APHIS Proposes Revised Regulatory Framework Regarding the Movement of Certain Genetically Engineered Organisms

Bergeson & Campbell, P.C.
Contact

Bergeson & Campbell, P.C.

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a proposed rule on June 6, 2019, on the movement of certain genetically engineered (GE) organisms. 84 Fed. Reg. 26514. The proposed rule would revise the regulations regarding the movement, including the importation, interstate movement, and environmental release of certain GE organisms in response to advances in genetic engineering and APHIS’ understanding of the plant pest risk posed by them, “thereby reducing regulatory burden for developers of organisms that are unlikely to pose plant pest risks.” APHIS notes that the proposed rule “would mark the first comprehensive revision of the regulations since they were established in 1987.” It would provide “a clear, predictable, and efficient regulatory pathway for innovators, facilitating the development of new and novel [GE] organisms that are unlikely to pose plant pest risks.” Comments on the proposed rule are due by August 5, 2019.

Overview of the New APHIS Regulatory Framework

APHIS proposes to revise the regulations in accordance with a new regulatory framework that APHIS believes will provide a “clear, predictable, and efficient regulatory pathway for innovators while facilitating the development of new and novel GE plants that are unlikely to pose a plant pest risk.” Interestingly, the approach contemplated is guided by the “the principles: Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient, or SECURE for short,” according to USDA Undersecretary for Marketing and Regulatory Programs Greg Ibach. As its name suggests, the goal is to modernize the regulations to ensure safety while promoting innovation. APHIS states that it anticipates that adopting the new framework will result in significant savings for developers of GE organisms.

The revised regulatory framework would reflect the Secretary of Agriculture’s March 28, 2018, statement that provided clarification on USDA’s oversight of plants produced through plant breeding innovations. According to APHIS, the proposed framework is also consistent with the UDSA Office of Inspector General’s (OIG) recommendations, the 2008 Farm Bill requirements, and with the guiding principle of the Coordinated Framework that “[i‌]n order to ensure that limited Federal oversight resources are applied where they will accomplish the greatest net beneficial protection of public health and the environment, oversight will be exercised only where the risk posed by the introduction is unreasonable.”

APHIS' new regulatory approach is intended to prepare it for future advances in the genetic modification of plants. APHIS notes that for convenience it sometimes refers to plant varieties produced with innovative techniques that could otherwise have been achieved using methods of traditional plant breeding as “plant breeding innovations.” Where genetic modifications are similar in kind to those modifications made through traditional breeding, APHIS states that the plant pest risks should also be similar. These types of plants are equivalent to those that have a well recognized history of safe use and would be exempted from the proposed regulation. On the other hand, genetic modifications made in the future may result in increasingly complex products that, in turn, may pose new types of risks with which APHIS has less familiarity. Based on this conceptual divide, the proposal establishes a bifurcated regulatory approach, imposing on more complex future genetic modifications the regulatory review contemplated under the proposed regulations. Once products are reviewed by APHIS and found unlikely to pose a plant pest risk, similar products would be exempt from further review.

APHIS states that its approach for GE organisms is consistent with the 2017 National Academy of Sciences (NAS) Preparing for Future Products of Biotechnology report, which stated that regulation should take into account familiarity. The report noted that unfamiliar products, and those that may be developed in the future, may have few or no comparators with existing products within the regulatory system. Such products, therefore, would require more regulatory oversight than familiar products until enough is known about the new products to enable APHIS to assess accurately the plant pest risks associated with them. By focusing regulatory resources and risk analyses on unfamiliar products, APHIS states that it will be able to avoid conducting repetitive analyses, use its staff time more efficiently, and provide better stewardship of taxpayer dollars.

Key Features of the Proposed Rule

APHIS notes that the approach it is proposing would differ from the current regulatory framework in that regulatory efforts would focus on the properties of the GE organism itself rather than on the method used to produce it. This approach is consistent with other agency approaches, including the U.S. Environmental Protection Agency’s (EPA) review of nanoscale materials. As EPA noted in its January 12, 2017, Section 8(a) Toxic Substances Control Act (TSCA) rule for certain nanoscale materials, EPA did not base the requirements of the rule on an assumption that nanoscale materials as a class are likely to cause harm. Rather, EPA bases its evaluation “on the specific nanoscale material's own properties and those of any structural analogs.” APHIS “believe[s] that this new approach, which reflects [its] current knowledge of the field of biotechnology, would enable [it] to evaluate GE organisms for plant pest risk with greater precision than the current approach allows.” GE organisms that are determined to pose a plant pest risk would fall within the scope of the proposed regulations and require permits for movement. APHIS would define plant pest risk as “[t]he possibility of harm resulting from introducing, disseminating, or exacerbating the impact of a plant pest.”

