dismissed L-1B Case: Surgical/Dental Instruments

U.S. Department of Homeland Security 
20 Massachusetts Ave., N.W., Rm. A3042 
Washington, DC 20529 
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File: EAC 02 243 50102 Office. VERMONT SERVICE CENTER Date: NOV 2 8 2005 
IN RE: Petrtioner: 
Beneficiary: 
Petition: Petition for a Nonimmigrant Worker Pursuant to Section 101(a)(15)(L) of the Immigration 
and Nationality Act, 8 U.S.C. $ 1101(a)(15)(L) 
IN BEHALF OF PETITIONER: 
INSTRUCTIONS: 
This is the decision of the Administrative Appeals Office in your case. All documents have been returned to 
the office that originally decided your case. Any further inquiry must be made to that office. 
Appeals Office 
EAC 02 243 50 102 
Page 2 
DISCUSSION: The Director, Vermont Service Center, denied the petition for a nonimmigrant visa. The 
matter is now before the Administrative Appeals Office (AAO) on appeal. The AAO will dismiss the appeal. 
The petitioner filed this nonimmigrant petition seeking to extend the employment of its general manager as an 
L-1B nonimmigrant intracompany transferee pursuant to section 101(a)(15)(L) of the Immigration and 
Nationality Act (the Act), 8 U.S.C. 8 1101(a)(15)(L). The petitioner is a corporation organized in the State of 
New York that is engaged in the import and distribution of surgical and dental instruments. The petitioner 
claims that it is the subsidiary of Aroma Surgical Company located in Sialkot, Pakistan. The beneficiary was 
initially granted a one-year period of stay to open a new office in the United States and the petitioner now 
seeks to extend the beneficiary's status for three years. 
The director denied the petition concluding that the petitioner did not establish that the beneficiary will be 
employed in the United States in a specialized knowledge capacity, or that the beneficiary possesses 
specialized knowledge. 
The petitioner subsequently filed an appeal. The director declined to treat the appeal as a motion and 
forwarded the appeal to the AAO for review. On appeal, counsel for the petitioner disputes the director's 
findings and asserts that the petitioner submitted sufficient evidence to establish that the position offered to 
the beneficiary requires the services of an individual possessing specialized knowledge. The petitioner also 
contends that the beneficiary possesses specialized knowledge of the foreign entity's products and applicable 
U.S. import regulations, as well as advanced knowledge of the company's processes. Finally, counsel asserts 
that the director's decision was arbitrary and is not based upon the evidence in the record. In support of these 
assertions, counsel submits a brief and additional evidence. 
To establish eligibility for the L-1 nonimmigrant visa classification, the petitioner must meet the criteria 
outlined in section 101(a)(15)(L) of the Act. Specifically, a qualifying organization must have employed the 
beneficiary in a qualifying managerial or executive capacity, or in a specialized knowledge capacity, for one 
continuous year within three years preceding the beneficiary's application for admission into the United 
States. In addition, the beneficiary must seek to enter the United States temporarily to continue rendering his 
or her services to the same employer or a subsidiary or affiliate thereof in a managerial, executive, or 
specialized knowledge capacity. 
The regulation at 8 C.F.R. $ 214.2(1)(3) states that an individual petition filed on Form 1-129 shall be 
accompanied by: 
(i) Evidence that the petitioner and the organization which employed or will employ the 
alien are qualifying organizations as defined in paragraph (l)(l)(ii)(G) of this section. 
(ii) Evidence that the alien will be employed in an executive, managerial, or specialized 
knowledge capacity, including a detailed description of the services to be perfomled. 
EAC 02 243 50102 
Page 3 
(iii) Evidence that the alien has at least one continuous year of full time employment 
abroad with a qualifying organization within the three years preceding the filing of 
the petition. 
(iv) Evidence that the alien's prior year of employment abroad was in a position that was 
managerial, executive or involved specialized knowledge and that the alien's prior 
education, training, and employment qualifies hider to perform the intended 
services in the United States; however, the work in the United States need not be the 
same work which the alien performed abroad. 
The regulation at 8 C.F.R. 9 214.2(1)(14)(ii) also provides that a visa petition, which involved the opening of a 
new office, may be extended by filing a new Form 1-129, accompanied by the following: 
(A) Evidence that the United States and foreign entities are still qualifying organizations 
as defined in paragraph (l)(l)(ii)(G) of this section; 
(B) Evidence that the United States entity has been doing business as defined in 
paragraph (l)(l)(ii)(H) of this section for the previous year; 
(C) A statement of the duties performed by the beneficiary for the previous year and the 
duties the beneficiary will perform under the extended petition; 
(D) A statement describing the staffing of the new operation, including the number of 
employees and types of positions held accompanied by evidence of wages paid to 
employees when the beneficiary will be employed in a management or executive 
capacity; and 
(E) Evidence of the financial status of the United States operation. 
At issue in the present matter is whether the beneficiary possesses specialized knowledge and would be 
employed by the United States entity in a specialized knowledge capacity. 
Section 214(c)(2)(B) of the Act, 8 U.S.C. 9 1 184(c)(2)(B), provides the following: 
For purposes of section 101(a)(15)(L), an alien is considered to be serving in a capacity 
involving specialized knowledge with respect to a company if the alien has a special 
knowledge of the company product and its application in international markets or has an 
advanced level of knowledge of processes and procedures of the company. 
