By Lara A. Hall, MS, RQAP-GLP, Jane S. Vergnes, Ph.D., DABT®, and Lisa M. Campbell
On Tuesday, August 25, 2015, in a Federal Register notice, the U.S. Environmental Protection Agency (EPA) announced the addition of three Office of Chemical Safety and Pollution Prevention (OCSPP) final test guidelines to its 890 Series, entitled “Endocrine Disruptor Screening Program Test Guidelines,” as follows:
These test guidelines are part of a series of test guidelines established by OCSPP for use in developing data on potentially adverse effects of pesticides and chemical substances on the endocrine system for submission to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408 (21 U.S.C. 346a), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.), and the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601, et seq.). These final guidelines have been revised based on public comments received following the release of draft test guidelines in January 2015, existing EPA test guidelines, and concurrent Organisation for Economic Co-operation and Development (OECD) test guidelines.
EPA worked with OECD to harmonize test guidelines for MEOGRT and LAGDA. The specific OECD Guidelines for the Testing of Chemicals, Section 2, that apply to MEOGRT and LAGDA, are available here. Substantive changes reflected in the final OCSPP MEOGRT and LAGDA test guidelines include:
1. The test will end following hatching of the second generation (F2) offspring. The option for extending the MEOGRT through reproduction by the F2 generation has been removed from the final test guideline pending additional data. This is consistent with the decision made in the draft OECD test guideline for MEOGRT. This test guideline may be updated as new information and data are considered. For example, guidance on extending the F2 generation through reproduction may be potentially useful under certain circumstances (e.g., chemicals with high bioconcentration potential or indications of trans-generational effects in other taxa).
2. The mean water temperature over the duration of the MEOGRT has been changed to 25 ± 2 °C to be consistent with the analogous OECD test guideline.
3. The LAGDA developmental stage terminology has been clarified to avoid confusion with what is meant by complete metamorphosis.
4. An effort was made to clarify and provide more explicit guidance as to what specific histopathology is appropriate based on the results of the study, e.g., the conduct of liver and kidney histopathology in the MEOGRT and LAGDA test guidelines with respect to overt toxicity.
5. The rationale for use of solvent control only, dilution water control only, or pooled controls in the statistical analyses for the MEOGRT and LAGDA was clarified.
6. The guidelines have been modified to address commenters' concerns that they be more flexible and less prescriptive. Examples have been provided as appropriate to add clarity.
The JQTT draft test guideline (OCSPP 890.2100) was revised to address comments provided by the public, the draft OECD test guideline for the avian two-generation toxicity test in the Japanese quail, as well as the existing EPA test guidelines and OECD test guidelines for avian one-generation toxicity tests.
EPA revised the terminology, procedures, endpoints measured, figures, tables, and appendices in the JQTT test guideline to clarify specific points raised by public commenters, and to address commenters' concerns that they be more flexible and less prescriptive, as follows:
1. The revised test guideline includes fewer endpoints. For example, the revisions eliminated behavioral endpoints to reduce the overall numbers of birds required for the study; eliminated endpoints that are difficult to obtain (i.e., hormone levels measured in embryo blood samples); and eliminated redundant endpoints and statistical analyses.
2. For clarity, the test terminates with measurement of the 14-day survival of the F2 generation chicks. This is the minimum length of the study necessary to evaluate and measure a chemical's effect on the first generation’s (F1) reproductive performance. If delayed reproduction is observed in F1 birds, a decision to extend the F2 generation may be made. If extended, the test should be terminated when F2 birds are approximately 6 weeks old, when 90 percent of control animals have reached sexual maturity. The decision to limit the length of the JQTT is consistent with EPA's efforts to move to extended one-generation reproduction test protocols for Tier 2 testing rather than require multigenerational studies. Extended one-generation reproduction tests are scientifically justified in many cases, reduce the use of animals in testing, and reduce costs.
Electronic access to OCSPP test methods and guidelines is available here.
