Spotlight on Animal Health Business Operations: A Legal Update. Husch Blackwell LLP March 5, 2015

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1 Spotlight on Animal Health Business Operations: A Legal Update Husch Blackwell LLP March 5, 2015 I. Potential Agency Inspections A. Federal Agencies Understanding and Preparing for Governmental Inspections i. Occupational Safety & Health Administration (OSHA) ii. U.S. Environmental Protection Agency iii. DOT iv. DHS/ICE v. DOJ/OSC vi. Coast Guard vii. DOL viii. USCIS/FDNS ix. FDA B. State Regulatory Agencies i. Environmental ii. Department of Labor C. Local Agencies D. Others i. Fire Marshall II. III. Types of Government Inspections A. Routine investigations of regulatory compliance B. Complaint follow up C. Incident investigations D. Special emphasis programs E. Information gathering F. Often unannounced G. All inspections should be treated similarly Inspection Pre Planning A. Inspection planning must begin long before the inspector is at the gate

2 B. Understand the applicable law as it applies to the facility and have an understanding of a particular agency s inspection procedures i. If you need help with the applicable statute or regulations consult legal counsel ii. Inspector will review agency files before inspection. 1. Be aware of the status of: a. Previous agency inspections b. Suggestions made c. Variances d. Past identified violations e. Previous correspondence from other agencies providing notice of problems 2. Know the response or action taken after the last inspection or after notice provided. C. Choose a person responsible for accompanying the inspector and several alternates i. Selected persons should understand the consequences of responses to inspector s questions ii. Appoint one knowledgeable company representative as the spokesperson and another as an observer/note taker 1. It is imperative that the spokesperson be extremely knowledgeable about the subject area under inspection. 2. He/she should draw on available personnel and other resources 3. Do not let the inspection be a committee effort a. One person controls the flow of information to the inspector D. Most laws protect the unauthorized disclosure of "confidential business information" and "trade secrets" i. Identify trade secrets and confidential information in advance E. Identify a meeting/work room for the inspector, such as a conference room i. Recommend that the room not contain any aerial photographs, process diagrams, documents, reports or a view onto the production floor F. Have a camera available G. Do a dry run IV. Records

3 A. Know what records apply to each regulatory program and where they can be found B. Make sure all records required to be kept are present including back up information C. Do not have required records mingled with other records D. Know and apply document retention requirements E. Audit your own records routinely F. Neatness counts V. Inspection day Factors Affecting Inspection Outcome A. Housekeeping B. Records organization C. Demeanor of company representative D. Knowledge of rules E. Willingness to comply VI. VII. VIII. First Contact with Inspector A. Assure that persons expected to greet an inspector first (e.g., receptionist, security guard) are aware of facility inspection response procedures and know who to call right away B. It is usually best not to refuse access, but to try to work out the terms and timing of the inspection i. If the inspector does not present credentials, be sure to ask to see theminspect credentials to identify name, title, government department, and telephone number and write this information down ii. Do not hesitate to verify legitimacy, if any doubt Warrant Procedure A. In the event the inspection is being conducted under authority of a search warrant obtain copy of warrant B. Forward a copy of the warrant to counsel immediately and obtain legal advice C. Review scope of warrant D. Do not obstruct or interfere with investigation within the scope of the warrant Opening Conference A. In all cases, you should request an opening conference B. The inspector should provide a copy of any warrant or employee complaint C. In any opening conference, be sure to: i. Clarify the purpose and the scope of the inspection

4 ii. Identify what areas the inspector needs to see iii. Ask what, if any, records will be reviewed iv. Discuss whether photographs, videos, or samples will be taken v. Inform the inspector up front of what information is considered confidential and what areas of the facilities contain trade secrets D. All safety procedures (hard hats, safety glasses, hearing protection, etc.) should be explained and a commitment obtained from the inspector to follow such procedures E. Document that all of these points were covered and the details of what was conveyed to the inspector IX. Records A. Many inspectors first ask to see records the company is required to keep under the pertinent law and within the scope of the inspection B. Ask the inspector whether it would be acceptable to assemble the documents and provide them for review at a later time and/or off site C. Limit record reviews to those records specifically requested by the inspector D. Someone other than the company spokesperson should pull the relevant documents and bring them to the inspector in a conference room E. Privileged communications (i.e. letters or memos to or from counsel) should be removed and NOT put in the same room with the documents for review F. Make sure to keep a record or an exact copy of all documents given to the inspector and keep a copy of each document the inspector takes back to the agency office G. In general, personnel records should not be released to the inspector, unless the records are required to be maintained by regulation and then only to the extent such record is required H. Facility Walk Through i. The inspector always must be escorted and never allowed to walk through the facility unaccompanied ii. Use proper personal protection equipment iii. An inspector can cite any alleged violation found within that inspector s agency jurisdiction, even if it is not within the stated scope of the inspection iv. Many agencies (e.g., EPA, OSHA and DHS) increasingly will refer matters among the agencies v. It is a good idea to have someone working ahead to attend to minor details so that everything is properly in place

