B&C's Practice

This document describes in more detail below the legal and regulatory advocacy services that Bergeson & Campbell, P.C. (B&C) offers.

B&C’s Practice

B&C is an AV-rated (highest ranking) Washington, D.C. law firm focusing on conventional and nanoscale industrial, agricultural, and specialty chemical product regulation and approval matters, including Toxic Substances Control Act (TSCA) matters, Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)/Food Quality Protection Act (FQPA) matters, U.S. Food and Drug Administration (FDA) medical device and product approval, registration and data compensation arbitrations, chemical product litigation, and associated business counseling and litigation issues.  The breadth of the firm’s substantive expertise in these areas reflects the diversity of our client base, which include many small, medium, and large domestic and foreign chemical manufacturers, industry coalitions, chemical testing consortia, trade associations, medical device manufacturers, research and development testing facilities, and other manufacturing entities.  B&C has extensive experience representing businesses in the conventional and nanoscale basic, specialty, and agricultural and antimicrobial chemicals industry; biotechnology, nanotechnology, and emerging transformative technologies; medical devices and diagnostic products; paints and coatings; plastic products; and chemical manufacturing, formulation, distribution, and consumer product sectors.  By far the largest percentage of our work is on behalf of the chemical industry on chemical-related matters.  A copy of our firm resume is appended.

We offer our clients extensive expertise in federal, state, and international requirements applicable to specific conventional chemicals, products of nanotechnology and biotechnology, and products subject to FDA regulation.  Our goal is to assist our clients in addressing proactively, or otherwise, emerging and existing legal, regulatory, and scientific risk standards that will significantly affect the regulation and marketing of their products, achieving government agency approval of new products and of new uses of existing products, achieving competitive goals by making optimum use of regulatory pathways, and otherwise maintaining their products in the best possible regulatory position.

We are also engaged in the legal, regulatory, and science policy issues associated with nanotechnologies.  We are actively engaged in addressing the implications under TSCA, FIFRA, the Federal Food, Drug, and Cosmetic Act (FFDCA), and related federal laws of nanoscale materials consisting of chemical substances.  We also represent large, medium-sized, and start-up companies engaged in the use of nanotechnologies.  More information on our nanotechnologies practice is found below.

TSCA Experience

B&C has substantial experience in assisting clients on a wide array of issues arising under TSCA, including the regulation of products of nanotechnology and biotechnology.  B&C is a long standing sponsor of the American Chemistry Council/Synthetic Organic Chemical Manufacturers Association Global Chemical Regulations Conference.  All of our attorneys have considerable experience in assisting clients with TSCA policy, regulatory, and litigation matters.  In addition, many of our attorneys and other professionals have scientific and regulatory backgrounds that make them uniquely qualified to address the science-based legal issues that arise under TSCA.

We are pleased that Jim Aidala, former U.S. Environmental Protection Agency (EPA) Assistant Administrator for Toxics under the Clinton Administration, is on our team.  Jim has a technical background, having attended Brown University, Harvard, and MIT before joining the government.  Jim has been intimately involved with TSCA and FIFRA legislative reauthorization and key regulatory matters for over two decades, and offers significant value in addressing chemical policy, legislative, and related issues.

We are also pleased that Charlie Auer is part of our team.  Charlie left EPA in December 2008 as Director of the Office of Pollution Prevention and Toxics and is now affiliated with B&C.  Charlie’s understanding of TSCA, its implementation and interpretation by EPA is unparalleled.

Dr. Joseph Plamondon, who has a Ph.D. in organic chemistry from the University of California at Davis, brings a unique perspective to TSCA issues, as he has spent over 25 years as part of the regulated community at the Rohm and Haas Company and Akzo Nobel.  Dr. Plamondon has had a long and distinguished career, and is well known in the industrial chemical community.  In addition to his work within the chemical industry, he has spent over ten years consulting with chemical companies on a broad range of TSCA issues.  These have included providing strategic preparation and submission of premanufacture notifications (PMN) designed to avoid TSCA Section 5(e) consent orders and other adverse regulations, as well as offering guidance to companies in the determination of whether certain health and safety information is reportable under TSCA Section 8(e).

