Contents

SUBCHAPTER 160 - PUBLIC RELATIONS, ETHICS & CONDUCT

161 - MASS MEDIA (Press, Radio, and TV)

Over the past few years, the inspectional and investigational activities of the FDA have received extensive coverage in the electronic and print media. Regional and District Directors are the spokespersons for FDA in their respective areas. However, investigators and inspectors are occasionally requested by the media to comment or provide information on their individual inspectional activities. Such requests include being interviewed and filmed during inspections, investigations and sample collections. If media representatives contact you, be courteous and helpful, but refer all requests for information, interviews and personal appearances to your supervisor. You may be permitted to appear on camera or be interviewed, but authorization must be gained in advance. Otherwise, your Regional or District office will handle the inquiry, or refer it to the Assistant Commissioner for Public Affairs (HFI-1) at headquarters.

Do not solicit media interviews or on-camera appearances. In those instances where media request you be interviewed or filmed, the request should be tactfully declined and referred to the district office, your immediate supervisor and/or District Director. There may be occasions when management of a firm you are inspecting invites representatives from the news media to observe the inspectional process. Please see IOM 504.03 for instructions on how to appropriately handle such events.

FDA publications, press releases and talk papers on a wide variety of subjects are available in your district, and are helpful in answering media and public inquiries. In addition, you should refer them to FDA's Internet Web site. Talk papers, press releases, FDA publications, federal register announcements, etc. are on-line at this Web site.

162 - NON-GOVERNMENT MEETINGS

Speakers and representation at meetings will be provided when such attendance is for official purposes, and consistent with the policies and best interest of FDA. As a public agency FDA must be responsive to public inquiries of all kinds.

Authorization - Attendance must be authorized in advance. Form DHHS 99 is required, unless the primary purpose of attendance is to officially explain, interpret or acquaint the public with FDA programs or activities.

Selectivity - Selection will not arbitrarily favor one sponsoring organization over another.

Fees - Acceptance of payment in cash or kind must be approved in advance. No such payment may be accepted when inspectional or administrative and/or a supervisory relationship exists between the employee and the non-federal organization offering to pay his/her expenses.

163 - RECRUITING

When assigned recruiting duties, your primary objective is to attract outstanding people to work for FDA. During recruiting discussions, explain the function and duties of the FDA, with emphasis on the relationship between the duties and the requirement for the highest standards of conduct and integrity.

Colleges - Your attitude in your contacts with the college placement officers, faculty members, and the students themselves will play an important part in the success of this program. Various booklets, prepared by FDA, set forth the objectives of the FDA college recruitment program. Obtain copies from your district for use in your recruitment activities.

Professional Societies - Since many experienced professional and scientific personnel are members of professional societies and organizations, this is another excellent recruitment source.

Do not overlook recruitment opportunities offered by such groups, e.g., in setting up displays and exhibits in connection with national or regional meetings or conventions. You are also encouraged to join and be active in professional organizations, including attendance at conventions and meetings.

Community Relations - Consumer information material has been prepared for use by FDA. In presenting such material to local business, civic, industrial, educational, and professional groups, the employment opportunities offered by the FDA may be discussed.

Publicity - Most consumer oriented publicity is handled by FDA's Consumer Affairs Officers, and you may be requested to assist at times. Radio and television stations are required to devote a certain percentage of broadcast time to public service programs, announcements, and other features. Therefore, most stations are eager to run spot announcements and/or feature stories about FDA employees who have made significant contributions to the Agency's program. These are also readily accepted and used by newspapers throughout the country. This is particularly so when the person featured is a local resident. Successful placement of physically or mentally handicapped persons, dedication of a new office building, awards ceremonies, etc., are other possibilities for development of news releases which could be used as recruitment tools. Be constantly alert, utilizing the recruitment potential of such situations as they present themselves, and alert your supervisor.