The release of these final testing guidelines marks another significant step in the overall Endocrine Disruptor Screening Program (EDSP), making way for the anticipated Tier 2 testing phase with the List 1 chemicals. EPA recently released Tier 1 weight-of-evidence assessments for List 1 substances in the EDSP and registrants are now receiving the associated data evaluation records (DER) for the Tier 1 screening studies. The purpose of the Tier 1 screening was to identify potential interactions with three hormonal pathways (estrogen, androgen and thyroid) in the endocrine system. As a result of the potential interactions with one or more of these pathways observed, EPA has recommended Tier 2, multigenerational studies across various species for 18 of the 52 List 1 chemicals, including the MEOGRTS (13 chemicals) and LAGDA (5 chemicals). Test Orders for Tier 2 studies will be issued following completion of the Information Collection Request (ICR) process within the Office of Management and Budget (OMB). The public review and comment period for this ICR concludes on September 2, 2015, with a response from OMB to follow in early October 2015. In the interim, registrants are closely reviewing their respective assessments and DERs, and industry groups are assessing the approach employed by EPA in these Tier 1 assessments, including but not limited to, the statistical reanalysis of study data and conclusions drawn by EPA.
By Lisa M. Campbell and Margaret R. Graham
On June 24, 2015, the U.S. Environmental Protection Agency (EPA) issued a notification that the EPA Administrator has forwarded to the Secretary of the United States Department of Agriculture (USDA) and the Secretary of the United States Department of Health and Human Services (HHS) a draft regulatory document concerning the draft final rule entitled ''Pesticides; Revisions to Minimum Risk Exemption.'' This notice states that the draft final rule will not be available to the public until after it has been signed and made available to EPA. Sections 25(a)(2)(B) and 21(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires the EPA Administrator to provide to the Secretary of USDA and the Secretary of HHS a copy of any draft final rule at least 30 days before signing it in final form for publication in the Federal Register; EPA must only provide any draft final rules pertaining to public health pesticides, however, to HHS.
The Spring 2015 Regulatory Agenda stated that EPA is developing the final rule related to revisions it proposed in December 2012: "Specifically, EPA proposed to more clearly describe the active and inert ingredients permitted in products eligible for the exemption from regulation for minimum risk pesticides. These lists would be reorganized by adding specific chemical identifiers that would make it clearer which ingredients are permitted in minimum risk pesticide products. No ingredients would be added or removed from the exemption. The label requirements in the exemption would also be modified to require the use of specific common chemical names in lists of ingredients on minimum risk pesticide product labels, and to require producer contact information on the label. These changes are intended to maintain the availability of minimum risk pesticide products while providing more consistent information for consumers, clearer regulations for producers, and easier identification by states, tribes and EPA as to whether a product is in compliance with the exemption." Further information regarding the proposed rule is available in Bergeson & Campbell, P.C.'s (B&C®) memorandum entitled EPA Proposes Revisions to Minimum Risk Exemption for Pesticides.
By Lisa R. Burchi and Lisa M. Campbell
On June 16, 2015, the California Superior Court for the County of Almeda denied the petition of the Pesticide Action Network North America, et al. (PANNA) for a writ of mandate to direct the California Department of Pesticide Regulation (DPR) to set aside and vacate its final decisions approving amended registrations of Dinotefuran 20SG manufactured by Mitsui Chemicals Agro and Venom manufactured by Valent USA.
The active ingredient in both products at issue, dinotefuran, is a neonicotinoid pesticide that has been subject to additional reviews and labeling requirements with regard to its impact on pollinating bees on the federal and state level. PANNA argued, in part, that under the California Environmental Quality Act (CEQA), DPR should not have approved the amended labels because it had not developed an Environmental Impact Report (EIR) describing the potential environmental impacts, analyzing direct, indirect, and cumulative impacts, and analyzing alternatives.
The court held as a matter of law that “to give effect to CEQA’s current policy goals as developed since 1979 in the Public Resources Code, in the CEQA Guidelines and in case law, that the court must read the DPR’s regulations as requiring that the DPR apply current CEQA analysis in deciding whether to register pesticides.” That does not, however, require DPR to comply with all of CEQA’s documentation requirements; instead, DPR’s environmental documentation is required to “address only those significant adverse environmental effects that can reasonably be expected to occur, directly or indirectly, from implementing the proposal.”
