dismissed EB-2 NIW Case: Regulatory Affairs

U.S. Citizenship 
and Immigration 
Services 
Non-Precedent Decision of the
Administrative Appeals Office 
Date: FEB. 5, 2024 In Re: 28944862 
Appeal of Texas Service Center Decision 
Form 1-140, Immigrant Petition for Alien Workers (National Interest Waiver) 
The Petitioner, an entrepreneur and regulatory affairs manager, seeks second preference immigrant 
classification as a member of the professions holding an advanced degree, as well as a national interest 
waiver of the job offer requirement attached to this EB-2 classification. See Immigration and 
Nationality Act (the Act) section 203(b)(2), 8 U.S.C. § 1153(b)(2). 
The Director of the Texas Service Center denied the petition, concluding that the record did not 
establish that a waiver of the required job offer, and thus of the labor certification, would be in the 
national interest. The matter is now before us on appeal. 8 C.F.R. § 103.3. 
The Petitioner bears the burden of proof to demonstrate eligibility by a preponderance of the evidence. 
Matter ofChawathe , 25 I&N Dec. 369, 375-76 (AAO 2010). We review the questions in this matter 
de novo. Matter of Christo 's, Inc., 26 I&N Dec. 537, 537 n.2 (AAO 2015). Upon de novo review, 
we will dismiss the appeal. 
I. LAW 
To establish eligibility for a 
national interest waiver, a petitioner must first demonstrate qualification 
for the underlying EB-2 visa classification, as either an advanced degree professional or an individual 
of exceptional ability in the sciences, arts, or business. Section 203(b )(2)(B)(i) of the Act. An 
advanced degree is any U.S. academic or professional degree or a foreign equivalent degree above 
that of a bachelor's degree. 1 8 C.F.R. § 204.5(k)(2). A U.S. bachelor's degree or a foreign equivalent 
degree followed by five years of progressive experience in the specialty is the equivalent of a master's 
degree. Id. 
Once a petitioner demonstrates eligibility for the underlying EB-2 visa classification, they must then 
establish that they merit a discretionary waiver of the job offer requirement "in the national interest." 
Section 203(b )(2)(B)(i) of the Act. While neither the statute nor the pertinent regulations define the 
term "national interest," Matter ofDhanasar, 26 l&N Dec. 884 (AAO 2016), provides the framework 
for adjudicating national interest waiver petitions. Dhanasar states that U.S. Citizenship and 
1 Profession shall include, but not be limited to, architects, engineers, lawyers, physicians, surgeons, and teachers in 
elementary or secondary schools, colleges, academics, or seminaries. Section 101 ( a)(32) of the Act. 
Immigration Services (USCIS) may, as matter of discretion2, grant a national interest waiver if the 
petitioner demonstrates that: 
• The proposed endeavor has both substantial merit and national importance; 
• The individual is well positioned to advance the proposed endeavor; and 
• On balance, waiving the requirements of a job offer and a labor certification would benefit the 
United States. 
II. ANALYSIS 
A. EB-2 Classification 
The Director's decision is silent as to whether the Petitioner qualifies as a member of the professions 
holding an advanced degree. However, a review of her education and work history credentials 
establishes that she qualifies for EB-2 classification as a member of the professions holding an 
advanced degree. 3 
B. Substantial Merit and National Importance 
The Director determined that the Petitioner's endeavor has substantial merit, but not national 
importance, and we agree. 
As an initial matter, we note that the Petitioner asserts that in denying the petition, the Director 
"imposed novel substantive and evidentiary requirements beyond those set forth in the regulations." 
However, the Petitioner does not point to specific examples of this within the Director's notice of 
intent to deny (NOID) and denial. The Petitioner also does not offer a detailed analysis explaining the 
particular ways in which the Director "imposed novel substantive and evidentiary requirements" in 
denying the petition, supported by pertinent law or regulation. 
The Petitioner also generally alleges that the Director "did not apply the proper standard of proof in 
this case, instead imposing a stricter standard, and erroneously applied the law, to the detriment of the 
[Petitioner]." The standard of proof governing immigration benefit requests is "preponderance of 
evidence." Matter of Chawathe, 25 I&N Dec. at 3 75-76. To determine whether a petitioner has met 
its burden under the preponderance standard, we evaluate whether a petitioner's claims are "more 
likely than not" or "probably" true, but also consider the quality (including relevance, probative value, 
and credibility) of the evidence. Id. at 376; Matter ofE-M-, 20 I&N Dec. 77, 79-80 (Comm'r 1989). 
