has not explained the need 

for a 180-day period to render a decision 

on admissibility. The statement in the 

proposed rule that the 180-day period is 

a reasonable period of time to allow the 

FDA to perform its enforcement 

functions is not supported by any 

explanation. 

Response 

Again, CBP agrees that the 180-day 

period is too long a time period to have 

this merchandise conditionally released 

by regulation. Accordingly, the 

conditional release period has been 

reduced to 30 days in the final 

regulation. The 30-day release period 

can be shortened by the earlier issuance 

of a may proceed notice or a notice of 

refusal of admission. It also can be 

extended by an express notification 

from FDA to the importer. 

Comment 

One commenter suggested that FDA 

import inspectors issue a notice of 

review with regard to any shipment for 

which a may proceed notice is not 

provided. The commenter stated that 

the conditional release period could be 

established from the issuance date of the 

notice of review. That same commenter 

stated that for perishable products, the 

conditional release period should not 

exceed 5 days. For non-perishable 

products, the conditional release period 

should not exceed 30 days. 

Response 

Issuance of a new FDA form of notice 

that a shipment is under review is 

beyond the scope of this regulation. CBP 

disagrees that a conditional release 

period should be for as little as 5 days. 

The taking of samples and testing of 

merchandise could exceed that 5-day 

time period. 

Comment 

Some commenters stated that the 180- 

day conditional release period is not 

consistent with the Customs-Trade 

Partnership Against Terrorism (C-TPAT) 

in that homeland security efforts are 

focused on increased review of imports 

at the time of admission. The proposed 

180-day period would provide no 

potential homeland security benefits 

since the materials would already be 

conditionally released to importers. 

Response 

CBP acknowledges that the proposed 

180-day conditional release period is 

too long and has revised the regulation 

accordingly. Review of cargo for 

terrorism concerns preferably is 

performed earlier than the time of 

admission of merchandise. In fact, 

review for terrorism concerns is 

performed in the information 

transmission or presentation process, 

which is in advance of arrival. For 

example, the FDA’s prior notice 

regulations (21 CFR 1.276 et seq.) 

require notice of food being imported or 

offered for import into the United States 

in advance of the foods’ arrival, and 

CBP’s advance electronic cargo 

information regulations (set forth in 68 

FR 68140) require information 

concerning cargo before the cargo is 

brought into the United States by any 

mode of transportation, so that CBP can 

pre-screen all cargo based on advance 

data transmission. CBP’s enforcement of 

these requirements is consistent with CTPAT. The conditional release period is 

meant to address the longstanding 

application of the provisions of the 

Federal Food, Drug, and Cosmetic Act, 

which allow for the release of 

merchandise under good and sufficient 

bond pending an admissibility 

determination and therefore is in 

addition to the prior notice and advance 

cargo information requirements that 

implement border security measures. 

Comment 

Many commenters stated that a 180 

day conditional release period is 

contrary to public policy in that 

merchandise which causes a public 

health or safety issue should be 

identified and refused by FDA as 

quickly as possible. A 180-day period 

raises an unreasonable risk. 

Response 

CBP has revised the regulation to 

provide for a 30-day conditional release 

period in order to address this concern. 

Comment 

Many commenters indicated that if 

the redelivery period was shorter than 

the 180-days prescribed, companies 

would hold merchandise pending such 

a period and there would be more 

chance for a successful recall for safety 

concerns, since there is less chance that 

the goods would have been used or 

consumed. 

Response 

CBP agrees and has revised the final 

rule to provide for a 30-day conditional 

release period in order to address this 

concern. 

Comment 

One commenter suggested that CBP 

should strive to allow unconditional 

release of FDA-regulated merchandise 

with the filing of the CF–3461 (CBP 

entry document) as long as the entry 

summary and carrier manifest data are 

consistent with information contained 

within the FDA approved product 

listings. 

Response 

CBP disagrees because this would 

have CBP making decisions as to 

admissibility under the Federal Food, 

Drug, and Cosmetic Act when this 

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4428 Federal Register / Vol. 72, No. 20 / Wednesday, January 31, 2007 / Rules and Regulations 

decision-making authority clearly 

resides with the Secretary of Health and 

Human Services. 

