By Lynn L. Bergeson and Margaret R. Graham
The U.S. Environmental Protection Agency (EPA) recently announced, in two separate notices, that it is initiating a process to revise (1) certain requirements in the Agricultural Worker Protection Standard (WPS) (82 Fed. Reg. 60576 (Dec. 21. 2017)); and (2) to revise the minimum age requirements in the Certification of Pesticide Applicators (C&T) rule. 82 Fed. Reg. 60195 (Dec. 19. 2017).
For the WPS rulemaking, the provisions at issue were identified as part of the public comments received in response to Executive Order (EO) 13777, Enforcing the Regulatory Reform Agenda. Three provisions in particular were the subject of public comment, and later consideration by the EPA’s Office of Pesticide Programs (OPP) Pesticide Program Dialogue Committee (PPDC) at its November 2, 2017, meeting. The three provisions are: minimum age (the 2015 WPS specifies a minimum age of 18 years, with an exemption for owners of agricultural establishments and their immediate family members); designated representative (the 2015 WPS requires employers to provide pesticide application information and safety data sheets to a designated representative of a worker or handler under specified circumstances); and application exclusion zones (AEZ) (the 2015 WPS requires the establishment of AEZs with respect to outdoor production on farms, nurseries, and forests to reduce the number of incidents where workers or others are exposed to pesticides during agricultural pesticide applications).
EPA also announced that the compliance dates in the revised WPS remain in effect and that EPA has no intent to extend them. This means that most provisions in the revised WPS went into effect on January 2, 2017, and compliance with two additional requirements will begin on January 2, 2018. The two requirements include compliance with the display of pesticide safety information, and pesticide handlers must temporarily suspend applications if workers or others enter in the application zone during pesticide applications. The only requirements in the revised WPS that will not be in effect as of January 2, 2018, are the requirements that the worker and handler pesticide safety training material cover the expanded content at 40 C.F.R. §§ 170.401(c)(3) and 170.501(c)(3). The 2015 revised WPS provided that compliance with the expanded pesticide safety content in these sections was not required until 180 days after EPA publishes in the Federal Register a notice of availability of certain training materials. While there are training materials available that meet the expanded content requirement, EPA has not yet published such a Federal Register and apparently does not intend to do so until after the rulemaking announced on December 21 has concluded.
For the C&T rule, EPA expects to “publish a Notice of Proposed Rulemaking to solicit public input on proposed revisions to the rule by the end of FY2018,” and it has no plans to change the implementation dates in the January 4, 2017, final rule. The C&T notice states that “EPA has determined that further consideration of the rule’s minimum age requirements is warranted through the rulemaking process” after it considered comments received pursuant to EO 13777, revisiting the record, and reviewing the applicable statutory.
More information on WPS issues is available on our blog under key phrase Worker Protection Standard.
By Timothy D. Backstrom, James V. Aidala, and Lisa M. Campbell
On December 18, 2017, the U.S. Environmental Protection Agency (EPA) announced it is releasing for public comment the draft human health and ecological risk assessments for glyphosate. EPA’s Draft Human Health and Ecological Risk Assessments for Glyphosate website states that the “draft risk assessments and supporting documents will be available in glyphosate’s registration review docket EPA-HQ-OPP-2009-0361 on www.regulations.gov in early 2018,” and that EPA will “open a 60-day public comment period for the draft risk assessments, evaluate the comments received, and consider any potential risk management options for this herbicide.” Many of the assessment documents, including the draft human health risk assessment, are already available on EPA’s website, but not yet posted in the docket.
The EPA announcement includes the following summary of EPA’s determinations:
- The draft human health risk assessment concludes that glyphosate is not likely to be carcinogenic to humans. The Agency’s assessment found no other meaningful risks to human health when the product is used according to the pesticide label. The Agency’s scientific findings are consistent with the conclusions of science reviews by a number of other countries as well as the 2017 National Institute of Health Agricultural Health Survey.
- EPA’s human health review evaluated dietary, residential/non-occupational, aggregate, and occupational exposures. Additionally, the Agency performed an in-depth review of the glyphosate cancer database, including data from epidemiological, animal carcinogenicity, and genotoxicity studies.
- The ecological risk assessment indicates that there is potential for effects on birds, mammals, and terrestrial and aquatic plants. EPA used the most current risk assessment methods, including an evaluation of the potential effects of glyphosate exposure on animals and plants.
EPA states the proposed interim registration review decision for glyphosate is scheduled to be published in 2019.