Furthermore, the regulation at 8 C.F.R. 5 214.2(1)(1 )(ii)(D) defines "specialized knowledge" as: 
[Slpecial knowledge possessed by an individual of the petitioning organization's product, 
service, research, equipment, techniques, management, or other interests and its application in 
EAC 02 243 50 102 
Page 4 
international markets, or an advanced level of lalowledge or expertise in the organization's 
processes and procedures. 
The petitioner filed the instant nonimmigrant petition on July 13, 2002, indicating that the beneficiary would 
be continuing L-1B employment in the United States as its general manager. In a statement submitted with 
the initial petition, the petitioner stated that the foreign entity is a manufacturer and exporter of dental and 
surgical instruments which exports to Singapore, Malaysia, Indonesia, New Zealand and the United States. 
The U.S. petitioner was established in January 2001 to import and distribute dental and surgical instruments 
manufactured by the foreign entity, and the beneficiary was transferred to the U.S. in L-1B status "to develop 
and direct the new U.S. subsidiary, to expand the company's business in the U.S., increasing its exports and 
distribution of its dental and surgical instruments in the U.S." The petitioner further explained that the 
beneficiary was employed by the foreign entity for a three-year period as a "Sales and Marketing Partner" 
where he determined demand for the company's products, identified potential customers, developed pricing 
strategies, ensured customer satisfaction, and monitored industry trends. The petitioner stated that the 
beneficiary supervised five employees engaged in quality control and packaging, and that he traveled 
extensively to meet with the foreign entity's current and potential clients in Singapore, Malaysia, Dubai, 
Muscat, Saudi Arabia, England, the Philippines, Kuwait and Thailand. 
In the statement appended to the petition, the petitioner explained the beneficiary's United States position as 
general manager and specialized knowledge qualifications as follows: 
[The beneficiary] possesses specialized knowledge which is not general knowledge held 
commonly throughout the industry. [The beneficiary] possesses specialized knowledge of the 
import requirements of surgical and dental instruments. The import into the U.S. of surgical 
and dental instruments is highly regulated by the U.S. Food and Drug Administration. This 
business is highly sophisticated and competitive, as [the beneficiary] must ensure that the 
dental instruments and surgical instruments comply with detailed and stringent FDA 
requirements, as well as customer specifications. Not all imports of surgical and dental 
instruments are required to have FDA approval. For example, imports of surgical instruments 
from Germany and other European countries do not have to pass FDA approval. FDA 
approval is only required for certain countries, such as Pakistan, and other third world 
countries. Thus for example, a U.S. firnl importing surgical instruments from Germany and 
Poland would not have to be knowledgeable about the FDA requirements. Additionally, a 
U.S. based manufacturer is not familiar with import requirements applying to third world 
countries. 
Thus, each shipment of dental and surgical instruments coming into the U.S. from Pakistan is 
held by customs pending FDA approval. [The beneficiary] must answer detailed technical 
questions posed by the FDA regarding the instruments included in the shipment, and provide 
the full specifications of the instruments to the FDA. Only a person with specialized 
knowledge of the composition and design of the hundreds of varieties of surgical and dental 
instruments is capable of interacting with the FDA personnel, and answering their technical 
questions. The FDA takes samples of the shipment, and sends them to the laboratory for 
EAC 02 243 50102 
Page 5 
analysis. During the one-month period required for FDA analysis, the shipment cannot be 
sold. Once the FDA approves the shipment, it is released for sale. However, if any of the 
samples do not meet the FDA's standards, the importer is required to destroy the entire 
shipment. The penalty for not destroying the shipment is a $10,000 fine and a prison term. 
Thus, the consequences of not meeting FDA requirements is very costly - the loss of tens of 
thousands of dollars worth of instruments. 
Additionally, specialized knowledge of the composition, design and use of surgical and 
dental instruments is required to answer customer concerns and complaints. The position 
requires [the beneficiary] to explain in technical terms to the customers the specifications of 
the instruments. Additionally, if customers have complaints about the instruments, or request 
the modification of a particular kind of instrument, specialized knowledge is required to 
understand the customers and to respond to their concerns. Additionally, specialized 
knowledge is required to communicate to the manufacturer in Pakistan complaints about the 
manufacture, and instructions regarding modifications of instruments. [The beneficiary] has 
specialized knowledge of more than 500 varieties of surgical instruments, 500 varieties of 
dental instruments, 100 varieties of optical instruments and 100 varieties of manicure 
instruments. 
Specialized technical knowledge of surgical and dental instruments is also required for 
marketing and developing new clients. [The beneficiary] must explain to potential customers 
how the composition, design and manufacture of [the petitioner's] surgical and dental 
instruments is superior to that of its competitors. 
Finally, [the beneficiary] is in charge of directing and developing the new business in the 
U.S. Thus extensive experience in managerial positions is required in order to develop and 
direct the new business and to create its policies and practices. 
[The beneficiary] has specialized knowledge of dental instruments and surgical instruments, 
and quality control regulations in the U.S. and other international markets, as well as an 
advanced level of knowledge of the processes and procedures of the company. 