Comment 

Many commenters stated that the 

proposed amendment to 19 CFR 151.10 

of the CBP regulations regarding the 

collection of samples is not necessary. 

The commenters noted that the 

provisions of section 702(a) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 372) already allow for the 

taking of samples by representatives of 

FDA. 

Response 

Under the provisions of 21 U.S.C. 

381(a), CBP delivers samples of food, 

drugs, devices, and cosmetics that are 

being imported or offered for import 

into the United States, to the Secretary 

of Health and Human Services upon his 

request. The proposed amendment 

simply clarifies that such delivery 

authority is delegated to representatives 

of FDA and is not intended to intrude 

on any other authority that the Secretary 

of Health and Human Services may 

already have. 

Comment 

A group of commenters suggested the 

adoption of regulatory language that 

would preclude the issuance of fines or 

penalties against an importer who 

distributes articles after having received 

an FDA may proceed notice. 

Response 

CBP disagrees with this proposed 

language. CBP cannot by regulatory 

amendment exempt an importer from 

incurring fines or penalties that may 

otherwise be imposed for violation of a 

statute. 

Comment 

Various commenters stated that 

imposition of a 180-day conditional 

release period is violative of U.S. 

international obligations under the 

GATT 1994, and one commenter 

indicated that the proposed rule is 

violative of the Agreement on the 

Application of Sanitary and 

Phytosanitary Measures. While 

conceding that some additional controls 

at the border are acceptable, these 

commenters asserted that extending 

CBP control over imports for a sevenmonth period after importation would 

not stand scrutiny. Additionally, it was 

noted that sanitary and phytosanitary 

procedures must be undertaken and 

completed without undue delay 

(commenter’s emphasis) and in no less 

favorable a manner for imported 

products than for like domestic 

products. Imposition of a conditional 

release period of 180 days is claimed to 

be violative of this ‘‘undue delay’’

proscription. 

Response 

Again, CBP has reduced the 

conditional release period from 180 to 

30 days in the final rule. 

Comment 

Some commenters indicated that 

continuation of a conditional release 

period after FDA admits goods into 

commerce is inconsistent with the 

provisions of the Federal Food, Drug, 

and Cosmetic Act. The commenters 

stated that conditional delivery of the 

merchandise to the owner is made 

pending a decision as to admission 

generally, and not solely a decision to 

deny admission. It is argued that 

conditional release also ends upon 

admission of the article and, as such, 

CBP’s proposal to extend the 

conditional release period to 180 days 

without concern as to whether the 

merchandise has been admitted defeats 

the statutory intent of the Act. In 

contrast, another commenter stated that 

once a positive determination as to 

admissibility is made, the importer 

should not have to be subjected to the 

possibility of a redelivery demand for 

sampling or testing of the product. The 

latter commenter further contended that 

even after receiving a may proceed 

notice, an importer is left in the dark as 

to the status of goods that are apparently 

admitted into the commerce. 

Response 

CBP agrees that issuance of a notice 

from FDA that the merchandise may 

proceed would usually make it 

unnecessary to issue a redelivery notice 

in order to establish liability under the 

bond. For purposes of clarity, CBP is 

amending the language in the final rule 

to indicate that one of three acts 

occurring first in time—issuance of a 

notice of refusal, issuance of a may 

proceed notice or passage of 30 days 

from the date of conditional release—

will end the conditional release period. 

However, it should be understood that 

issuance of a may proceed notice does 

not mean that CBP is precluded from 

issuing a subsequent demand to 

redeliver within 30 days from the end 

of that conditional release period. 

Comment 

Two commenters suggested that 

sureties be given the earliest possible 

notice (preferably in electronic form) 

that goods they have secured are subject 

to detention, refusal, and/or redelivery 

in order that immediate action can be 

taken with regard to pending and future 

importations. Also, mitigation 

guidelines should be adopted that 

provide extraordinary mitigation to 

sureties for efforts to locate, redeliver, 

and/or rehabilitate goods which are 

subject to liquidated damages for failure 

to redeliver into CBP custody. 