APHIS will continue to regulate GE organisms that are in and of themselves plant pests, as well as other GE non-plant organisms that pose plant pest risks. Such organisms would require permits for movement. Other GE non-plant organisms that do not pose a plant pest risk would not fall under the scope of the regulations and therefore would not require permits for movement.

Under the current system, when making decisions regarding regulatory oversight of GE plants, APHIS assesses each transformation event (also sometimes referred to as the individual transformed line, transgenic line, or GE line) separately, even though the inserted genetic material may be identical or very similar to transformation events already assessed. This has sometimes been referred to as an “event-by-event” approach.

Under the proposed rule, developers would have the option of requesting a permit or a regulatory status review of a GE plant that has not been previously reviewed and determined to be nonregulated. APHIS would base decisions on regulatory status on its assessment of plant pest risk. If movement of a GE plant, by which APHIS means its importation, interstate movement, or environmental release, is found to be unlikely to pose a plant pest risk, APHIS would not have authority under the Plant Protection Act (PPA) to regulate the plant in accordance with 7 C.F.R Part 340. If APHIS is unable to reach such a finding, it would regulate the subject plant, which would be allowed to move only under permit.

Under Section 340.1(b) of the proposed rule, certain categories of modified plants would be exempted from the regulations in Part 340 because they could be produced through traditional breeding techniques and thus are unlikely to pose a greater plant pest risk than traditionally bred crops, which APHIS has historically not regulated. APHIS states that these products of biotechnology are likely to pose no greater plant pest risk than their traditionally bred comparators. APHIS restricts these exemptions to plants “because the long history of plant breeding gives us extensive experience in safely managing associated plant pest risks.”

Proposed Section 340.1(c) would exempt GE plants with plant-trait-mechanism of action (MOA) combinations that APHIS has already evaluated by conducting a regulatory status review and found to be unlikely to pose a plant pest risk. MOA refers to the biochemical basis for the new trait. The results of all completed regulatory status reviews would be publicly accessible on the APHIS website.

Under the proposed new regulatory framework, a developer would have the option to make a self-determination as to whether his or her GE plant belongs to one of the categories listed under Section 340.1(b) or (c) and is therefore exempt from the regulations. A developer who determines that his or her GE plant belongs to an exempted category would have the option under proposed Section 340.1(d), to request written confirmation from APHIS that the self-determination is valid. According to APHIS, “[t]hese confirmation letters, which would provide a clear and succinct statement about the regulatory applicability of the GE plant and the nexus to plant health, may be useful to developers wishing to market their products domestically or overseas by allowing them to provide verification to an importing country or other party that APHIS concurs with their self-determinations.” APHIS states that it “anticipates a timely turnaround time” in preparing and providing these confirmation letters to developers. Allowing for self-determinations would provide developers with regulatory relief and open more efficient and predictable pathways for innovators to get new modified plants that are unlikely to pose a plant pest risk to market, in turn supporting further innovation. APHIS expects that benefits will accrue to developers of all sizes, including small- and mid-sized ones, as well as academic institutions. At the same time, according to APHIS, it would be able to allocate its resources more efficiently than under the current regulations. Because APHIS would no longer have to perform the redundant task of assessing GE plants with plant-trait-MOA combinations that it has already determined are not subject to these regulations, it would be able to devote more attention to assessing and regulating those GE organisms that are likely to be associated with potential plant pest risks.

APHIS notes that a developer making a self-determination that APHIS then determines not to be valid may be subject to remedial measures or penalties if the organism is moved without proper authorization under Part 340. In addition, APHIS may exercise penalties and remedial measures (including but not limited to, quarantine, seizure, and/or destruction) under the authority of the PPA.