Here, the Petitioner does not further explain or identify any specific instance in which the Director 
applied a standard of proof other than the preponderance of evidence in denying the petition. 
2 See also Poursina v. USCIS, No. 17-16579, 2019 WL 4051593 (Aug. 28, 2019) (finding USCIS' decision to grant or 
deny a national interest waiver to be discretionary in nature). 
3 The Petitioner submitted evidence of her completion of a dual diploma undergraduate program in environmental 
engineering from thd Icarried out jointly withl lin October 2011. 
Furthermore, the Petitioner submitted experience letters demonstrating that she has five years of post-baccalaureate, 
progressive experience in the specialty. (She also submitted an academic evaluation showing that her foreign degree is 
equivalent to a U.S. bachelor's degree in environmental engineering, however because she received a U.S. undergraduate 
degree, the foreign credentials evaluation is superfluous.) 
2 
Counsel's unsubstantiated assertions do not constitute evidence. See, e.g., Matter of S-M-, 22 I&N 
Dec. 49, 51 (BIA 1998) ("statements in a brief: motion, or Notice of Appeal are not evidence and thus 
are not entitled to any evidentiary weight"). 
We also note that the Director's NOID explained the deficiencies and concerns in the Petitioner's 
initial filing relating to Dhanasar's three prongs and provided a non-exhaustive list of documentation 
and material that the Petitioner could submit to address such deficiencies. Therefore, the Director 
followed the applicable regulations and procedure in adjudicating this petition. See 8 C.F.R. 
§ 103 .2(b )(8). 
Following completion of her undergraduate education, the Petitioner worked in regulatory affairs as a 
manager and specialist for several employers in Turkey, from 2012 to 2021. In July 2021, she entered 
the United States as a B-2 nonimmigrant visitor. She filed the present immigrant petition in December 
2021. After she filed the petition and secured employment authorization, in October 2022, she began 
working as a regulatory manager for a company in New York that focuses on the design and 
manufacture of small medical devices. 
The first Dhanasar prong, substantial merit and national importance, focuses on the specific endeavor 
that the individual proposes to undertake. The endeavor's merit may be demonstrated in a range of 
areas such as business, entrepreneurialism, science, technology, culture, health, or education. In 
determining whether the proposed endeavor has national importance, we consider its potential 
prospective impact. Matter ofDhanasar, 26 I&N Dec. at 889. The term "endeavor" is more specific 
than the general occupation; a petitioner should offer details not only as to what the occupation 
normally involves, but what types of work the person proposes to undertake specifically within that 
occupation. For example, while engineering is an occupation, the explanation of the proposed 
endeavor should describe the specific projects and goals, or the areas of engineering in which the 
person will work, rather than simply listing the duties and responsibilities of an engineer. See 
generally 6 USCIS Policy Manual F.5(D)(l), https://www.uscis.gov/policy-manual. 
Dhanasar 's first prong focuses on the specific endeavor that the foreign national proposes to undertake 
and its "potential prospective impact." Dhanasar, 26 I&N Dec. at 889. As such, we will first identify 
the Petitioner's endeavor as shown in the record. Then, we will evaluate the Petitioner's evidence in 
support of the endeavor's substantial merit and national importance. 
The Petitioner describes her endeavor and the impacts that will stem from it in several documents. 
First, in her professional plan statement, she describes her endeavor, as follows: "continue using my 
expertise and knowledge in the medical devices and environmental engineering field ... via two ... 
channels," her company, and her employment at her current employer where she is a regulatory affairs 
manager. She further elaborates that her "overall proposed endeavor in the United States is to offer 
my expertise to continue expanding my business operations in the United States and continue 
contributing to building wealth within the economy with my investments, which will generate both 
capital and jobs." She provides that the goal of her company is to "provide guidance on regulatory & 
environmental compliance, quality and project management, and engineering processes to medical 
device companies that will overcome obstacles in the constantly changing regulatory landscape." 