Response 

Mitigation guidelines for claims for 

liquidated damages are outside the 

scope of this rulemaking. Issuance of 

notices of detention and refusal are 

governed by FDA statute and regulation 

and any changes to issuance of those 

documents are also outside the scope of 

this regulation. Notices of redelivery 

may include private or confidential 

business information that would not be 

releasable to a surety unless a demand 

for payment was made against its bond. 

Comment 

One commenter proposed that the 

regulation require that all demands for 

redelivery be made contemporaneously 

with the notice of refusal issued by 

FDA. The commenter contended that 

this change would promote cooperation 

between FDA and CBP and encourage 

compliance through the more efficient 

issuance of required notices. 

Response 

CBP does not agree because, for 

operational reasons, it may not always 

be possible for notices to be issued 

contemporaneously. 

Conclusion 

In accordance with the foregoing 

analysis of the comments and further 

consideration of the matter, CBP has 

determined that the amendments of the 

proposed rule should be adopted as 

final with the sole major change being 

a reduction in the conditional release 

period from 180 days to 30 days, as set 

forth in the regulatory text further 

below. In addition, cross-references to 

the section of the regulations involving 

conditional release periods are being 

added to the relevant portion of the 

section on basic importer and entry 

bond conditions in 19 CFR 113.62. 

Executive Order 12866 and the 

Regulatory Flexibility Act 

This rule is not considered to be a 

significant regulatory action under 

Executive Order 12866. Accordingly, a 

regulatory assessment is not required. 

It is certified, pursuant to the 

provisions of the Regulatory Flexibility 

Act (5 U.S.C. 601 et seq.), that the 

regulatory amendments set forth in this 

final rule will not have a significant 

economic impact on a substantial 

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Federal Register / Vol. 72, No. 20 / Wednesday, January 31, 2007 / Rules and Regulations 4429 

number of small entities. The rule 

should not affect small entities that are 

compliant with redelivery requirements, 

and the rule does not impose further 

entry requirements or additional 

paperwork burdens. 

A review of data for FY2004 indicates 

actual CBP liquidated damage 

collections for FDA jurisdiction goods 

are comparatively rare and of modest 

amounts. The total amount of liquidated 

damages collected in FY2004 for these 

goods was approximately $4 million. 

The total revenue (including those 

liquidated damages) collected for all 

imports was $27 billion. This amount 

reflects 6,000 liquidated damage cases, 

compared to 28.1 million entries of all 

goods worth $1.41 trillion. Pertinent 

cases and liquidated damage amounts 

are a tiny fraction (less than 1 percent) 

of overall revenue collected and import 

value. The value of liquidated damages 

collected changes minimally from year 

to year based on the number of 

importers, the number of bonds, and the 

number of violations. CBP does not 

expect this amount to change as a result 

of this rule. 

Additionally, the conditional release 

period should help importers, regardless 

of size, by clarifying that CBP must 

issue a redelivery notice within 30 days 

if it wishes to collect liquidated 

damages. As noted previously, there is 

currently no set date to issue a 

redelivery notice. The rule will compel 

CBP to act more quickly to provide 

notice to importers that violate the 

conditions of their bond. If CBP cannot 

act within the 30 days, it then foregoes 

collecting any liquidated damages. 

List of Subjects 

19 CFR Part 113 

Customs bond conditions. 

19 CFR Part 141 

Bonds, Customs duties and 

inspection, Entry procedures, Imports, 

Prohibited merchandise, Release of 

merchandise. 

19 CFR Part 151 

Customs duties and inspection, 

Examination, Sampling and testing, 

Imports, Laboratories, Penalties, 

Reporting and recordkeeping 

requirements. 

Amendments to the Regulations 

■ For the reasons stated above, parts 

113, 141, and 151 of the CBP regulations 

(19 CFR Parts 141 and 151) are amended 

as set forth below. 