The petitioner submitted a letter from its claimed Pakistani parent company, confirming the beneficiary's 
employment as its sales and marketing partner from November 1998 to 2001. The petitioner also submitted a 
letter from the beneficiary's former employer in Pakistan, A1 Riaz & Co. Pak. (Pvt) Ltd., where he worked as 
an Import Director from 1986 to November 1998, and was responsible for oversight of quality control for 
dental instruments, import of raw materials to Pakistan, and exports of dental and surgical instruments to 
Singapore, the Philippines, Indonesia, Thailand, Dubai, Saudi Arabia and the United Kingdom. 
The director issued a request for additional evidence on August 23, 2002, stating that the record was not 
persuasive in demonstrating that the beneficiary has truly specialized knowledge or that the beneficiary has 
been and would be employed in a truly specialized knowledge capacity. The director asked that the petitioner 
submit the following: (1) evidence verifying that the beneficiary's knowledge is uncommon, noteworthy, or 
EAC 02 243 50102 
Page 6 
distinguished by some unusual quality and is not generally known by practitioners in the beneficiary's field of 
endeavor; (2) evidence that the beneficiary's advanced level of knowledge of the company's processes and 
procedures distinguishes him from those with elementary or basic knowledge; (3) evidence to substantiate 
that the knowledge possessed by the beneficiary is not general knowledge held commonly throughout the 
industry, but that it is truly special or advanced, including evidence that the beneficiary possesses knowledge 
that is valuable to the employer's competitiveness in the marketplace; (4) evidence that the beneficiary is 
qualified to contribute to the employer's knowledge of foreign operating conditions as a result of special 
knowledge not generally found in the industry; (5) evidence to verify that the beneficiary has been utilized 
abroad in a capacity involving significant assignments which have enhanced the employer's productivity, 
competitiveness, image or financial position, and that he possesses special knowledge which normally can be 
gained only through prior experience with that particular employer; (6) verification that the beneficiary 
possesses knowledge of a product or process that cannot be easily transferred or taught to another individual; 
and (7) evidence that the petitioning organization would experience a significant interruption in business in 
order to train a replacement employee for the beneficiary. 
The petitioner responded in a letter from the foreign entity's partner, dated October 7, 2002, stating that 
during his three years as sales and marketing partner with the Pakistani company, the beneficiary achieved a 
250% increase in the value of the company's exports. The partner attributed this success to the beneficiary's 
specialized knowledge of "all kinds of dental and surgical instruments." The partner states: 
The import requirements established by the FDA's Good Manufacturing Practices (GMP) for 
imports fiom Pakistan are highly detailed and "known only to those who have dental and 
surgical manufacturing business in pakistan [sic] (which are very few) and certain other third 
world companies and export to the U.S. This knowledge is not held by those importing 
products to the U.S. generally, nor is this knowledge held by those exporting dental and 
surgical instruments to the U.S. from European and other countries. 
This knowledge is highly specialized and known only to a few, and takes many years to 
develop an expertise. Prior to joining our company, [the beneficiary] already had 12 years of 
experience in this area of surgical and dental manufacture and export.to [sic] be able to export 
to the U.S. from pakistan [sic] requires approval of the company manufacturing processes by 
the FDA. 
It would take at least five years to train someone to be minimally competent in this 
specialized area of surgical/dental instruments manufacture and export to the U.S. 
Additionally, because the position requires the individual to work alone and unsupervised, 
even more experience would be required. Thus, there would be a significant interruption in 
business to train a U.S. worker. 
As discussed above, our manufacturing procedures and methods of operation are highly 
specialized, having been approved by the FDA. Anyone not specifically knowledgeable about 
our manufacturing processes and methods would jeopardize entire shipments to U.S., causing 
significant losses in income and also our FDA approval, jeopardizing our entire U.S. market. 
EAC 02 243 50 102 
Page 7 
Also in response to the request for evidence, counsel submitted a letter dated October 9, 2002, which repeats 
in its entirety the job description provided with the initial petition. The only additional information regarding 
the beneficiary's duties is the following: 
[The beneficiary] spends about 45% of his time maintaining existing customers and about 
15% of his time developing new clients. He spends about 15% to 20% of his time with the 
FDA and Customs. He spends about 20% of his time on administrative duties necessary to 
run a business, and formulating the company's policies and procedures. 
In her letter, counsel notes that the beneficiary possesses specialized knowledge that is not general knowledge 
held commonly throughout the industry, and that he "possesses specialized knowledge of the import 
requirements of surgical and dental instruments specifically pertaining to imports of Pakistani-manufactured 
instruments into the U.S." 
In support of its response to the request for evidence, the petitioner also submitted: (1) an excerpt from the 
public Internet site of the FDA, which provides an overview of the Good Manufacturing Practices 
(GMP)/Quality System (QS) Regulation; (2) an excerpt from the public Internet site of the FDA which 
provides an overview of labeling requirements under the Quality System Regulation; and (3) a copy of the 
FDA's draft guidance for FDA staff on its Civil Money Penalty Policy under the Safe Medical Devices Act of 
1990, released for comment in June 1999. 
