dismissed EB-2 NIW Case: Pharmaceutical Chemistry

U.S. Department of Homeland Security 
20 Mass. Ave., N.W., Rm. A3042 
Washington; DC 20529 
U. S. Citizenship 
and Immigration 
,- 
FILE: Office: VERMONT SERVICE CENTER Date: uo 3 1 ~005 
EAC 03 203 51010 
PETITION: Immigrant Petition for Alien Worker as a Member of the Professions Holding an Advanced 
Degree or an Alien of Exceptional Ability Pursuant to Section 203(b)(2) of the Immigration 
and Nationality Act, 8 U.S.C. fj 1 153(b)(2) 
ON BEHALF OF PETITIONER: 
This is the decision of the Administrative Appeals Office in your case. A11 documents have been returned to 
the office that originally decided your case. Any further inquiry must be made to that office. 
3,. Robert P. Wiemann, Director 
Administrative Appeals Office 
DISCUSSION: The Director, Vermont Service Center, denied the employment-based immigrant visa petition. 
The matter is now before the Administrative Appeals Office on appeal. The appeal will be dismissed. 
The petitioner seeks to classify the beneficiary pursuant to section 203(b)(2) of the Immigration and Nationality 
Act (the Act), 8 U.S.C. 5 1153(b)(2), as a member of the professions holding an advanced degree. The petitioner 
is a chemical and pharmaceutical manufacturing company that seeks to employ the beneficiary as a senior 
analyst. The petitioner asserts that an exemption from the requirement of a job offer, and thus of a labor 
certification, is in the national interest of the United States. The director found that the beneficiary qualifies for 
classification as a member of the professions holding an advanced degree, but that the petitioner has not 
established that an exemption from the requirement of a job offer would be in the national interest of the United 
States. 
Section 203(b) of the Act states in pertinent part that: 
(2) Aliens Who Are Members of the Professions Holding Advanced Degrees or Aliens of Exceptional 
Ability. -- 
(A) In General. -- Visas shall be made available . . . to qualified immigrants who are members of 
the professions holding advanced degrees or their equivalent or who because of their exceptional 
ability in the sciences, arts, or business, will substantially benefit prospectively the national 
economy, cultural or educational interests, or welfare of the United States, and whose services in 
the sciences, arts, professions, or business are sought by an employer in the United States. 
(B) Waiver of Job Offer. 
(i) . . . the Attorney General may, when the Attorney General deems it to be in the 
national interest, waive the requirements of subparagraph (A) that an alien's services in 
the sciences, arts, professions, or business be sought by an employer in the United 
States. 
The director did not dispute that the petitioner qualifies as a member of the professions holding an advanced 
degree. The sole issue in contention is whether the petitioner has established that a waiver of the job offer 
requirement, and thus a labor certification, is in the national interest. 
Neither the statute nor the pertinent regulations define the term "national interest." Additionally, Congress did 
not provide a specific definition of "in the national interest." The Committee on the Judiciary merely noted in its 
report to the Senate that the committee had "focused on national interest by increasing the number and proportion 
of visas for immigrants who would benefit the United States economically and otherwise. . . ." S. Rep. No. 55, 
10lst Cong., 1st Sess., 11 (1989). 
Supplementary information to regulations implementing the Immigration Act of 1990 (IMMACT), published at 
56 Fed. Reg. 60897,60900 (November 29, 1991), states: 
The Service [now Citizenship and Immigration Services] believes it appropriate to leave the 
application of this test as flexible as possible, although clearly an alien seeking to meet the 
[national interest] standard must make a showing significantly above that necessary to prove the 
"prospective national benefit" [required of aliens seeking to qualify as "exceptional."] The 
burden will rest with the alien to establish that exemption from, or waiver of, the job offer will be 
in the national interest. Each case is to be judged on its own merits. 
Matter of New York State Dept. of Transportation, 22 I&N Dec. 215 (Comm. 1998), has set forth several factors 
which must be considered when evaluating a request for a national interest waiver. First, it must be shown that 
the alien seeks employment in an area of substantial intrinsic merit. Next, it must be shown that the proposed 
benefit will be national in scope. Finally, the petitioner seeking the waiver must establish that the alien will serve 
the national interest to a substantially greater degree than would an available U.S. worker having the same 
minimum qualifications. 
