June 29, 1978

78-37 MEMORANDUM OPINION FOR THE CHIEF

COUNSEL, FOOD AND DRUG ADMINISTRATION

Advisory Committees— Food and Drug

Administration— Conflicts of Interest

(18 U.S.C. § 208)

This responds to your inquiry regarding the scope of the term “ particular 

matter” as used in 18 U.S.C. § 208(a), in connection with the service of 

persons from the private sector on advisory committees in the Food and Drug 

Administration (FDA).

Section 208 requires an officer or employee of the executive branch to 

disqualify himself in any “ particular matter(s)” in which, to his knowledge, 

he, his spouse or minor child, or an organization in which he is serving as an 

officer, director, trustee, partner, or employee has a financial interest. Thus, 

the meaning of the term determines the sort of occasions on which an advisory 

committee member must disqualify himself under the statute.

We understand that the advisory committees involved in the inquiry are 

utilized by FDA in the areas of premarketing approval of prescription drugs, 

classification of medical devices, and drafting of monographs for ingredients 

used in over-the-counter drugs. Your Office indicated in conversations with 

this Office last spring that without the use of these advisory committees, the 

members of which are expert in the areas involved, FDA could not discharge its 

statutory responsibilities at the level which the safety and the health of the 

public warrant.

Four examples of participation by members of various FDA advisory 

committees were given to us. Three of the members were on the faculties of 

universities that received research grants from pharmaceutical firms or 

manufacturers of medical devices. At least two actually worked on the 

university projects funded by the firms. You state that none of the individuals 

participated as an advisory committee member in any deliberations relating 

specifically to the firm or the product of the firm that funded the particular 

research grant to his university, but that each did participate in the committee’s 

deliberations relating to general categories of medical devices or ingredients of

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a certain classification of products, some of which were manufactured by the 

firm that funded the research.

The fourth example involved a member of the National Advisory Food and 

Drug Committee who had substantial holdings in a cattle feedlot operation and 

who participated in deliberations concerning the desirability of continuing the 

use of low levels of antibiotics in animal feeds for prophylactic purposes and 

growth promotion. He was not a manufacturer of any of the products involved 

and no competitive advantage or disadvantage would be conferred upon him 

vis-a-vis other members of his industry1 regardless of the Agency’s ultimate 

decision. It was also pointed out that this example and those of the university 

faculty members involved advisory committees established to advise the FDA 

about matters that involve segments of the regulated industry as a whole rather 

than particular products or companies.

The relevant statute, 18 U.S.C. §208(a), provides:

(a) Except as permitted by subsection (b) hereof, whoever, being 

an officer or employee of the executive branch of the United States 

Government, of any independent agency of the United States, or of 

the District of Columbia, including a special Government employee, 

participates personally and substantially as a Government officer or 

employee, through decision approval, disapproval, recommendation, 

the rendering of advice, investigation, or otherwise, in a judicial or 

other proceeding, application, request for a ruling or other determination, contract, claim,- controversy, charge, accusation, arrest, or 

other particular matter in which, to his knowledge, he, his spouse, 

minor child, partner, organization in which he is serving as officer, 

director, trustee, partner or employee, or any person or organization 

with whom he is negotiating or has any arrangement concerning 

prospective employment, has a financial interest—

Shall be fined not more than $10,000, or imprisoned not more than 

two years, or both.

You have informed us that the members of FDA advisory committees are 

designated as special Government employees. The question presented is 

whether participation in deliberations of the committees concerning a class of 

related products or an ingredient common to many products involves participant was not indicated whether the phrase "h is industry" refers to the feedlot industry or to the 

cattle industry as a whole. It is possible, for exam ple, that the banning of antibiotics in animal feeds 

would work to the com petitive advantage o f those portions of the cattle industry that do not rely on 

animal feeds to the degree that feedlot operators do.

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tion in a “ particular matter” within the meaning of § 208(a). We believe that it 

does.2

As an initial matter, some confusion regarding the scope of § 208(a) may 

arise because of the use of the word “ particular.” It is our understanding that 

the word “ particular” was included to make clear that an individual would not 

be disqualified from an entire area or range of activities merely because he 

might have a financial interest in a certain decision, proceeding, transaction, or 

recommendation arising within that area or range; disqualification is only 

required in the “ particular” matter, not as to the entire area or range. C f,

Hearings on Federal Conflict of Interest Legislation before Subcommittee No.

