Crowell & Moring LLP attorneys have long and extensive experience in representing clients in administrative and regulatory matters in federal, state, and international contexts.
Our Practice
Administrative Law/Regulatory - Administrative Rulemaking
Crowell & Moring attorneys participate in rulemaking proceedings before most federal administrative agencies, many state agencies and the European Union. Where necessary, we represent clients challenging or defending final rules in court. We represent our clients' interests in the rulemaking arena by:
- Working with agency officials before a rule is proposed
- Preparing written comments on proposed rules and responses to comments submitted by others
- Providing oral testimony at public hearings
- Seeking administrative or judicial stays of rules
- Challenging rules in court or intervening in support of rules in judicial proceedings brought by others
Our attorneys have many years of experience in rulemaking, ratemaking and supply allocation proceedings, including tariff matters affecting common carriers and the unbundling of energy services. Other examples of our rulemaking representations include: preparing comments on behalf of a major US airline and monitoring submissions of other parties in an extended rulemaking on computer reservations systems; preparing comments and participating in litigation on regulations affecting health care providers, health care plans participating in the Medicare program, academic medical centers and research institutions affected by regulations governing clinical trial research; environmental rulemakings involving air, water, wetlands, mining regulations and reclamation, and occupational safety and health for general industry and construction (OSHA) and for mining (MSHA).
Administrative Law/Regulatory - Judicial and Administrative Review of Agency Actions/Citizen Suits
Crowell & Moring's attorneys have long experience in representing a broad array of clients in proceedings for judicial and administrative review of agency actions—whether as a petitioner seeking to stay or overturn unfavorable agency decisions, a respondent in agency enforcement proceedings, or an intervener defending more favorable agency action against citizen suits and other challenges. We have represented clients in seeking administrative and, if necessary, judicial review of:
- Agency rulemakings and adjudications
- Ratemakings
- Agency policy decisions and guidelines
- Licensing and permitting decisions
- Civil penalty and enforcement actions
Administrative Law/Regulatory - Commercial Transactions
In connection with our extensive administrative and regulatory practice, we often have occasion to assist our clients in commercial transactions. These generally arise in one of two ways. First, where an industry remains heavily regulated, we are often called upon to structure transactions and review documents with an eye to the surrounding regulatory climate. Second, as an industry becomes less regulated (such as the natural gas and electric industries in recent years), our expertise in the industry permits us to contribute value to the planning of the competitive commercial transactions that increasingly replace regulated relationships.
Examples of our work in this area include, in the Health Care area, representing hospitals, HMOs, clinics, pharmacies, and ambulatory surgery centers in connection with mergers, joint ventures, loans and other financial transactions; in the FDA area, performing due diligence in purchase transactions and counseling on statements in prospectuses for stock offerings; in the Aviation area, advising airlines on aircraft transactions and the formation of alliances and other cooperative marketing arrangements; in the Environmental area, performing due diligence review in connection with product or business acquisitions; and in the Energy area, preparing contract documents for domestic and international energy projects and arranging for both individual company and cooperative purchases of energy supplies.
Administrative Law/Regulatory - Compliance Review
Crowell & Moring provides compliance review counseling, and related strategic planning, in a variety of substantive areas. The purpose of a compliance review is to provide an objective determination as to the extent of compliance with the relevant laws and regulatory requirements in a particular field, such as Environmental, Health and Safety; Antitrust; FDA; or the regulatory regimes applicable to a particular industry, such as Aviation. For example, our Health Care area provides such compliance reviews for hospitals, HMOs, teaching institutions and clinical research organizations. Our international lawyers conduct audits of export control practices and procedures. Our natural resources and environmental lawyers conduct transactional "due diligence" reviews and environmental, health and safety compliance audits. Following the compliance review, we typically provide recommendations for corrective measures and long-term compliance assurance. This may lead to training and education programs, risk assessment and management programs, and other strategic measures. For many of our clients, the scope of this work is international.