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In her "Definitive Statement," the Petitioner asserts that her business, called I._______ _. 
~-----------~ (the Company), will be based in Maryland in a designated 
HUBZone and "provide training and consulting focused on process enhancement customized to follow 
the regulatory demands, using price elasticity adaptation targeting the medical device manufacturing 
sector." Her statement explains that by year five, the Company will have 22 employees, and total 
wages of $1,450,000, which would generate $168,000 in federal tax payments. The Company's 
business plan provides more details about the endeavor, and explains that the Company will be self­
funded and will target medical device manufacturers. The business plan also identifies the specific 
HUBZones in which she will establish her offices in Maryland and Virginia. 
According to her business plan, the Company will provide the following training and consulting 
services: 
"(l) Training - Qualification for IPC A- 610 Regulatory Standard, (2) Training -
Qualification for IPC 7711/ 7721 - Regulatory Standard, (3) Training - Qualification 
for J-STD-030 Regulatory Standard, ( 4) Training- Quality improvement Polyurethane 
Foam Segment and (5) Consulting and training in Quality improvement, Japanese 
management methods based on per course / per person consulting day revenue model." 
By year five, the Company aims to provide "3,400 hours of ( l) Quality Management 
System Improvement Consulting, 750 hours of (2) Engineering Work, 40 contract 
projects of (3) Consulting for Regulatory Affair Systems, 12 months of (4) Six Sigma 
implementations." 
The Company will create, by year five, the following positions: chief entrepreneur, regulatory affairs 
specialists, lawyers, quality control analysts, environmental engineers, administrative assistants, sales 
representatives, accountants and auditors, and janitors and cleaners. It also describes that by year five, 
the Company will have total revenue of $3 .26 million and "total rentable space of 4,170 commercial 
office square feet, impacting positive [sic] in the local communities, generating $ 278 thousand in 
rental income in the Community, and also developing the region commercially by attracting customers 
and[] develop[ing] the local market, [sic] as Grocery Stores, Restaurants, Pharmacy .... " Finally, 
the Petitioner provided evidence that she has incorporated her business in the state of Maryland. As 
the endeavor's merit may be demonstrated in a range of areas such as business, entrepreneurialism, 
science, technology, culture, health, or education, we agree with the Director that the endeavor has 
substantial merit. Id. 
On appeal, she asserts her endeavor is of national importance because the field of medical devices is 
growing worldwide and will prospectively benefit the national economy because it will create jobs, 
income for spending and investing, tax revenue, and serve as an economic boom to the local 
communities where her offices will be located. She contends that her endeavor will help the U.S. 
compete globally because she has knowledge of United States, European, Middle Eastern, Turkish, 
and African medical device qualification standards. She also states that there is an impending shortage 
of business professionals in the United States, and because of her expertise, she is well equipped to 
fill in that gap. We note, however, that a shortage of workers within a given occupation does not 
render a proposed endeavor nationally important under the Dhanasar framework because the U.S. 
Department of Labor directly addresses these shortages through the labor certification process. 
4 
The Petitioner relies heavily on industry reports and articles concerning such topics as the challenges 
faced by small businesses ( especially following the pandemic), the Bi den Administration's efforts to 
revive the "International Entrepreneur Rule," how the COVID-19 pandemic affected the global supply 
chain for medical devices, and the types of reforms needed in the medical device and healthcare 
systems to reduce the environmental impact of waste byproducts and overall energy waste. However, 
while the articles provide a context for some of her assertions, they do not discuss the Petitioner's 
proposed endeavor or explain how her endeavor would have broader implications. Matter of 
Chawathe, 25 I&N Dec. at 375-76. Further, merely working in an important field or profession is 
insufficient to establish the national importance of the proposed endeavor, as we explained in 
Dhanasar. Dhanasar, 26 I&N Dec. at 889. In determining whether the proposed endeavor has 
national importance, the relevant question is not the importance of the field, industry, or profession in 
which the individual will work; instead, we focus on the "the specific endeavor that the foreign 
national proposes to undertake." Id. 