Additionally, R. David Peveler, with a Ph.D. in organic chemistry, is part of our team.  Dr. Peveler’s many areas of expertise include domestic and Canadian product regulatory compliance, FFDCA food contact and packaging matters, FIFRA product registration and labeling matters, Department of Transportation (DOT) classification and labeling issues, and product safety (Occupational Safety and Health Administration (OSHA) and Workplace Hazardous Materials Information Systems (WHMIS) compliant Material Safety Data Sheets (MSDS) and labels).  Dr. Peveler has served as a consultant to Evonik Degussa Corporation and managed a variety of product regulatory compliance matters under TSCA, FFDCA, and related chemical product laws and regulatory programs with special emphasis on FDA regulations around bulk Active Pharmaceutical Ingredients, including Drug Master Files, Drug Establishment Registrations, Drug Product Listings, labeling, and import requirements.  Prior to his work with Evonik Degussa, Dr. Peveler was a Senior Regulatory Scientist with Chemtura Corporation, where he managed TSCA and Canadian Domestic Substance List (DSL) issues and chemistries, ranging from mineral oils to complex reaction products, a wide variety of FFDCA direct and indirect food contact matters, and DOT classification and training issues.  Previously, Dr. Peveler was Chemtura’s predecessor in interest, Witco Corporation, R&D Group Leader where he directed a group of researchers in a variety of areas involving polymer additives including PVC heat stabilizers and polymeric plasticizers, and antioxidants for polyolefins.

Susan Hunter Youngren, who has a Ph.D. in environmental biology, has more than 18 years of experience in the field of risk assessment, with particular emphasis on exposure assessment.  She has served as the project manager/senior scientist for a diverse range of risk assessments required under FIFRA, including residential, dietary, and microbial exposure assessments; under Proposition 65, including Maximum Allowable Dose Level (MADL) and No Significant Risk Level (NSRL) development; and under the Resource Conservation and Recovery Act (RCRA), including Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA)/RCRA hazardous waste site assessment.  Dr. Youngren is well versed in the preparation of individual, aggregate, and cumulative residential and consumer product exposure assessments using deterministic and Monte Carlo techniques.  Dr. Youngren has managed and conducted numerous residential and occupational exposure assessments and is well suited to assist clients before EPA when exposure issues are raised in the context of PMN reviews.

B&C’s TSCA experience includes:

  • TSCA compliance audits, assessing compliance with all TSCA provisions;
  • TSCA’s application to nanoscale materials;
  • Section 4 test rules and related Organization for Economic Cooperation and Development (OECD), EPA, and Interagency Testing Committee (ITC) testing issues;
  • Negotiating TSCA Enforcement Consent Agreements (ECA);
  • Managing data development under voluntary programs, including the High Production Volume (HPV) Chemical Challenge Program, Extended HPV Program, Voluntary Children’s Chemical Evaluation Program (VCCEP), and International Council of Chemical Associations (ICCA) testing programs, including testing coalition formation and representation;
  • Sections 8(a), (d), and (e) recordkeeping and reporting requirements, Standard Operating Procedures (SOP), and systems development issues;
  • PMN/Microbial Commercial Activity Notice (MCAN) requirements;
  • PMN requirements pertinent to products of nanotechnology and engineered nanoscale materials;
  • Section 5 Significant New Use Rules (SNUR);
  • Section 6 chemical restrictions, including bans;
  • Export issues;
  • Inventory issues;
  • Polychlorinated biphenyl (PCB) issues;
  • Approval and regulation of products enabled by nanotechnology and biotechnology; and
  • Defense advocacy.

We also often work closely with clients on ensuring that their facilities have the expertise and tools necessary to avoid TSCA compliance problems.  We prepare TSCA compliance manuals and SOPs, and regularly conduct in-house TSCA training seminars.

In addition, we work on many chemical-specific issues that cut across EPA programs.  For example, we are now representing manufacturers of several chemicals in connection with EPA’s notices announcing the Integrated Risk Information System (IRIS) review of certain chemicals.  Both cancer and non-cancer endpoints are being assessed.