With regard to the standard of review, the court found that DPR’s decision is in the nature of an EIR, which required the court to review the adequacy of the decision for substantial evidence, and not, as PANNA had argued, the functional equivalent of a negative declaration that would have triggered a “fair argument” review standard. The court then found there was substantial evidence in the administrative record supporting DPR’s decision that the proposed mitigation measures will eliminate any significant environmental impact. The court held that the record supported DPR’s assertion that the product labels provide necessary environmental protections, noting, for example, that EPA’s conclusion that the federal labeling is adequate to protect bees is substantial evidence to support DPR’s “identical conclusion.” The court further held that DPR was not required to consider the feasibility of alternatives.
Since the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) preempts a state from imposing label requirements that are different from the U.S. Environmental Protection Agency (EPA)-approved label, the court noted that DPR’s decision was either to register the products consistent with EPA’s approved labels or not register the products for use in California. Although DPR’s failure to conduct a risk-benefit analysis was not argued before the court, the decision, by way of dicta, noted that the “record suggests that the DPR conducted a de facto risk-benefit analysis and did not actually conclude that the labeling on the Insecticides would mitigate all adverse affect on bees.” Instead, the court suggests DPR’s risk-benefit analysis was based on the fact that under FIFRA, the only alternative would be to deny the registrations and that would be infeasible considering economic, social, or other considerations.
The decision is a significant judgment regarding DPR’s ability to make decisions regarding label amendments and the court’s ability to review such decisions. It appears likely an appeal will be filed. It is also important to note that DPR’s reevaluation of neonicotinoids is still pending -- DPR is required under AB 1789 (codified at Food and Agricultural Code Section 12838(a)) to issue a determination before July 1, 2018, regarding the neonicotinoid registrations and to adopt any control measures determined to be necessary to protect pollinator health.
By Lisa R. Burchi
On June 19, 2015, the United States District Court for the District of Columbia granted a motion for default judgment by the Non-Dietary Exposure Task Force (Task Force) and confirmed an arbitration award against an Indian pesticide manufacturer, Tagros Chemicals India, Ltd. (Tagros) (Non-Dietary Exposure Task Force v. Tagros Chems. India Ltd., 2015 BL 195490, D.D.C., 1:15-cv-00132, 6/19/15). The Task Force sued Tagros after Tagros refused to sign a $500,000 settlement agreement negotiated by the parties in the midst of a Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) arbitration proceeding, and continued its refusal to pay after the Task Force successfully moved the arbitrator to issue an award enforcing the settlement agreement. The Court determined it has jurisdiction because FIFRA “confers jurisdiction on the judiciary to enforce [such] arbitration awards” in federal court and Tagros’ participation in the arbitration allowed the court to exercise jurisdiction over Tagros. The Court found that the arbitration award must be confirmed in full absent evidence of fraud, misrepresentation, or other misconduct by one of the parties, and no such allegations were put forth. The Court also granted the Task Force’s motion seeking permission to register this judgment in other district courts based on information that Tagros’ assets were not in the District of Columbia and evidence of assets in other jurisdictions.
This decision adds to a growing number of recent cases where companies have sought judicial enforcement of a FIFRA arbitration award. Judicial judgments enforcing arbitration awards, in addition to judicial authority to register such judgments in districts where assets are available, are tools data owners are increasingly using to obtain the compensation owed.
By Lisa M. Campbell and Lisa R. Burchi
On June 10, 2015, and June 15, 2015, the U.S. Environmental Protection Agency (EPA) held a webinar entitled “eDisclosure: EPA's Plan to Modernize the Implementation of the Audit Policy and the Small Business Compliance Policy.” During the webinar, EPA set forth its plans to release in fall 2015 a centralized online portal called eDisclosure to allow companies to submit self-disclosures electronically under EPA’s Incentives for Self-Policing: Discovery, Disclosure, Correction and Prevention of Violations (Audit Policy) and Small Business Compliance Policy. EPA stated that it is developing eDisclosure in an effort to continue to promote the benefits of self-disclosures, while also saving time and resources by modernizing and streamlining the disclosure procedure.
Companies with potential Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) violations that can satisfy all nine conditions of self-disclosure under the Audit Policy (i.e., systematic discovery; voluntary discovery; prompt disclosure; independent discovery and disclosure; correction and remediation; prevent recurrence; repeat violations are ineligible; certain types of violations are ineligible; and cooperation) are eligible for 100 percent penalty mitigation, while companies that satisfy conditions 2-9 (i.e., all except systematic discovery) are eligible for 75 percent penalty mitigation. A related policy for small businesses (those with 100 or fewer employees) modifies the conditions as further incentives (e.g., 100 percent penalty mitigation even if the discovery is not systematic, with longer compliance timeframes).