Under Section 340.4 of the proposed rule, the process by which APHIS would evaluate GE plants for plant pest risk would be called a regulatory status review. When evaluating the plant pest risk posed by a newly developed GE plant, APHIS would consider three fundamental elements in combination and individually: (1) the basic biology of the plant prior to modification; (2) the trait that resulted from the genetic modification; and (3) the MOA. Since any one or any combination of these three elements may affect plant pest risk, APHIS would determine the need for regulatory oversight by appraising the risk posed by the plant’s unique combination of the three elements.

The proposed rule would define trait as an observable (able to be seen or otherwise identified) characteristic of an organism. MOA would be defined as the “biochemical process(es) through which genetic material determines a trait.” For example, a plant may be modified to confer the trait of male sterility by either of two MOAs in pollen: expression of a protein that is toxic to the pollen grain (barnase system); or expression of a protein that changes deoxyribonucleic acids (DNA) in pollen-producing tissues (DNA adenine methylase system) in a disruptive way that ultimately results in death of those tissues.

For reasons described in greater detail in the proposed rule, the regulatory status review process would apply only to plants and not to GE plant pests or other GE non-plant organisms that fall within the scope of the regulations. APHIS requests comments, however, on whether the scope of the regulatory status review should be expanded to include non-plant GE organisms as well as GE plants, whether some equivalent process for evaluating such organisms for regulatory status should be developed instead, and, if so, what factors APHIS should consider in its analyses.

Information pertaining to the results of all completed regulatory status reviews would be publicly accessible on the APHIS website. This information would include a comprehensive list of GE plant-trait-MOA combinations that APHIS has evaluated for plant pest risk via the regulatory status review process under proposed Section 340.4. The list would also include GE plants for which APHIS has made determinations of nonregulated status under the petition process. Developers could use the list to aid them in making their self-determinations. For example, if a developer were to find that his or her newly developed GE plant had the same plant-trait-MOA combination as a GE plant previously found by APHIS to be not subject to its regulations, the developer “would know immediately that the newly developed plant would not be subject to APHIS regulation.” APHIS “anticipate[s] that should this rule be implemented, this list would grow as new regulatory status reviews are completed.”

For GE plants that do not fall into one of the exempted categories and have not previously been assessed through the regulatory status review process, developers would have the option of either requesting an immediate regulatory status review or requesting a permit for the movement of their GE plant in lieu of a regulatory status review. A developer who initially requests a permit would also have the option of following up with a request for a regulatory status review. According to APHIS, providing these options would allow for maximum flexibility in the research and development of novel GE plants for all types of developers (multi-national companies, small companies, and public sector researchers). Developers of GE organisms that are plant pests would continue to need permits to move those organisms.

Regulation of Plants that Produce Plant-Made Industrials and Pharmaceuticals

APHIS states that it recognizes that certain plants are genetically engineered to produce pharmaceutical and industrial compounds, also known as plant-made industrials and pharmaceuticals (PMPI). According to APHIS, federal oversight of outdoor plantings of PMPI-producing plants could be necessary to prevent the unlawful introduction into the human or animal food supply of pharmaceutical or industrial PMPI products, even when the principal purpose of the plants is not for human or animal food use. In addition to potential adulteration issues posed by such plants should they enter the food supply, APHIS notes that a gap in federal oversight could generate concerns from the general public regarding the safety and wholesomeness of the human or animal food supply, adversely impacting agricultural interests. Establishing growing and handling conditions to confine such plants, and inspecting to ensure such conditions are followed, may enable corrective actions before material from the plants is inadvertently released and causes public health or economic impacts.

Under the current regulations, APHIS requires permits for the environmental release of all GE plants that meet the definition of a regulated article and produce PMPIs. APHIS exercises oversight of all outdoor plantings of these regulated PMPI-producing plants. This oversight includes establishing appropriate environmental release conditions, inspections, and monitoring. PMPI-producing plants and the products obtained from them may also be regulated by the U.S. Food and Drug Administration (FDA) (authority over food and drugs) or EPA (chemical substances as defined by TSCA), depending on their use or intended use. If a PMPI-producing plant or plant product were potentially to be used for human or animal food, food additive approval might be required under the Federal Food, Drug, and Cosmetic Act.