This latest EPA announcement is consistent with other determinations concerning glyphosate made by EPA in recent years, including statements made during the Obama Administration. EPA presented its analysis of the carcinogenic potential of glyphosate to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) in December 2016. EPA has consistently taken the position that the human health risks from glyphosate are low, and that food and water residues of glyphosate easily satisfy the requirement that they be “safe” for human consumption.
Critics of glyphosate use often focus on the widespread adoption of glyphosate-resistant bioengineered crops. If these genetically modified organism (GMO) crops were not specifically designed for use in conjunction with glyphosate, there would likely be much less discussion about the safety of the herbicide.
Because EPA’s announcement includes a statement that “there is potential for effects on birds, mammals, and terrestrial and aquatic plants,” critics of glyphosate and the associated GMO crops will likely continue to press for restrictions based on the ecological effects of glyphosate. Moreover, there is also likely to be continued controversy concerning the human health effects of glyphosate. Notwithstanding the human health safety findings in this EPA assessment and the other assessments cited in EPA’s statement, the International Agency for Research on Cancer (IARC) has classified glyphosate as “probably” carcinogenic to humans. It is thus probable that the controversy concerning glyphosate and the associated GMO crops will continue unabated.
More information on glyphosate issues is available on our blog under key word glyphosate.
By James V. Aidala
On December 15, 2017, the U.S. Environmental Protection Agency (EPA) announced its release of preliminary ecological and human health risk assessments for three neonicotinoid insecticides: clothianidin, thiamethoxam, and dinotefuran, as well as a preliminary ecological risk assessment for imidacloprid, assessing risks to birds, mammals, non-target insects, and plants. The assessments are available in the dockets linked below:
EPA also released new cotton and citrus benefits assessments for foliar applications of the neonicotinoids as well as its response to public comments on the 2014 Benefits of Neonicotinoid Seed Treatment to Soybean Production. These are available in Docket No. EPA-HQ-OPP-2014-0737.
For all of the dockets listed above, EPA states that it is particularly interested in public comment on the benefits for cotton and citrus, since previous assessments identified potential risks to pollinators. Further, EPA states that “early input from the public will be helpful in developing possible mitigation options that may be needed to address risks to bees. Among the benefits identified, the neonicotinoids were found to be critical for management of Asian citrus psyllid -- which causes citrus greening, a devastating pest for citrus growers, and for control of plant bugs and stink bugs in cotton.” The comment period will begin when the Federal Register notice is published and will be open for 60 days. EPA states that it plans to release the final pollinator risk assessments and proposed interim decisions for these chemicals in mid-2018.
These documents EPA has added to the dockets linked above add to a trove of continued EPA assessments of the neonicotinoid compounds. In January 2016, EPA assessed the risks to pollinators and concluded that the seed treatment uses are generally not of concern, but that there are possible risks of importance in citrus and cotton production. This is why this recent batch of documents, including the benefits assessments of the neonicotinoid products in citrus and cotton production, along with the long-awaited response to comments to EPA’s earlier benefit assessment of the soybean use, has been anticipated for some time. In summary, the benefits assessment for both cotton and citrus indicate significant benefits for these uses. And regarding the earlier benefits assessment of soybeans, EPA now concludes that it underestimated the benefits of the soybean uses generally and in particular has concluded significant benefits in some regions from soybean seed treatments.
With EPA now concluding these uses have significant benefits, there may be some need for risk mitigation of certain use patterns, but generally the estimated benefits will offset and preclude the imposition of more general label restrictions for these crops. For example, the benefits assessment for the citrus uses states flatly that the continued sustainability of the citrus crop requires continued use of the neonicotinoid products (to control the insect that is the vector for citrus greening disease).
Regarding other formulations and risk to organisms other than honeybees, the documents do identify some possible adverse impacts on non-target aquatic insects, birds, and possibly some aquatic invertebrates. These initial findings will likely continue to fuel the debate about the impacts of neonicotinoid use. Registrants will likely submit significant amounts of rebuttal data to further refine these risk estimates and currently do not anticipate significant additional label restrictions as a result, especially since EPA has concluded these products have more significant economic benefits which will be part of any risk-benefit considerations as EPA moves forward.
More information on neonicotinoid issues is available on our blog under key word neonicotinoids.
By Lisa M. Campbell and Heather F. Collins, M.S.