Nanotechnologies Practice

B&C works with its individual and trade association clients on emerging nanotechnologies issues, many of which are relevant to, or dependent for their resolution on, nomenclature and terminology.  Most recently, Lynn Bergeson served on the Steering Committee of the OECD’s Conference on Potential Environmental Benefits of Nanotechnology:  Fostering Safe Innovation-Led Growth, presented in Paris, France on July 15-17, 2009.  Ms. Bergeson presented remarks at the plenary session and organized and moderated a panel discussion on agriculture and nanotechnology.  Ms. Bergeson served on the President’s Council of Advisors on Science and Technology (PCAST) Nanotechnology Technical Advisory Group (PCAST nTAG), and also served on EPA’s Steering Committee for the Pollution Prevention Through Nanotechnology Conference.  Ms. Bergeson served in 2004 and 2005 on the American National Standards Institute (ANSI) Nanotechnology Standards Panel (NSP) Steering Committee and is a member of the ISO Technical Committee 229 on Nanotechnologies.

Issues that we are often asked to explore involve assessing the opportunities for exposure to engineered nanoparticles in occupational settings, assisting in the characterization of risk, and assessing the potential application of existing chemical regulatory laws and regulations to engineered nanoscale materials and nanostructures to ensure legal compliance and effective risk communication.  These issues arise in the context of how products of nanotechnologies fit within the existing regulatory framework governing the production and importation of industrial chemicals and/or products (industrial and consumer) containing these chemicals and potential human and environmental exposure to them.  Examples include:

  • TSCA -- whether an existing Inventory listing includes a nanoscale material, or whether it is a new chemical substance, and the resulting regulatory issues flowing from those determinations.
  • Clean Air Act (CAA) -- particulate matter issues (coarse/fine/ultrafine) and issues pertaining to emissions generated by fuel additives using micro particles of atypical metals that are added to diesel fuel for on-road use under CAA Section 211.
  • RCRA -- whether conventional waste disposal practices are adequate to protect against the release of engineered nanoscale materials into the environment.
  • Workplace Standards -- as they might govern, for example, potential respiratory irritation posed by nanotechnologies products manufacturing.
  • Workplace Hazard Communication -- including labeling, notification, and MSDS preparation.
  • Food Safety and Related Food Packaging Approval Issues.
  • Medical Device Approval Issues.

FIFRA Experience

B&C has substantial experience in FIFRA regulatory and business matters.  B&C works closely with our consulting affiliate, The Acta Group, L.L.C. (Acta), on product registration issues.  Both B&C and Acta represent large, medium, and small agricultural chemical and non-agricultural biocide producers on a broad range of FIFRA regulatory compliance and data compensation issues, and related business issues.  In addition, we represent several pesticide producer task forces and are thoroughly familiar with the legal and business issues that arise in such coalitions.  More information on Acta is noted below.

B&C professionals have substantial experience in the developing law, regulation, and policy of antimicrobial products.  Tim Backstrom, for example, worked for years with EPA’s Office of General Counsel in the toxics area working extensively under FIFRA and CAA, particularly with fuel additive issues.  As noted above, Jim Aidala was Assistant Administrator of EPA’s Toxics Office and worked extensively with FIFRA issues.  We routinely counsel companies on how best to promote their antimicrobial products in ways that maximize marketing opportunities without running afoul of the often shifting regulatory requirements EPA and FDA impose.  In this regard, we have assisted many clients in addressing legal issues affecting product marketing under EPA’s reinterpretation of the treated article exemption from pesticide regulation and in obtaining EPA approval of expanded claims for their products.

We routinely advise clients on a full range of FIFRA issues.  Other areas in which we practice include:

  • FQPA implementation issues;
  • Data compensation rights;
  • Experimental use permits (EUP);
  • Tolerance revocation, maintenance, and establishment proceedings, including those relating to import tolerances;
  • Reregistration Eligibility Decision (RED) documents;
  • Cancer and related risk issues;
  • EPA/FDA dual jurisdiction issues;
  • Section 25(b) matters;
  • Pesticide Registration Improvement Renewal Act (PRIA 2) matters;
  • Antimicrobial pesticides;
  • Biochemical and microbial pesticides;
  • FIFRA enforcement policy issues;
  • Section 6(a)(2) notice requirements;
  • Supplemental registrations;
  • The formulators’ exemption;
  • Data requirements;
  • Reregistration;
  • Joint data development agreements;
  • FIFRA compliance obligations;
  • Task force agreements; and
  • California registration regulations.

