31448 Federal Register / Vol. 86, No. 112 / Monday, June 14, 2021 / Rules and Regulations 

1 85 FR 20195 (Apr. 10, 2020) (codified at 44 CFR 

part 328). See also 85 FR 22622 (Apr. 23, 2020) 

(correcting the date filed from ‘‘4–8–20’’ to’’ 4–7– 

20’’). 

2 85 FR 48113 (Aug. 10, 2020) and 85 FR 86835 

(Dec. 31, 2020) (codified at 44 CFR part 328). 

3 50 U.S.C. 4501 et seq. 

4See 85 FR 20195 at 20196–20197. 

WISCONSIN—2015 8-HOUR OZONE NAAQS—Continued 

[Primary and Secondary] 

Designated area 1

Designation Classification

Date 2 Type Date 2 Type

Inclusive and east of the following roadways going from the northern county 

boundary to the southern county boundary: Highway 45 to Washington Ave. 

to South Beaumont Ave.

Washington County (part): .......................................................................................... July 14, 2021 5.

Inclusive and east of the following roadways going from the northern county 

boundary to the southern county boundary: County H to N Main St/Old US 

Hwy 45 to WI–60 Trunk E to WI–164 S.

Waukesha County (part) ............................................................................................. July 14, 2021 5.

Going from the western county boundary to the southern county boundary: Inclusive 

and north of I–94 and inclusive and east of Highway 67.

Sheboygan County, WI ...................................................................................................... ................................... Nonattainment ...... .................... Marginal. 

Sheboygan County (part): .......................................................................................... July 14, 2021 5.

Inclusive and east of the following roadways with the boundary starting from 

north to south: Union Road which turns into County Road Y which turns into 

Highland Drive, to Lower Road which turns into Monroe Street, to Broadway/Main Street to Highway 32 which turns into Giddings Avenue to County 

Road W to County Road KW.

*******

Racine County (part) remainder ........................................................................................ ................................... Attainment/ 

Unclassifiable.

*******

Washington County (part) remainder ................................................................................ ................................... Attainment/ 

Unclassifiable.

Waukesha County (part) remainder .................................................................................. ................................... Attainment/ 

Unclassifiable.

*******

1 Includes any Indian country in each county or area, unless otherwise specified. EPA is not determining the boundaries of any area of Indian country in this table, 

including any area of Indian country located in the larger designation area. The inclusion of any Indian country in the designation area is not a determination that the 

state has regulatory authority under the Clean Air Act for such Indian country. 2This date is August 3, 2018, unless otherwise noted. 

3 Includes Indian country of the tribe listed in this table located in Forest County, Wisconsin. Information pertaining to areas of Indian country in this table is intended for Clean Air Act planning purposes only and is not an EPA determination of Indian country status or any Indian country boundary. EPA lacks the authority to 

establish Indian country land status, and is making no determination of Indian country boundaries, in this table. 4EPA revised the nonattainment boundaries of the Door County area that was designated as nonattainment on April 30, 2018, in response to a court decision, 

which did not vacate any designations for the 2015 ozone NAAQS, but which remanded the designation for the identified county. Because this additional portion of 

Door County is associated with a previously designated nonattainment area, the associated implementation dates (e.g., the August 3, 2021 attainment date) remain 

unchanged regardless of this later designation date. 5EPA revised the nonattainment boundary in response to a court decision, which did not vacate any designations for the 2015 ozone NAAQS, but which remanded 

the designation for the identified county. Because this additional area is part of a previously designated nonattainment area, the associated implementation dates for 

the overall nonattainment area (e.g., the August 3, 2021 attainment date) remain unchanged regardless of this later designation date. 

* * * * * 

[FR Doc. 2021–11454 Filed 6–11–21; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 328 

[Docket ID FEMA–2020–0018] 

Prioritization and Allocation of Certain 

Scarce and Critical Health and Medical 

Resources for Domestic Use; 

Additional Exemptions 

AGENCY: Federal Emergency 

Management Agency, Department of 

Homeland Security (DHS). 