On Friday, November 3, 2017, the California Department of Pesticide Regulation (DPR) issued guidance (California Notice 2017-13) that DPR indicates is intended to align DPR policy with the U.S. Environmental Protection Agency’s (EPA) guidance on secondary container labeling for pesticides. DPR’s guidance states that secondary containers are used by the pesticide industry as part of the process of applying pesticides and “cannot be sold or distributed.” The guidance further notes that secondary containers are “most commonly used in institutional settings for concentrated antimicrobials that are diluted prior to use or to hold pesticides filled from a larger container to be used and stored prior to application.”
Registrants may elect to provide users with labels for secondary containers. DPR’s new guidance states: “Secondary container labels are not required to be submitted to U.S. EPA or DPR.” Under the new DPR policy, however, effective immediately, if a registrant submits a secondary container label to DPR, “it must bear the same signal word as the concentrate label or no signal word.” DPR states that it will accept a secondary container label with a lesser signal word, precautionary statements, and alternate directions for use for the diluted product only if acute toxicity data are submitted or are currently on file to support these lesser statements.
DPR’s new guidance also incorporates EPA guidance on what a secondary label should contain. (EPA does not require secondary containers to be labeled, but notes that the applicator remains responsible for following the requirements on the pesticide product’s labeling, and complying with other relevant requirements in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and other statutes.) Although registrants are not required to submit secondary container labels to EPA for review, EPA recommends that the applicator identify the material in the secondary container in the event of a spill to ensure that adequate information regarding the pesticide can be obtained in case of a medical or environmental emergency. EPA recommends that such labels include the following information:
- Product name;
- EPA registration number;
- Name and percentage of active ingredient of the concentrated product or if known, the percentage of active ingredient in the end-use dilution;
- If the product in the secondary container is diluted, it should be followed by the phrase: “The product in this container is diluted as directed on the pesticide product label”;
- The same signal word as the registered concentrate container label;
- The same precautionary statements as the registered concentrate container label unless the registrant has acute toxicity data supporting lesser precautionary statements for the diluted product and alternate directions for the diluted product are indicated on the concentrate container label; and
- The statement: “Follow the directions for use on the pesticide label when applying this product.”
DPR states: “If currently registered products have secondary container labels on file with DPR that do not meet the above criteria, registrants should submit revised labels to DPR as an amendment.”
Each submission must include:
- California Application to Amend Pesticide Product (DPR-REG-035);
- $25 application fee (payable to: Cashier, Department of Pesticide Regulation);
- A copy of the most current EPA stamp-accepted label;
- Six copies of the concentrate container label; and
- Six copies of the secondary container label.
- If the precautionary statement on the secondary container label bears lesser precautionary statements, the submission must be accompanied by acute toxicity data or a reference to data on file with DPR.
As an alternative to submitting revised labels, registrants have the option of requesting that DPR rescind acceptance of the current stamp-accepted secondary container label previously submitted. Registrants may submit their request in writing on company letterhead to their assigned Regulatory Scientist. If a secondary container label is inconsistent with the DPR-approved label, DPR will consider the product misbranded, and DPR notes that misbranded products are subject to enforcement action.
Registrants that have previously submitted secondary labels to DPR should review the label in comparison to the DPR-approved concentrate container label and the requirements in this notice. All inconsistencies must be corrected via amendment submission to DPR or by making a request that DPR rescind acceptance of the current stamp-accepted secondary label so that the product is not considered misbranded and therefore subject to enforcement action.
By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala
On October 13, 2017, the U.S. Environmental Protection Agency (EPA) announced that it had reached an agreement with Monsanto, BASF, and DuPont on measures “to further minimize the potential for drift to damage neighboring crops from the use of dicamba formulations used to control weeds in genetically modified cotton and soybeans,” and “new requirements for the use of dicamba ‘over the top’ (application to growing plants) will allow farmers to make informed choices for seed purchases for the 2018 growing season.”
EPA states that in a series of discussions, it “worked cooperatively with states, land-grant universities, and the pesticide manufacturers to examine the underlying causes of recent crop damage in the farm belt and southeast,” “sought extensive input from States and [U.S. Department of Agriculture (USDA)] cooperative extension agents from across the country, as well as the pesticide manufacturers, on the underlying causes of damage,” and “reviewed all available information carefully and developed tangible regulatory changes for the 2018 growing season.”
The label changes that certain registrants of dicamba products have agreed to impose additional requirements for "over the top" use of these products next year. These new requirements include:
- Classifying products as "restricted use," permitting only certified applicators with special training, and those under their supervision, to apply them; dicamba-specific training for all certified applicators to reinforce proper use;
- Requiring farmers to maintain specific records regarding the use of these products to improve compliance with label restrictions;
- Limiting applications to when maximum wind speeds are below 10 mph (from 15 mph) to reduce potential spray drift;
- Reducing the times during the day when applications can occur;
- Including tank clean-out language to prevent cross contamination; and
- Enhancing susceptible crop language and recordkeeping with sensitive crop registries to increase awareness of risk to especially sensitive crops nearby.