164 - COMMUNITY ACTIVITIES

All FDA employees are encouraged to take part in normal community, civic, charitable, or religious activities. See your supervisor if you have any questions about conflict of interest limitations.

165 - EQUIPMENT CARE, CUSTODY, AND LOSS

Care and custody

You are responsible for the proper care and custody of all government property entrusted to you. This includes:

1. Storing government vehicles in protected off-street parking facilities, when possible.
2. Keeping inspectional and investigational equipment securely locked in the trunk of the car while the car is under your direct control. Do not leave valuable equipment in the car's trunk while the car is in for servicing, unless you stay with the car. Do not leave electronic equipment, such as computers, in the trunk of the car for extended periods in extreme hot or cold weather conditions.
3. Storing all property in safe, secure areas.
   Your responsibility for government property in your custody is specified in the Staff Manual Guide FDA 2280.5. See [Intranet Only Link].

165.02 - Maintenance of Equipment

First-line maintenance rests with you as, the custodian of the items entrusted to you. You are expected to perform, or have performed, the normal maintenance such as checking oil, tires, battery, windshield wipers, etc. on the GFV you are using. Other equipment requires little or no maintenance as such, other than dusting, replacing batteries and bulbs, making minor adjustments, properly packing in carrying cases, and proper protection as necessary. Common sense, and handling the equipment as if it belonged to you, should suffice.

1. Repairs - Any repairs needed, defects, or inoperative equipment observed, should be immediately reported to your supervisor.
   When in travel status, necessary minor repairs to equipment may be obtained locally, if possible, and reimbursement claimed on your travel voucher. Major repairs should be cleared through your supervisor.
2. Equipment Calibration - You are responsible to assure equipment assigned to you is calibrated for accuracy. This includes thermometers, pyrometers, balances, scales, stopwatches, etc. Keep a record of the calibration with each item requiring calibration. Calibration of certain inspectional equipment can be done by your District laboratory.

Stopwatches may be calibrated using the atomic clock at the U.S. Naval Observatory in Washington D.C., using the commercial number at (202) 762-1401 or (202) 762-1069. Calibrate stopwatches at several different time intervals within the expected parameters of use. At least three runs should be made at each interval, then averaged for each interval and the correction factor, if any, entered on the record of calibration maintained with the watch. Calibration of your computer's internal clock can be obtained from the same source. Information and software is available on the U.S. Naval Observatory's Website .

165.03 - Lost or Stolen Equipment

As soon as you discover any government property assigned to you or in your custody is missing, report it verbally to your supervisor. Normally, you must submit a form GSA-3155, "Offense/Incident Report". Your district should have these in stock. This form must be supplemented by a memorandum detailing the circumstances surrounding the loss, including the comprehensive steps you took to recover the items. The procedure is outlined in the Staff Manual Guide FDA 2280.5.

Follow your district procedures for any additional requirements.

166 - OFFICIAL CREDENTIALS, BADGE

Show your credentials to appropriate firm personnel during all non-undercover investigations, inspections, sample collections, recall effectiveness checks, etc.

1. Delegated Authority - When you are issued the FDA official forms FDA-200 A&B, certain parts of the Commissioner's enforcement authority, as specified in 21 CFR 5.35, is re-delegated to you. You are expected to use this authority wisely and judiciously. See IOM 501 on cautions against Xeroxing or photocopying your credentials.
   Your investigator badge, if you are issued one, is for use in certain situations to reinforce the official credentials when needed. Check your district Staff Manual Guide, FDA 2280.3, 5b, for situations in which use of the badge may be appropriate.
2. Qualifications for Credentials - FDA employees engaged in general inspectional and investigational operations are issued FDA-200 A&B credentials. By virtue of their position, these employees are recognized as qualified to perform the duties assigned.
   FDA Official Credentials confer extensive inspectional authority on you. Exercise the utmost care of your badge and credentials. Carry them in a manner that will assure positive protection against loss. For example, do not carry them in the upper pockets of your clothing where they may fall out if you bend over. You may not only lose your credentials and badge, but they may, during inspections, fall into vats or machinery resulting in embarrassment and possible financial loss to you as well. Also, carrying your credentials and badge in the glove compartment of your car or leaving them in the pocket of an unattended coat or jacket are invitations to loss or theft.
3. Lost or Stolen Credentials, Badge - The procedure for reporting loss or theft of credentials and/or badge is in the Supervisory Staff Manual Guide, SMG 2280.3. Notify your supervisor immediately, and submit a written report of the loss or theft to him. If instructed, report the loss or theft to local law enforcement authorities and request the police report identification number. Also ask that the number of the lost credentials/badge be entered into the National Crime Information Center (NCIC). Include this information in your report.