In a decision dated April 24, 2003, the director determined that the petitioner did not demonstrate that the 
beneficiary would be employed under the extended petition in a specialized knowledge capacity. The director 
also concluded that the petitioner had not shown that the beneficiary possesses specialized knowledge. The 
director stated that the duties outlined by the petitioner do not appear to be significantly different from those 
of any manager in any dental and surgical equipment firm and therefore do not establish that they warrant the 
expertise of someone possessing truly specialized knowledge. The director acknowledged the petitioner's 
claim that the position requires someone who has knowledge of different types of surgical and dental 
instruments, but noted that the petitioner had not demonstrated that its surgical and dental instruments are 
significantly different from those of other manufacturers, or how understanding of them constitutes 
"specialized knowledge." The director also stated that it is not unusual for a manager to possess an in-depth 
knowledge of the systems and functions of the organization, and is not indicative of the beneficiary's claimed 
advanced expertise. Further, the director noted that the petitioner's explanation of the duties seems to merely 
paraphrase the regulatory definition of specialized knowledge. Lastly, the director noted that the petitioner did 
not document how the beneficiary's knowledge of the processes and procedures of the organization are 
substantially different from, or advanced in relation to, any individual similarly employed. 
Counsel for the petitioner submitted an appeal on May 27, 2003. In a brief submitted on May 13, 2004, 
counsel claims that the director improperly applied the applicable statute and regulation governing the instant 
matter and incorrectly examined the evidence on record. Counsel also contends that CIS' denial of the petition 
contradicts prior case law and CIS guidance for interpreting the statute defining specialized knowledge. 
EAC 02 243 50 102 
Page 8 
Counsel states on appeal that the U.S. position absolutely requires an individual with specialized knowledge 
of the importation requirements and manufacturing procedures of surgical and dental instruments from 
Pakistan. Citing Matter of Penner, 18 I&N Dec. 49 (Reg. Comm. 1982), counsel asserts that "the test for 
specialized knowledge is whether a person is to be employed primarily for his or her ability to cany out a key 
process or function which is important or essential to the business firm's operation." Counsel contends that 
the beneficiary's position within the U.S. company requires him to ensure that all of the imported instruments 
comply with stringent FDA requirements and meet customer specifications, and again notes the special 
restrictions imposed by the FDA on imports from Pakistan and "certain countries," and reiterates the potential 
penalty imposed by the FDA if shipments do not meet requirements. In support of these assertions, counsel 
submits an FDA document entitled "Revision of Import Alert #76-01, Automatic Detention of Surgical 
Instruments from Pakistan,"and an opinion letter from Sheny L. Singer, an attorney specializing in customs 
and international trade law and regulatory compliance. Counsel concludes with the following: 
An advanced level of knowledge of the processes and procedures of the Petitioner's company 
is critical to the successful performance of the beneficiary's position because the 
consequences for not meeting FDA requirements are extremely costly. Consequently, in order 
for an individual to adequately perform the duties of the Beneficiary's current position, it is 
necessary for that person to have specialized knowledge of the Petitioner's products and the 
processes involved in the importation of these products to the United States. 
With regard to the level of knowledge possessed by the beneficiary, counsel contends that the beneficiary 
possesses a special and advanced knowledge far greater than the general knowledge commonly held 
throughout the industry. Counsel quotes from an April 23, 2004 CIS memorandum which states that in 
matters relating to extension of nonimmigrant petition validity involving the same petitioner and beneficiary, 
and the same underlying facts, a prior approval for the classification sought should be given deference, absent 
material error, changed circumstances or new material information which adversely impacts eligibility. 
Counsel further references a March 9, 1994 CIS memorandum on the interpretation of specialized knowledge, 
and asserts that the beneficiary meets the requirements outlined in the memo in that he possesses knowledge 
which is different from that generally found in the industry, based on his special knowledge of the petitioning 
company's products and application in international markets as well as an advanced level of knowledge of the 
processes and procedures of the petitioning company. Specifically, counsel states that the beneficiary's 
"noteworthy and distinctive understanding of the petitioner's products and the processes involved in the 
importation of these products into the United States obviously surpasses the usual level of knowledge held 
within the industry" and is therefore "truly special and advanced." Counsel also notes the beneficiary's twelve 
years of experience with an unrelated Pakistani dental instrument manufacturer and states that he gained 
"unique insight into the complex issues involved in the manufacturing of these products" and that he gained 
extensive experience in export requirements of many countries while employed with the unrelated company. 
Finally, counsel cites the beneficiary's acquisition of three U.S. clients as evidence that he has enhanced the 
foreign employer's productivity and competitiveness in the market place. Counsel concludes that the 
beneficiary possesses knowledge that normally can be gained only through prior experience with a foreign 
employer, that knowledge of the petitioner's products and processes cannot be easily transferred to another 
individual, and that the functions he canies out are "absolutely vital to the success of the Petitioner's 
company's operations." 
EAC 02 243 50 102 
Page 9 
On appeal, counsel concludes that "while the beneficiary's specialized knowledge of surgical and dental 
instruments and the application of these instruments in international markets as well as his advanced level of 
knowledge of the processes and procedures of the company's overseas suppliers may not be entirely exclusive 
it certainly qualifies as different and uncommon." 