ACTION: Notification of additional 

exemptions. 

SUMMARY: The Federal Emergency 

Management Agency (FEMA) 

announces additional exemptions from 

a temporary final rule that FEMA 

published in the Federal Register on 

December 31, 2020. 

DATES: Applicability date: This 

notification applies beginning on June 

11, 2021. 

ADDRESSES: You may review the docket 

by searching for Docket ID FEMA–2020– 

0018, via the Federal eRulemaking 

Portal: http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Daniel McMasters, Program Analyst, 

Office of Policy and Program Analysis, 

202–212–2900, FEMA-DPA@

fema.dhs.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

On April 10, 2020, the Federal 

Emergency Management Agency 

(FEMA) published a temporary final 

rule (the ‘‘rule’’) to allocate certain 

health and medical resources for 

domestic use, so that these resources 

may not be exported from the United 

States without explicit approval by 

FEMA.1 The rule aids the response of 

the United States to the spread of 

COVID–19 by ensuring that certain 

health and medical resources are 

appropriately allocated for domestic 

use. The rule was modified and 

extended on August 10, 2020 and 

December 31, 2020, respectively.2

FEMA issued the rule under the 

authority of the Defense Production Act 

of 1950, as amended (DPA),3 and related 

Executive orders and delegations.4 Most 

prominently, on April 3, 2020, the 

President signed a Memorandum on 

Allocating Certain Scarce or Threatened 

Health and Medical Resources to 


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Federal Register / Vol. 86, No. 112 / Monday, June 14, 2021 / Rules and Regulations 31449 

5See Memorandum on Allocating Certain Scarce 

or Threatened Health and Medical Resources to 

Domestic Use for the Secretary of Health and 

Human Services, the Secretary of Homeland 

Security, and the Administrator of the Federal 

Emergency Management Agency (Apr. 3, 2020), 

https://trumpwhitehouse.archives.gov/presidentialactions/memorandum-allocating-certain-scarcethreatened-health-medical-resources-domestic-use/ 

(last accessed May 12, 2021). 

6 85 FR 22021 (Apr. 21, 2020). 

7See 85 FR 48113 (Aug. 10, 2020); 85 FR 86835 

(Dec. 31, 2020). 

8 44 CFR 328.102(a). 

9 44 CFR 328.102(b). 

10 Id. 

11 44 CFR 328.102(c). 

12 44 CFR 328.102(d)(1). 

13 Id. 

14See 85 FR 86835, 86838 (Dec. 31, 2020). 

15FEMA fills requests from state, local, tribal, and 

territorial partners for respirators through the 

standard Resource Request Form process. The 

agency does not have any open requests for 

industrial N95 respirators and is equipped to fill 

requests as they are received. 

Domestic Use (Memorandum).5 In the 

Memorandum, the President directed 

the Secretary of Homeland Security, 

through the FEMA Administrator, and 

in consultation with the Secretary of 

Health and Human Services (HHS), to 

use any and all authority available 

under section 101 of the DPA to allocate 

to domestic use, as appropriate, the five 

types of personal protective equipment 

(PPE) materials identified in the 

Memorandum. FEMA executed this 

direction by publishing an allocation 

order on April 10, 2020, as a temporary 

final rule pursuant to the Memorandum. 

On April 21, 2020, FEMA published 

notification of 10 exemptions in 

addition to the exemption listed in the 

original temporary final rule.6 The 

temporary final rule was modified and 

extended on August 10, 2020, and again 

on December 31, 2020, to ensure certain 

health and medical resources were 

appropriately allocated for domestic 

use.7

Consistent with the Memorandum, 

the December 31, 2020 rule provides 

that until June 30, 2021, and subject to 

certain exemptions, no shipments of 

covered materials may leave the United 

States without explicit approval by 

FEMA.8 The rule requires U.S. Customs 

and Border Protection (CBP), in 

coordination with such other officials as 

may be appropriate, to notify FEMA of 

an intended export of covered 

materials.9 CBP must temporarily detain 

any shipment of such covered materials 

pending the Administrator’s 

determination whether to return for 

domestic use, issue a rated order for, or 

allow the export of part or all of the 

shipment.10 In making such 

determination, the Administrator may 

consult other agencies and will consider 

the totality of the circumstances, 

including: (1) The need to ensure that 

scarce or critical items are appropriately 

allocated for domestic use; (2) 