168 - BUSINESS CARDS

In June 1999, the FDA determined it is proper to use general appropriation funds to purchase business cards for employees whose interactions with outside organizations further the agency's mission. Due to certain restrictions pertaining to the purchase of business cards, employees should consult with local management prior to purchasing such items, to ensure adherence to agency policy and procedures.

169 - EMPLOYEE CONDUCT

As a government employee of the FDA, as few limits as possible are placed on your interests and activities. Nonetheless, certain limitations are necessary to protect the interest of the government. These constraints are briefly covered in the various subsections in this section. Study the Standards of Ethical Conduct for Employees of the Executive Branch, and consult with your supervisor if you have any questions or concerns in this regard. The Standards of Ethical Conduct for Employees of the Executive Branch can be found on FDA's intranet under the Office of Human Resources & Management Services' (OHRMS) ethics laws.

As you work to advance the health and welfare of the public, seek to maintain the highest standards of ethical conduct. The essence of good government is the personal responsibility that each public servant feels for the public trust he/she holds. You are responsible for complying with the regulations, obtaining advice from your supervisor, personnel or AO, and when required, obtaining advanced approval for certain outside activities.

FDA employees must be persons of unrivalled integrity, and observe the highest standards of conduct. Because of FDA's special regulatory responsibility, its personnel must carry on the agency's business effectively, objectively, and without even the appearance of impropriety. Their actions must be unquestionable, and free of suspicion.

The Standards of Ethical Conduct for Employees of the Executive Branch (5 CFR Part 2635) gives concise details on what is expected, insofar as conduct is concerned. In addition, certain subparts, and Appendix A to Part 73 of the HHS Standards of Conduct , remain in effect. Additional information is also available on FDA's intranet.

169.01 - Professional Stature

You are the eyes and ears of FDA, and to most of the public you are their only contact with FDA. Your actions may be the basis upon which they judge the entire FDA. The public expects exemplary behavior and conduct from the government employee. This responsibility applies to both on the job and off the job activities. As you inspect or appraise individuals, you are, in turn, being evaluated. Both the industries FDA regulates and the public-at-large are keenly aware of, and are quick to report, what they consider improper actions by government employees.

Integrity - This is steadfast adherence to a strict moral or ethical code. It characterizes a person of deep-seated honesty and dependability, with a devotion to accuracy, objectivity and fairness.

Employees may not use or permit others to use official information not available to the general public for gain or to advance a private interest.

You are expected to conduct yourself in a prudent manner, so that the work of the Agency is effectively accomplished. Your job is to gather and present the facts. Accuracy and objective observation are absolutely essential.

The Office of Internal Affairs (OIA), Office of the Commissioner (OC), is responsible for obtaining factual information for the FDA on any matter relating to allegations of misconduct, impropriety, conflict of interest, or other violations of Federal statutes by Agency personnel. If you uncover or suspect any such problems, report them to your supervisor. The District/Region will contact OIA. 21 CFR 19.21(b) requires the facts be forwarded to OIA, HF-9, in writing. OIA will maintain the anonymity of your complaint, if you so desire.

