Inspections, Compliance, Enforcement, and Criminal Investigations
SUBCHAPTER 1.6 - PUBLIC RELATIONS, ETHICS & CONDUCT
FDA's ethics program is administered to help ensure that decisions made by Agency employees are not, nor appear to be, tainted by any question of conflict of interest. The "ethics" laws and regulations were established to promote and strengthen the public's confidence in the integrity of the Federal Government. The ethics program is available on the FDA intranet and standards of conduct are available at http://www.fda.gov/AboutFDA/WorkingatFDA/Ethics/ucm071702.htm.
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 220.127.116.11 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 website.
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 HHS 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.
You are responsible for the proper care and custody of all government property entrusted to you. This includes:
- Storing government vehicles in protected off-street parking facilities, when possible.
- 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.
- Storing all property in safe, secure areas.
Your responsibility for government property in your custody is specified in the Staff Manual Guide 2280.5.
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 GOV 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.
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.
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.
As soon as you discover any government property assigned to you or in your custody is missing, report it verbally to your supervisor. A memorandum should be prepared detailing the circumstances surrounding the loss, including the comprehensive steps you took to recover the items.
Follow your district procedures for any additional requirements.
Show your credentials to appropriate firm personnel during all non-undercover investigations, inspections, sample collections, recall effectiveness checks, etc.
To apply for official credentials, you must complete FDA 2115 and submit it to Gail Katz in the Office of Operations.
When you are issued the FDA official forms, certain parts of the Commissioner’s enforcement authority, as specified in Staff Manual Guide 1410.32, are re-delegated to you. You are expected to use this authority wisely and judiciously. See IOM 18.104.22.168 on cautions against 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.
FDA employees engaged in general inspectional and investigational operations are issued FDA 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.
The procedure for reporting loss or theft of credentials and/or badge is in the Staff Manual Guide (SMG) 2280.3. Notify your supervisor immediately. Report the loss or theft to local law enforcement authorities (police department) and request a copy of the report including the police report identification number. Also report the loss or theft to the local (state) FBI field office so that the number of the credentials/badge can be entered into the National Crime Information Center (NCIC) system. A written report containing the police report number and a statement that the local FBI field office was notified must be submitted to your supervisor. Copies of the written report must be sent to Office of Security and Office of Operations prior to new credentials and/or badge being reissued.
Business Cards are defined as cards of introduction bearing the name, address, phone number, fax number and e-mail address of active agency representatives. The distribution of business cards facilitates prompt and efficient communications by the persons and organizations with whom the Agency transacts business. The purpose of the business card is to further the Agency’s statutory mission and; therefore, the purchase constitutes a proper expenditure from the Salaries and Expense Appropriation.
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.
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 covered the Standards of Ethical Conduct for Employees of the Executive Branch. 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 and 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 local administrative staff, 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 internet at http://www.fda.gov/AboutFDA/WorkingatFDA/Ethics/default.htm.
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.
When you issue an FDA 483, the firm is provided with information as to how to contact the District Office with such reports and information on the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), which provides regulated industry a means for addressing industry concerns about government agency enforcement activities. See IOM 22.214.171.124.1. You may receive complaints or other questions from the regulated industry during routine field operations, such as sample collections, investigations, import entry reviews and establishment inspections where an FDA 483 was not issued. In these circumstances, provide the firm the “Information for FDA - Regulated Industry” Website “www.fda.gov/oc/industry”. Explain there are Small Business links on the webpage and the FDA Ombudsman link is located under the Contact FDA heading and they may also call the District Office. Document this discussion in your regulatory notes and include it in your Establishment Inspection Report (EIR) in the Discussion with Management section, your Memorandum of Investigation, or the remarks section of your collection report.
If the firm does not have internet access, provide the firm the main District phone number.
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 Criminal Investigations (OCI), 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 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 Office of Management Programs.
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.
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 1.5.1 and IOM 5.2.10.
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:
- From a prohibited source
- Given because of the employee’s official position.
Notwithstanding any of the exceptions provided in Subpart B, an employee shall not:
- Accept a gift in return for being influenced;
- Solicit or coerce the offering of a gift;
- 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:
- Holding a conflicting financial interest
- Loss of impartiality in performing official duties
- 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.
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.
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:
- Attempt to obtain a clarification of the offer (e.g., Ask questions like, "What is this for?").
- Do not accept or refuse the offer. Appear to vacillate, and keep the door open for future contact.
- Calmly terminate the exchange.
- As soon as possible, prepare detailed notes concerning what transpired.
- 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.