This announcement follows two compliance advisories issued by EPA in August 2016 and July 2017 on what EPA described as the high number of complaints received regarding crop damage from the alleged misuse of herbicides containing the active ingredient dicamaba. EPA’s August 2016 compliance advisory stated that the Missouri Department of Agriculture received 117 complaints alleging misuse of pesticide products containing dicamba, and Missouri growers estimated that more than 42,000 acres of crops had been adversely affected. Further, that similar complaints alleging misuse of dicamba products were received by Alabama, Arkansas, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Tennessee and Texas. In the spring of 2016, EPA issued a proposal to register dicamba to control weeds in cotton and soybean that have been genetically engineered to tolerate dicamba. In November 2016, EPA issued a conditional registration for dicamba on dicamba-tolerant cotton and soybean to Monsanto for its Xtendimax product; and EPA recently approved a label amendment made by Monsanto for Xtendimax which includes “additional restrictions further minimizing off-field movement of the active ingredient dicamba.”
EPA’s July 2017 compliance advisory states that by early July, EPA had received reports of hundreds of complaints to state agencies in Arkansas, Missouri, and Tennessee, a significant increase from 2016; lists the three new conditional registrations issued late last year (including Xtendimax); and states that only these new registered products may be lawfully applied over-the-top of growing soybeans and cotton. It discusses what it describes as unlawful applications of dicamba products, and states that “[e]xcept for the new conditionally registered dicamba products, application of a dicamba product during either the cotton or soybean crop growing season is unlawful under FIFRA.”
EPA’s July 2017 compliance advisory further states that each of the conditionally approved dicamba herbicide products has labeling that provides mandatory directions for use, restrictions, and special precautions that must be followed, and that the labels of the new products require specific and rigorous drift mitigation measures to further reduce the potential for exposure from spray drift including:
- No application from aircraft;
- No application when wind speed is over 15 mph;
- Application only with approved nozzles at specified pressures; and
- Buffer zones to protect sensitive areas when the wind is blowing toward them.
The reports of and concerns about potential damage to crops in connection with the application of dicamba illustrate a problem that has long been discussed, which is the potential for unintended impact when a pesticide that has been specifically designed for use with one or more crops that have been genetically engineered to be tolerant to the pesticide is applied in close proximity to other crops that do not share these tolerant characteristics.
The dicamba case also illustrates the differing views on potential misuse issues. Some observers have questioned whether all of the reported dicamba incidents were due to misuse or misapplication of the product. Although the 2018 label changes are designed to mitigate the potential for damage to sensitive crops, some question whether some unanticipated or as yet not completely understood factor may be at play in some of the incident reports. One issue raised by some researchers concerns potential unexpected volatility of the product even when applied according to the label directions by well-trained applicators. The registrants have disputed this suggestion, but it is an area which will likely be more thoroughly researched over the next few growing seasons.
More information on EPA’s regulatory action on dicamba is available on EPA’s website.
By Lisa M. Campbell and Timothy D. Backstrom
On October 13, 2017, Petitioners League of United Latin American Citizens (LULAC), et al. filed a motion to expedite briefing and hearing in League of United Latin American Citizens v. Pruitt, Case No. 17-71636 (9th Cir. June 5, 2017). In their motion, Petitioners request that the court “expedite proceedings because of the harm being caused by [U.S. Environmental Protection Agency (EPA)] Administrator Pruitt leaving chlorpyrifos tolerances in effect when he did not and cannot determine that chlorpyrifos is safe under the Food Quality Protection Act.”
Petitioners state there is good cause for expedition “because children continue to be exposed to chlorpyrifos in their food, drinking water, and the air around their homes, schools, and playfields, putting them at risk of such brain impairments as lower IQ, attention deficit disorders, and developmental delays,” and “Ninth Circuit Rule 27-12 provides that ‘motions to expedite briefing and hearing may be filed and will be granted upon a showing of good cause,’” including ‘“situations in which … in the absence of expedited treatment, irreparable harm may occur.’” Pursuant to Ninth Circuit Rule 27-12, Petitioners determined the position of EPA counsel on the motion, who stated that, “EPA opposes the motion to expedite as premature under Circuit Rule 27-11(b).”