On review, the petitioner has not demonstrated that the beneficiary possesses specialized knowledge, or that 
he would be employed in the United States organization in a specialized knowledge capacity. In examining 
the specialized knowledge capacity of the beneficiary, the AAO will look to the petitioner's description of the 
job duties. See 8 C.F.R.9 214.2(1)(3)(ii). The petitioner must submit a detailed description of the services to 
be performed sufficient to establish specialized knowledge. Id. In this case, the petitioner has not submitted 
any evidence of the knowledge and expertise required for the beneficiary's position that would differentiate 
that employment from the position of general manager of a small operation within the petitioner's industry. 
Simply going on record without supporting documentary evidence is not sufficient for the purpose of meeting 
the burden of proof in these proceedings. Matter of Soffici, 22 I&N Dec. 158, 165 (Comm. 1998) (citing 
Matter of Treasure Craft of California, 14 I&N Dec. 190 (Reg. Comm. 1972)). Specifics are clearly an 
important indication of whether a beneficiary's duties involve specialized knowledge, otherwise, meeting the 
definitions would simply be a matter of reiterating the regulations. See Fedin Bros. Co., Ltd. v. Suva, 724 F. 
Supp. 1103 (E.D.N.Y. 1989), aff'd, 905 F.2d 41 (2d. Cir. 1990). The petitioner and counsel have adopted the 
language of the definitions and interpretations of specialized knowledge, liberally using the tenns "special," 
"advanced," "uncommon," "noteworthy," and "proprietary" throughout their letters. However, conclusory 
assertions regarding the beneficiary's employment are not sufficient. Merely repeating the language of the 
statute does not satisfy the petitioner's burden of proof. Id. at 1108; Avyr Associates, Inc. v. Meissner, 1997 
WL 188942 at *5 (S.D.N.Y.). 
Although the petitioner has provided a general position description and the tasks that its general manager 
position entails, the petitioner has not even attempted to document the beneficiary's claimed specialized 
knowledge. Both counsel and the petitioner repeatedly assert throughout the record that the beneficiary has 
specialized knowledge of U.S. FDA regulations pertaining to the import of surgical instruments from 
Pakistan, and that this knowledge is an absolute requirement for the position. However, a review of the job 
description for the beneficiary's last position with the claimed foreign parent company reveals that he was 
primarily involved in marketing and sales of the petitioner's product to clients in "Singapore, Malaysia, 
Dubai, Muscat, Saudi Arabia, England, the Philippines, Kuwait and Thailand." The petitioner also notes his 
extensive prior experience with another Pakistani company in the same industry, where he served as an 
"Import Director" responsible for exports to "Singapore, Philippines, Indonesia, Thailand, Dubai, Saudi 
Arabia and the United Kingdom." There is no evidence in the record to suggest that the beneficiary had any 
prior experience with the U.S. market or any familiarity with U.S. FDA import regulations pertaining to 
surgical instruments prior to being transferred to the U.S. approximately eight months before the instant 
petition was filed. This evidence is particularly relevant as counsel and the petitioner base their claims of the 
beneficiary's knowledge to a large degree on his expertise with FDA regulations pertaining to the import of 
Pakistani surgical instruments to the United States. Without documentary evidence to support the claim, the 
assertions of counsel will not satisfy the petitioner's burden of proof. Matter of Obaigbena, 19 I&N Dec. 533, 
534 (BIA 1988); Matter of Ramirez-Sanchez, 17 I&N Dec. 503, 506 (BIA 1980). Furthermore, doubt cast on 
any aspect of the petitioner's proof may, of course, lead to a reevaluation of the reliability and sufficiency of 
EAC 02 243 50 102 
Page 10 
the remaining evidence offered in support of the visa petition. Matter of Ho, 19 I&N Dec. 582, 591 (BIA 
1988). 
In addition, contrary to the assertions of counsel and the petitioner, there is no evidence on record to suggest 
that the FDA regulations pertaining to imports of surgical instruments from Pakistan are different from those 
applied to imports of identical products from any other country. In fact, the overview of the FDA's Good 
Manufacturing Practice requirements provided by the petitioner states that the relevant regulation "requires 
that domestic or foreign manufacturers have a quality system for the design, manufacture, packaging, 
labeling, storage, installation and servicing of finished medical devices for commercial distribution in the 
United States." The same standards appear to apply to any manufacturer, regardless of location, whose 
products will be used in the United States. The evidence does simply not support counsel's repeated statement 
that "not all imports of surgical and dental instruments are required to pass FDA approval." In addition, the 
petitioner has not explained how the knowledge of FDA standards amounts to specialized knowledge, 
particularly since the regulations are a matter of public record. While individual manufacturers would 
develop their own internal quality processes according to FDA guidelines, it seems unlikely that there would 
be substantial differences such that knowledge of a particular company's quality standards would be 
"specialized knowledge." 
The AAO acknowledges the evidence presented that the FDA places special inspection procedures on certain 
Pakistani manufacturers who have previously been shown to be in violation of the universal GMP 
requirements. However, the evidence submitted reveals that the underlying quality control requirements 
remain the same for all importers, and that not all Pakistani manufacturers are affected by the "detention 
without physical examination" guidance provided in the FDA "Import Alert" submitted by counsel. 