It must be noted that, while the national interest waiver hinges on prospective national benefit, it clearly must be 
established that the alien's past record justifies projections of hture benefit to the national interest. The 
petitioner's subjective assurance that the alien will, in the future, serve the national interest cannot suffice to 
establish prospective national benefit. The inclusion of the term "prospective" is used here to require future 
contributions by the alien, rather than to facilitate the entry of an alien with no demonstrable prior achievements, 
and whose benefit to the national interest would thus be entirely speculative. 
Counsel discusses the petitioning company and the beneficiary's role therein: 
[The petitioner] is a contract manufacturer of bulk active pharmaceutical ingredients (APIs) 
and advanced intermediates for use in the development, clinical testing, and manufacture of 
pharmaceutical products. . . . 
A senior research and development analyst, such as [the beneficiary], has overall 
responsibility for testing procedures: establishing test protocols, carrying on or supervising 
actual testing procedures, and validating results. His duties also include developing 
analytical methods to monitor drug reactions for producing the anti-cancer drug Taxane, a 
highly toxic material, which calls upon his expertise in handling toxic materials. . . . 
[The beneficiary] has overall responsibility for the projects. He is the lead person. In 
addition, he supervises and trains others to participate in the work. . . . 
[The beneficiary] won honors as a graduate student; his papers, published in peer-reviewed 
journals, are widely cited; he is a member of two prestigious professional societies; and he 
mentors and supervises the work of others. He also serves as a referee for technical journals. 
In addition, other people prominent in his field think highly of his work. 
Regarding counsel's claim that the beneficiary's "papers . . . are widely cited," the petitioner submits copies 
of five articles that cite the beneficiary's work. The petitioner is a co-author of three of the five citing articles. 
Another co-author of those three articles, as well as the fourth citing article, is Professor Sirasani 
Satyanarayana, who supervised the beneficiary's doctoral studies at Osmania University. We cannot 
reasonably conclude the petitioner's work to be "widely cited," when all but one of the citations of his work 
are by the beneficiary himself and/or his former mentor. 
The petitioner submits seven witness letters with the petition; we shall discuss examples of these letters. One 
of the seven witnesses is Prof. Satyanarayana, identified above. Another witness studied alongside the 
beneficiary at Osmania University. Three others are employees of the petitioning company. The remaining 
two witnesses do not specifL exactly how they first came to know of the beneficiary's work. 
Page 4 
Prof. Satyanarayana states: 
In 1996, [the beneficiary] joined my lab for his PhD and selected to work on the synthesis, 
kinetics and stabilities of axial ligation of vitamin BIZ model compounds with various 
biologically important ligands. The axial ligation is the key step involved in the activity of 
vitamin BIZ and its deficiency caused diseases such as anemia, depression and color 
blindness, these class of model compounds are sensitive to light. Consequently, a method of 
quantification for measuring low concentrations to study the key step mechanism was needed. 
[The beneficiary] has developed Ultra-Violet spectrophotometer solution methods in which 
he demonstrated the axial base release mechanism of vitamin BIZ and the behavior of vitamin 
BI2 in biological systems. 
After he was awarded [a] Senior Research Fellowship in 1998, he extended these concepts to 
the reaction mechanism and structural elucidation of these vitamin BI2 model compounds 
with the help of modern instrumentation. He elaborately established a comparative study 
between cyanide and imidazole by studying their speeds and stabilities of the association and 
dissociation with the vitamin BIZ model compounds, he also demonstrated substituents effect 
of the incoming ligants on the mechanism, these two presentations at American Chemical 
Society national meetings has brought recognition to [the beneficiary]. During his PhD, [the 
beneficiary] has made major contributions for the better understanding of vitamin BIZ 
chemistry and published articles in international journals, his work is being cited and 
discussed by others within his field. . . . 
[The beneficiary's] area of capability is such that there are very few people who possess his 
background and expertise. This is because there are only few centers of academic learning in 
the world where the research is on the stabilities and kinetics of biologically important 
compounds in solutions by different modern scientific instrumentation. 
Regarding Prof. Satyanarayana's last statement (that the beneficiary possesses hard-to-obtain training), we 
note that special or unusual knowledge or training, while perhaps attractive to the prospective U.S. employer, 
does not inherently meet the national interest threshold. The issue of whether similarly-trained workers are 
available in the U.S. is an issue under the jurisdiction of the Department of Labor. Matter of New York State 
Dept. of Transportation at 22 1. 