APHIS states that to date, PMPI-producing GE plants regulated by it have been genetically engineered using a plant pest as the donor, vector, or vector agent, and thus fall under the scope of “regulated article” in the current regulations. Under the provisions of the proposed rule, a GE plant that is developed using a plant pest as a vector, vector agent, or donor of genetic materials would not necessarily be regulated, however. Rather, the GE plant would be regulated only if it had a plant-trait-MOA combination that APHIS has not yet evaluated for plant pest risk or if it was evaluated and found to pose a potential plant pest risk. Additionally, APHIS’ evaluations of GE plants for plant pest risk would generally not require data from outdoor plantings. Even if the plant represents a new plant-trait-MOA combination not previously reviewed, there is a likelihood that most, if not all, GE PMPI-producing plants that are currently under APHIS permits could be determined to be not regulated under the provisions of the proposed regulations after a regulatory status review because they are unlikely to pose a plant pest risk. Thus, according to APHIS, such plants could be grown outdoors without the need for APHIS permits and without APHIS oversight.

APHIS states that one of the reasons its oversight of such crops has been an important part of the coordinated framework for oversight of GE plants is that companies are not necessarily required to notify FDA or EPA when the developer plants PMPI-producing plants. For example, for PMPI-producing plants whose products are subject to FDA oversight, FDA has no regulations governing planting of such crops. For crops genetically engineered to produce human drugs, companies only have to go to FDA when they have reached the point that they are ready to begin clinical trials with the pharmaceutical derived from the plant. According to APHIS, “[t]his could be years after they first started growing the pharmaceutical-producing plant in the field.”

Under TSCA, EPA has requirements for new chemical substances, including industrial compounds produced in GE plants. APHIS states that, given its existing oversight, EPA does not currently have an oversight program nor regulations for GE plants that produce industrial compounds, however.

APHIS identified two options that have the potential for adequate federal oversight of outdoor plantings of plants engineered to produce PMPIs. Under one option, APHIS would use other authorities (e.g., 7 C.F.R. Part 360) to regulate outdoor planting of plants engineered to produce PMPIs. Under a second option, a statute would be enacted, or existing statutory authority amended, to grant one or more federal agencies explicit authority to provide oversight of outdoor plantings of all GE PMPI-producing plants and to evaluate GE PMPI-producing plants for all possible risks, beyond plant pest and noxious weed risks. APHIS states that it does not prefer one of these options over the other, nor does it consider the two options necessarily to be exhaustive. Rather, APHIS put them forward to indicate that it is aware of the implications of the proposed rule with regard to PMPIs, and to request specific public comment regarding the best manner to address this issue.

Plant-Incorporated Protectant Small-Scale Field Testing

Certain plants are genetically engineered to produce plant-incorporated protectants (PIP), meaning that they produce pesticides. PIPs fall under the regulatory oversight of EPA. Currently, only APHIS exercises regulatory oversight of PIP plantings on ten acres or less of land. Under the current regulations, APHIS requires permits or notifications for the environmental release of all GE plants that meet the definition of a regulated article and produce PIPs. APHIS states that it exercises oversight of all outdoor plantings of these regulated PIP-producing plants. This oversight includes the establishment of appropriate environmental release conditions, inspections, and monitoring.

According to APHIS, to date, PIP-producing GE plants regulated by APHIS have been genetically engineered using a plant pest as the donor, vector, or vector agent, and thus fall under the scope of a regulated article in the current regulations in Part 340. Under the provisions of the proposed rule, a GE plant that is developed using a plant pest as a vector, vector agent, or donor of genetic materials would not necessarily be regulated. Instead, the GE plant would be regulated only if it had a plant-trait-MOA combination that APHIS has not yet evaluated for plant pest risk or if it was evaluated and found to pose a potential plant pest risk. Additionally, APHIS’ evaluations of GE plants for plant pest risk would generally not require data from outdoor plantings. Even if the plant represents a new plant-trait-MOA combination not previously reviewed, there is a likelihood that many GE PIP-producing plants that are currently regulated under APHIS permits or notifications could be determined not regulated under the provisions of the proposed regulations after a regulatory status review because they are unlikely to pose plant pest risks. Thus, such plants could be grown outdoors without the need for an APHIS permit and without undergoing APHIS oversight.

APHIS states that it understands that this proposal would shift federal oversight of small-scale (ten acres or less) outdoor plantings of some PIPs to EPA. According to APHIS, EPA may decide to require experimental use permits for all, some, or none of such PIPs, and may conduct inspections of all, some, or none of those PIPs under permit. APHIS “is fully committed to coordinating with EPA on these issues.”

