Most food manufacturing companies maintain strict written policies for plant visitors. Besides safety directives and personal protective equipment, visitors are routinely required to sign confidentiality agreements that protect trade secrets and confidential information that may be viewed by visitors while at the facility. Not only are confidentiality policies good business practice, but they are often contractual requirements with the customer. Private label customers outsource production with the understanding that formulas and processes will be protected.

Routinely, these confidentiality agreements also preclude the taking of any photographs or video during the visit. Photos and videos are the most likely method by which confidential information is inadvertently captured and taken off site. Information on film won’t be seen by the company or visitor before the visit ends and the company may never learn that confidential information was captured.

But what about representatives of the U.S. Food and Drug Administration (FDA) who show up for either a routine inspection or an investigation? What rights do manufacturing companies have with respect to confidentiality of customer information, including the taking of photographs or videos by FDA? And what control do they have, if any, of the means by which photos are taken for evidence of alleged adulteration? FDA certainly believes it has the right to take photos as a part of its routine oversight responsibilities. But what position should a manufacturing company take when FDA is at the front door?

FDA’s Position
Each year the FDA issues an Investigations Operational Manual (IOM) (www.fda.gov/ICECI/Inspections/IOM/default.htm), which is the primary source of directives for its field investigators and inspectors. It contains the everyday policies and procedures for its representatives to follow when entering facilities over which the FDA has oversight responsibilities. With respect to photographs, the IOM recommends a rather aggressive approach:

5.3.4.1 - In-Plant Photographs
Do not request permission from management to take photographs during an inspection. Take your camera into the firm and use it as necessary just as you use other inspectional equipment.

If management objects to taking photographs, explain that photos are an integral part of an inspection and present an accurate picture of plant conditions. Advise management the U. S. Courts have held that photographs may lawfully be taken as part of an inspection.

If management continues to refuse, provide them with the following references:

1. “Dow Chemical v. United States,” 476 U.S. 227 (1986). This Supreme Court decision dealt with aerial photographs by the U.S. Environmental Protection Agency, but the Court’s language seems to address the right to take photographs by any regulatory agency. The decision reads in part, “**When Congress invests an agency with enforcement and investigatory authority, it is not necessary to identify explicitly each and every technique that may be used in the course of executing the statutory mission.***”

2. “United States of America v. Acri Wholesale Grocery Company, A Corporation, and JOSEPH D. ACRI and ANTHONY ACRI, Individuals,” U.S. District Court for Southern District of Iowa. 409 F. Supp. 529. Decided February 24, 1976.

If management refuses, obtain name and contact information for the firm’s legal counsel, and advise your district management immediately. If the firm does not have legal counsel on retainer, collect the name and contact information for the most responsible individual. District management will inform their ORA Regional Counselor in the Office of Chief Counsel (OCC) of the situation, and OCC will then contact the firm’s legal counsel or most responsible individual to discuss FDA’s legal right to take pictures during inspections. OCC will relay the results of this conversation to district management. If you have already taken some photos do not surrender film to management. Advise the firm it can obtain copies of the photos under the Freedom of Information Act.

FDA believes that there are statutory safeguards in place to protect the confidentiality of information and photographs that are collected in the course of its investigation per the provisions of several statutes [e.g., Trade Secrets Act (18 U.S.C. 1905), FD&C Act (21 U.S.C. 331(j)), the Freedom of Information Act, (5 U.S.C. 552) and the agency’s information disclosure regulations at 21 CFR Parts 20 and 21 govern the agency’s disclosure of information to the public. But it concedes that FDA personnel may disclose nonpublic information that is otherwise protected from disclosure to the public, if that disclosure is permitted by law and FDA’s procedures (see e.g. 21 U.S.C. 375(b)]. For example, FDA’s regulations, set forth in 21 CFR Parts 20 and 21, permit agency officials to disclose certain nonpublic information to other federal, state, local or foreign government officials, or to FDA’s contractors, when that disclosure is carried out according to law and FDA’s procedures.

Company’s Position
Given that FDA clearly intends to take photos whether in the scope of a routine inspection or a directed investigation, what, if anything, should the company’s response be? First it should be understood why a company may want to oppose FDA’s taking of photographs: a) it may violate the contracts with customers to allow photos to be taken without prior notice to the customer; b) the photos may ultimately include confidential or proprietary information that is totally irrelevant to the focus of FDA’s investigation; and c) singular, close-up photos of alleged small examples of adulteration can be prejudicial evidence in later litigation if taken out of context and exclude overall images of the plant’s Good Manufacturing Practices. For these reasons, a company may want to attempt to prohibit an FDA investigator from taking photos inside its plant.

The cases referenced by the IOM as authority for taking photos during investigations do not in fact totally stand for the conclusions FDA alleges. Both Dow Chemical and Acri Wholesale Grocery Company held that when a company had consented to an inspection, any photos taken during that inspection are admissible in later litigation. It is clear that FDA has a right to conduct investigations under its enforcement responsibilities [21 C.F.R. § 374(a)]. But if management takes the position before the inspection begins that no photographs are allowed, neither Dow Chemical nor Acri Wholesale Grocery Company apply. And according to the IOM, management’s refusal to allow photos should stop the inspection and the inspector should refer the conflict to the company’s legal counsel and the inspector’s district manager.
 
At some point, FDA will likely return with a warrant for the inspection. Because FDA’s standard warrant includes the specific authority to take photographs, the company’s legal counsel should be prepared to immediately file a motion to quash the warrant or seek an injunction challenging its scope. Restrictions on photography could be sought, which would preclude the photographing of confidential of proprietary information, unless necessary to document the alleged adulteration. If necessary, the proprietary information could by agreement be shielded or possibly redacted. Furthermore, if the goal is to be able to present an array of photos in later litigation that show the area of alleged adulteration in context to the overall plant, restrictions could be sought that photos be taken at periodic intervals throughout the plant. At a minimum, the company should simultaneously photograph or videotape the plant and overall area where the narrow photo of alleged adulteration is being photographed by FDA.

Conclusions
FDA has no statutory right to take photographs or video tapes during a routine inspection or an investigation. Agents have been given the directive to take photos without asking permission of the manufacturing company. Courts have held that photos are an acceptable part of a governmental agencies’ enforcement authority when the plant owner has consented to an inspection. What remains a viable option is to refuse any photography during the inspection and before the inspection begins, and seek legal restrictions on the photographic process beforehand.

Kathy Hardee, Esq., is co-chair of the Food & Agriculture Industry Group at Polsinelli, PC, which is comprised of a team of attorneys from every legal practice area and who each have a focused background in the food industry.