Regarding the letter from a professor at.__ ____________ ____, it is in conflict with the 
Petitioner's stated endeavor because the letter describes how she will use her skills and knowledge in 
environmental engineering to grow the value of U.S. companies. While we recognize the Petitioner 
has degrees in environmental engineering, her stated endeavor is to act as a consultant and trainer for 
companies and businesses requiring expertise in medical device regulations and sustainability 
programs, which is not consistent with how the letter describes her endeavor. The letter explains the 
role that environmental engineers, such as the Petitioner, play in environmental protection and climate 
action, and how her endeavor will improve health outcomes and reduce health costs, which will 
broadly enhance "societal welfare." The letter also describes alternative sources of energy like wind 
turbines and solar energy, and states that "[ w ]ind turbine technicians are expected to be the fastest­
growing occupation over the next lOyears." The Petitioner's proposed endeavor does not mention or 
touch on wind turbines or alternative sources of energy. The letter further discusses the net increase 
in jobs as the United States transitions from fossil fuels to clean energy, and concludes that "in this 
context, the proposed endeavor has significant potential to employ U.S. workers and has other 
substantial positive economic effects." Again, because the Petitioner's proposed endeavor is to assist 
companies facing the regulatory barriers to bring their medical device products to the global market, 
the letter, on the whole, does not bolster the national importance of her endeavor because it touches 
on different concerns. The section of the letter dedicated to Dhanasar 's first prong describes the 
national importance of her endeavor as being "beneficial to U.S. companies and institutions across 
various industries ... improv[ing] business operations and boost[ing] safety in the workplace and 
employees' health and well-being, ... promoting social welfare and resulting in a more productive 
and revenue-generating workforce." Because the letter's description of her endeavor is unrelated to 
her stated proposed endeavor, in the exercise of our considered discretion, it is of little probative value. 
See Matter of Caron Int'l, Inc., 19 I&N Dec. 791, 795 (Comm'r 1988) (standing for the proposition 
that we may, in our discretion, use opinion statements submitted by a petitioner as advisory but, where 
an opinion is not in accord with other information or is in any way questionable, we are not required 
to accept or may give less weight to that opinion); see also Matter ofChawathe, 25 I&N Dec. at 375-
76 (standing for the proposition that a petitioner must support their assertions with relevant, probative, 
and credible evidence). 
In addition, while the Petitioner's resume and recommendation letters address her past 
accomplishments in regulatory affairs, they do not demonstrate the national importance of her 
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endeavor's "potential prospective impact." Dhanasar, 26 T&N Dec. at 889. Further, although the 
Petitioner has made valuable contributions to her employers, these documents pertain to Dhanasar 's 
second prong, which "shifts the focus from the proposed endeavor to the foreign national." Id. at 890. 
The issue here is whether the specific endeavor she proposes to undertake has national importance 
under Dhanasar' s first prong. 
As contemplated by Dhanasar, we examined the record to determine if there is sufficient evidence to 
conclude the Petitioner's "undertaking may have national importance ... because it has national or 
even global implications within a particular field, such as those resulting from certain improved 
manufacturing processes or medical advances." Id. at 893. Here, there is no evidence to find the 
Petitioner's regulatory affairs methodologies differ from or improve upon those already available and 
in use in the United States. The Petitioner's recommendation letters discuss her successful handling 
of past projects, her expertise in global regulatory affairs, her success at helping her employers enter 
the regulated global trade of medical devices for commercialization, and her professionalism, 
diligence, and work ethic, however they do not address or explain how the endeavor will substantially 
benefit the United States or differ from current regulatory affairs practices. We point out that her goal 
of offering training in various regulatory standards does not sufficiently explain how the training she 
will offer will change or alter current Jegulator affairs to find national importance. Moreover, the 
letter provided by her current employer describes how her past work experience in regulatory 
affairs makes her "more than equipped ... to assist [them] with all the regulatory requirements ... 
such [as] FDA, ISO 13485, CE, MDD to MDR transition, EU UDO, GUDID UDI, as well as device 
registration within different countries of Europe, Africa, and Asia." The letter does not mention any 
new processes, practices, or advances that the Petitioner is providing them other than an application 
of her expertise in regulatory affairs, which she gained by working in her field. Overall, the letters 
demonstrate that the Petitioner's past services and professional contributions have provided value to 
her employers, but do not show that her endeavor or methodologies will impact more than just the 
clients and companies she will serve. Id. 
