This section of the FEDERAL REGISTER

contains documents other than rules or

proposed rules that are applicable to the

public. Notices of hearings and investigations,

committee meetings, agency decisions and

rulings, delegations of authority, filing of

petitions and applications and agency

statements of organization and functions are

examples of documents appearing in this

section.

Notices Federal Register

46174 

Vol. 86, No. 157 

Wednesday, August 18, 2021 

1To view the notice, the PRA, CIED, and the 

comments we received, go to www.regulations.gov. 

Enter APHIS–2018–0078 in the Search field. 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2018–0078] 

Decision To Revise the Requirements 

for the Importation of Fresh Citrus 

Fruit From Australia Into the 

Continental United States 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are advising the public of 

our decision to revise the requirements 

for the importation of citrus from 

Australia in order to authorize the 

importation into the continental United 

States of citrus from additional areas of 

production. Based on the findings of a 

pest risk analysis, which we made 

available to the public for review and 

comment through a previous notice, we 

have determined that the application of 

one or more designated phytosanitary 

measures will be sufficient to mitigate 

the risks of introducing or disseminating 

plant pests or noxious weeds via the 

importation of citrus from these 

additional authorized areas of 

production in Australia. 

DATES: The articles covered by this 

notification may be authorized for 

importation under the revised 

requirements beginning August 18, 

2021. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Tony Roma ́n, Senior Regulatory Policy 

Specialist, Regulatory Coordination and 

Compliance, PPQ, APHIS, 4700 River 

Road, Unit 133, Riverdale, MD 20737– 

1231; (301) 851–2242. 

SUPPLEMENTARY INFORMATION: 

Background 

Under the regulations in ‘‘Subpart L— 

Fruits and Vegetables’’ (7 CFR 319.56– 

1 through 319.56–12, referred to below 

as the regulations), the Animal and 

Plant Health Inspection Service (APHIS) 

of the U.S. Department of Agriculture 

(USDA) prohibits or restricts the 

importation of fruits and vegetables into 

the United States from certain parts of 

the world to prevent plant pests from 

being introduced into and spread within 

the United States. 

Section 319.56–4 of the regulations 

provides the requirements for 

authorizing the importation of fruits and 

vegetables into the United States, and it 

revises existing requirements for the 

importation of fruits and vegetables. 

Paragraph (c) of that section provides 

that the name and origin of all fruits and 

vegetables authorized importation into 

the United States, as well as their 

importation requirements, are listed on 

the internet in APHIS’ Fruits and 

Vegetables Import Requirements 

database, or FAVIR (https://

epermits.aphis.usda.gov/manual). It 

also provides that, if the Administrator 

of APHIS determines that any of the 

phytosanitary measures required for the 

importation of a particular fruit or 

vegetable are no longer necessary to 

reasonably mitigate the plant risk posed 

by the fruit or vegetable, APHIS will 

publish a notice in the Federal Register 

making its pest risk documentation and 

determination available for public 

comment. 

In accordance with that process, we 

published a notice 1 in the Federal 

Register on December 17, 2020 (85 FR 

81869–81871, Docket No. APHIS–2018– 

0078), in which we announced the 

availability, for review and comment, of 

a pest risk analysis that evaluated the 

risks associated with the importation 

into the United States of citrus from 

three additional areas of Australia: The 

inland region of Queensland, the 

regions that compose Western Australia, 

and the shires of Bourke and Narromine 

within New South Wales District. The 

pest risk analysis consisted of a pest risk 

assessment (PRA) identifying pests of 

quarantine significance that could 

follow the pathway of importation of 

citrus from these regions of Australia 

into the United States and a commodity 

import evaluation document (CIED), a 

type of risk management document, that 

identified phytosanitary measures to be 

applied to that commodity to mitigate 

the pest risk. The national plant 

protection organization (NPPO) of 

Australia also asked us to reevaluate 

whether Epiphyas postvittana (light 

brown apple moth, also known as 

LBAM) could follow the pathway of 

citrus fruit from Australia into the 

United States. Currently, consignments 

of citrus fruit imported from Australia 

must be accompanied by a 

phytosanitary certificate with an 

additional declaration stating that the 

fruit in the consignment was subject to 

phytosanitary measures to ensure the 

consignment is free of LBAM. As a 

result of this reevaluation, we found 

that LBAM does not follow the pathway 

of citrus fruit from Australia into the 

United States, and we announced our 

intention to remove the additional 

declaration requirement. This change 

would affect both the currently 

authorized importations of citrus fruit 

from Australia and the importations 

from the additional production areas 

authorized by this notice. 