Administrative Law/Regulatory - Transportation of Hazardous Materials
Crowell & Moring’s lawyers represent shippers, carriers and manufacturers in hazardous materials (“hazmat”) proceedings instituted by the government and advise clients on compliance with the Department of Transportation’s Hazardous Materials Regulations (HMR). The HMR prescribes packaging, labeling, employee training and other requirements for the shipment of hazmat. Enforcement activity and fines for violations of the HMR have increased over the past few years, and DOT has imposed additional requirements on hazmat shippers and carriers related to security issues since the events of September 11, 2001.
Our lawyers help US and foreign companies stay in compliance with the hazmat rules by, for example:
- Monitoring and advising companies on relevant regulatory developments
- Proposed and final rules
- New agency policies or procedures
- Significant enforcement actions or trends
- Drafting comments in rulemaking proceedings li>Providing guidance related to particular shipments, requirements or other questions
- Conducting audits to determine compliance deficiencies
- Recommending and designing compliance strategies and procedures
- Preparing exemption applications
- Defending or advising on enforcement actions
- Providing awareness or other training
Administrative Law/Regulatory - Enforcement Counseling and Defense
Crowell & Moring attorneys routinely assist clients facing government investigations and counsel clients in connection with agency inspection and enforcement actions. If a whistleblower files charges or an agency threatens civil or criminal penalties, we are experienced in counseling and defending clients - from negotiations and internal investigations to litigation.
Our enforcement counseling and defense practice includes representation of businesses and individuals facing adverse action by federal and state regulatory agencies - for example, the CPSC, DOT, EPA, FAA, FDA, FERC, FTC, HCFA, NHTSA, OFCCP, OSHA, MSHA, and the SEC. We often are retained to prosecute appeals from agency decisions that impose penalties, disqualify contractors or revoke licenses. Our reputation and location in Washington DC gives us opportunities to reach top officials in federal agency headquarters, where final decisions are made to impose — or not impose — penalties or other sanctions.
Administrative Law/Regulatory - Legislative Practice
Lawyers at Crowell & Moring represent clients on Capitol Hill and in state capitals when a need arises for legislative action. During the course of such representation, our lawyers utilize many tools and strategies to help clients solve their problems. Careful analysis of the particular statute at issue is the fundamental starting point. Issues of committee jurisdiction and composition provide a filter through which any viable approach must go. Our services can be as limited or complete as the client needs, depending on its own legislative resources.
Our strength is our in-depth knowledge of the substantive areas of the law and our ability to understand how substance and process interact to change existing law or plow new ground. Often this work entails consultation and negotiation with the Executive Branch Agencies and senior Administration officials, as well as legislators, to produce an acceptable legislative compromise. Our lawyers maintain bi-partisan relationships with government officials. A representative sample of the work of our legislative lawyers is:
- Working with Treasury, NSC and OMB to fashion final compromise language advising aerospace and airline companies on legislative developments in Washington affecting their operations domestically and internationally
- Representing clients on matters related to forest products, livestock agriculture, and mining, focusing on environmental, public lands, endangered species, employee safety and health, as well as other compliance issues faced by these industries
- Preparing government contractors and trade associations for hearings, helping to draft written testimony and oral summaries; and developing statutory language to address clients' needs
- Lobbying in support of compensation for victims of terrorism, developing a bi-partisan coalition to work the issue with key Senators and Congressional representatives
Administrative Law/Regulatory - Government Ethics
Our Government Ethics practice resides with attorneys that have dealt with ethics rules and written legal opinions that guided policy and procedure at the highest levels of our nation. Because of our experience, Crowell & Moring advises companies and organizations on the ethical rules and policies that apply to government business and contact, including the rules on gifts and entertainment, the revolving door, and conflicts of interest; lobbying; and corporate political activity. Partner Beth Nolan served in the White House as Counsel to the President from 1999 to 2001 and was responsible for overseeing all legal matters for President Clinton and the White House staff. She served in the Department of Justice from 1996 to 1999 and was also in the White House as Associate Counsel from 1993 to 1995. Formerly she was an Associate Professor of Law at George Washington Law School. Our clients range from a major government contractor with a sophisticated Washington office – to which we provide advice on complex political activity questions for the corporation, its Political Action Committee (PAC), and its corporate officers – to corporations requiring fundamental guidance on establishing a PAC and registering as lobbyists. Moreover, we advise our corporate clients on the intricate legal questions that can arise when one of their executives enters or leaves government, and on the standards that apply whenever they are dealing with government officials in the Executive or Legislative branches.