Under the Federal Managers' Financial Integrity Act, it is your duty to report any serious problems of waste, mismanagement, fraud or misuse of Government funds by any personnel from other agencies or government contractors. These problems should be reported to your supervisor, who will, in-turn, notify the Division of Management Programs (HFA-320).

Attitude - Be dignified, tactful, courteous and diplomatic. Make your approach firm but not unresponsive. Do not display strong-arm tactics, an air of superiority, an attitude of special authority, or an over-bearing posture. Do not apologize or justify your request for necessary and authorized information.

Attire - Good public relations and practical common sense requires you dress appropriately for the activity in which you are engaged. Consult your supervisor for district policy on normal office attire.

Protective clothing is required for many inspectional tasks. The District provides coveralls or other clothing for this purpose. Failure to wear suitable attire, including head coverings, while the firm's employees are so attired, is indefensible. Plastic foot guards over street shoes are required, if walking on raw materials such as bulk grains, bagged material, etc. Prophylactic measures - to guard against the spread of disease may be required during certain investigations. See IOM 141 and IOM 519 .

Prohibitions - Gifts, Luncheons, and Snacks - The Standards of Ethical Conduct for Employees of the Executive Branch, 5 CFR Part 2635, Subpart B, specifically provide that an employee shall not, directly or indirectly, solicit or accept a gift: (1) from a prohibited source; or (2) given because of the employee's official position. Notwithstanding any of the exceptions provided in Subpart B, an employee shall not (1) accept a gift in return for being influenced; (2) solicit or coerce the offering of a gift; or (3) accept gifts from the same or different sources on a basis so frequent that a reasonable person would be led to believe the employee is using his/her public office for private gain.

The Standards of Ethical Conduct for Employees of the Executive Branch cover many aspects governing employee conduct and provide that an employee shall avoid any action, whether or not specifically prohibited by the regulation which might result in or create the appearance of: (1) holding a conflicting financial interest; (2) loss of impartiality in performing official duties; or (3) using public office for private gain.

An area of concern for inspectional personnel is a setting where, during an establishment inspection, you have lunch with plant officials and/or personnel and find your lunch paid for by them, or there is no way you can pay for your portion of the luncheon.

It is always best for an employee to decline any gift, including meals, offered by a regulated company's staff. However, when circumstances arise where refusal is imprudent or impractical, such as finding your lunch paid for by the firm, be gracious, but make it clear the situation cannot be repeated. Always use your best judgment. Modest items of food and refreshment, such as soft drinks, coffee, and donuts offered as other than part of a meal, are excluded from consideration as gifts.

ORA's policy requires you do not use or consume a firm's products at any of the firm's facilities. This can be interpreted as acceptance a product is satisfactory and could embarrass the Agency, particularly in the event of a subsequent regulatory action against the firm.

Professional Personnel Contacts - During inspections and investigations, your activities often involve discussions, conferences, and interviews with professional people.

When dealing with top management officials and other professional persons, your presence may often be disruptive to their activities. Many times you may be squeezed into already crowded schedules and your interviews or investigations may, of necessity, be conducted in offices, waiting rooms, or other areas where customers, patients, or employees are present. If you find yourself in this type of situation, be aware your conversations or activities may be overheard by others.

If it is necessary to review records or conduct interviews, conduct your activities in a quiet and dignified manner. Always try to arrange with management for a private area for this work.

If the person becomes unreasonable, and it is impossible to continue the assignment, terminate the interview and consult your supervisor.

169.02 - Outside Activity

Each FDA employee is encouraged to engage in outside activities which contribute to his technical or professional development, or advances the mission of FDA.