We solicited comments on the notice 

for 60 days ending February 16, 2021. 

We received seven comments by that 

date. They were from producers, 

exporters, researchers, and 

representatives of State and foreign 

governments. Three of the commenters 

supported authorizing citrus imports 

from the additional regions of Australia 

as described in the notice and 

supporting documents. One commenter 

supported authorizing these imports 

with some revisions to the PRA. Two 

commenters opposed authorizing these 

imports. The commenters also raised a 

number of questions and concerns about 

the pest risk assessment and the 

conditions under which citrus could be 

imported from these additional regions 

in Australia. 

Pest Risk Assessment 

The PRA and CIED that we prepared 

in response to the Government of 

Australia’s request evaluated the pest 

risk associated with the importation of 

citrus fruit from the inland region of 

Queensland, the regions that compose 

Western Australia, and the shires of 

Bourke and Narromine within New 

South Wales District into the 

continental United States. However, in 

our previous notice we mistakenly did 

not specify that the PRA and CIED only 

evaluated the risk to the continental 

United States. In this notice we are 

clarifying that permits for importation of 


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Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Notices 46175 

2See footnote 1 for directions on how to view the 

updated PRA. 

citrus fruit from the inland region of 

Queensland, the regions that compose 

Western Australia, and the shires of 

Bourke and Narromine within New 

South Wales District will be issued only 

for ports in the continental United 

States. 

Currently, citrus fruit from the 

Riverina, Riverland, and Sunraysia areas 

of Australia is allowed importation into 

all ports of the United States. This 

action will allow importation from three 

additional production areas of Australia 

to the continental United States, but 

will not affect currently authorized 

imports of citrus fruit from Australia 

except that the phytosanitary certificate 

will no longer require an additional 

declaration stating that the consignment 

is free of light brown apple moth 

(Epiphyas postvittana, also known as 

LBAM). 

The scope of the initial request was 

for specific additional production areas 

of the inland region of Queensland, the 

regions that compose Western Australia, 

and the shires of Bourke and Narromine 

within New South Wales; however, the 

Government of Australia stated that they 

consider that these production areas 

were intended to represent production 

and pest status across the broader 

jurisdictions and that the risk profiles 

associated with access granted at the 

broader whole-state levels of 

Queensland, Western Australia and 

New South Wales would not be 

appreciably greater than those 

associated with the specifically 

identified areas. As explained in greater 

detail below, this notice is limited to the 

scope of the initial request. 

The regulations in 7 CFR 319.5 

provide the process for submitting a 

request for a revision to importation 

requirements for plants or plant 

products. Based on the scope of the 

request submitted by the NPPO of 

Australia in accordance with this 

process, APHIS prepared the PRA that 

we made available with the initial 

notice. The areas covered by the PRA 

were not considered to be illustrative or 

representative of a broader jurisdiction 

but were rather the specific areas 

requested by the NPPO itself. Moreover, 

we disagree that adjacent areas within a 

region can be presumed to have an 

equivalent pest profile to the regions 

evaluated by the PRA; in our 

experience, risk profiles can vary 

considerably within a geographical area. 

For these reasons, APHIS cannot expand 

the scope of the areas of Australia 

allowed to export citrus to the United 

States without first revising the PRA to 

include the expanded area Australia 

proposes, and publishing a new notice 

with the revised PRA in the Federal 

Register for public comment. 

One commenter stated that the PRA 

did not assess the risk of the pink 

hibiscus mealybug (Maconellicoccus 

hirsutus (Green)). The commenter noted 

this pest is present in parts of the 

United States but is currently not found 

in Arizona. The commenter further 

stated that pink hibiscus mealybug is 

found in Australia and may be found in 

the regions where additional citrus 

imports into the United States may be 

approved. The commenter stated that 

the PRA should indicate whether the 

pink hibiscus mealybug is a pest of 

concern in the Australian regions under 

consideration for export and its risk of 

introduction evaluated. 