We also explained in Dhanasar that "[a]n endeavor that has significant potential to employ U.S. 
workers or has other substantial positive economic effects, particularly in an economically depressed 
area ... may well be understood to have national importance." Id. at 890. In the financial analysis 
portion of the Petitioner's business plan, it is projected that the Company will have 22 U.S. workers 
hired and 19 workers engaged by its fifth year of operation. Her business plan also projects a boom 
to the local economy where her offices will be located. However, the business plan by itself does not 
sufficiently detail the basis for its financial and staffing projections. Matter of Chawathe, 25 I&N 
Dec. at 375-76. The Petitioner has not provided corroborating evidence as to how the Company's 
activity stands to provide "substantial economic benefits" in the United States. Id. The Petitioner 
must support her assertions with relevant, probative, and credible evidence. Id. 
To bolster her statement that her endeavor will provide "substantial positive economic effects," the 
Petitioner asserts that the Company's three offices will be located within a Small Business 
Administration designated historically underutilized business zone (HUBZone). The HUBZone 
program promotes business growth in underutilized business zones with the goal of awarding three 
percent of federal contract dollars to companies that are HUBZone certified. 
See https ://www.sba.gov/federal-contracting/ contracting-assistance-programs/hubzone-program. 
6 
Operating a business in an HUBZone offers several advantages including eligibility for federal 
contracting preferences, access to set-aside contracts, and potential tax incentives. Id. Businesses 
seeking HUBZone certification must ensure that their business is owned and controlled by U.S. 
citizens, a community development corporation, an agricultural cooperative, or an Indian tribe. Id. 
Further, the business's principal office must be located in the designated HUBZone, and it must be the 
location where the greatest number of employees perform their work. Id. Here, there is no indication 
in the record that the Petitioner's business meets the requirements for HUBZone certification. Further, 
to the extent that the Petitioner is trying to equate her business being in a HUBZone with Dhanasa r 's 
emphasis on job creation and economic effects in an "economically depressed area," the evidence does 
not establish the Company's ability to qualify for HUBZone certification, nor does it sufficiently 
explain how merely locating her office in an HUBZone qualifies as job creation in an "economically 
depressed area." And, even if the Company were to provide jobs in a HUBZone location, the number 
of projected jobs is not sufficiently high to be considered of national importance. As such, the 
Petitioner has not provided independent, corroborating evidence to substantiate that the Company 
would hire a significant number of workers in the economically depressed areas of Maryland or 
Virginia or how her investment would specifically impact these regions. Matter ofChawath e, 25 I&N 
Dec. at 375-76. Accordingly, the Petitioner has not established the national importance of the 
proposed endeavor in satisfaction of Dhanasar 's prong one. See generally, 6 USCIS Policy Manual , 
F. 5(D)(2 ), https :/ /www. uscis. gov /po licymanual. 
Here, the record does not show that the Petitioner ' s proposed endeavor stands to sufficiently extend 
beyond her clients to impact her field more broadly at a level commensurate with national importance. 
Nor has she shown that the work she proposes to undertake offers original innovations that contribute 
to advancements or otherwise has broader implications for her field. Furthermore, the Petitioner has 
not demonstrated that her specific endeavor has significant potential to employ U.S. workers or 
otherwise offers substantial positive economic effects for our nation. Without evidence regarding any 
projected U.S. economic impact or job creation directly attributable to her future work, the record does 
not show that benefits to the regional or national economy resulting from the Petitioner's endeavor would 
reach the level of "substantial positive economic effects" contemplated by Dhanasar. Id. at 890. 
As the Petitioner has not established the national importance of her proposed endeavor, we decline to 
reach and hereby reserve the Petitioner's arguments regarding her eligibility under the second and 
third prongs. See INS v. Bagamasbad , 429 U.S. 24, 25 (1976) ("courts and agencies are not required 
to make findings on issues the decision of which is unnecessary to the results they reach"); see also 
Matter of L-A-C- , 26 I&N Dec. 516, 526 n.7 (BIA 2015) (declining to reach alternative issues on 
appeal where an applicant is otherwise ineligible). 
The Petitioner has not established the national importance of the proposed endeavor, and consequently 
that a waiver of the job offer and labor certification process, in the exercise of our discretion, is in the 
national interest. 
ORDER: The appeal is dismissed. 
7