dismissed EB-2 NIW Case: Pharmaceutical Production

U.S. Citizenship 
and Immigration 
Services 
Non-Precedent Decision of the
Administrative Appeals Office 
Date: JUL. 10, 2024 In Re: 31654369 
Appeal of Texas Service Center Decision 
Form 1-140, Immigrant Petition for Alien Workers (National Interest Waiver) 
The Petitioner, a pharmaceutical industrial production manager, seeks employment-based second 
preference (EB-2) 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 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 pursuant to 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 Christa's , Inc., 26 I&N Dec. 537,537 n.2 (AAO 2015). Upon de novo review, 
we will dismiss the appeal. 
I. LAW 
To qualify for the underlying EB-2 visa classification
, a petitioner must establish they are an advanced 
degree professional or an individual of exceptional ability in the sciences, arts, or business. 
Section 203(b)(2)(A) of the Act. 
If a petitioner establishes eligibility for the underlying EB-2 classification, they must then demonstrate 
that they merit a discretionary waiver of the job offer requirement "in the national interest." 
Section 203(b )(2)(B)(i) of the Act. Our precedent decision in Matter ofDhanasar, 26 I&N Dec. 884, 
889 (AAO 2016), provides the framework for adjudicating national interest waiver petitions. 
Dhanasar states that U.S. Citizenship and Immigration Services (USCIS) may, as matter of 
discretion, 1 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 their proposed endeavor; and 
1 See Flores v. Garland, 72 F.4th 85, 88 (5th Cir. 2023) (joining the Third, Ninth, Eleventh, and D.C. Circuit Courts in 
concluding that USCIS ' decision to grant or deny a national interest waiver is discretionary in nature) . 
• On balance, waiving the job offer requirement would benefit the United States. 
Id. 
II. ANALYSIS 
The Director determined that the Petitioner qualifies for the underlying EB-2 classification as an 
advanced degree professional. The remaining issue to be determined is whether the Petitioner has 
established that a waiver of the requirement of a job offer, and thus a labor certification, would be in 
the national interest. 
The Petitioner proposes to work as a pharmaceutical industrial production manager, where he will 
plan, direct, and coordinate work activities and resources necessary for the manufacture of 
pharmaceutical products. In his personal statement, he claims he will make production resilient and 
implement a risk mitigation strategy to (1) ensure the adequate supply of safe, effective, and quality 
medicines through strengthening the supply chain, and (2) anticipate drug shortages. 
The Director concluded that the Petitioner's endeavor has substantial merit but not national importance 
under Dhanasar 's first prong. 2 On appeal, the Petitioner asserts that he submitted sufficient evidence 
to demonstrate his proposed endeavor's national importance and claims the Director summarily denied 
his petition without any articulated, specific reasoning. In particular, he contends, among other things, 
that the Director erred in finding the Petitioner did not demonstrate his endeavor's significant potential 
for positive economic effects and job creation, and that the Director overreached by attempting to 
introduce a novel interpretation of Dhanasar. 
Upon de novo review, we conclude the Petitioner's proposed endeavor has substantial merit. 
However, for the reasons discussed below, we agree with the Director's determination that the 
Petitioner has not demonstrated his proposed endeavor's national importance and, thus, has not shown 
that he satisfies Dhanasar 's first prong. 3 
The first prong, substantial merit and national importance, focuses on the specific endeavor that the 
individual proposes to undertake. In determining whether the proposed endeavor has national 
importance, we consider its potential prospective impact. Matter ofDhanasar, 26 l&N Dec. at 889. 
In Dhanasar, we noted that "we look for broader implications" of the proposed endeavor and 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, for instance, may well be understood 
to have national importance." Id. at 889-90. 
2 The Petitioner claims he satisfied Dhanasar 's second prong because the Director did not object to or address this issue 
in her decision. This is incorrect. The Director concluded that the Petitioner had not established eligibility under 
Dhanasar 's first prong, which was dispositive. Therefore, it was unnecessary for her to reach the remaining two prongs. 
See INS v. Bagamasbad , 429 U.S. 24, 25 (1976) ("As a general rnle 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). 
3 While we do not discuss every piece of evidence individually, we have reviewed and considered the whole record. 
2 
Here, the Petitioner has not offered sufficient evidence to demonstrate that the prospective impact of 
his proposed endeavor rises to the level of national importance. In support of his claim, the Petitioner 
emphasizes the importance of the pharmaceutical industry and submitted various articles and reports, 
including documents generally discussing the industry, drug shortages, and various government 
initiatives to strengthen the supply chain. However, in determining national importance, the relevant 
question is not the importance of the field, industry, or profession in which the individual will work; 
instead, the focus is on "the specific endeavor that the foreign national proposes to undertake." Id. 
at 889. In this case, the articles and reports provide only general background information on these 
industries and fields and do not specifically relate to or discuss the Petitioner's proposed endeavor, 
including how his endeavor might impact these areas more broadly, such that it rises to the level of 
national importance. Merely working in an important field is insufficient to establish the national 
importance of the proposed endeavor. 