APHIS states that it understands that a memorandum of understanding (MOU) and services agreement may be necessary to provide personnel and other resources to assist EPA during the interim period while EPA implements its own program for the oversight of outdoor planting of PIPs of ten acres or less.

APHIS notes that it recognizes that there are challenges associated with such a transition that would also require EPA to incur the costs associated with setting up a revised regulatory program. Further, such a transition would require policies, procedures, and guidance regarding APHIS’ interaction with EPA. APHIS does not consider the approach listed above necessarily to be exhaustive. Rather, APHIS puts it forward to indicate that it “is aware of the implications of this rule with regard to small-scale testing of PIPs and to request specific public comment regarding the best manner to address this issue.”

Commentary

The proposed rule moves the needle significantly in updating and modernizing the federal government’s approach to evaluating and assessing risks posed by GE organisms. Under the current regulations, a GE organism is a regulated article if the donor organism, recipient organism, vector, or vector agent is a plant pest, or if APHIS has a reason to believe the GE organism is a plant pest. Based on its experience under current regulations, APHIS has compiled evidence that genetically engineering a plant with a plant pest as a vector, vector agent, or donor does not necessarily result in a GE plant that itself poses a plant risk. Additionally, APHIS recognizes that genetic engineering techniques have been developed that do not use plant pests and yet may result in GE organisms that pose a plant risk.

APHIS thus is proposing to revise its regulatory approach to align with current scientific knowledge and to base its decision to regulate on the plant-trait-MOA set of considerations. The focus on the inherent risks of a particular product, as opposed to the method by which the product was made, is correct and aligns with other federal agency approaches to assessing risks.

The proposal’s streamlining of the APHIS permitting process is commendable. Through transparent decision making and permitting developers to self-determine that their GE plants are exempt from regulation (with potential penalties to encourage careful self-determinations), APHIS eliminates a regulatory bottleneck that can stifle innovation and will be able to focus its resources on GE plants that are more likely to pose a risk. The approach set forth in the proposal is a step in the right direction to addressing some of the challenges innovators in this space have faced in commercializing new technologies, as discussed in our report from the Synthetic Biology Project, The DNA of the U.S. Regulatory System: Are We Getting It Right for Synthetic Biology? As discussed there, the pathway to market for new products utilizing evolving technologies can be difficult to navigate, posing a challenge for companies in their efforts to commercialize new ideas. Similarly, the novelty posed by some of these evolving products can make it difficult for regulatory agencies to evaluate risks. Comment is specifically requested on many aspects of the proposal. Stakeholders are urged to review the proposal and comment by August 5, 2019.

Additional Resources

As reported in our July 24, 2018, memorandum, “APHIS/USDA Prepare to Revise Regulations Pertinent to Genetically Engineered Organisms,” APHIS signaled on June 29, 2018, its intent to prepare a “programmatic environmental impact statement (EIS) in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms.” The EIS will have a significant impact on how APHIS chooses to amend its regulation of GE organisms. APHIS requested comment on issues to be considered in preparing the EIS, as well as how to define the scope of the alternatives and environmental impacts. Comments were due July 30, 2018.

On January 4, 2017, the Obama White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The 2017 Update provides a comprehensive summary of the roles and responsibilities of EPA, FDA, and USDA with respect to regulating biotechnology products. Together with the National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, the 2017 Update offers a “complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology.” Within that regulatory structure, the federal agencies “maintain high standards that, based on the best available science, protect health and the environment, while also establishing transparent, coordinated, predictable and efficient regulatory practices.” More information is available in our January 9, 2017, memorandum, “White House Announces Release of Final Update to the Coordinated Framework for the Regulation of Biotechnology.”

On March 9, 2017, NAS published a report entitled Preparing for Future Products of Biotechnology, prepared by the Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System. Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), was an external contributor to the Committee’s deliberations and presented before the Committee on the subject of the biotechnology regulatory system. More information on the report is available in our March 13, 2017, memorandum, “National Academies Report Finds Future Biotechnology Products May Overwhelm Agencies.”