[The beneficiary] has developed very critical HPLC methods to separate, identify and 
quantify related diastereomers making his expertise very important to the manufacturing 
process. . . . [The beneficiary] has demonstrated his unique qualities by developing methods 
using Head Space Gas Chromatography to reliably identify and quantify minute amounts of 
residual solvents. 
Most of [the beneficiary's] projects are in the phase 111111 clinical stages for cancer treatment. 
At present, his two projects are under the class of targeted Taxane therapy, which is the latest 
and most effective chemotherapy for targeting only the cancer cells. . . . [The beneficiary] has 
accomplished technical tasks that have eluded many more-experienced researchers around the 
world. 
~r.- a group leader at Novartis Pharmaceuticals Corporation, states: 
I know [the beneficiary] for the past several years through his outstanding publications and 
also through his graduate research advisor, Prof. d. . . I found his work 
interesting and very useful from both an academic an an in ustria point of view. . . . 
He has developed methods to study the interaction of biological molecules with metal ions 
under physiological conditions. These studies are extremely useful in understanding the drug 
interactions with receptors related to targeted diseases. . . . 
[The beneficiary] has developed High Performance Liquid Chromatography (HPLC) methods 
to identify and quantify the impurities during the scale up and production of several important 
anticancer drugs. These studies are very valuable to the development of anticancer drugs and 
addresses [sic] many issues related to the purity and potency of the molecules. [The 
beneficiary's] past experience in the area of reaction kinetics helped him to make significant 
contributions to understanding the degradation pathways of drug molecules under various 
conditions. In addition, [the beneficiary] utilized his research expertise in developing 
methods for the quantification of volatile organic compounds and residual solvents in drug 
molecules using headspace Gas Chromatography (GC). These studies would help in 
eliminating any traces of toxic material from the drug molecules thus increasing the safety for 
using the drugs during the treatment of cancer. 
Dr. CEO of Psyche Pharmaceuticals, Inc., states that the beneficiary "has developed a 
critical HPLC method to identify and quantify diastereomers of potentially important cancer dru s," and "has 
completed significant studies that place him in the upper ranks of bio-analytical chemists." Drh does 
not specify how he knows of the beneficiary's work, but he states that the beneficiary "is an avi IS erman 
[who] has many non-Asian friends among his co-workers . . . and neighbors in Rensselaer." Psyche 
Pharmaceuticals is based in Rensselaer. 
The director denied the petition, acknowledging the intrinsic merit and national scope of the beneficiary's 
work, but finding that the petitioner had not shown the beneficiary's accomplishments to be of a caliber that 
would merit a national interest waiver. The director noted that the witnesses were primarily the beneficiary's 
personal acquaintances, and that the record does not establish significant independent citation of the 
beneficiary's published work. 
On appeal, counsel argues that the standards set forth in Matter of New York State Dept. of Transportation are 
"excessively high." Counsel (who was also the attorney of record for the petitioner in Matter of New York 
State Dept. of Transportation) does not show that any federal court has invalidated that precedent decision in 
whole or in part. As long as Matter of New York State Dept. of Transportation remains standing precedent, 
the director is required to follow that decision, pursuant to 8 C.F.R. 5 103.3(c). The director's mandatory 
adherence to published precedent cannot reasonably be construed as error requiring reversal on appeal. 
Counsel asserts that the director's decision "completely ignores the realities of the labor certification process. 
A labor certification application filed in New York State takes approximately three years to be adjudicated." 
Complaints about the labor certification process itself, however justified they might be, are not persuasive 
arguments in favor of granting a national interest waiver. Nothing in the legislative history suggests that the 
national interest waiver was intended simply as a means for employers (or self-petitioning aliens) to avoid the 
inconvenience of the labor certification process. Matter of New York State Dept. of Transportation at 223. 
Counsel's complaint implies either that a lengthy backlog should qualify every alien in that locality for a 
waiver; or that the petitioner would happily apply for a labor certification if the waiting time were shorter. 
Neither of these implied arguments rests on the merits of the individual alien. 
Counsel states that three of the initial seven letters "are from scientists who are neither [the beneficiary's] 
colleagues nor his mentors. They know of his work from his publications and his reputation in his field." 