Furthermore, the requirements applied to Pakistani manufacturers who are subject to the detention procedures 
merely require submission of documentation that the exporting firm is operating in accordance with GMP 
regulations, as well as visual inspections and laboratory analyses. Accordingly, it appears that the 
responsibility for meeting the "special procedures" referenced by the petitioner would be left to the foreign 
company, and would be satisfied by continually updating their Good Manufacturing Practice procedures, and 
providing documentation of same to the FDA, via the beneficiary, until it qualifies for an exemption. 
Counsel states on appeal that failure to meet FDA standards will result in destruction of an entire shipment or, 
alternatively, payment of a $10,000 fine and a prison term. The petitioner further claims that the beneficiary is 
responsible for ensuring that all shipments from the foreign company meet FDA requirements; however, this 
assertion is not credible. The foreign company is certainly aware of the FDA requirements and its 
manufacturing and quality control personnel would reasonably be the individuals responsible for producing 
the documentation and technical data needed to meet the requirements. While the beneficiary's job 
description includes interacting with the FDA, and responding to customer's technical questions, there is no 
documentary evidence, such as correspondence, reports, etc., to establish the true nature of his 
communications with government authorities or customers, or the level of knowledge of the company's 
products and processes acfually required to perform his role as general manager. Going on record without 
supporting documentary evidence is not sufficient for purposes of meeting the burden of proof in these 
proceedings. Matter of Soffice, 22 I&N Dec. at 165. Based on the above discussion, the AAO cannot 
conclude that the knowledge of the FDA regulations pertaining to imports of surgical instruments from 
EAC 02 243 50 102 
Page 11 
Pakistan constitutes specialized knowledge or that the beneficiary even possessed any knowledge of U.S. 
import regulations prior to commencing L-1B employment with the petitioner. 
The AAO also acknowledges receipt of the advisory opinion letter of-, an attorney who has 
expertise in customs and international trade law, regulatory compliance and trademarks. In her letter, Ms. 
iscusses the above-mentioned FDA Import Alert mandaflng detention of surgical instruments From 
Pakistan, and related customs issues, which she claims further complicate the import of such goods from 
Pakistan. She concludes "the complexity of regulatory issues faced by companies importing surgical 
instruments necessitates the employment of personnel with experience in the intricacies of US government 
regulatory requirements as well as expertise in manufacturing processes." While the opinions expressed by 
re certainly respected, they are not persuasive in this matter, as they do not address the context of 
the' beneficiary's job duties in light of the applicable regulations governing this visa petition. Further, as 
already discussed, there is no evidence that the beneficiary actually possessed any experience with U.S. 
government regulatory requirements prior to his transfer to the U.S. Relying onanalysis, the 
beneficiary would not be qualified to serve in the position offered. 
In addition to the beneficiary's knowledge of U.S. FDA regulations, counsel and the petitioner repeatedly 
reference the beneficiary's "specialized knowledge of the petitioner's product," "knowledge of the 
composition, design and use of surgical and dental instruments" and "expert understanding of the processes 
involved in the manufacturing and sales of surgical instruments." However, there is no evidence on record 
that the beneficiary actually possesses the claimed advanced knowledge of the petitioner's products or 
manufacturing processes. Prior to his transfer to the U.S., the beneficiary was employed by the foreign entity 
as a sales and marketing partner responsible for determining market demand, pricing strategies, identifying 
customers, monitoring market trends, and meeting with customers. The petitioner has not claimed that the 
beneficiary has previous experience in manufacturing, research and development, or quality control, which 
might have reasonably given him an advanced knowledge of the manufacturing processes. It is not clear how 
the beneficiary, in performing routine sales and marketing functions, would acquire or need an advanced 
knowledge of the company's manufacturing processes which would distinguish him from any other sales 
employees within the foreign entity. While the AAO does not doubt that the beneficiary is familiar with the 
company's product catalogs and capable of answering questions about the products, there is no evidence on 
record to suggest that his knowledge is uncommon within the petitioner's organization or within the industry. 
Nor is there any indication that the petitioner's products are particularly unique or different from similar 
products in the industry. In fact, counsel states on appeal that the beneficiary gained much of his knowledge 
of manufacturing processes with an unrelated company in the same industry, and that it was with the other 
company that he gained his knowledge of "hundreds of different kinds of surgical and dental instruments." In 
making this statement, counsel has acknowledged that prior employment with the petitioner's foreign entity is 
not a prerequisite for performing the duties of the U.S. position offered, which strongly suggests that the U.S. 
position does not meet the statutory definition of a specialized knowledge position. 
Citing Matter of LeBlanc and Matter of Raulin, counsel notes on appeal that it is appropriate for CIS to look 
beyond the stated job duties and consider the importance of the beneficiary's knowledge of the business' 
product or service, management operations, or decision-making process. Matter of Colley, 18 I&N Dec. 117, 
120 (Comm. 198 l)(citing Matter of Raulin, 13 I&N Dec. 61 8 (R.C. 1970) and Matter of LeBlanc, 13 I&N 
EAC 02 243 50102 
Page 12 
Dec. 816 (R.C. 1971)). As stated by the Commissioner in Matter of Penner, when considering whether the 
beneficiaries possessed specialized knowledge, "the LeBlanc and Raulin decisions did not find that the 
occupations inherently qualified the beneficiaries for the classification sought." 18 I&N Dec. at 52. Rather, 
the beneficiaries were considered to have unusual duties, skills or knowledge beyond that of a skilled worker. 