APHIS agrees with the commenter 

that pink hibiscus mealybug should be 

included in the pest list for citrus from 

Australia and has revised the PRA 

accordingly.2 The pink hibiscus 

mealybug has already been introduced 

into the United States, however, and 

there is no eradication or control 

program for it in areas of the United 

States in which it is established. We 

have determined the overall likelihood 

of pink hibiscus mealybug following 

citrus fruit imports into the continental 

United States to be negligible. These 

changes do not affect the overall 

conclusions of the analysis and the 

Administrator’s determination of risk. 

Phytosanitary Measures 

Two commenters expressed concern 

that the phytosanitary measures 

discussed in the CIED may not 

adequately prevent the introduction of 

Oriental red mite (Eutetranychus 

orientalis), brown citrus rust mite 

(Tegolophus australis), Lebbeck 

mealybug (Nipaecoccus viridis), and 

Kelly’s citrus thrips (Pezothrips 

kellyanus) and stated that the risk of 

introducing these pests is not negligible. 

As we concluded in the PRA, the 

overall likelihood of introduction of 

brown citrus rust mite, Oriental red 

mite, Lebbeck mealybug, and Kelly’s 

citrus thrips is negligible. Occurrence of 

these pests is infrequent in the export 

area. Furthermore, as outlined in the 

PRA, growers in Australia employ 

integrated pest management and 

cultural practices that further reduce the 

prevalence of these pests on the 

harvested commodity. This is also 

supported by the absence or low 

numbers of interceptions of these four 

pests of concern on citrus fruit from 

Australia at ports of entry. The control 

of mites is achieved by close monitoring 

during spring and autumn, 

encouragement of natural enemies, and 

the use of selective miticides. Mealybug 

and thrips populations are closely 

monitored from early spring and may be 

controlled through the release and 

promotion of natural enemies. The welltimed use of oil sprays is also highly 

effective. 

We also note that Lebbeck mealybug 

was added to the list of pests no longer 

regulated at U.S. ports of entry for the 

continental United States and Hawaii on 

September 8, 2020. To re-categorize 

pests so they no longer require action at 

ports of entry, APHIS submits a 

proposal to the National Plant Board 

(NPB), an organization composed of 

plant regulatory officials for State 

departments of agriculture. In this 

proposal to NPB, we propose to change 

the regulatory status of certain insects 

and plant diseases and provide our 

rationale for why they should no longer 

be considered of quarantine 

significance. The NPB reviews each 

proposal and must concur with the 

recommendation to change the pest’s 

regulatory status. The NPB concurred 

with our proposal to deregulate Lebbeck 

mealybug and accordingly we added it 

to the list of pests no longer regulated. 

The list of pests no longer regulated can 

be viewed on the APHIS website at 

https://www.aphis.usda.gov/aphis/ 

ourfocus/planthealth/plant-pest-anddisease-programs/frsmp/frsmp-non-regpests. We have revised the PRA to 

remove this pest from the list of pests 

associated with citrus from Australia. 

One commenter noted that APHIS 

proposed removing the additional 

declaration requirement that ensures the 

consignment is free of LBAM. The 

commenter stated that the PRA notes 

that LBAM population pressure is 

sometimes high in Australia, however, 

and larvae suspected to be LBAM have 

been intercepted from Australia on 

permit cargo of citrus. Despite removal 

of this declaration making import 

requirements consistent with APHIS 

domestic requirements for LBAM, the 

commenter expressed concern that 

removal of this declaration requirement 

at the international level may lead to the 

pest escaping detection during routine 

production, post-harvest, and packing 

practices. 

As we explained in the CIED, the 

current host list for APHIS domestic 

pest management for LBAM exempts 

conventionally produced citrus from 

LBAM quarantined areas from any 


jbell on DSKJLSW7X2PROD with NOTICES
46176 Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Notices 

3The host list can be viewed on the APHIS 

website at https://www.aphis.usda.gov/ 

plant_health/plant_pest_info/lba_moth/downloads/ 

exempted_host_list.pdf. 

4The USDA Treatment Manual can be viewed on 

the APHIS website at https://www.aphis.usda.gov/ 

import_export/plants/manuals/ports/downloads/ 

treatment.pdf. 

specific mitigations.3 The host list states 

that this is because LBAM survival on 

citrus is low compared with non-citrus 

hosts. The PRA also found that there 

was low larval survival on oranges, that 

oranges are a suboptimal host, that fruit 

fall prematurely if infested, and that 

damage symptoms are easily seen and 

culled. For these reasons we concluded 

that under normal population 

conditions and strict adherence to good 

harvest and packing procedures, LBAM 

is unlikely to follow the pathway of 

commercial fruit. 