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Bergeson & Campbell, P.C. | Attorney Advertising

Written by:

Bergeson & Campbell, P.C.
Contact
more
less

Bergeson & Campbell, P.C. on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide

JD Supra Privacy Policy

Updated: May 25, 2018:

JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.

This Privacy Policy describes how JD Supra, LLC ("JD Supra" or "we," "us," or "our") collects, uses and shares personal data collected from visitors to our website (located at www.jdsupra.com) (our "Website") who view only publicly-available content as well as subscribers to our services (such as our email digests or author tools)(our "Services"). By using our Website and registering for one of our Services, you are agreeing to the terms of this Privacy Policy.

Please note that if you subscribe to one of our Services, you can make choices about how we collect, use and share your information through our Privacy Center under the "My Account" dashboard (available if you are logged into your JD Supra account).

Collection of Information

Registration Information. When you register with JD Supra for our Website and Services, either as an author or as a subscriber, you will be asked to provide identifying information to create your JD Supra account ("Registration Data"), such as your:

  • Email
  • First Name
  • Last Name
  • Company Name
  • Company Industry
  • Title
  • Country

Other Information: We also collect other information you may voluntarily provide. This may include content you provide for publication. We may also receive your communications with others through our Website and Services (such as contacting an author through our Website) or communications directly with us (such as through email, feedback or other forms or social media). If you are a subscribed user, we will also collect your user preferences, such as the types of articles you would like to read.

Information from third parties (such as, from your employer or LinkedIn): We may also receive information about you from third party sources. For example, your employer may provide your information to us, such as in connection with an article submitted by your employer for publication. If you choose to use LinkedIn to subscribe to our Website and Services, we also collect information related to your LinkedIn account and profile.

Your interactions with our Website and Services: As is true of most websites, we gather certain information automatically. This information includes IP addresses, browser type, Internet service provider (ISP), referring/exit pages, operating system, date/time stamp and clickstream data. We use this information to analyze trends, to administer the Website and our Services, to improve the content and performance of our Website and Services, and to track users' movements around the site. We may also link this automatically-collected data to personal information, for example, to inform authors about who has read their articles. Some of this data is collected through information sent by your web browser. We also use cookies and other tracking technologies to collect this information. To learn more about cookies and other tracking technologies that JD Supra may use on our Website and Services please see our "Cookies Guide" page.

How do we use this information?

We use the information and data we collect principally in order to provide our Website and Services. More specifically, we may use your personal information to:

  • Operate our Website and Services and publish content;
  • Distribute content to you in accordance with your preferences as well as to provide other notifications to you (for example, updates about our policies and terms);
  • Measure readership and usage of the Website and Services;
  • Communicate with you regarding your questions and requests;
  • Authenticate users and to provide for the safety and security of our Website and Services;
  • Conduct research and similar activities to improve our Website and Services; and
  • Comply with our legal and regulatory responsibilities and to enforce our rights.

How is your information shared?

  • Content and other public information (such as an author profile) is shared on our Website and Services, including via email digests and social media feeds, and is accessible to the general public.
  • If you choose to use our Website and Services to communicate directly with a company or individual, such communication may be shared accordingly.
  • Readership information is provided to publishing law firms and authors of content to give them insight into their readership and to help them to improve their content.
  • Our Website may offer you the opportunity to share information through our Website, such as through Facebook's "Like" or Twitter's "Tweet" button. We offer this functionality to help generate interest in our Website and content and to permit you to recommend content to your contacts. You should be aware that sharing through such functionality may result in information being collected by the applicable social media network and possibly being made publicly available (for example, through a search engine). Any such information collection would be subject to such third party social media network's privacy policy.
  • Your information may also be shared to parties who support our business, such as professional advisors as well as web-hosting providers, analytics providers and other information technology providers.
  • Any court, governmental authority, law enforcement agency or other third party where we believe disclosure is necessary to comply with a legal or regulatory obligation, or otherwise to protect our rights, the rights of any third party or individuals' personal safety, or to detect, prevent, or otherwise address fraud, security or safety issues.
  • To our affiliated entities and in connection with the sale, assignment or other transfer of our company or our business.

How We Protect Your Information

JD Supra takes reasonable and appropriate precautions to insure that user information is protected from loss, misuse and unauthorized access, disclosure, alteration and destruction. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. You should keep in mind that no Internet transmission is ever 100% secure or error-free. Where you use log-in credentials (usernames, passwords) on our Website, please remember that it is your responsibility to safeguard them. If you believe that your log-in credentials have been compromised, please contact us at privacy@jdsupra.com.