The Petitioner also has not adequately supported his assertions that his proposed endeavor has broader 
implications. Specifically, the Petitioner claims in his updated personal statement that his "ability to 
prevent supply shortages in pharmaceuticals is directly and tangibly related to ongoing pharmaceutical 
drug shortages nationwide." He contends that his endeavor is geared towards solving two of the major 
causes of drug shortages-manufacturing contamination and quality issues, as well as misallocation 
of pharmaceutical product distribution. The Petitioner, however, does not adequately detail how 
providing his services as a pharmaceutical industrial production manager for one company would have 
such broader impact in the industry that it rises to the level of national importance. 
For instance, while he asserts in his updated personal statement that his undertaking will prevent 
"significant harm to consumers who cannot access the medications they require," he also states that 
"supply chain issues are rarely limited to a single geographic area or a single manufacturer." He does 
not explain how his future activities for a single manufacturer would sufficiently extend beyond his 
immediate employer and its clients to impact the business, healthcare, or pharmaceutical industries 
more broadly. Aside from his vague assertions that his endeavor has a "significant potential" to 
alleviate disruptions causing drug shortages in the United States, he does not elaborate how his 
proposed endeavor specifically will address this issue and have such broader impact in the industry 
that it would rise to the level of national importance. 
The Petitioner also has not shown that his proposed endeavor has a significant potential to employ 
U.S. workers or otherwise offer substantial positive economic effects for our nation. The Petitioner 
has not offered sufficient, specific evidence regarding any projected U.S. economic impact directly 
attributable to his future work. For example, the Petitioner contends that his employer tasked him 
with managing the company's new production facility in Brazil. He claims this increase in production 
capacity will directly lead to the creation of jobs and have other ripple effects including a decrease in 
unemployment, an increase in payroll taxes to the government, and an increase in workers who will 
pay taxes and consume more goods in the market. However, as noted in the Director's decision, the 
evidence indicates that the facility will be located in Brazil, not the United States. As such, the claimed 
economic benefits associated with this facility do not sufficiently demonstrate the endeavor's regional 
or national impacts in the United States, but rather, as acknowledged by the Petitioner, it demonstrates 
benefits to "the broader national Brazilian economy" ( emphasis added). Additionally, to the extent 
the Petitioner asserts his work with this facility illustrates his ability to provide similar direct positive 
economic benefits to the United States, the Petitioner's skills, knowledge, and record of successes are 
3 
considerations under Dhanasar 's second prong, which "shifts the focus from the proposed endeavor 
to the foreign national." Id. at 890. When conducting an analysis under Dhanasar's first prong, as 
we are doing here, we look to the proposed endeavor itself. Id. at 889. 
However, even if we were to consider the Petitioner's claims of alleged job creation and tax revenue, 
we would still conclude that he has not adequately explained how his endeavor plays more than an 
indirect, tangential role in producing such claimed economic benefits, particularly where his employer 
is responsible for building the factory, hiring any employees, and paying any associated taxes. Any 
basic business activity has the potential to positively impact the economy. However, the Petitioner 
has not adequately shown how working as a single pharmaceutical industrial production manager for 
an individual employer-the specific endeavor proposed here-generates such significant economic 
activity that it rises to the level of "substantial positive economic effects" as contemplated by 
Dhanasar. 
Without adequate evidence demonstrating any specific U.S. economic impact, job creation, or other 
significant economic activity directly attributable to his future work, the Petitioner's claims that his 
endeavor will provide substantial, direct positive economic effects is unpersuasive. The Petitioner 
must support his assertions with relevant, probative, and credible evidence. See Matter ofChawathe, 
25 I&N Dec. at 376. The Petitioner's references to abstract tax revenue, job creation, and other 
unspecified economic benefits rely on more generalizations about the results of typical business 
activity, rather than providing probative information about what the Petitioner plans to accomplish 
through the endeavor and how it may have national importance. 
The Petitioner also claims he will train new employees at his company in pharmaceutical industrial 
production, which will result in a "multiplier effect both in terms of job creation and substantive 
economic effects." In addition, he contends his training will help fill "critical shortages" within his 
industry. In Dhanasar, we determined that the petitioner's teaching activities did not rise to the level 
of having national importance because they would not impact his field more broadly. Matter of 
Dhanasar, 26 I&N Dec. at 893. Similarly, in this case, the Petitioner has not sufficiently explained 
how his training activities at one company would extend beyond his employer and the employees that 
he will train to impact the pharmaceutical field, healthcare industry, or the U.S. economy more broadly 
at a level commensurate with national importance. Furthermore, although the Petitioner argues the 
shortage of industrial production managers "endangers the health and safety of Americans," the record 
contains insufficient evidence that the proposed endeavor stands to impact or significantly reduce this 
claimed shortage. We also note that shortages of qualified workers are directly addressed by the 
U.S. Department of Labor through the labor certification process. 
The Petitioner 's reliance on his "proven experience" and "25 years of knowledge and experience" to 
illustrate his proposed endeavor's potential prospective impact is also misplaced. In support of his 
claim, the Petitioner submitted an expert opinion letter written by a professor at I I 
I I and reference letters written by former work colleagues to demonstrate the national 
importance of his endeavor. However, as noted above, the Petitioner's knowledge, skills, education, 
and experience are considerations under Dhanasar 's second prong. Id. at 890. The issue under the 
first prong is whether the Petitioner has demonstrated the national importance of the proposed 
endeavor itself. 