FIFRA self-disclosures will fall into Tier 2, under which the eDisclosure system will automatically issue an electronic Acknowledgement Letter (AL) confirming EPA’s receipt of the disclosure, and promising that EPA will make a determination as to eligibility for penalty mitigation if and when it considers taking an enforcement action for environmental violations. There are timeframes set for the submission, and/or potential extension, of compliance reports certifying violations have been corrected.
If an extension is sought for more than 60 days (or within 90 days of submitting an online Small Business Compliance Policy disclosure) past the date of discovery of such violation(s), EPA states that eDisclosure will automatically grant the request, but that EPA could later determine, if and when it considers taking an enforcement action, that the correction was not made promptly and thus this Audit Policy condition is not satisfied.
Companies with potential FIFRA violations can benefit from EPA’s development of eDisclosure, as this is a positive step indicating EPA’s support for and interest in encouraging continued use of its Audit Policy There are several issues that companies will need to review carefully, including Central Data Exchange (CDX) registration, protection of confidential business information, special issues for “new” owners disclosing violations of recently acquired companies, and changing EPA policies regarding its potential disclosure of settled and unsettled Audit Policy cases.
EPA will issue in fall 2015 a Federal Register notice simultaneously with its launch of e-Disclosure to describe the new portal and how EPA plans to implement the Audit Policy and Small Business Compliance Policy. Although there is no formal comment period, stakeholders should consider providing input now while EPA is in the midst of developing eDisclosure.
By Lisa M. Campbell and Jane S. Vergnes, Ph.D.
On June 19, 2015, the U.S. Environmental Protection Agency (EPA) announced a plan for incorporating validated high throughput assays and a computational model into the Endocrine Disruptor Screening Program (EDSP) to screen chemicals for their ability to interact with the endocrine system. These proposed new methods would serve as an alternative for three of the eleven current assays in the EDSP Tier 1 screening battery, specifically the estrogen receptor binding (ER), estrogen receptor transactivation (ERTA), and uterotrophic assays.
These computational high-throughput (HTP) tools will have the potential to impact significantly the prioritization for testing and will have a significant impact on List 2 test orders. EPA states that use of these alternative methods will accelerate the pace of screening, decrease costs, and reduce animal testing. In addition, this approach advances the goal of providing sensitive, specific, quantitative, and efficient screening using alternative test methods to some assays in the Tier 1 battery to protect human health and the environment. EPA has stated its commitment to the development of HTP and computational tools to improve regulatory science, as recommended in the 2007 National Research Council report, “Toxicity Testing in the 21st Century: A Vision and a Strategy,” and to meet its statutory obligations in the face of challenging budget constraints.
Comments are due by August 18, 2015. EPA specifically seeks comment on the following issues, which are related to its stated intention to use the scientific tools discussed as alternatives to some of the current EDSP Tier 1 screening assays:
- The use of the ToxCastTM “ER Model” for bioactivity as an alternative method for the current ER binding and ERTA Tier 1 screening assays.
- The use of the ToxCastTM “ER Model” for bioactivity as an alternative method for the current uterotrophic Tier 1 screening assay.
- The use of results from the ToxCastTM “ER Model” for bioactivity on over 1800 chemicals as partial screening for the estrogen receptor pathway.
EPA concludes that the ToxCastTM “ER Model” meets the criteria for use as “other scientifically relevant information” to satisfy Tier 1 for the ER, ERTA, and uterotrophic assays. EPA’s conclusion is based upon the findings of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) peer review held in December, 2014 that endorsed the ToxCastTM “ER Model” as a replacement for the ER and ERTA assays, and additional data developed by EPA to address the SAP’s concerns regarding the uterotrophic assay. Recipients of EDSP Tier 1 test orders would have three options for addressing the Tier 1 requirements with respect to the three EDSP Tier 1 endpoints that EPA considers validated:
- Cite existing ToxCastTM “ER Model” data, if it is applicable.
- Generate new data using the 18 ER HTP assays and the ToxCastTM “ER Model.”