Id. The Commissioner also provided the following clarification: 
A distinction can be made between a person whose skills and knowledge enable him or her to 
produce a product through physical or skilled labor and the person who is employed primally 
for his ability to cany out a key process or function which is important or essential to the 
business' operation. 
Id. at 53. 
Citing Matter of Penner, 18 I&N Dec. 49 (Reg. Comm. 1982), counsel further argues that "the test for 
specialized knowledge is whether a person is to be employed primarily for his or her ability to carry out a key 
process or function which is important or essential to the business firm's operation." Counsel asserts that the 
position offered to the beneficiary requires him to perform duties that are necessary in order for the 
petitioner's organization to remain competitive, and requires him to have a specialized knowledge of the 
importation requirements and manufacturing procedures of surgical and dental instruments from Pakistan. 
The AAO does not doubt that the beneficiary, as the sole employee of the U.S. company, carries out all of the 
functions essential to the petitioner's operation nor that the duties he performs are necessary in order for the 
company to remain competitive. However, these elements alone do not establish the beneficiary's eligibility 
for the classification sought. Essential as the position of general manager may be, the petitioner has not 
established that this position requires specialized knowledge, or that the beneficiary has in fact acquired such 
knowledge. 
The statutory definition of specialized knowledge requires the AAO to make comparisons in order to 
determine what constitutes specialized knowledge. The term "specialized knowledge" is not an absolute 
concept and cannot be clearly defined. As observed in 1756, Inc. v. Attorney General, "[slimply put, 
specialized knowledge is a relative . . . idea which cannot have a plain meaning." 745 F. Supp. 9, 15 (D.D.C. 
1990). The Congressional record specifically states that the L-1 category was intended for "key personnel." 
See generally, H.R. REP. NO. 91-851, 1970 U.S.C.C.A.N. 2750. The term "key personnel denotes a position 
within the petitioning company that is "of crucial importance." Webster's II New College Dictionary 605 
(Houghton Mifflin Co. 2001). In general, all employees can reasonably be considered "important" to a 
petitioner's enterprise. If an employee did not contribute to the overall economic success of an enterprise, 
there would be no rational economic reason to employ that person. An employee of "crucial importance" or 
"key personnel" must rise above the level of the petitioner's average employee. Accordingly, based on the 
definition of "specialized knowledge" and the congressional record related to that term, the AAO must make 
comparisons not only between the claimed specialized knowledge employee and the general labor market, but 
also between that employee and the remainder of the petitioner's workforce. 
A 1994 Immigration and Naturalization Service (now CIS) memorandum written by the Acting Associate 
Commissioner also allows CIS to compare the beneficiary's knowledge to the general United States labor 
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market and the petitioner's workforce in order to distinguish between specialized and general knowledge. The 
Associate Commissioner notes in the memorandum that "officers adjudicating petitions involving specialized 
knowledge must ensure that the knowledge possessed by the beneficiary is not general knowledge held 
commonly throughout the industry but that it is truly specialized." Memorandum from James A. Puleo, 
Acting Associate Commissioner, Immigration and Naturalization Service, Interpretation of Specialized 
Knowledge, CO 214L-P (March 9, 1994). A comparison of the beneficiary's knowledge to the knowledge 
possessed by others in the field is therefore necessary in order to determine the level of the beneficiary's skills 
and knowledge and to ascertain whether the beneficiary's knowledge is advanced. In other words, absent an 
outside group to which to compare the beneficiary's knowledge, CIS would not be able to "ensure that the 
knowledge possessed by the beneficiary is not general knowledge held commonly throughout the industry but 
that it is truly specialized." Id. The analysis for specialized knowledge therefore requires a test of the 
knowledge possessed by the United States labor market, but does not consider whether workers are available 
in the United States to perfom the beneficiary's job duties. 
The beneficiary's job description does not distinguish the beneficiary's lcnowledge as more advanced or 
distinct among other managers or sales and marketing personnel employed by the foreign or U.S. entities or 
by other unrelated companies in the petitioner's industry. To differentiate the beneficiary, the petitioner 
places great emphasis on his specialized knowledge of FDA quality control regulations as they apply to the 
import of surgical instruments from Pakistan, and his "advanced level of knowledge of the processes and 
procedures of the petitioner's operations." As already discussed, the petitioner has not documented that the 
beneficiary actually had any prior experience with FDA regulations, nor has it specified in any detail the 
processes and procedures of which the beneficiary is claimed to have "advanced knowledge." As the 
petitioner failed to document its assertions, these claims have little value. 
Moreover, as previously noted, counsel and the petitioner have stated that the beneficiary's claimed 
knowledge of manufacturing processes in the industry was primarily gained with an unrelated employer, 
which suggests that there is nothing uncommon or special to distinguish the petitioner's products or processes 
from that of any other manufacturer of surgical and dental instruments. This assumption is further supported 
by the petitioner's statement that "it would take at least five years to train someone to be minimally competent 
in this specialized area of surgicalldental instruments manufacture and export to the U.S." The beneficiary 
himself was only employed by the petitioner's foreign parent company for three years prior to his transfer to 
the U.S. and thus, using the petitioner's standards, was only qualified for the position based on his general 
experience in the industry. Furthermore, the petitioner has provided no documentary evidence regarding its 
"specialized" manufacturing procedures, nor is there any evidence that the beneficiary, who is and has been 
engaged primarily in sales and marketing since joining the company, possesses an advanced knowledge of 
such procedures. 