Additionally, B&C attorneys have substantial experience in representing basic data owners and follow-on, generic registrants in addressing all aspects of FIFRA data compensation matters.  We assist clients in developing strategies to minimize data compensation and represent clients in data compensation negotiations and arbitration proceedings.

B&C represented a data owner in its successful effort to recover data compensation in an arbitration proceeding that involved landmark issues for data owners.  Our client prevailed on the major issues on which a data owner must carry its burden of proof.  The arbitrators found that our client’s actual external costs of conducting the studies were accurate and allocated internal management costs equal to those that our client claimed.  In addition, the panel awarded our client its claimed adjustment of the costs to reflect the cost of capital calculated at the prime rate of interest.  The panel allocated these costs between the parties on an equal sharing basis, with some modest adjustment for the time required for the respondents to become an equal competitor in the marketplace.  Moreover, the panel awarded our client a significant "risk premium" for the commercial and regulatory risks that it assumed in developing its data.

We have substantial experience in defending products in proceedings that involve, for example, Notices of Intent to Suspend, cancellations, and special reviews, among others.  In addition, we have worked on many FIFRA enforcement matters, which have involved labeling, export/import, EUPs, and other issues.  This work has included related negotiations of supplemental environmental projects (SEP) included in enforcement agreements.

Global Product Stewardship Experience

We routinely advise clients on all aspects of product stewardship, on a state, national, and global basis.  Product stewardship issues are increasingly a significant and critical component of any successful product defense or approval strategy.  Issues on which we assisted clients include designing and implementing appropriate chemical notification compliance strategies; designing training programs, including requirements for customer certifications before product sales are permitted; labeling issues, including advising and helping to create labeling language that minimizes the potential for misuse; ensuring that appropriate recognition for stewardship efforts is received from relevant government agencies; and providing related regulatory counseling on all aspects of product stewardship concerns, including the development of policies and procedures that maximize product stewardship goals and regulatory compliance concerns, and assisting with required reporting and disclosure issues that may arise as a result of stewardship activities.

Endocrine Experience

We conduct advocacy on behalf of many clients on endocrine disruptor issues.  EPA has issued over 700 testing orders since October 2009 and how recipients respond to such orders is critically important for FIFRA and TSCA compliance purposes.  It is essential that chemical producers, as well as manufacturers of products that contain chemicals believed to pose endocrine effects, respond effectively to these testing orders and continue to monitor and participate in all EPA and related global endocrine disruptor initiatives.

Air Experience

B&C assists clients with a host of different, but complementary, federal CAA and state air law issues, as well as litigation concerning air issues.  Our significant representation of general and specialty chemical producers has enabled us to work closely with toxicologists, biostatisticians, and epidemiologists in other, more specialized areas of air regulation.  These include the following:

  • On behalf of various chemical consortia, we work to persuade EPA’s Air and Toxics Offices to reconsider their decision to propose a TSCA Section 4 test rule for hazardous air pollutants (HAP).
  • We are actively with fuel additive manufacturers to ensure their products are registered in accordance with CAA Section 211.  These efforts involve the resolution of technical issues for the Tier 1 testing required for fuel additive manufacturer notifications, and legal issues pertaining to the obligation to update registration materials when slight changes are made to the registered additive.  We also assist with data generation issues that often arise in connection with Section 211 registration issues.
  • We have commented on many rulemaking proposals and other EPA initiatives under CAA Section 112, including Sections 112(r) (accidental releases), 112(g) (modifications), and 112(i)(5) (early reduction) for various coalitions of organic and inorganic chemical producers.  We have also advised clients on a variety of matters relating to the listing and delisting of chemical substances and the delisting of source categories under Section 112.
  • We routinely render advice for clients on prevention of significant deterioration (PSD) regulations and federal regulations aimed at protecting the stratospheric ozone layer.
  • We counsel clients on EPA’s risk management program (RMP) provisions under CAA Section 112(r).
  • We routinely counsel clients in the development of National Emissions Standards for Hazardous Air Pollutants (NESHAP) and residual risk issues.