The combination of low field 

prevalence and packing procedures 

make it highly unlikely that a 

foundation LBAM population could be 

moved out of the registered place of 

production after conventional 

production and harvesting practices. 

The CIED determined that these 

considerations are also applicable to 

citrus fruit from Australia, and thus 

merit removal of the additional 

declaration requirement for LBAM. 

Furthermore, interception data from 

1984 to 2018 shows only one 

interception of LBAM in citrus fruit 

from Australia, and 90 interceptions of 

Tortricidae (the next highest taxa) in 

citrus fruit from Australia. The most 

recent interceptions were in 2005. In the 

event of Tortricidae interceptions in 

citrus fruit from Australia, APHIS can 

require additional mitigations for 

LBAM. We are making no changes in 

response to this comment. 

Pest Free Areas 

One commenter stated that the option 

of allowing citrus fruit to originate from 

an area that is free of Queensland fruit 

fly (Bactrocera tryoni), Mediterranean 

fruit fly (Ceratitis capitata, also known 

as Medfly), and/or Lesser Queensland 

fruit fly (Bactrocera neohumeralis) may 

be problematic. The commenter 

expressed concern that this could allow 

fruit to enter an area evaluated in the 

PRA which may have been deemed a 

pest free area (PFA) for only one of the 

listed fruit flies. The commenter further 

stated that the approved production area 

should certify that all three fruit flies are 

not present at time of export or be 

subject to the most appropriate cold 

treatment schedule. 

We agree that if an area is not a pest 

free area for all three species of fruit 

flies, citrus must be subject to 

phytosanitary treatment for the relevant 

species of fruit fly, and this is the 

mitigation structure that we proposed in 

the CIED with regard to pest free areas. 

Treatments 

Two commenters noted that the 

treatment evaluation document assessed 

the effectiveness of schedules T107–d– 

2 and T107–d–3 on Lesser Queensland 

fruit fly and concluded that they would 

provide sufficient control. One of the 

commenters stated that this conclusion 

was based on a small-scale, comparative 

study of the relative cold tolerances of 

eggs and early instar larvae of 

Queensland fruit fly, Lesser Queensland 

fruit fly, and Jarvis’ fruit fly (Bactrocera 

jarvisi) in mandarin. The commenter 

stated that additional larger-scale 

studies on alternative citrus hosts 

should be conducted to provide more 

significant findings which could further 

(or diminish) support of the addition of 

Lesser Queensland fruit fly to T107–d– 

2 and T107–d–3. 

The other commenter raised the same 

point but added that without scientific 

evidence confirming the referred 

efficacy, T107–d–2 and T107–d–3 must 

not be accepted as a phytosanitary 

treatment for Lesser Queensland fruit 

fly. 

Jarvis’ fruit fly and Lesser Queensland 

fruit fly both have narrow coastal 

distributions in Northeastern Australia. 

Jarvis’ fruit fly is also found in the 

tropical area of Northern Australia. Both 

species only inhabit areas that are 

subtropical and tropical in climate. This 

supports the Australian research that 

these species are not more cold-tolerant 

than Queensland fruit fly. Citrus is also 

not the preferred host of either fruit fly. 

In contrast, the mandarin fruit that the 

Australian scientists used to test cold 

tolerance for Lesser Queensland fruit fly 

is an optimal host and would be the 

preferred host to test cold tolerance of 

this species. The small-scale 

comparative study conducted by the 

Australian Department of Agriculture 

and Water Resources to determine the 

relative cold tolerance of Queensland 

fruit fly, Lesser Queensland fruit fly, 

and Jarvis’ fruit fly supplemented the 

large scale studies that supported our 

recommendations to approve the T107– 

d–2 and T107–d–3 treatment schedules. 

We note that small-scale comparative 

studies of this kind compare two points 

or a small number of points to see if 

they are significantly different. In the 

case of the fruit fly study, they were not. 

We are making no changes in response 

to these comments. 