Thus, as the petitioner has not established the beneficiary possesses a special knowledge of the petitioner's 
product or an advanced level of knowledge of the company's processes or procedures, nor has it established 
that the position of general manager within its organization requires specialized knowledge, the director 
rationally determined that the beneficiary does not qualify as a specialized knowledge worker. While the 
AAO recognizes that the beneficiary canies out key functions within the petitioner's organization, and 
recognizes the petitioner's preference to secure the services of an employee who has worked for its parent 
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Page 14 
company, these elements are insufficient to establish eligibility for classification as a specialized knowledge 
worker. There is nothing in the record to suggest that any other experienced employee within the parent 
company's organization, or any employee with a record of success a similar role within the petitioner's 
industry, could not adequately perform the proposed duties. 
It is noted that the current petition is for an extension of an L-IB petition that was previously approved by the 
director. Counsel references a CIS memorandum in which the service centers are advised that adjudicators 
processing extensions of a nonimmigrant petition involving the same beneficiary and petition and the same 
underlying facts should give deference to a prior approval for the classification sought. See Memorandum of 
, Associate Director for Operations, U.S. Citizenship & Immigration Services, The 
Significance of a prior CIS Approval of a Nonimmigrant Petition in the Context of a Subsequent 
Detennination Regarding Eligibility for Extension of Petition Validity, HQOPRD 7211 1.3 (April 23, 2004.) 
However, the memorandum specifically states prior approval of a petition need not be given deference where 
it is determined that there was a material error with regard to the previous petition approval, with material 
error involving the misapplication of an objective statute or regulatory requirement to the facts at hand. Id. 
If the previous nonimmigrant petition was approved based on the same unsupported assertions that are 
contained in the current record, the approval would constitute a material error on the part of the director. The 
AAO is not required to approve applications or petitions where eligibility has not been demonstrated, merely 
because of prior approvals that may have been erroneous. See, e.g. Matter of Church Scientology 
International, 19 I&N Dec. 593, 597 (Comm. 1988). It would be absurd to suggest that CIS or any agency 
must treat acknowledged errors as binding precedent. Sussex Engg. Ltd. v. Montgomety, 825 F.2d 1084, 1090 
(6'h Cir. 1987); cert denied 485 U.S. 1008 (1988). 
Furthermore, the AAO's authority over the service centers is comparable to the relationship between the court 
of appeals and the district court. Even if a service center director had approved a nonimmigrant petition on 
behalf of the beneficiary, the AAO, would not be bound to follow the contradictory decision of a service 
center. Louisiana Philharmonic Orchestra v. INS, 2000 WL 282785 (E.D. La.), aff'd 248 F.3d 1139 (5th Cir. 
2001), cert. denied, 122 S.Ct. 51 (2001). 
Beyond the findings in the director's decision, another issue in this proceeding is whether the petitioner has 
established that a qualifying relationship exists between the petitioning entity and a foreign entity pursuant to 
8 C.F.R. $I 214.2(1)(l)(ii)(G). The petitioner claims that it is the wholly-owned subsidiary of the beneficiary's 
foreign employer, which is owned equally by five shareholders. The petitioner has submitted a single stock 
certificate indicating that all 200 of its shares were issued to the claimed parent company in January 2001. 
However, the petitioner has also submitted its 2001 IRS Form 1120, U.S. Corporation Income Tax Return, on 
which it indicated on Schedule E that the beneficiary owns 100% of the company's stock. On Schedule K of 
Form 1120, the petitioner indicated that no individual or corporation owned 50% or more of its stock. Based 
on the limited information provided, it is not possible to conclude that the petitioner had a qualifying 
relationship with the foreign entity at the time the petition was filed. It is incumbent upon the petitioner to 
resolve any inconsistencies in the record by independent objective evidence. Any attempt to explain or 
reconcile such inconsistencies will not suffice unless the petitioner submits competent objective evidence 
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Page 15 
pointing to where the truth lies. Matter of Ho, 19 I&N Dec. 582, 591-92 (BIA 1988). For this additional 
reason, the petition cannot be approved. 
An application or petition that fails to comply with the technical requirements of the law may be denied by the 
AAO even if the Service Center does not identify all of the grounds for denial in the initial decision. See 
Spencer Enterprises, Inc. v. United States, 229 F. Supp. 2d 1025, 1043 (E.D. Cal. 2001), afd. 345 F.3d 683 
(9th Cir. 2003); see also Dor v. INS, 891 F.2d 997, 1002 n.9 (2d Cir. 1989)(noting that the AAO reviews 
appeals on a de novo basis). 
The petition will be denied for the above stated reasons, with each considered as an independent and 
alternative basis for denial. In visa petition proceedings, the burden of proving eligibility for the benefit 
sought remains entirely with the petitioner. Section 291 of the Act, 8 U.S.C. 5 1361. Here, that burden has 
not been met. 
ORDER: The appeal is dismissed.