PART 113—CUSTOMS BOND 

CONDITIONS 

■ 1. The authority citation for part 113 

continues to read in part as follows: 

Authority: 19 U.S.C. 66, 1623, 1624. 

* * * * * 

§ 113.62 [Amended] 

■ 2. Section 113.62(d) is amended by 

adding a sentence at the end to read as 

follows: ‘‘(See §§ 141.113(b), 12.73(b)(2), 

and 12.80 of this chapter.)’’

PART 141—ENTRY OF MERCHANDISE 

■ 3. The authority citation for part 141 

continues to read in part as follows: 

Authority: 19 U.S.C. 66, 1448, 1484, 1624. 

* * * * * 

Section 141.113 also issued under 19 

U.S.C. 1499, 1623. 

■ 4. Section 141.113 is amended as 

follows: 

■ a. The heading of the section is 

revised to read as set forth below; 

■ b. Paragraph (a) is amended by, after 

the heading, designating the 

introductory text of paragraph (a) as 

paragraph (a)(1), redesignating current 

paragraphs (1) through (5) as paragraphs 

(a)(1)(i) through (v), and designating the 

remaining text, after redesignated 

paragraph (a)(1)(v), as paragraph (a)(2); 

■ c. In redesignated paragraph (a)(2), 

first sentence, the words ‘‘Customs 

custody’’ are removed and replaced 

with the words ‘‘CBP custody’’; 

■ d. In paragraph (b), the two references 

to ‘‘Customs’’ are replaced with 

reference to ‘‘CBP’’ and the three 

references to ‘‘Customs custody’’ are 

replaced with reference to ‘‘CBP 

custody’’; 

■ e. Current paragraphs (c) through (h) 

are redesignated as paragraphs (d) 

through (i); 

■ f. New paragraph (c) is added; 

■ g. In redesignated paragraph (d), the 

words ‘‘in paragraph (a) or (b) of this 

section’’ are removed and replaced with 

the words ‘‘in paragraph (a), (b), or (c) 

of this section’’, and the words 

‘‘Customs custody’’ are removed and 

replaced with the words ‘‘CBP custody’’; 

■ h. In redesignated paragraphs (e) and 

(f), the words ‘‘Customs custody’’ are 

removed and replaced with the words 

‘‘CBP custody’’; 

■ i. In redesignated paragraph (g), first 

sentence, the words ‘‘Customs custody’’

are removed and replaced with the 

words ‘‘CBP custody’’; and 

■ j. In redesignated paragraph (h) and in 

the first sentence of redesignated 

paragraph (i), the words ‘‘Customs 

custody’’ are removed and replaced 

with the words ‘‘CBP custody’’. 

The revisions read as follows: 

§ 141.113 Recall of merchandise released 

from Customs and Border Protection 

custody. 

* * * * * 

(c) Food, drugs, devices, and 

cosmetics—(1) Conditional release 

period. For purposes of determining the 

admissibility of any food, drug, device, 

or cosmetic imported pursuant to 

section 801(a) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 381(a)), as 

amended, the release from CBP custody 

of any such product will be deemed 

conditional. Unless extended in 

accordance with paragraph (c)(2) of this 

section, the conditional release period 

will terminate upon the earliest 

occurring of the following events: 

(i) The date that FDA issues a notice 

of refusal of admission; 

(ii) The date that FDA issues a notice 

that the merchandise may proceed; or 

(iii) Upon the end of the 30-day 

period following the date of release. 

(2) Extension of conditional release 

period. The conditional release period 

provided under this paragraph (c) may 

be extended. The FDA must issue a 

written or electronic notice of sampling, 

detention, or other FDA action to the 

bond principal (i.e., importer of record) 

within 30 days of the release of the 

merchandise in order for the extension 

of the conditional release period to be 

valid. 