4 
Further, while the professor's letter makes sweeping claims that the Petitioner's endeavor would have 
a significant national impact, stimulate economic growth, and positively influence individual and 
societal well-being, the letter does not offer specific details on how the Petitioner's endeavor would 
accomplish these goals or how any impact would extend beyond the direct companies and clients that 
the Petitioner will serve. For example, the opinion letter claims the endeavor will have a national or 
even global impact on the pharmaceutical industry. However, instead of explaining how the proposed 
endeavor is tied to these alleged national or global impacts, the letter focuses on the general issue of 
patient access to medications, the typical duties of an industrial production manager in the production 
and manufacturing process, the educational background requirements of the position, and employment 
growth statistics in this sector. Similarly, the letter claims the proposed endeavor will have substantial 
positive economic effects and "contribute greatly to the U.S. economy." But rather than elaborating 
on the Petitioner's proposed endeavor and how it, specifically, will result in such effects, the opinion 
letter largely discusses the economic significance of the manufacturing and industrial production fields 
in general, the number of individuals employed in the sector, and statistics on prescription drug 
expenditure. Consequently, the opinion letter does not provide sufficient corroborating evidence to 
support the endeavor's alleged broader impacts to the industry or nation. 
Likewise, while the letters of support from the Petitioner's former work colleagues praise the 
Petitioner's performance in his past roles, personal attributes, expertise, and past contributions to his 
workplace, these are considerations under Dhanasar 's second prong. The letters lack detail regarding 
the Petitioner's proposed endeavor and its specific impact thereof, including discussion of any potential 
broader implications of his future work. Without more, the expert opinion and other support letters 
provide little probative evidence of the Petitioner's eligibility under Dhanasar's first prong. 
We note that the support letters mention the Petitioner's past contributions to his employer's company, 
including improvements to the manufacturing process. The Petitioner asserts on appeal that the 
Director did not give due consideration to these "innovations," which he claims have "greatly 
improved efficiency and productivity for the Brazilian pharmaceutical industry." He also argues that 
the Director attempted to introduce a "novel interpretation of Dhanasar" regarding improved 
manufacturing processes and "arbitrarily" imposed a need for different or improved processes than 
those already available in the United States. 
First, while we acknowledge the Petitioner's claims regarding the benefits of these processes, evidence 
related to the Petitioner's past contributions to his employer and the Brazilian pharmaceutical industry 
speak to whether the Petitioner is well-positioned to advance his proposed endeavor under Dhanasar 's 
second prong and is not probative of the proposed endeavor's national importance under the first 
prong. 
Second, in Dhanasar, we noted that "[ a ]n undertaking may have national importance for example, 
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 889. While we agree 
Dhanasar does not require a petitioner to show how a proposed endeavor's methodology or process 
differs from or improves upon those already available in the United States, this information is, 
nevertheless, relevant to the question of whether an undertaking would have national or even global 
implications within the field to support its national importance. 
5 
Here, although the Petitioner claims he introduced improved manufacturing processes to the Brazilian 
pharmaceutical industry, he has provided little evidence to show any broader implications to the field. 
He has not demonstrated, for example, specific data demonstrating his processes' effects on the drug 
manufacturing field, evidence of widespread adoption in the industry, or evidence that the Petitioner's 
processes were, in fact, different from or better than those already available in the United States at the 
time. Additionally, we note that the record is unclear as to whether the Petitioner created these 
processes or simply introduced existing technologies to his company. The evidence also appears to 
indicate that the Petitioner's improved processes were implemented approximately in the 2008 to 2010 
timeframe, over a decade ago. Although the Petitioner contends that "[i]t is this capacity and capability 
to innovate improved manufacturing processes that [the Petitioner] intends to offer to the United 
States," the record contains little evidence demonstrating the Petitioner has made any innovations or 
notable process improvements since that time. Based on the evidence in the record, we agree with the 
Director that the Petitioner did not adequately corroborate his claim that his proposed endeavor will 
have national or even global implications within his field or industry. 
The petitioner bears the burden of proof to demonstrate eligibility by a preponderance of the evidence. 
Matter ofChawathe, 25 I&N Dec. at 375. Because the Petitioner has not established through sufficient 
evidence in the record that his proposed endeavor meets the first prong of the Dhanasar framework, 
he has not demonstrated eligibility for a national interest waiver. Since the identified reasons for 
dismissal are dispositive of the Petitioner's appeal, we decline to reach and hereby reserve remaining 
issues concerning whether he has established eligibility under the remaining two Dhanasar prongs. 
See INS v. Bagamasbad, 429 U.S. at 25. 
III. CONCLUSION 
The Petitioner has not met the requisite first prong of the Dhanasar analytical framework. We, 
therefore, conclude that the Petitioner has not established that he is eligible for, or otherwise merits, a 
national interest waiver as a matter of discretion. 
ORDER: The appeal is dismissed. 
6