Children's Information

Our Website and Services are not directed at children under the age of 16 and we do not knowingly collect personal information from children under the age of 16 through our Website and/or Services. If you have reason to believe that a child under the age of 16 has provided personal information to us, please contact us, and we will endeavor to delete that information from our databases.

Links to Other Websites

Our Website and Services may contain links to other websites. The operators of such other websites may collect information about you, including through cookies or other technologies. If you are using our Website or Services and click a link to another site, you will leave our Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We are not responsible for the data collection and use practices of such other sites. This Policy applies solely to the information collected in connection with your use of our Website and Services and does not apply to any practices conducted offline or in connection with any other websites.

Information for EU and Swiss Residents

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

  • Our Legal Basis for Processing: Generally, we rely on our legitimate interests in order to process your personal information. For example, we rely on this legal ground if we use your personal information to manage your Registration Data and administer our relationship with you; to deliver our Website and Services; understand and improve our Website and Services; report reader analytics to our authors; to personalize your experience on our Website and Services; and where necessary to protect or defend our or another's rights or property, or to detect, prevent, or otherwise address fraud, security, safety or privacy issues. Please see Article 6(1)(f) of the E.U. General Data Protection Regulation ("GDPR") In addition, there may be other situations where other grounds for processing may exist, such as where processing is a result of legal requirements (GDPR Article 6(1)(c)) or for reasons of public interest (GDPR Article 6(1)(e)). Please see the "Your Rights" section of this Privacy Policy immediately below for more information about how you may request that we limit or refrain from processing your personal information.
  • Your Rights
    • Right of Access/Portability: You can ask to review details about the information we hold about you and how that information has been used and disclosed. Note that we may request to verify your identification before fulfilling your request. You can also request that your personal information is provided to you in a commonly used electronic format so that you can share it with other organizations.
    • Right to Correct Information: You may ask that we make corrections to any information we hold, if you believe such correction to be necessary.
    • Right to Restrict Our Processing or Erasure of Information: You also have the right in certain circumstances to ask us to restrict processing of your personal information or to erase your personal information. Where you have consented to our use of your personal information, you can withdraw your consent at any time.

You can make a request to exercise any of these rights by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

You can also manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard.

We will make all practical efforts to respect your wishes. There may be times, however, where we are not able to fulfill your request, for example, if applicable law prohibits our compliance. Please note that JD Supra does not use "automatic decision making" or "profiling" as those terms are defined in the GDPR.

  • Timeframe for retaining your personal information: We will retain your personal information in a form that identifies you only for as long as it serves the purpose(s) for which it was initially collected as stated in this Privacy Policy, or subsequently authorized. We may continue processing your personal information for longer periods, but only for the time and to the extent such processing reasonably serves the purposes of archiving in the public interest, journalism, literature and art, scientific or historical research and statistical analysis, and subject to the protection of this Privacy Policy. For example, if you are an author, your personal information may continue to be published in connection with your article indefinitely. When we have no ongoing legitimate business need to process your personal information, we will either delete or anonymize it, or, if this is not possible (for example, because your personal information has been stored in backup archives), then we will securely store your personal information and isolate it from any further processing until deletion is possible.
  • Onward Transfer to Third Parties: As noted in the "How We Share Your Data" Section above, JD Supra may share your information with third parties. When JD Supra discloses your personal information to third parties, we have ensured that such third parties have either certified under the EU-U.S. or Swiss Privacy Shield Framework and will process all personal data received from EU member states/Switzerland in reliance on the applicable Privacy Shield Framework or that they have been subjected to strict contractual provisions in their contract with us to guarantee an adequate level of data protection for your data.

California Privacy Rights

Pursuant to Section 1798.83 of the California Civil Code, our customers who are California residents have the right to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes.

You can make a request for this information by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

Some browsers have incorporated a Do Not Track (DNT) feature. These features, when turned on, send a signal that you prefer that the website you are visiting not collect and use data regarding your online searching and browsing activities. As there is not yet a common understanding on how to interpret the DNT signal, we currently do not respond to DNT signals on our site.