Our clients range from a major government contractor with a sophisticated Washington office – to which we provide advice on complex political activity questions for the corporation, its Political Action Committee (PAC), and its corporate officers – to corporations requiring fundamental guidance on establishing a PAC and registering as lobbyists. Moreover, we advise our corporate clients on the intricate legal questions that can arise when one of their executives enters or leaves government, and on the standards that apply whenever they are dealing with government officials in the Executive or Legislative branches.
Administrative Law/Regulatory - Licensing, Permitting, and Certificating
Crowell & Moring attorneys have extensive experience representing a broad array of clients in wide range of matters relating to licensing, permitting, and certificating. This includes (1) assisting regulated individuals and entities in obtaining these important rights, (2) opposing entities who are seeking these rights, and (3) defending adverse actions against regulated individuals and entities, such as revocation, suspension, or the imposition of civil monetary penalties.
Licenses, approvals and authorizations include such things as radio frequency licenses, food and drug authorizations, health plan qualifications, mine plan approvals, mine permits, lifting Applicant Violator System permit blocks, and federal and state pesticide registrations.
When new owners acquire a regulated business or entities merge, we can help the new entity obtain the necessary license transfers and other regulatory approvals. In the energy area, C & M attorneys frequently assist companies seeking to obtain a certificate, as well as aiding competitors, customers or landowners who oppose the grant of a certificate to someone else. We have also provided assistance in drafting licensing laws and commenting on licensing regulations.
Administrative Law/Regulatory - Employee Training
Crowell & Moring attorneys regularly provide seminars and training for client personnel in the fundamental and fine points of a broad range of regulatory frameworks and requirements.
Among the diverse subjects on which we develop and conduct training programs are: antitrust compliance; environmental law; export control compliance requirements; fraud, waste and abuse issues for contractors; hazardous materials transportation requirements for shippers and transporters; health care employee training (including Medicare and Medicaid requirements); health safety and environmental compliance auditing (including self-inspections) and awareness training; mine safety and health law and compliance, including miners' rights and discrimination law; and requirements for retailers under the Consumer Product Safety Act and Flammable Fabrics Act.
Administrative Law/Regulatory - Regulatory Issues Affecting New Technologies
Crowell & Moring lawyers are experienced in dealing with the special regulatory burdens confronting companies that develop emerging technologies or bring the results of new technologies to market. Often, an important first step is helping make sure the regulators and the public understand what the technology is (and what it is not), and what the risks are (and are not). Sometimes the existing regulatory environment just doesn't fit the new technology. At other times, new regulations are developed that simply do not work in practice, however appropriate they seemed in theory. And aside from the substance, the pace of developing new regulations often lags significantly behind the technology, which can create its own set of difficulties.
We represent clients (companies and industry associations) in their interactions with agencies developing new regulatory schemes, and we've helped clients challenge new policies administratively, in court, and before Congress. For example, our Biotech and Intellectual Property practice areas can help clients involved with genetically modified organisms (such as plants, foods, and pharmaceuticals) plan for, and deal with, evolving regulation by the Agriculture Department, Environmental Protection Agency, and Food and Drug Administration, as well as the novel patent issues that arise. Similarly, our Health Care practice area assists clients on HCFA reimbursement issues for new medical technologies, and our Aviation practice area advises clients in FAA certification of new aviation technologies.
The development of new technology and new products is, by itself, difficult and uncertain. For more information on how we help clients minimize the likelihood that the regulatory process will add to the difficulty and uncertainty, please visit one of the practice areas: Aviation, Biotechnology, Health Care and Intellectual Property.