Standards Setting Activity - FDA encourages organizations to set standards of quality and safety, and to promote adherence to them. Since FDA considers such standards as supplemental to its own regulatory functions, its employees may, with limitations, be authorized to participate in such outside standards setting activities. These include such activities as: (1) development of standard performance requirements; (2) testing methodology; (3) manufacturing practices; (4) product standards; (5) scientific protocols; (6) compliance criteria; (7) ingredient specifications; (8) labeling; (9) other technical or policy criteria. For information and procedures to follow in obtaining approval for these activities see your district copy of the Staff Manual Guides, Guide Number 2125.1.

Outside Employment - Certain outside activities, paid or unpaid, unrelated to FDA's activities are permissible. Such employment must be approved. Outside jobs must not involve a real or apparent conflict of interest. They must not interfere with your efficiency, or require official time or use of official facilities or records. These limitations apply to all outside activities. In addition, you may not:

1. Engage in any work that identifies the DHHS or FDA with any commercialization of products.
2. Accept anything of value for helping a contractor in the procurement of a government contract.
3. Represent the Department in dealing with a matter in which you have a conflicting interest.
4. Be paid from outside sources for services in any matter "in which the United States has an interest."
5. Accept, from the outside, pay for the performance of your official duties.

Political Activity - As a Federal employee you may vote as you please and express your opinion on political subjects. However you may not:

1. Use your official authority or influence for the purpose of affecting the results of an election.
2. Take an active part in political management of political campaigns. Consult your supervisor if there is any doubt in your mind regarding departmental regulations on activities prohibited by the Hatch Act.

Teaching, Speaking and Writing - The Standards of Ethical Conduct contain detailed information on teaching, writing and speaking. Please review them in detail if you are involved in outside activities of this nature. Employees may participate in these activities, however, advance approval is required and there are certain restrictions on accepting compensation for these activities.

Financial Interest - You may not have financial interests that conflict, or appear to conflict, with your responsibilities and duties as an FDA employee. You cannot engage, directly or indirectly, in financial transactions as a result of or primarily relying upon information obtained through your job. If you are required to file a Public or Confidential Financial Disclosure Report, you may not have substantial financial interest in industries regulated by FDA. See your supervisor if you have any reservation or question relative to financial interest or contact the Division of Management Programs, Ethics and Integrity Staff at 301-827-5511.

169.03 - Financial Responsibility

You are expected to conduct your financial affairs in accordance with accepted standards of ethical business practice, and to pay your just debts promptly.

169.04 - Gifts

Under Subpart C of the Standards of Ethical Conduct, guidance is provided on rules governing gifts between employees, including gifts to supervisors. On an occasional basis, such as a birthday or holiday, you may give an unsolicited gift valued at $10 or less to your supervisor. Also, you may give a gift to your supervisor to mark a special occasion such as his/her marriage, the birth of his/her child, and his/her retirement or transfer.

169.05 - Attempted Bribery

Bribery is the practice of offering something, such as money or a favor, to a person in a position of trust to influence that person's views or conduct. Occasionally, FDA employees experience bribery attempts.

Bribery or attempted bribery of a Federal Officer is a crime (18 U.S.C. 201). If you are offered money or anything else of value, pursue the following course of action:

1. Attempt to obtain a clarification of the offer (e.g., Ask questions like, "What is this for?").
2. Do not accept or refuse the offer. Appear to vacillate, and keep the door open for future contact.
3. Calmly terminate the exchange.
4. As soon as possible, prepare detailed notes concerning what transpired.
5. Contact your supervisor as soon as possible. The District should notify the OCI office immediately.  You may be asked to assist the OCI and other investigative bodies by accepting proffered money as evidence, under controlled conditions. Do not participate in any such activity, or accept anything of value outside the controlled conditions of an undercover activity conducted by OCI and/or other involved Federal law enforcement agencies.

169.06 - Health and Hygiene

Inoculations - FDA provides operating field personnel with various inoculations for protection from infection or injury on the job.