5 of the House Judiciary Committee, 87th Cong., 1st sess. 38 (1961). But it 

was evidently the purpose to make the enumeration of particular matters in 

§ 208(a) and the other sections of the conflict of interest laws, in which the 

same enumeration appears, “ comprehensive of all matters that come before a 

Federal department or agency.” Id.; see also id., at 41. Thus, it has been and 

continues to be our view that § 208(a) applies to any discrete or identifiable 

decision, recommendation, or other matter even though its outcome may have a 

rather broad impact. Accordingly, the word “ particular” serves to limit the 

application of § 208(a) in terms of discrete areas of the employee’s activities, 

not the number of outside parties who may be affected.

Our reading of § 208(a) in this manner finds support as well in the structure 

of the statute and its contemporaneous interpretation. To determine the proper 

scope of the language of §208(a), it must be examined as part of a 

comprehensive statutory scheme rather than in isolation. Utilizing that approach, 

we find, for example, that 18 U.S.C. § 203(a) and the first paragraph of §205 

both bar regular Government employees from representing other parties in all 

“ particular matters” involving the United States. However § 203(c) and the 

second paragraph of § 205 impose narrower restrictions on special Government 

employees, barring them from acting as agent or attorney only in “ particular 

matter[s] involving a specific party or parties” that are pending before the 

Departments or agencies in which they are serving. Similarly, the postemployment 

statute, 18 U.S.C. § 207, bars a former Government employee, whether regular

2There may be some question whether a "financial interest” within the meaning of the statute is 

present on the facts involving the three faculty members. It may be that if the research grant to a 

university concerns the types o f products involved in the advisory com m ittee’s deliberations, the 

committee’s deliberations could influence FD A 's decision with respect to the products. This could 

in turn have an impact on the continuity of a research grant pertaining to the same products. But it is 

arguable that neither the faculty member nor his employing university has a "financial interest” in 

the advisory com m ittee’s recommendations where the university's research has no relation to the 

products the advisory committee is considering.

On the other hand, there is at least some basis for concluding that a substantial contractual 

relationship with an affected company could itself give the university a financial interest in matters 

touching on the com pany’s products. See Association o f the Bar of the City of New York, Conflict

of Interest and Federal Service, 200-201 (1960). M oreover, where a faculty member is actually a 

principal participant in a university research grant funded by a company, the situation presents 

much the same type of potential for divided loyalty in governmental matters affecting the company 

as if the member were actually employed directly by the company and therefore expressly required 

by § 208(a) to disqualify him self in matters relating to the company.

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or special, from representing another person in a “ particular matter involving a 

specific party or parties” in which he participated or had official responsibility 

while in Government.

The Memorandum of the Attorney General Regarding Conflict of Interest 

Provisions of Public Law 87-849, 18 U.S.C. §201, n., points out that “ the 

phrase ‘particular matter involving a specific party or parties’ does not include 

general rulemaking, the formulation of general policy or standards, or other 

similar matters. Thus, past participation in or official responsibility for a matter 

of this kind on behalf of the government does not disqualify a former employee 

from representing another person in a proceeding which is governed by the rule 

or other result of the matter.” The clear implication is that general rulemaking 

and the formulation of general policy would be covered in the absence of the 

reference to specific parties.

Bayless Manning, an authoritative commentator on the conflict of interest 

laws, describes the importance of the limiting phrase “ involving a specific 

party or parties” as follows:

Where the language is used [in the conflict of interest laws], it is clear 

that the statute is concerned with discrete and isolatable transactions 

between identifiable parties. Thus, the former employee of the 

Defense Department who worked on the'establishment of contract 

procedures is not on that account forbidden by subsection (a) of 

Section 207 to act as agent or attorney with respect to any particular 

Defense contract ....

The significance of the phrase “ involving a specific party or 

parties” must not be dismissed lightly or underestimated. Law 

87-849 discriminates with great care in its use of this phrase. 

Wherever the phrase does appear in the new statute it will be found 

to reflect a deliberate effort to impose a more limited ban and to 

narrow the circumstances in which the ban is to operate. [B. 

Manning, Federal Conflict o f Interest Law, 204 (1964)]

The implication of this passage would appear to be that the establishment of 

general contracting or similar procedures is a “ particular matter,” but that 

participation in formulating such procedures does not trigger the postemployment 

bar of 18 U.S.C. § 207 because no specific parties are involved. See also, id.,

at 70-71.