(3) Issuance of a redelivery notice. If 

FDA refuses admission of a food, drug, 

device or cosmetic into the United 

States, or if any notice of sampling or 

other request is not complied with, FDA 

will communicate that fact to the CBP 

port director who will demand the 

redelivery of the product to CBP 

custody. CBP will issue a notice of 

redelivery within 30 days from the date 

the product was refused admission by 

the FDA or from the date FDA 

determined the noncompliance with a 

notice of sampling or other request. The 

demand for redelivery may be made 

contemporaneously with the notice of 

refusal issued by the FDA. 

Notwithstanding the provisions of 

paragraph (i) of this section, a failure to 

comply with a demand for redelivery 

made under this paragraph (c) will 

result in the assessment of liquidated 

damages equal to three times the value 

of the merchandise involved unless the 

port director has prescribed a bond 

equal to the domestic value of the 

merchandise pursuant to § 12.3(b) of 

this Chapter. 

* * * * * 

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4430 Federal Register / Vol. 72, No. 20 / Wednesday, January 31, 2007 / Rules and Regulations 

PART 151—EXAMINATION, 

SAMPLING, AND TESTING OF 

MERCHANDISE 

■ 5. The general authority citation for 

part 151 continues to read, and a 

specific authority citation for § 151.11 is 

added to read, as follows: 

Authority: 19 U.S.C. 66, 1202 (General 

Notes 3(i) and 3(j), Harmonized Tariff 

Schedule of the United States (HTSUS)), 

1624. 

Section 151.11 also issued under 21 U.S.C. 

381; 

* * * * * 

■ 6. Section 151.11 is amended as 

follows: 

■ a. In the first sentence, the words 

‘‘Customs custody’’ are removed and 

replaced with the words ‘‘CBP custody’’; 

■ b. In the second sentence, the words 

‘‘Customs custody’’ are replaced with 

the words ‘‘CBP custody’’; and 

■ c. After the second sentence, a third 

sentence is added, to read as follows: 

§ 151.11 Request for samples or additional 

examination packages after release of 

merchandise. 

* * * For purposes of determining 

admissibility, representatives of the 

Food and Drug Administration may 

obtain samples of any food, drug, 

device, or cosmetic, the importation of 

which is governed by section 801 of the 

Federal Food, Drug, and Cosmetic Act, 

as amended (21 U.S.C. 381). 

Deborah J. Spero, 

Acting Commissioner, Customs and Border 

Protection. 

Approved: January 25, 2007. 

Timothy E. Skud, 

Deputy Assistant Secretary of the Treasury. 

[FR Doc. 07–408 Filed 1–30–07; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF TRANSPORTATION 

Saint Lawrence Seaway Development 

Corporation 

33 CFR Part 402 

[Docket No. SLSDC 2006–26584] 

RIN 2135–AA25 

Tariff of Tolls 

AGENCY: Saint Lawrence Seaway 

Development Corporation, DOT. 

ACTION: Final rule. 

SUMMARY: The Saint Lawrence Seaway 

Development Corporation (SLSDC) and 

the St. Lawrence Seaway Management 

Corporation (SLSMC) of Canada, under 

international agreement, jointly publish 

and presently administer the St. 

Lawrence Seaway Tariff of Tolls in their 

respective jurisdictions. The Tariff sets 

forth the level of tolls assessed on all 

commodities and vessels transiting the 

facilities operated by the SLSDC and the 

SLSMC. The SLSDC is revising its 

regulations to reflect the fees and 

charges levied by the SLSMC in Canada 

starting in the 2007 navigation season, 

which are effective only in Canada. An 

amendment to increase the minimum 

charge per lock for those vessels that are 

not pleasure craft or subject in Canada 

to tolls under items 1 and 2 of the Tariff 

for full or partial transit of the Seaway 

will apply in the U.S. Also, the SLSDC 

is changing the toll charged per pleasure 

craft using the U.S. locks from $25 U.S. 

or $30 Canadian to $30 U.S. or $30 

Canadian. Several minor editorial 

corrections are being made in § 402.3, 

‘‘Interpretation.’’ and § 402.6, 

‘‘Description and weight of cargo.’’ (See 

SUPPLEMENTARY INFORMATION.) 