The following schedules of shots are recommended:

1. Domestic Work (a) Tetanus: Permanent immunity through the Tetanus Toxoid series followed by a booster dose every ten years; (b) Typhoid: No longer required even if working in a contaminated environment. Booster dose may be given every three years if desired and requested by employee; (c) Smallpox: No longer required in the U.S.; (d) Other: As required by your specific job.
   Hepatitis B Vaccine: a synthetic vaccine has been developed and is available to those employees that may be exposed to the virus during the normal course of official duties. Contact your AO to arrange for this vaccination. Keep in mind a vaccination is not to be considered a substitute for good laboratory/field safety practices. This vaccine is specific for Hepatitis B virus (HBV) only, and not for other blood pathogens.
2. Foreign Travel - Check with your supervisor well in advance of planned foreign travel as to specific requirements of the countries to be visited.
   1. Typhoid: recommended for travel to areas where typhoid fever is endemic.
   2. Cholera: a primary vaccination or a booster within six months is required for traveling to India and Korea. May also be required occasionally for other nations.
   3. Other: as required for specific country.

Physical Examinations - There is no requirement for periodic physical examinations. Even so, it is your responsibility to adhere to good personal hygiene and health practices.

If any firm management demands evidence of recent physical examination before permitting inspection, consult your supervisor. A mere request to examine your hands for sores, etc., is not unreasonable. However, do not accede to a physical examination.

169.07 - Sexual Harassment

Sexual Harassment is a violation of Sec. 703 of Title VII of the Civil Rights Act of 1964. Unwelcome sexual advances and other verbal or physical conduct constitute sexual harassment when:

1. Submission to such conduct is made, either explicitly or implicitly, a term or condition of an individual's employment,
2. Submission to, or rejection of, such conduct by an individual is used as the basis for employment decisions affecting such an individual, or
3. Such conduct has the purpose or effect of unreasonably interfering with an individual's work performance, or creating an intimidating, hostile, or offensive working environment.

In identifying sexual harassment, keep the following in mind: (1) the harasser's behavior must be unwelcome, (2) the gender of the harasser or the victim (whether opposite or same sex) does not lessen the legal relevance of a claim of sexual harassment, (3) even without suffering economic loss, (fired, demoted, denial of training) the mere fact the person is the recipient of unwelcome advances or working in a hostile environment makes the employee a victim of sexual harassment, (4) any person who is exposed to sexual harassment, regardless of whether he/she is the direct recipient, may be considered a victim.

FDA is responsible when an employee is sexually harassed, regardless of whether supervisors knew or should have known of the conduct.

Some actions a supervisor may take if sexual harassment complaints occur:

1. Conduct an inquiry of the sexual harassment allegation, and determine the facts.
2. Inform the alleged harasser(s) of the allegations.
3. Warn the alleged harasser(s) sexual harassment is a violation of Federal law and will not be tolerated.
4. Provide the alleged harasser(s) a copy of the FDA's sexual harassment policy and a copy of Sec. 703 of Title VII of the Civil Rights Act of 1964.

If the inquiry supports the victim's allegation(s) of sexual harassment, the supervisor should contact the Equal Employment Opportunity (EEO) office for guidance, and the Employee Relations Branch to determine if disciplinary action is warranted.

If a field employee is sexually harassed by a non-FDA employee during an inspection/investigation they should tell the individual to stop the harassing behavior, inform the individual's supervisor, and immediately notify their supervisor. If appropriate, the firm's management should be contacted by District management by phone, followed by correspondence informing them sexual harassment on the basis of sex is a violation Federal law. A copy of the FDA's sexual harassment policy should also be included. If the harassment continues contact FDA's EEO Office (HF-15) at 301-827-4848.

169.09 - Disciplinary Action

Penalties for violation of the statutes covering employee conduct are prescribed by law. They range from suspension or dismissal to fine and/or imprisonment. Some laws specify prohibitions but leave the penalty to administrative action. In any such violation, FDA will take such disciplinary action as best meets the objectives of deterring similar offenses and maintaining high standards of employee conduct and public confidence.