- Generate Tier 1 data using the validated methods for the ER, ERTA, and uterotrophic endpoints in the traditional EDSP Tier 1.
EPA is careful to note that activity in the ToxCastTM “ER Model” is not a determination that a chemical causes endocrine disruption, only that is has the potential to do so, and that further testing (Tier 2) would be needed to make a determination regarding the ability to cause “adverse effects in an intact organism or its progeny, or subpopulations,” as stated in the World Health Organization International Programme on Chemical Safety definition.
More detailed information on the Endocrine Disruptor Screening Program and its use of computational tools is available at: http://www.epa.gov/endo/ or http://www.epa.gov/endo/pubs/pivot.htm.
By Lynn L. Bergeson and Carla N. Hutton
On May 19, 2015, the U.S. Environmental Protection Agency (EPA) announced that it issued a conditional registration for a nanosilver-containing antimicrobial pesticide product named “NSPW-L30SS,” or “Nanosilva.” This is the second nanosilver registration issued by EPA and reflects the Agency’s growing expertise in addressing, processing, and approving nanopesticide registration applications. According to EPA, the product will be used as a non-food-contact preservative to protect plastics and textiles from odor- and stain-causing bacteria, fungi, mold, and mildew. Items to be treated include household items, electronics, sports gear, hospital equipment, bathroom fixtures, and accessories. EPA based its decision “on its evaluation of the hazard of nanosilver after reviewing exposure data and other information on nanosilver from the applicant, as well as data from the scientific literature.” EPA states that these data show that treated plastics and textiles release “exceedingly small amounts of silver.” Based on this evaluation, EPA “determined that NSPW-L30SS will not cause unreasonable adverse effects on people, including children, or the environment and that it would be beneficial because it will introduce less silver into the environment than competing products.” EPA notes that it is requiring the company “to generate additional data to refine the Agency’s exposure estimates.” According to EPA, it will post a response to comments received on its 2013 proposed registration decision document, as well as the current decision document, in the rulemaking docket.
By Lisa M. Campbell and James V. Aidala
On April 2, 2015, the U.S. Environmental Protection Agency (EPA) sent a letter to all registrants of nitroguanidine neonicotinoid pesticide products stating that “until the data on pollinator health have been received and appropriate risk assessments completed,” EPA is “unlikely to be in a position to determine that such uses would avoid ‘unreasonable adverse effects on the environment’ as required under FFIRA to support further regulatory expansion of these pesticides in outdoor settings.” EPA asks that the affected registrants withdraw or modify pending new outdoor use/expansion and/or pending nitroguanidine neonicotinoid registrations with a new outdoor use by April 30, 2015.
The letter states that the letter recipients are companies that have submitted an application for a new outdoor use and/or hold registrations for products containing imidacloprid, dinotefuran, clothianidin or thiamethoxam that have directions for outdoor application.
Affected neonicotinoid actions include:
* New Uses (including crop group expansion requests);
* Addition of New Use Patterns, such as aerial application;
* Experimental Use Permits; and
* New Special Local Needs Registrations.
The letter does not, however, preclude the approval of “me-too” products -- “products that are identical or substantially similar to existing uses.” In addition, EPA states that if a significant new pest issue should arise that may be uniquely addressed by one of these chemicals, EPA may consider whether an emergency use under FIFRA Section 18 might be appropriate. In the event that an emergency use is requested, EPA plans to assess such requests by relying on available information and risk mitigation strategies.
This new missive from EPA provides yet another example of a recent trend that many registrants believe is of concern, whereby EPA makes a broadly applicable set of regulatory decisions without an associated administrative process. With this approach, EPA summarily issues a letter to a class of registrants with immediate direct affect on their registrations with little or no room for consideration of individual facts, and with little explanation of important risk issues. In this letter, for example, EPA precludes the expansion of new uses, but yet allows the continued processing of “me-too” applications with no explanation from a risk profile of the risk difference that allows one type of product to be processed, but not the other. There are many possible scenarios where a new or expanded use of a product would not present any more risk to pollinators than the me-too product that EPA indicates will be considered.