The Government of Australia 

requested the addition of several 

treatment options for fruit flies. These 

treatments are already in the USDA 

Treatment Manual. Specifically, they 

requested adding T107–a–1, T107–a–2, 

and T107–a–3, which are approved for 

use as stand-alone cold disinfestation 

against Medfly for citrus fruit. They also 

requested adding schedule T105 at a 

dose of 100Gy for fruit flies, as listed in 

table 5–2–2 in the USDA Treatment 

Manual.4

These additional treatments, which 

appear in the USDA Treatment Manual, 

may be used for citrus fruit that 

originates in an area where the only 

fruit flies present are those for which 

these treatments are approved. We note 

that the schedule T105 treatment is 

approved at a dose of 100Gy for Jarvis 

fruit fly, Lesser Queensland fruit fly, 

and Medfly. There is an option for a 

dose of 150Gy for all other fruit flies in 

the family Tephritidae not listed in table 

5–2–2. Guidelines for the approval of 

additional treatments can be found in 7 

CFR 305.3. 

The Government of Australia further 

stated that standard commercial 

production practices implemented by 

the Australian citrus industry, such as 

disease management strategies used to 

control citrus black spot disease (CBS) 

in the field and packinghouses in 

Australia and complemented by 

phytosanitary inspection, would 

appropriately manage the risks posed by 

the fungus. The Government of 

Australia noted that over the history of 

inspection of citrus exports from these 

production areas, CBS has not been a 

problem, and stated that Australia 

considers that any additional import 

requirements would exceed reasonable 

requirements to manage the risk. 

The phytosanitary measures we 

proposed to address the risk of CBS in 

citrus fruit from Australia are the same 

measures we require of domestic 

producers to ship citrus interstate 

within the United States. We are making 

no changes in response to this comment. 

Therefore, in accordance with the 

regulations in § 319.56–4(c)(2)(ii), we 

are announcing our decision to 

authorize the importation into the 

continental United States of Citrus 

sinensis (L.) Osbeck (orange), C. limonia 

Osbeck (Rangpur), C. meyeri Yu. Tanaka 

(lemon), C. aurantiifolia (Christm.) 

Swingle (Key lime), C. latifolia (Yu. 

Tanaka) Tanaka (lime), C. paradisi 

Macfad. (grapefruit), C. reticulata 

Blanco (mandarin), and their hybrids 

from three additional areas of Australia 

(the inland region of Queensland, the 

regions that compose Western Australia, 

and the shires of Bourke and Narromine 


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Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Notices 46177 

within New South Wales District), 

subject to the following phytosanitary 

measures: 

• The citrus must either originate 

from an area within these approved 

production areas that is free of the fruit 

flies Queensland fruit fly, Medfly, and/ 

or Bactrocera neohumeralis (Lesser 

Queensland fruit fly), or be treated with 

cold treatment or other approved 

treatment for the relevant fruit flies. 

• If the area has Queensland fruit fly 

or Lesser Queensland fruit fly, cold 

treatment schedules T107–d–2 or T107– 

d–3 must be used. 

• The citrus fruit must be 

accompanied by a phytosanitary 

certificate issued by the NPPO of 

Australia that attests that citrus fruit 

were produced in a fruit fly pest-free 

area or that indicates that cold treatment 

was applied to the consignment during 

transit to the continental United States, 

or a combination of PFAs and 

quarantine treatments; were inspected 

by the NPPO of Australia and found free 

of pests of concern. We are not requiring 

an additional declaration for light 

brown apple moth because the PRA 

considers this pest unlikely to follow 

the pathway on citrus fruit from these 

areas. 

• The citrus fruit is subject to 

inspection at the port of entry into the 

United States. 

• Only commercial consignments of 

Australian citrus fruit may be imported 

into the United States. 

• Fruit must be washed, brushed, 

surface disinfected in accordance with 7 

CFR part 305 and according to treatment 

schedules listed in the USDA Treatment 

Manual, treated with fungicide at 

labeled rates, and waxed at 

packinghouses. 

• An operational work plan that 

details the requirements under which 

citrus will be safely imported is in 

place. 

• The citrus fruit must be imported 

under permit. 

These revised conditions will be 

listed in the FAVIR database (available 

at https://epermits.aphis.usda.gov/ 

manual). In addition to these specific 

measures, citrus from Australia will be 

subject to the general requirements 

listed in § 319.56–3 that are applicable 

to the importation of all fruits and 

vegetables. 

Paperwork Reduction Act 

In accordance with the Paperwork 

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

et seq.), the burden requirements 

associated with this action are included 

under the Office of Management and 

Budget control number 0579–0049. 