By way of contrast, a Presidential Memorandum of May 2, 1963, entitled 

“ Preventing Conflicts of Interest on the Part of Special Government Employees,” explains the broader scope of the term “ particular matter” in § 208(a) as 

follows:

The matters in which special Government employees are disqualified 

by section 208 are not limited to those involving a specific party or 

parties in which the United States is a party or has an interest, as in 

the case of sections 203, 205 and 207. Section 208 therefore 

undoubtedly extends to matters in addition to contracts, grants, 

judicial and quasi-judicial proceedings, and other matters of an

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adversary nature. Accordingly, a special Government employee 

should in general be disqualified from participating as such in a

matter o f any type the outcome of which will have a direct and 

predictable effect upon the financial interests covered by the section. 

However, the power of exemption may be exercised in this situation 

if the special Government employee renders advice of a general 

nature from which no preference or advantage over others might be 

gained by any particular person or organization. The power of 

exemption may of course be exercised also where the financial 

interests involved are minimal in value. 28 Fed. Reg. 4539, 4543. 

[Emphasis added.]3

The broad statement in the memorandum that the disqualification requirement 

in § 208(a) applies to a “ matter of any type” in which the employee has a 

financial interest does not on its face suggest that certain types of governmental 

decisionmaking should be excluded merely because they involve rules, 

policies, or recommendations that affect several or a number’ of different 

companies or products. Indeed, the further statement in the memorandum to the 

effect that the power of exemption in § 208(b)( 1) may be exercised to permit a 

special Government employee to participate notwithstanding the ordinary 

disqualification requirement if the special Government employee renders 

“ advice of a general nature from which no preference or advantage over others 

might be gained” necessarily proceeds on the assumption that “ advice of a 

general nature” is covered by § 208(a).

Based on the contemporaneous construction of the statute reflected in the 

Presidential memorandum, we have consistently interpreted § 208(a) to apply 

to rule-making proceedings or advisory committee deliberations of general 

applicability where the outcome may have a “ direct and predictable effect” on 

a firm with which the Government employee is affiliated, even though all other 

firms similarly situated will be affected in a like manner. An example might be 

the drafting or review of environmental regulations which would require 

considerable expenditures by all firms in the particular industry of which the 

company is a part.4

In one example cited in your letter, banning the use of antibiotics in animal 

feed could well have a direct and predictable effect on the operations of the 

feedlot owned by the advisory committee member, even though other feedlot 

owners would also, be affected. Similarly, we would suppose that FDA’s 

decision with respect to the classification of medical devices or use of

■’The Presidential memorandum was drafted by the Office of Legal Counsel and therefore reflects 

a contemporaneous interpretation of the conflict of interest laws by the Department charged with 

construing them. The substance of the paragraph of the Presidential memorandum quoted in the text 

is now incorporated at page 4 of Appendix C , Chapter 735 of the Federal Personnel Manual, which 

prescribes the policies and procedures for appointing special Government employees.

“Of course the outcome of the particular matter must affect the firm distinctively, and not merely 

as a member of the general public or as part o f the entire business community. For exam ple, a 

member of an FDA advisory committee would not be disqualified from participating in the 

formulation of a recommendation about ingredients in aspirin merely because he purchased aspirin 

as a consumer.

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ingredients in drugs could have a direct and predictable effect on a manufacturer of a given device or drug although the manufacturer’s competitors who 

produce the same drug or device were affected in a like fashion.

Interpreting the term “ particular matter” in the manner described above is 

consistent with the purposes of § 208(a). A benefit conferred on an industry 

generally can be as much of a boon to a firm within that industry as a 

competitor’s going out of business. Typically, stockholders are primarily 

interested in the earnings of their corporation, and only secondarily in the 

corporation’s relative standing in the industry. Thus, the fact that others will 

also be affected should not render wholly inapplicable the prohibition against a 

Government employee’s participation in a matter in which he would have the 

opportunity to further his firm’s financial interests. Moreover, to interpret 

§ 208(a) in the way you have suggested—i.e., requiring disqualification only 

where the firm with which the advisory committee member is affiliated is 

specifically involved— would be to introduce by way of construction the phrase 

“ involving a3specific party or parties” that was deliberately omitted from that 

section at the time of enactment.