DATES: This rule is effective March 2, 

2007. 

FOR FURTHER INFORMATION CONTACT: 

Craig H. Middlebrook, Acting Chief 

Counsel, Saint Lawrence Seaway 

Development Corporation, 400 Seventh 

Street, SW., Washington, DC 20590, 

(202) 366–0091. 

SUPPLEMENTARY INFORMATION: The Saint 

Lawrence Seaway Development 

Corporation (SLSDC) and the St. 

Lawrence Seaway Management 

Corporation (SLSMC) of Canada, under 

international agreement, jointly publish 

and presently administer the St. 

Lawrence Seaway Tariff of Tolls 

(Schedule of Fees and Charges in 

Canada) in their respective jurisdictions. 

The Tariff sets forth the level of tolls 

assessed on all commodities and vessels 

transiting the facilities operated by the 

SLSDC and the SLSMC. The SLSDC is 

revising 33 CFR 402.8, ‘‘Schedule of 

tolls’’, to reflect the fees and charges 

levied by the SLSMC in Canada 

beginning in the 2007 navigation 

season. With one exception, the changes 

affect the tolls for commercial vessels 

and are applicable only in Canada. The 

collection of tolls by the SLSDC on 

commercial vessels transiting the U.S. 

locks is waived by law (33 U.S.C. 

988a(a)). Accordingly, no notice or 

comment was necessary on these 

amendments. 

The SLSDC is amending 33 CFR 

402.8, ‘‘Schedule of tolls’’, to increase 

the minimum charge per vessel per lock 

for full or partial transit of the Seaway 

from $20.40 to $25.00. This charge is for 

vessels that are not pleasure craft or 

subject in Canada to the tolls under 

items 1 and 2 of the Tariff. This increase 

is due to higher operating costs at the 

locks. 

The SLSDC is modifying its practice 

regarding the collection of pleasure craft 

tolls by allowing pleasure craft 

operators to pay the toll for transiting 

the U.S. locks, Eisenhower and Snell, in 

either $30 U.S. or $30 Canadian. 

Currently the toll is payable in $25 U.S. 

or $30 Canadian; however, this has 

resulted in confusion to pleasure craft 

operators when transiting both 

Canadian and U.S. locks. With almost 

eighty (80) percent of the tolls for 

pleasure crafts being paid in Canadian 

dollars and little disparity between the 

U.S. and Canadian exchange rates, the 

SLSDC is streamlining the pleasure craft 

toll collection process by allowing for 

payment in either $30 U.S. or $30 

Canadian. Additionally, the SLSDC is 

making several minor editorial changes 

to 33 CFR402.3 and 33 CFR 402.5. 

Interested parties have been afforded an 

opportunity to comment; however no 

comments were received. 

Regulatory Notices: Privacy Act: 

Anyone is able to search the electronic 

form of all comments received into any 

of our dockets by the name of the 

individual submitting the comment (or 

signing the comment, if submitted on 

behalf of an association, business, labor 

union, etc.). You may review DOT’s 

complete Privacy Act Statement in the 

Federal Register published on April 11, 

2000 (Volume 65, Number 70; Pages 

19477–78) or you may visit http:// 

dms.dot.gov. 

Regulatory Evaluation 

This regulation involves a foreign 

affairs function of the United States and 

therefore Executive Order 12866 does 

not apply and evaluation under the 

Department of Transportation’s 

Regulatory Policies and Procedures is 

not required. 

Regulatory Flexibility Act 

Determination 

I certify this regulation will not have 

a significant economic impact on a 

substantial number of small entities. 

The St. Lawrence Seaway Tariff of Tolls 

primarily relate to commercial users of 

the Seaway, the vast majority of whom 

are foreign vessel operators. Therefore, 

any resulting costs will be borne mostly 

by foreign vessels. 

Environmental Impact 

This regulation does not require an 

environmental impact statement under 

the National Environmental Policy Act 

(49 U.S.C. 4321, et reg.) because it is not 

a major federal action significantly 

affecting the quality of the human 

environment. 

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