B&C additionally represents businesses on a full range of Title V issues.  We also routinely represent clients in enforcement proceedings arising under federal and state air laws.

EPCRA Experience

B&C has extensive experience in counseling clients on regulatory and enforcement matters under the Emergency Planning and Community Right-to-Know Act (EPCRA).  B&C’s representations included the following projects:

  • B&C has prepared several petitions to delist chemicals from the EPCRA Section 313 toxic chemicals list and has assisted clients in conducting advocacy efforts relating to other pending delisting petitions.
  • B&C has worked with many clients in defending EPCRA enforcement actions.  These actions have addressed issues such as the definition of an "article" and the alleged failure of industrial entities to file required Form R reporting reports.
  • B&C is counsel of record to a consortium that is seeking to persuade EPA not to lift the administrative stay to EPCRA Section 313 reporting with respect to hydrogen sulfide, imposed in August 1994.

RCRA/CERCLA Experience

B&C has significant experience in all aspects of the federal RCRA and CERCLA programs.  Under RCRA, we routinely counsel clients on waste classification issues and newer aspects of the RCRA program, including the land disposal restrictions and corrective action programs.  With respect to waste classification issues, for example, B&C counseled the Dithiocarbamate Task Force, which won its challenge to the carbamate listing rule before the United States Court of Appeals for the District of Columbia Circuit.  The appeal raised novel questions relating to EPA’s then newly announced waste listing determination policy.  B&C assisted the Task Force in persuading the court to vacate 28 of 29 waste listing determinations, based on the court’s conclusion that EPA failed to satisfy the Administrative Procedure Act.  Dithiocarbamate Task Force v. EPA, 98 F.3d 1394 (D.C. Cir. 1996).

We also counsel clients on state RCRA analog programs, including those in California, New York, New Jersey, Florida, and many other states.  Because RCRA is a mature program, we do not further detail here the many types of RCRA issues in which B&C has experience.  We would be pleased to respond to questions upon request.

B&C’s CERCLA experience is similarly substantial.  B&C routinely serves as counsel to clients across the nation with regard to their liability at CERCLA sites and their disputes with the government and other potentially responsible parties relating to those sites.  B&C also coordinates CERCLA litigation conducted by local firms for a number of its clients that have ongoing CERCLA matters in many different states.

Water Experience

B&C has extensive experience in Clean Water Act (CWA) and Safe Drinking Water Act (SDWA) matters, both in the counseling and enforcement areas.  Like the RCRA program, the CWA/SDWA programs are mature and we do not detail here our experience with these matters, but would be pleased to do so upon request.

NTP Experience

B&C has significant experience in counseling clients and conducting advocacy initiatives with the National Toxicology Program (NTP).  B&C represents a number of companies and trade organizations that have disputed, or are in the process of disputing, the findings of an NTP study.  Our assistance in this regard has consisted of marshaling the technical resources necessary to launch a full-scale attack of the findings, drafting the advocacy documents necessary to support such an effort, and representing our clients in discussions with NTP staff.  All too often, chemical manufacturers and producers of products sold to the public are unaware of NTP’s research initiatives involving critical compounds and the effects that adverse cancer bioassays have on the marketability of chemicals that are the subject of NTP review.

We work closely with companies and chemical testing consortia to ensure that NTP’s selection of chemicals, protocols used once a chemical has been nominated for chemical testing, and the technical conclusions and inferences drawn from the test results are presented in a fair and technically defensible way.  B&C offers clients an NTP tracking system that advises clients of the status of NTP’s chemical testing initiatives with respect to particular chemical compounds.  This tracking system allows companies an opportunity to participate proactively in the chemical testing process.  Doing so helps blunt the possibility for erroneous test results, and hence minimizes the possibility that ill-conceived conclusions will be drawn with respect to test chemicals.

One notable success in this area relates to the NTP Board of Scientific Counselors’ Report on Carcinogens Subcommittee 2002 decision that diethanolamine (DEA) not be added to the 11th Report on Carcinogens.  B&C assisted the manufacturers of DEA in their advocacy before NTP.