E-Government Act Compliance 

The Animal and Plant Health 

Inspection Service is committed to 

compliance with the E-Government Act 

to promote the use of the internet and 

other information technologies, to 

provide increased opportunities for 

citizen access to Government 

information and services, and for other 

purposes. For information pertinent to 

E-Government Act compliance related 

to this notice, please contact Mr. Joseph 

Moxey, APHIS’ Paperwork Reduction 

Act Coordinator, at (301) 851–2483. 

Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), the Office of 

Information and Regulatory Affairs 

designated this action as not a major 

rule, as defined by 5 U.S.C. 804(2). 

Authority: 7 U.S.C. 1633, 7701–7772, 

and 7781–7786; 21 U.S.C. 136 and 136a; 

7 CFR 2.22, 2.80, and 371.3. 

Done in Washington, DC, this 12th day of 

August 2021. 

Mark Davidson, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2021–17709 Filed 8–17–21; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF COMMERCE 

Foreign-Trade Zones Board 

[B–29–2021] 

Foreign-Trade Zone (FTZ) 107—Des 

Moines, Iowa; Authorization of 

Production Activity; Lely North 

America, Inc. (Automated Milking and 

Feeding Equipment); Pella, Iowa 

On April 14, 2021, Lely North 

America, Inc. (Lely) submitted a 

notification of proposed production 

activity to the FTZ Board for its facility 

within Subzone 107E, in Pella, Iowa. 

The notification was processed in 

accordance with the regulations of the 

FTZ Board (15 CFR part 400), including 

notice in the Federal Register inviting 

public comment (86 FR 21686, April 23, 

2021). On August 12, 2021, the 

applicant was notified of the FTZ 

Board’s decision that no further review 

of the activity is warranted at this time. 

The production activity described in the 

notification was authorized, subject to 

the FTZ Act and the FTZ Board’s 

regulations, including Section 400.14. 

Dated: August 12, 2021. 

Andrew McGilvray, 

Executive Secretary. 

[FR Doc. 2021–17691 Filed 8–17–21; 8:45 am] 

BILLING CODE 3510–DS–P 

DEPARTMENT OF COMMERCE 

Foreign-Trade Zones Board 

[B–58–2021] 

Foreign-Trade Zone (FTZ) 43—Battle 

Creek, Michigan; Notification of 

Proposed Production Activity; Pfizer, 

Inc. (mRNA COVID–19 Vaccine); 

Kalamazoo, Michigan 

Pfizer, Inc. (Pfizer) submitted a 

notification of proposed production 

activity to the FTZ Board for its 

facilities in Kalamazoo, Michigan. The 

notification conforming to the 

requirements of the regulations of the 

FTZ Board (15 CFR 400.22) was 

received on August 6, 2021. 

Pfizer already has authority to 

produce pharmaceutical, consumer 

healthcare and animal healthcare 

products within Subzone 43E. The 

current request would add a finished 

product and a foreign-status material/ 

component to the scope of authority. 

Pursuant to 15 CFR 400.14(b), 

additional FTZ authority would be 

limited to the specific foreign-status 

material/component and specific 

finished product described in the 

submitted notification (as described 

below) and subsequently authorized by 

the FTZ Board. 

Production under FTZ procedures 

could exempt Pfizer from customs duty 

payments on the foreign-status material/ 

component used in export production. 

On its domestic sales, for the foreignstatus material/component noted below 

and in the existing scope of authority, 

Pfizer would be able to choose the duty 

rate during customs entry procedures 

that applies to the mRNA COVID–19 

vaccine (duty-free). Pfizer would be able 

to avoid duty on foreign-status 

components which become scrap/waste. 

Customs duties also could possibly be 

deferred or reduced on foreign-status 

production equipment. 

The proposed foreign-status material/ 

component is mRNA bulk drug 

substance (duty rate—6.5%). The 

company currently intends to ship 

mRNA bulk drug substance produced at 

its facility in Andover, Massachusetts 

(Subzone 27R) to its Kalamazoo 

facilities for further processing. 

Public comment is invited from 

interested parties. Submissions shall be 

addressed to the Board’s Executive 

Secretary and sent to: ftz@trade.gov. The 

closing period for their receipt is 

September 27, 2021. 

A copy of the notification will be 

available for public inspection in the 

‘‘Reading Room’’ section of the Board’s 

website, which is accessible via 

www.trade.gov/ftz. 


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