Agencies Before Which Crowell & Moring LLP Lawyers Practice
Administrative & Regulatory
Animal and Plant Health Inspection Service
Board of Land Appeals
Bureau of Export Administration
Bureau of Land Management
Centers for Disease Control and Prevention
Centers for Medicare and Medicaid Services
Department of Agriculture
Department of Defense
Department of Energy
Department of Health and Human Services
Department of Homeland Security
Department of Justice, Antitrust Division
Office of Government Ethics
Department of Labor
Department of State
Department of Transportation
Employment Standards Administration
Federal Aviation Administration
Federal Highway Administration
Federal Motor Carrier Safety Administration
U.S. Fish and Wildlife Service
Food and Drug Administration
Food Safety and Inspection Service
U.S. Forest Service
Immigration and Naturalization Service
U.S. Customs Agency
Medicare Administrative Contractors
Medicare Appeals Council
Mine Safety and Health Administration
Minerals Management Service
National Highway Traffic Safety Administration
National Institutes of Health
National Marine Fisheries Service
National Oceanic and Atmospheric Administration
National Park Service
Natural Resources Conservation Service
Occupational Safety and Health Administration
Office of Aviation Analysis
Office of Aviation Negotiations
Office of Defense Trade Controls
Federal Election Commission
Office of Federal Contract Compliance Programs
Office of Foreign Assets Control
Office of International Aviation
Office of Pipeline Safety
Office of Surface Mining Reclamation and Enforcement
DOT Office of Transportation Policy
Employee Benefits Security Administration
Provider Reimbursement Review Board
Research and Special Programs Administration
U.S. Army Corps of Engineers
United States Customs Service
United States Patent and Trademark Office
Employment Standards Admin. - Wage and Hour Division
National Institute for Occupational Safety and Health
Independent Agencies
Advisory Council on Historic Preservation
Consumer Product Safety Commission
Environmental Protection Agency
Equal Employment Opportunity Commission
Federal Communications Commission
Federal Energy Regulatory Commission
Federal Mine Safety and Health Review Commission
Federal Trade Commission
National Labor Relations Board
Nuclear Regulatory Commission
Occupational Safety and
Health Review Commission
Office of Federal Housing Enterprise Oversight
Office of Personnel Management
Pension Benefit Guarantee
Corporation
Railroad Retirement Board
Securities and Exchange Commission
Executive Office of the President
Council on Environmental Quality
Office of Information and Regulatory Affairs
Office of Science and Technology Policy
Office of the United States Trade Representative
Legislative Branch
Copyright Arbitration Royalty Panels
General Accounting Office
United States Copyright Office
United States House of Representatives
United States Senate
International
Comision Reguladora de Energia, Mexico
European Commission
Office of Fair Trading, United Kingdom
Administrative Law/Regulatory - Responding to Dynamic Business Needs
As clients' needs change, so do Crowell & Moring LLP's responses to those needs. While traditional administrative rulemaking and counseling practice is still of critical importance to clients, regulatory "reinvention," changes in the world economy and the speed with which business is transacted require greater versatility in providing legal services and meeting the competitive needs of clients. C&M attorneys bring a wealth of legal and practical experience in such areas as:
- Transactional counseling, which, for example, has become at least as important for the energy industries as ratemaking
- Counseling in connection with the development of biotechnology products and regulatory efforts to bolster public trust in the new science
- Counseling in the legal implications of introducing new technology, including policy proceedings affecting the application of controls under the Copyright Act
- Assistance in merger/acquisition review, in due diligence review, and in obtaining the necessary regulatory approvals, license transfers, and the like
- Maximizing use of electronic media to obtain and analyze information, to file documents, and to assist clients in working through the regulatory requirements of establishing their own web sites and commencing e-business ventures
- Counseling in connection with global market access, including import/export controls, international standard-setting, and regulatory controls applicable in the European Union.