We also assist clients on NTP matters before the Center for the Evaluation of Risks to Human Reproduction (CERHR).  We represented the producers of ethylene glycol in the NTP-CERHR Expert Panel review of ethylene glycol.  The CERHR has since determined that ethylene glycol was of "minimal concern" by NTP-CERHR for human reproduction and developmental toxicity.

Occupational Safety and Health Experience

B&C routinely counsels clients on a wide variety of matters under the Occupational Safety and Health Act (OSH Act).  B&C’s representations have included the following projects:

  • B&C assisted manufacturers of titanium dioxide (pigment grade) with developing the National Institute for Occupational Safety and Health (NIOSH) Comprehensive Intelligence Bulletin (CIB) on Titanium Dioxide.  B&C is also working with other clients in identifying occupational and safety workplace practices intended to mitigate potential risks posed by engineered nanoscale materials in occupational settings.
  • B&C is assisting, or has assisted, several chemical consortia in the development of American Conference on Governmental Industrial Hygienists’ threshold limit values (TLV) applicable to, among other chemicals, carbon disulfide, hydrogen sulfide, phenol, ethylene glycol, and certain nickel compounds.
  • We have assisted the producers of DEA and triethanolamine (TEA), chemicals found in metalworking/machining fluids, in OSHA’s review of the permissible exposure limit (PEL) for oil mists.  We also assisted the producers of DEA and TEA in challenging NTP’s findings with respect to DEA’s and TEA’s carcinogenicity, as both OSHA and NIOSH are relying upon these findings in reviewing the PEL.
  • B&C assisted the producers/users of carbon disulfide in challenging the final air contaminant standard (PEL) for carbon disulfide promulgated in 1989.  We are assisting the producers of several chemical manufacturers in addressing the PEL update initiative.
  • B&C is defending, or has defended, companies in enforcement actions brought by federal and state OSHA offices, including, among others, Alabama, California, Maryland, New York, Indiana, and Tennessee.  These actions have been based on allegations of noncompliance with, among other provisions, health and safety standards, the general duty clause, and Section 11(c) (whistle blower provision).

FDA Experience

We represent a variety of medical and chemical companies that develop and market products regulated under the FFDCA.

  • We assist companies in bringing food-contact substances (FCS) and food packaging materials to market.  We provide advice regarding the possible pathways to marketing without the requirement of a filing to the Center for Food Safety and Applied Nutrition (CFSAN), and if those avenues are not open, we assist with the preparation and prosecution of Food Contact Notifications (FCN).  In that regard, we arrange and participate in pre-submission conferences intended to refine and limit data requirements.  We review draft notifications for sufficiency, and we assist with the answers to questions CFSAN poses.
  • We consult with companies and individuals regarding the steps necessary to bring medical devices to market, and how to manage the difficult issue of the regulation of drug-device combination products.  As with the food packaging practice, we assist in picking the appropriate pathway to approval or concurrence to market, review draft submissions, and help move them through the channels at the Center for Devices and Radiological Health (CDRH).
  • We also represent clients in many types of compliance proceedings involving the FFDCA.  B&C helps resolve disputes during factory inspections and helps prepare responses to Warning Letters and letters alleging violations regarding promotion, particularly claims of promoting off-label uses.  We meet with the compliance officers at all the Centers to resolve compliance issues, and assist clients in designing and implementing corrective action plans to resolve outstanding compliance issues.
  • We advise clients on cosmetic issues, including:
    • Preparation, review, and defense of label and advertising claims;
    • Defending cosmetic ingredient use in challenges involving the toxicological properties of chemical substances used as ingredients; and
    • Counseling clients on all matters involving enforcement and compliance sensitivities.

We additionally assist many clients in navigating the often murky jurisdictional divide between EPA and FDA concerning chemicals used in one or more pesticidal, food additive, and medical device applications, particularly with regard to the regulation of antimicrobial claims.