Access/Correct/Update/Delete Personal Information

For non-EU/Swiss residents, if you would like to know what personal information we have about you, you can send an e-mail to privacy@jdsupra.com. We will be in contact with you (by mail or otherwise) to verify your identity and provide you the information you request. We will respond within 30 days to your request for access to your personal information. In some cases, we may not be able to remove your personal information, in which case we will let you know if we are unable to do so and why. If you would like to correct or update your personal information, you can manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard. If you would like to delete your account or remove your information from our Website and Services, send an e-mail to privacy@jdsupra.com.

Changes in Our Privacy Policy

We reserve the right to change this Privacy Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our Privacy Policy will become effective upon posting of the revised policy on the Website. By continuing to use our Website and Services following such changes, you will be deemed to have agreed to such changes.

Contacting JD Supra

If you have any questions about this Privacy Policy, the practices of this site, your dealings with our Website or Services, or if you would like to change any of the information you have provided to us, please contact us at: privacy@jdsupra.com.

JD Supra Cookie Guide

As with many websites, JD Supra's website (located at www.jdsupra.com) (our "Website") and our services (such as our email article digests)(our "Services") use a standard technology called a "cookie" and other similar technologies (such as, pixels and web beacons), which are small data files that are transferred to your computer when you use our Website and Services. These technologies automatically identify your browser whenever you interact with our Website and Services.

How We Use Cookies and Other Tracking Technologies

We use cookies and other tracking technologies to:

  1. Improve the user experience on our Website and Services;
  2. Store the authorization token that users receive when they login to the private areas of our Website. This token is specific to a user's login session and requires a valid username and password to obtain. It is required to access the user's profile information, subscriptions, and analytics;
  3. Track anonymous site usage; and
  4. Permit connectivity with social media networks to permit content sharing.

There are different types of cookies and other technologies used our Website, notably:

  • "Session cookies" - These cookies only last as long as your online session, and disappear from your computer or device when you close your browser (like Internet Explorer, Google Chrome or Safari).
  • "Persistent cookies" - These cookies stay on your computer or device after your browser has been closed and last for a time specified in the cookie. We use persistent cookies when we need to know who you are for more than one browsing session. For example, we use them to remember your preferences for the next time you visit.
  • "Web Beacons/Pixels" - Some of our web pages and emails may also contain small electronic images known as web beacons, clear GIFs or single-pixel GIFs. These images are placed on a web page or email and typically work in conjunction with cookies to collect data. We use these images to identify our users and user behavior, such as counting the number of users who have visited a web page or acted upon one of our email digests.

JD Supra Cookies. We place our own cookies on your computer to track certain information about you while you are using our Website and Services. For example, we place a session cookie on your computer each time you visit our Website. We use these cookies to allow you to log-in to your subscriber account. In addition, through these cookies we are able to collect information about how you use the Website, including what browser you may be using, your IP address, and the URL address you came from upon visiting our Website and the URL you next visit (even if those URLs are not on our Website). We also utilize email web beacons to monitor whether our emails are being delivered and read. We also use these tools to help deliver reader analytics to our authors to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

Analytics/Performance Cookies. JD Supra also uses the following analytic tools to help us analyze the performance of our Website and Services as well as how visitors use our Website and Services:

  • HubSpot - For more information about HubSpot cookies, please visit legal.hubspot.com/privacy-policy.
  • New Relic - For more information on New Relic cookies, please visit www.newrelic.com/privacy.
  • Google Analytics - For more information on Google Analytics cookies, visit www.google.com/policies. To opt-out of being tracked by Google Analytics across all websites visit http://tools.google.com/dlpage/gaoptout. This will allow you to download and install a Google Analytics cookie-free web browser.

Facebook, Twitter and other Social Network Cookies. Our content pages allow you to share content appearing on our Website and Services to your social media accounts through the "Like," "Tweet," or similar buttons displayed on such pages. To accomplish this Service, we embed code that such third party social networks provide and that we do not control. These buttons know that you are logged in to your social network account and therefore such social networks could also know that you are viewing the JD Supra Website.

Controlling and Deleting Cookies

If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

The processes for controlling and deleting cookies vary depending on which browser you use. To find out how to do so with a particular browser, you can use your browser's "Help" function or alternatively, you can visit http://www.aboutcookies.org which explains, step-by-step, how to control and delete cookies in most browsers.

Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.