A determination that the term “ particular matter” includes recommendations 

affecting a category of products or a number of firms similarly situated does 

not, however, automatically foreclose participation on advisory committees by 

persons with related outside affiliations. Section 208(b)(1) provides that the 

disqualification requirement in § 208(a) shall not apply if the Government 

employee first advises the Government official responsible for appointment to 

his position of the nature and circumstances of the particular matter, makes full 

disclosure of the relevant financial interest, and receives an advance written 

determination from the appointing official that the interest is not so substantial 

as to be deemed likely to affect the integrity of the services which the 

Government may expect from the employee.5 There may be a question, of 

course, whether the financial interests involved in each of the four examples 

you cite are “ insubstantial” in an absolute sense. However, the paragraph in 

the 1963 Presidential memorandum quoted above states that in addition to 

situations in which the financial interest is minimal, “ the power of exemption 

may be exercised . . . if the special Government employee renders advice of a 

general nature from which no preference or advantage over others might be 

gained by any particular person or organization.” This is an interpretation of 

§ 208(b)(1) given soon after its enactment, and, as indicated above, this policy 

has been carried forward in Appendix C to Chapter 735 of the Federal

Personnel Manual.

The effect of this interpretation is to put a gloss on the statutory language that 

the interest “ is not so substantial as to be deemed likely to affect the integrity of 

the services which the Government may expect” from the special Government

’Although by its literal terms § 208(b)( 1) would appear to require the appointing official to issue 

a separate exemption for each particular matter in which a given financial interest may arise, we 

have consistently taken the position that a blanket exemption covering a given financial interest 

may be issued in appropriate circum stances if the appointing official concludes that the financial 

interest will not be so substantial as to affect the integrity of the em ployee’s services in whatever 

context it arises.

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employee. It seems to be particularly geared to special Government employees, 

members of advisory committees, who are often specifically chosen because of 

an expertise that results from their affiliation with particular organizations, 

firms, or groups having a general interest in the very matters before the 

advisory committee.

The responsibility for issuing exemptions under § 208(b)(1) lies with the 

Agency concerned. We should stress, however, that § 208(b)(1) contemplates a 

close scrutiny of each special Government employee’s outside affiliation to 

determine whether an affiliation may properly be deemed unlikely to affect the 

integrity of service as an advisory committee member. It may also be 

appropriate in certain cases to tailor the exemption in a way that permits the 

employee to participate in general policy matters but not in those proceedings 

which more narrowly affect the organization or firm with which he is affiliated. 

While the ultimate result of utilizing the exemption procedure in this manner to 

facilitate participation in general policy matters may be the same as if § 208(a) 

were construed to be wholly inapplicable in such a setting, this does not mean 

that granting an exemption should be viewed as a mere formality or an empty 

exercise. The process of granting an exemption compels the responsible 

Agency official to focus on the question of the special Government employee’s 

outside affiliations and to make a specific, written finding with respect to the 

expected integrity of the individual’s services. We may assume as well that this 

procedure will also have a beneficial effect on the advisory committee 

member’s own perception of his responsibilities.

Finally, it should be noted that § 208(b)(1) requires that an exemption be 

granted prior to the employee’s participation in the particular matter. We 

assume that separate exemptions were not granted to the four individuals 

described in your letter. It cannot be said with certainty whether the decisions 

with which the advisory committees were concerned would have a direct and 

predictable effect on the members’ outside interests. Because your letter refers 

to past conduct, the determination of the application of § 208(a) in a case such 

as this would ordinarily be for the Criminal Divison of this Department to 

make. However, after consultation with the Criminal Division regarding the 

facts described in your letter, we can advise you that in the absence of some 

element of bad faith or other aggravating factor, a referral to the Criminal 

Division is not in order here. In the future, the principles outlined in this letter 

should be followed and advisory committee members should be notified of their 

obligations under whatever arrangements are made in each case.

The Office of the General Counsel of the Department of Health, Education, 

and Welfare is familiar with the application of § 208(a) to special Government 

employee members of advisory committees and the exemption procedures 

under § 208(b)(1). That Office no doubt can assist you in these matters, and we 

are of course prepared to offer additional guidance if necessary.

J o h n M . H a r m o n

Assistant Attorney General

Office of Legal Counsel

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