FDA-EPA Jurisdictional Questions

Many of B&C’s legal and scientific professionals are highly skilled in various aspects of chemical and product-specific regulatory and enforcement-related activities invited by the joint regulation of some products, like certain antimicrobials, by EPA and FDA.   Some of the issues we address include the following:

  • Materials Used in Applications Making Contact with Food Surfaces -- This is a challenging area, particularly when the substance in question is an antimicrobial regulated by FIFRA that is added to the product in question as a materials preservative. Such an application raises thorny questions of FDA/EPA jurisdiction.  The extensive experience of B&C legal professionals in dealing with FIFRA issues before EPA is available to augment the FDA professionals in addressing these matters efficiently and effectively.
  • Antimicrobials Added to Drug or Device Products -- B&C’s multidisciplinary team of experts is well versed in addressing approval and/or registration issues, concerns about the possibility of antimicrobial resistance, and the affect this and other complex issues may have on approvals.  In addition, B&C professionals have considerable experience in navigating the complicated nature of substantiating antimicrobial claims in accord with FDA and the Federal Trade Commission (FTC) standards.

Food Contact Notification Experience

B&C professionals have extensive experience assisting clients in obtaining appropriate authority to market FCSs.  An FCS is "any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have a technical effect in such food."

The FCN process replaces, in most instances, the time consuming and expensive petition process for authorizing new uses of food additives that are FCS.  B&C professionals, which include in-house polymer chemists and other scientists, assist clients in determining whether an FCN should be filed and how best to prepare the submission to FDA’s CFSAN.

There are several situations where a proposed use does not meet the definition of an FCS, where CFSAN does not regard a substance in use as an FCS, or where the proposed use is exempted.  B&C routinely assists clients in analyzing, preparing, and defending an appropriate regulatory pathway for such substances, including determining the product is Generally Recognized as Safe (GRAS) or exempted on the basis of the fact that any migration is below the Threshold of Regulation (TOR).

If submission of an FCN is necessary, B&C scientists and attorneys help clients determine the needed testing and assist in the preparation of a draft document to facilitate a Pre-Notification Consultation (PNC) with CFSAN.

Medical Device Experience

B&C professionals are also highly experienced in the area of medical device law.  We assist clients on a wide range of areas, including:

  • Determination of the regulatory status of the proposed product;
  • Preparation of the necessary application when one is required;
  • Following the application through the system and assisting the client in responding to questions raised by reviewers;
  • Organizing and attending meetings with FDA and the client when appropriate;
  • Implementing Good Manufacturing Practice (GMP) systems, focusing on complaint handling systems and on regulations regarding device adverse experience reporting;
  • Compliance with the quality systems regulations, and requirements applicable to promotion, with a focus on issues relating to alleged off-label use; and
  • Defending medical device products before FDA in all compliance matters, including product recall, FDA inspection practices and related compliance and enforcement sensitivities.

Drug Approval, Marketing, and Compliance Experience

B&C’s professionals have extensive experience in counseling clients with products regulated by FDA as prescription or over-the-counter (OTC) drugs.  Representative issues handled by B&C’s attorneys include:

  • Advising clients on development of claims, labeling, and promotional materials, including websites, social networking, and clinical medical education (CME);
  • Managing compliance risks and promotional violations, including FDA inspections, responding to deficiencies and warning letters, conducting recalls, and coordinating press and media relations;
  • Developing corporate policy and training client personnel on promotion, CME, direct sales, and other compliance matters;
  • Counseling clients on life-cycle management strategies using patent and non-patent (Hatch-Waxman) options, including seeking orphan drug designation;
  • Petitioning FDA on a variety of issues;
  • Conducting due diligence and offering regulatory opinions in connection with financing and corporate transactions;
  • Guiding clients with food, dietary supplement, and cosmetic products to market through appropriate regulatory pathways; and
  • Representing clients before other agencies, including the Consumer Product Safety Commission and the FTC, for products with multi-jurisdictional issues.

International Experience

In addition to traditional environmental counseling, B&C has developed a strong international practice.  In addition to representing foreign entities with U.S. regulatory matters, our consulting affiliate, Acta, opened an office in Manchester, U.K., The Acta Group EU, Ltd (Acta EU), in 2004.  Acta EU is actively engaged in product registration matters in the European Union (EU) and elsewhere.  B&C is actively involved in monitoring and advocacy activities before the regulating bodies formed under the United Nations Environmental Programme (UNEP), agencies of EU member states, and the OECD, and is significantly engaged in Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) issues.  B&C offers a variety of services relating to REACH, which entered into force on June 1, 2007.  These services include acting as "Only Representative" under REACH for entities that do not have a legal entity in EU countries, providing up-to-date information regarding the rapidly changing REACH implementation plan, and responding to company-specific issues.