This one-size-fits-all approach also appears to exclude consideration of any risk reduction potential of the pending applications (for example, when a pending neonic application represents a reduction in worker risk or endangered species when compared to an existing use pattern). Some applications may replace current exposure levels to organophosphate insecticides that EPA has generally sought to reduce. The potential processing of Section 18 exemptions may provide an avenue for such considerations, but the presumption that the pollinator issue a priori makes all other risk elements secondary is a tacit admission of where EPA currently evaluates the potential risk to honeybees in comparison to other possible impacts from pesticide use, including human health risks.
More information on EPA’s efforts to protect pollinators: http://www2.epa.gov/pollinator-protection.
By Lisa M. Campbell and Lisa R. Burchi
On March 1, 2015, the U.S. Environmental Protection Agency (EPA) released the 11th Annual Report on EPA’s implementation of the Pesticide Registration Improvement Extension Act (PRIA 3) that is required under Section 33(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
This annual report details changes in processes, practices, and policies for Fiscal Year (FY) 2014 that ran from October 1, 2013, through September 30, 2014. The report is divided into different sections related to: (1) pesticide registration service fees; (2) maintenance fees; and (3) process improvements in the pesticide program; all of which can be accessed on EPA’s website at the below links. Specifically, the report covers the following topics:
Pesticide Registration Service Fees
* Fees Collected, Waived, Exempted and Expended
o Pesticide Worker Protection
o Partnership Grants
o Progress in Meeting Decision Times
* Fees Collected and Expended
o Expedited Processing FIFRA Section 3(c)(3)(B)
o Pesticide Reevaluation Programs
Process Improvements in the Pesticide Program
* Pesticide Reevaluation Programs
* Information Technology and Labeling
* Science Review/Assessment Improvements
EPA’s report addressing process improvements in the pesticide program discusses several areas where EPA believes its registration programs have improved, either through increased efficiency, consistency, and/or transparency. The areas discussed are:
* EPA’s use of the “Lean” business model to improve business processes;
* Delegation of authority to EPA’s Biopesticides and Pollution Prevention Division (BPPD) to expedite fast track and notification actions to reduce approval times and the number of actions in backlog status;
* Biopesticide Industry Alliance Registration Workshops to improve quality of application submissions;
* Release of testing guidelines to clarify scenarios under which efficacy testing at the lower certified limit is needed;
* Reduction of registered products for which EPA is taking action under the Antimicrobial Testing Program;
* Continued crop grouping regulations to save resources and reduce the number of required residue studies;
* Establishment of a Pre-decisional Determination Due Date to provide adequate time to reach agreement with the registrant on required label changes prior to EPA approving the label; and
* International work sharing to assist in individual country registration decisions while striving to harmonize regulatory decisions with global partners.
With regard to EPA’s review of electronic labels, EPA states the following:
1. Of approximately 6,300 labels submitted to EPA in FY 2014, almost half included an electronic label. Comparing the statistics from FY 2011 to FY 2014 reveals a steady increase of approximately 10 percent each year in the percentage of labels submitted in electronic format.
2. The use of electronic label review software varies significantly across the three regulatory divisions with the Registration Division reporting the highest use, the Antimicrobials Division reporting moderate use, and BPPD the lowest use.
PRIA 3 is effective from October 1, 2013, through September 30, 2017.
March 12, 2015
2:00 p.m. - 3:00 p.m. (EST)
Bergeson & Campbell, P.C. (B&C®) is pleased to host a complimentary webinar on recent compliance and enforcement issues regarding the importation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The U.S. Environmental Protection Agency's (EPA) 2014 revisions to its Notice of Arrival (NOA) form (EPA Form 3540-1), coupled with EPA's increasing scrutiny of pesticide imports, indicate that this is an issue of growing interest to EPA and could result in a rise of enforcement cases or, at a minimum, business disruption for shipments that are refused entry.
Speakers who will be highlighting recent developments and steps for importers to take to ensure compliance and avoid potential enforcement include: Eileen B. Salathé Gernhard, Lead Counsel -- Regulatory and EH&S at Dow AgroSciences, LLC, B&C's Lisa M. Campbell and Lisa R. Burchi, and attorney Jon Jacobs, a 25-year veteran of EPA's Office of Enforcement and Compliance Assurance, now in private practice at Jacobs Stotsky PLLC. There will be 45 minutes of presentation followed by a 15 minute Q&A period.
Please save the date -- registration details will follow.