minimization of disruption to the 

supply chain, both domestically and 

abroad; (3) the circumstances 

surrounding the distribution of the 

materials and potential hoarding or 

price-gouging concerns; (4) the quantity 

and quality of the materials; (5) 

humanitarian considerations; and (6) 

international relations and diplomatic 

considerations.11

In addition to providing for the 

determination described above, the rule 

includes eleven exemptions to the 

requirement that covered materials not 

leave the United States without explicit 

approval by FEMA. In the interest of 

promoting the national defense, the 

Administrator determined that FEMA 

will not purchase covered materials 

from shipments made by or on behalf of 

U.S. manufacturers with continuous 

export agreements with customers in 

other countries since at least January 1, 

2020, so long as at least 80 percent of 

such manufacturer’s domestic 

production of such covered materials, 

on a per item basis, was distributed in 

the United States in the preceding 12 

months.12 If FEMA determines that a 

shipment of covered materials falls 

within this exemption, such materials 

may be exported without further review 

by FEMA, provided that the 

Administrator may waive this 

exemption and fully review shipments 

of covered materials, if the 

Administrator determines that doing so 

is necessary or appropriate to promote 

the national defense.13 Additionally, the 

Administrator determined that it is 

necessary and appropriate to promote 

the national defense to continue the 10 

additional exemptions to the original 

temporary final rule that were published 

on April 21, 2020.14

Pertinent to this notification, the rule 

also provides that the Administrator 

may establish, in his or her discretion, 

additional exemptions that he or she 

determines necessary or appropriate to 

promote the national defense and will 

announce any such exemptions by 

notice in the Federal Register. This 

notification announces additional 

exemptions. 

Notice of Additional Exemptions 

Pursuant to 44 CFR 328.102(d)(2), 

section 101 of the DPA, and related 

authorities, the Administrator has 

determined that it is necessary and 

appropriate in order to promote the 

national defense to exempt certain 

categories of covered materials from the 

requirements of 44 CFR 328.102(a) and 

(b). The Administrator may waive any of 

these exemptions at any time and fully 

review shipments of covered materials 

under 44 CFR 328.102(b) if the 

Administrator determines that doing so 

is necessary or appropriate to promote 

the national defense. In addition, if CBP 

believes that any manufacturer, broker, 

distributor, exporter, or shipper of any 

covered materials is intentionally 

modifying its shipments in a way to take 

advantage of one or more of these 

exemptions, diverting materials from 

the United States market, or otherwise 

trying to circumvent the FEMA review 

requirements in 44 CFR 328.102(b) 

through application of any of the 

exemptions, CBP may detain a shipment 

and forward information about that 

shipment (including the basis for CBP’s 

belief) to FEMA for determination. 

The additional exemptions are as 

follows: 

(1) Exports of Industrial N95 

Respirators. The Administrator issues 

this exemption to narrow the scope of 

the allocation order to exempt 

shipments of industrial N–95 respirators 

from the allocation order. The 

Administrator believes that this 

exemption is necessary to narrow the 

scope of the allocation order to be 

limited to surgical N95 filtering 

facepiece respirators that are single-use, 

disposable respiratory protective 

devices used in a healthcare setting that 

are worn by healthcare personnel during 

procedures to protect both the patient 

and healthcare personnel from the 

transfer of microorganisms, body fluids, 

and particulate material at an N95 

filtration efficiency level per 42 CFR 

84.171. A surgical N95 respirator is a 

class II device, regulated by the U.S. 