China represents another international venue of increasing importance to companies wishing to do business there.  B&C’s consulting affiliates, Acta and Acta EU, entered into strategic alliances with several entities that offer unique expertise in Chinese chemical registration matters and access to testing facilities located in China.  These affiliations enable Acta to offer unique services that enable us to assess whether a particular chemical substance or mixture must be registered in China and, if so, how to accomplish the registration.  We also have significant abilities to access modern testing laboratories in China, which not only meet Chinese requirements, but which provide alternative Good Laboratory Practice testing at a competitive cost for other purposes, such as those required under REACH.

B&C also has considerable expertise with Canada’s New Substance Notification (NSN) regulations, including major changes implemented in October 2005.  Drs. Joseph Plamondon and David Peveler have significant experience with the Canadian system, which is somewhat different than that of the U.S. under TSCA, and understanding these subtle differences is critical to conduct business there effectively.

B&C counsels clients on legal issues arising in connection with the formation of international joint ventures formed to test the toxicology of chemicals, particularly in the pesticide and biocide areas.  Our work has required us to become familiar with other countries’ regulatory agencies and registration requirements.  Our consulting affiliate, Acta EU, offers more robust regulatory services in the U.K. and EU.

B&C’s Consulting Affiliates The Acta Group, L.L.C. and The Acta Group EU, Ltd

B&C’s consulting affiliates, Acta and Acta EU, were established to control the spiraling costs and inefficiencies encountered by clients seeking approvals to market chemicals and medical device products.  Acta and Acta EU manage products from concept to approval, utilizing the skills and experience of professionals who have worked in the specific product areas in government and industry.  Acta and Acta EU professionals represent the following disciplines:  regulatory affairs, toxicology, and government affairs.  Acta and Acta EU professionals have experience in regulations affecting chemical product notifications and approvals under North American (USA, Canada, and Mexico), EU, South American, Asian, and Pacific Rim regulatory programs.  They regularly track significant legislative, administrative, and scientific initiatives that relate to the business of clients marketing chemicals and medical products for multiple uses.  Attached is a more specific breakdown of the jurisdictions and substantive areas we address.

The experience and expertise of Acta and Acta EU professionals cover a wide range of chemicals and products, including pesticides; industrial and specialty chemicals regulated under TSCA; products of nanotechnology and biotechnology; EPA/FDA-regulated products; and medical devices.  Acta and Acta EU concentrate on obtaining and maintaining product approvals and overcoming impediments to the successful and profitable marketing of approved products.  The multi-disciplinary skills possessed by members of Acta and Acta EU are essential to a cost-effective and timely product approval project.  Today’s regulatory approvals hinge on the utilization of multiple sources of information, resources, and skills.  Acta and Acta EU offer a complete line of services intended to take a product or product concept to the point of its commercial marketing, to protect the market position of new and existing products, and to maintain products once they are approved.

B&C’s Consortia Management Affiliate B&C Consortia Management, L.L.C.

B&C Consortia Management, L.L.C. (BCCM) provides core support services for industrial, agricultural, and biocide chemical advocacy, testing, and research consortia.  BCCM provides a full compliment of consortia management services, including consortia formation, full financial services managed by a C.P.A., organizational support, administration services, and infrastructure/communication platforms to ensure consortium participants have secure access to consortia documents and operations wherever they may happen to be located.  BCCM also provides effective and efficient laboratory communication and management services for consortia that expend significant resources on study data production.

BCCM structures and manages its consortia to conform with the realities of the industrial and agricultural chemical business communities, and offers a variety of state-of-the-art actual and/or virtual electronic platforms or a combination of the two to ensure consortia participants have a business organizational model that allows seamless access to and communication with the consortia and its business affairs.  These services free time for consortium members to focus on substantive issues, thus helping to ensure the consortium’s interests are protected and its voice heard on a wide range of domestic and international regulatory, scientific, legal, and related issues.