5 X. Discussions with the Inspector A. Anything the inspector says is calculated to learn something B. Maintain an arm s length relationship they are trained to be nice C. Do not admit a violation or attempt to explain it D. Correct any violation identified by the inspector immediately, if possible E. When asked a question, take the time to think i. Let the inspector finish the question ii. Ask for clarification, if needed iii. Never guess iv. I don t know or "I can t remember is acceptable, if true v. Can answer later, if needed F. Be polite, patient, and never lose your temper G. Correct incorrect responses as soon as possible H. Be alert and on your toes until the inspector leaves XI. XII. Photographs and Samples A. If photographs or videos are to be taken, the inspector should be asked to provide a duplicate set to the facility B. The facility should also take its own photographs and videos from several different views and distances C. If physical samples (air, water, soil, etc.) are to be taken, ideally the facility should split the samples with the inspector and hold them for possible analysis D. If this is not feasible, the facility should consider taking samples in the same locations as soon as possible E. Keep detailed record of the inspector s and the facility's sampling, including the number, when, and how samples were taken Employee Interviews A. The inspector may ask questions of employees during the walk through i. Difficult to manage, but if the employee is busy, you can ask to postpone to a better time ii. Employees are not required to speak to an inspector iii. Company representative may correct incorrect information iv. Employees cannot be disciplined in any way for statements made to an investigator

6 B. Formal interviews i. Only OSHA may conduct employee conferences without the employer present ii. If not an OSHA inspection, the company spokesperson should remain in the interview to know what is being said and to correct all inaccuracies. C. Instructions to employees (if asked) i. Employees are NOT obligated to provide information to an inspector. It is the employee s choice ii. If the employee chooses to participate, he/she must tell the truth iii. Listen carefully to the question and ask for clarification, if needed D. Upon completion of a salaried employee interview, the employee should be asked to write down their best recollection of the questions asked and the answers given, if no company representative was present XIII. XIV. Closing Conference A. Normally held to discuss the results of the inspection. i. Take careful notes B. Ask whether the inspector will be filing a report and, if so, when the employer can expect to receive a copy C. Any responses to the inspector s observations or citations should be well thought out and discussed with appropriate technical and support personnel i. No responses are necessary at this time D. If there are open items, find out and make a note of what you need to provide E. Pay careful attention to suggested abatement measures F. Provide e mail address for follow up questions G. Do not make any statements regarding an alleged violation. Follow Up Questions A. Increasing use of follow up questions B. Answers over the phone are treated like formal responses C. Company is bound by the inspector s notes of the conversation D. To the extent possible, communicate at least by e mail i. Consider response carefully ii. Obtain legal counsel

7 SPECIFIC CONSIDERATIONS FOR ICE I 9 INSPECTIONS While all inspections and investigations have certain common characteristics, the I 9 inspection is unique in some ways. It can begin with an administrative audit of documents and evolve into a criminal investigation. Employers usually receive notice of the investigation and an opportunity to bring their documents into compliance where possible before the inspection. Here are some pointers for dealing with this type of inspection: 1. Unless ICE plans a surprise visit to apprehend groups of unauthorized workers (not a common practice at this time), employers normally receive a Notice of Inspection either by certified mail or by hand delivery. In this case, employers receive three days advance notice of the inspection. 2. Notify immigration counsel. Counsel may be able to negotiate with ICE for more time before inspection and the scope of documents ICE requests to inspect and can assist with preparation for the inspection and spot problems up front. 3. Review scope of I 9 inspection notice. 4. Determine if workforce should be notified of I 9 inspection. 5. Gather documentation requested by the audit. 6. Conduct in house audit of I 9 records identify deficiencies and correct where possible. 7. Prepare personnel who will assist with investigation. 8. Interview appropriate executives, hiring managers, and HR personnel as necessary and prepare them for possible ICE interviews. During the inspection, ICE will inspect I 9 forms and compare them with employment records (payroll records, lists of employees, tax filings, ownership information, etc.) to determine if there are any paperwork violations or hiring violations. ICE will inspect any documents (such as Social Security Administration correspondence) which should have put the employer on notice of possible work authorization violations and inquire about employer response. ICE may also interview personnel. After the document inspection and any interviews, ICE will notify the employer by letter whether the employer is in compliance or whether deficiencies are found. If technical violations are found, employer will have 10 days to correct the forms. ICE may issue a Notice of Intent to Fine.

8 9. Review and analyze ICE s assessment. 10. Correct errors and address issues as directed by ICE. 11. If necessary, outline strategies for potential negotiation with ICE and work to reach a settlement with ICE, with the assistance of immigration counsel. A criminal investigation may follow an I 9 inspection or be initiated through a tip from a current/former employee or other member of the public due to suspected employment of undocumented workers. (See below for best practices.) A. Best Practices During Worksite Enforcement Audit Do Don t Contact immigration counsel. Develop a transparent process for interacting with employees during the audit. If you need specific information from an employee, tell them it s in response to an ICE audit. If workers are represented by a union, inform the union of the ICE audit and consult labor counsel about compliance with the collective bargaining agreement. Review the agreement. Conduct an internal I 9 audit. Provide all workers with a reasonable amount of time to correct discrepancies in their records identified by your audit or by ICE. Communicate in writing with employees from whom you seek information and describe the basis for the discrepancy and the information needed. Selectively verify the employment eligibility of certain employees based on their national origin or citizenship status. Terminate or suspend employees without providing notice and a reasonable opportunity to correct deficiencies. Require employees to provide more documents than required. Limit the range of documents that employees can produce for I 9 purposes.

9 B. Best Practices During Criminal Worksite Investigation Contact counsel. Conduct an internal audit. Carefully scrutinize the employment history of any employees detained or arrested during the investigation. Ensure agents are accompanied at all times while on the premises. Do not sign any documents or make any statements about company policies or practices or particular employees without counsel s review and/or presence. Do not assist employees in exiting the premises or offer advice to them about their interactions with ICE. Separate counsel may be needed for employees. Retain copies of any records seized. Prepare for potential media coverage.

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