One of those three witnesses states that, in 1996, he and the beneficiary "were both in the Department of 
Chemistry [at] Osmania University." Another witness, writing from a Rensselaer address, mentions the 
beneficiary's compatibility with his neighbors in Rensselaer as well as his proclivity for fishing, details which 
are unlikely to surface from a review of the beneficiary's scholarly writings. We must rely on review of the 
evidence itself, rather than on counsel's claims and assertions regarding that evidence. 
The appeal submission includes two new letters. One is from Professo of the State University 
of New York (SUNY) at Albany. Prof- states: 
[The beneficiary's] major expertise is in various types of modern chromatography. 
Chromatography is one of the key techniques used widely in pharmaceutical industry, both 
on research-and-development stage and during the manufacturing process. Specialists with 
background and expertise of [the beneficiary] are very valuable for further advancement of 
pharmaceutical industry in the U.S. . . . 
A high level of [the beneficiary's] background is evidence from his publication record in top 
Indian scientific journals. In addition, he was a recipient of several awards during his 
graduate study. 
While ~rof.mendorses the beneficiary as a highly skilled researcher, he appears to lay greater emphasis 
on the overall importance of expertise in chromatography within the pharmaceutical industry. Counsel states 
and the beneficiary, "it is not clear that they have even met," the implication being that Prof. 
ows t e beneficiary only through the beneficiary's work. In this context, it is not a trivial detail Profm 
that Psyche Pharmaceuticals (whose CEO knows personal details of the beneficiary's life) is located on a 
campus of SUNY Albany. prof- letter does not dispel the impression that the beneficiary's 
reputation in the United States is very heavily concentrated in the Albany area. 
The other new letter is from a senior research scie 
She identifies the petltlon~ng corporation is a subsidiary 
street address, telephone number, and fax number. She states: 
Given that our business is as a contract research organization supporting projects for 
pharmaceutical clients it is difficult for [the beneficiary] to frequently and extensively publish 
the results of his research he does because of the confidentiality policy of our company and 
our clients. . . . 
[The beneficiary] has developed many Analytical methods in the areas of HPLC, GC, 
Spectrophotometry and ICP-AES that helped the very success of the projects he was involved 
with variety of pharmaceutical products [sic]. 
We acknowledge that work undertaken for private industry will sometimes involve confidentiality agreements 
that preclude publication. Because the beneficiary cannot disseminate his findings through publication, the 
petitioner must establish some alternative means by which the beneficiary's work is in the national interest, as 
opposed to the more limited interest of the petitioner's clients. The record contains no objective, 
documentary evidence to show that the beneficiary is responsible for a nationally significant improvement in 
the quality or quantity of pharmaceutical products, or for ensuring that such drugs reach the market 
substantially sooner than they would have done if a different qualified worker had been in the beneficiaw's 
lace.  he record contains-only one letter from a witness at a pharmaceutical company (Dr.-at 
I,, and D- never even indicates that Novartis is one of the petitioner's client companies. 
It is not.fully clear that the beneficiary's current activities constitute research per se, as opposed to quality 
control testing on products devised and manufactured by others. Therefore, his past work as a researcher 
appears to be of diminished relevance. 
The argument that the beneficiary possesses the necessary skills to perform his job is not sufficient because 
Congress has created no blanket waiver for aliens in the beneficiary's occupation. If such blanket waivers 
were simply implied by the very existence of the national interest waiver, then section 203(b)(2)(B)(ii) of the 
Act (pertaining to certain physicians) would arguably be redundant. 
As is clear from a plain reading of the statute, it was not the intent of Congress that every person qualified to 
engage in a profession in the United States should be exempt from the requirement of a job offer based on 
national interest. Likewise, it does not appear to have been the intent of Congress to grant national interest 
waivers on the basis of the overall importance of a given profession, rather than on the merits of the individual 
alien. On the basis of the evidence submitted, the petitioner has not established that a waiver of the requirement 
of an approved labor certification will be in the national interest of the United States. 
The burden of proof in these proceedings rests solely with the petitioner. Section 291 of the Act, 8 U.S.C. 5 1361. 
The petitioner has not sustained that burden. 
This denial is without prejudice to the filing of a new petition by a United States employer accompanied by a 
labor certification issued by the Department of Labor, appropriate supporting evidence and fee. 
ORDER: The appeal is dismissed.