Food and Drug Administration under 21 

CFR 878.4040. Narrowing the scope of 

the covered materials ensures that only 

those items that are scarce or critical 

items in the domestic supply chain are 

affected by the allocation order. The 

Administrator believes that industrial 

N95 respirators are in sufficient 

domestic supply 15 and that worldwide 

demand for these items remains high. 

As such, it is necessary and appropriate 

to promote the national defense and 

consistent with the purposes of the 

Presidential Memorandum and the 

subsequent allocation order to exempt 

these items from the list of covered 

materials. 

(2) Exports of PPE Surgical Masks. 

The Administrator believes it is 

necessary and appropriate to promote 

the national defense to exempt these 

items from the list of covered materials 

to support the efforts of domestic 


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31450 Federal Register / Vol. 86, No. 112 / Monday, June 14, 2021 / Rules and Regulations 

16FEMA fills requests from state, local, tribal, and 

territorial partners for respirators through the 

standard Resource Request Form process. The 

agency does not have any open requests for PPE 

surgical masks. 

17As of May 11, 2021, approximately 35.1 

percent of the U.S. population has been fully 

vaccinated, while 46.2 percent of the U.S. 

population has received at least one dose of a 

vaccine. Over 71 percent of the U.S. population 65 

years of age or older (one of the highest at-risk 

segments of the U.S. population) have now been 

fully vaccinated. See www.covid.cdc.gov/coviddata-tracker/#vaccinations (last accessed May 12, 

2021 at 1:30 p.m.). 

manufacturing to combat COVID–19 

around the world and consistent with 

the position of the United States as a 

world leader. A key element of national 

defense is the ability of the United 

States to convey international 

leadership during times of crisis, 

including the COVID–19 pandemic. 

This includes our ability to assist in 

meeting the global demand for items 

where domestic supply needs have been 

met, help those in need, and to remain 

stalwarts of the international 

community. The Administrator also 

recognizes the international nature of 

many U.S. companies, and believes that 

allowing these companies to continue to 

produce at a high level is crucial to 

promoting the U.S. economy. One of the 

factors specifically identified in the 

allocation order that the Administrator 

considers in determining whether to 

return for domestic use, issue rated 

order for, or allow the export of a 

shipment is minimization of disruption 

of the supply chain, both domestically 

and abroad. The Administrator believes 

that this exemption would not disrupt 

the domestic supply chain,16 nor cause 

a detrimental shortage of covered 

materials to Americans. 

(3) Exports of Specific Syringes and 

Needles. The Administrator believes it 

is necessary and appropriate to promote 

the national defense to exempt the 

specific syringes and needles covered 

under the current rule given the 

worldwide efforts to provide COVID–19 

vaccinations. Similar to PPE surgical 

masks above, the Administrator believes 

these items should be exempted from 

the list of covered materials to support 

the efforts to combat COVID–19 around 

the world and consistent with the 

position of the United States as a world 

leader. A key element of national 

defense is the ability of the United 

States to convey international 

leadership during times of crisis, 

including the COVID–19 pandemic. 

This includes our ability to assist in 

meeting the global demand for items 

where domestic supply needs have been 

met, help those in need, and to remain 

stalwarts of the international 

community. The Administrator also 

recognizes the international nature of 

many U.S. companies, and believes that 

allowing these companies to continue to 

produce at a high level is crucial to 

promoting the U.S. economy. One of the 

factors specifically identified in the 

allocation order that the Administrator 

considers in determining whether to 

return for domestic use, issue rated 

order for, or allow the export of a 

shipment is minimization of disruption 

of the supply chain, both domestically 

and abroad. The Administrator believes 

that this exemption would not disrupt 

the domestic supply chain, nor cause a 

detrimental shortage to Americans given 

the current state of vaccination rates in 

the United States.17

Deanne Criswell, 

Administrator, Federal Emergency 

Management Agency. 

[FR Doc. 2021–12484 Filed 6–11–21; 8:45 am] 

BILLING CODE 9111–19–P 


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