The Petitioners’ motion to expedite briefing was submitted despite the pendency of an unresolved motion to dismiss submitted by Respondents Administrator Pruitt and EPA on August 21, 2017. In that motion, EPA argued that the court lacks jurisdiction to review the March 29, 2017, order denying the petition by Pesticide Action Network North America (PANNA) and Natural Resources Defense Council (NRDC) to revoke all Federal Food, Drug, and Cosmetic Act (FFDCA) tolerances for chlorpyrifos, until after the Petitioners have exhausted their administrative remedies by filing objections to the denial, and EPA has issued a final order ruling on such objections. In its motion to dismiss, EPA noted that the Ninth Circuit denied a motion by PANNA and NRDC for further mandamus relief in In re PANNA on July 18, 2017, stating that “one valid agency response to a petition challenging a pesticide’s tolerances is to ‘issue an order denying the petition,’” and ‘“now that EPA has issued its denial, substantive objections must first be made through the administrative process mandated by’ the FFDCA.”
On September 27, 2017, Petitioners filed their opposition to the motion to dismiss. Petitioners argued that exhaustion of administrative remedies by filing objections under the FFDCA is not an absolute jurisdictional prerequisite to judicial review, and that the court can proceed with review under the “futility doctrine” because EPA’s refusal to revoke the tolerances for chlorpyrifos constitutes a “flagrant violation of a statutory prohibition.” Petitioners also argued that even if FFDCA exhaustion is required, EPA has also denied the petition by PANNA and NRDC to cancel the registrations of chlorpyrifos, and that additional denial constitutes a final order that is subject to immediate review under FIFRA Section 16(b) because the notice and comment process concerning the petition was a “public hearing” under the applicable precedent.
The new motion by Petitioners LULAC, et al. to expedite briefing on the challenge to EPA’s denial of the PANNA and NRDC petition reflects the view of the Petitioners that this matter is urgent because continued use of chlorpyrifos jeopardizes the health of children, but this motion is unlikely to be resolved before the court rules on EPA’s pending motion to dismiss. EPA has stated that it will oppose the Petitioners’ motion to expedite briefing as premature. Moreover, EPA has not yet replied to the arguments made by the Petitioners in their opposition to the pending dismissal motion.
To prevail on their argument that exhausting the administrative process prescribed by the FFDCA will be “futile,” the Petitioners likely will have to persuade the Court that these FFDCA procedures are not jurisdictional prerequisites to judicial review, and that there is little likelihood that EPA will change its mind in response to their objections. With respect to the argument that EPA’s denial of the petition to cancel the registrations for chlorpyrifos is final agency action subject to immediate review under FIFRA Section 16(b), EPA will likely contend that this argument is contravened by 21 U.S.C. § 346a(h)(5), which states: “any issue as to which review is or was obtainable under this subsection shall not be the subject of judicial review under any other provision of law.” It could be difficult for Petitioners to defeat this jurisdictional prohibition in the FFDCA; they would presumably need to show the court that their substantive contentions concerning the hazards posed by chlorpyrifos would not be directly implicated in EPA’s final determination of whether or not to revoke the tolerances for chlorpyrifos.
This case will be carefully watched by pesticide industry observers.
More information on regulatory issues related to chlorpyrifos is available on our blog.
By Lisa M. Campbell, Heather F. Collins, M.S., and Margaret R. Graham
On October 5, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice of extension of the comment period for the draft guidance Pesticide Registration Notice (PR Notice) 2017-XX: Notifications, Non-notifications and Minor Formulation Amendment issued on September 6, 2017. Comments now must be received by EPA on or before December 5, 2017. The notice states that it will “allow stakeholders additional time to submit comments on the proposed guidance.” Eleven comments were filed in the docket, most of which expressed significant concern with changes EPA is proposing, in addition to requesting an extension to the previous deadline which was set to end on October 6, 2017.
EPA states that PR Notice 2017-XX will update and clarify “the scope of changes accepted by notification, non-notification and minor formulation amendments for all pesticide products, and supersedes both PR Notices 95-2 and 98-10 in their entirety.” A full summary of the changes in the draft guidance is available in our blog item "EPA Releases Draft Guidance for Pesticide Registrants on Notifications, Non-notifications, and Minor Formulation Amendments."
Some of the more substantive comments noted the following issues:
- Several commenters stated objections to the provisions in the draft PR Notice that would eliminate the ability of registrants of formulated products to use notification to add or change sources of either registered technical active ingredients or inert ingredients. Concerns expressed with this proposed change included the effect it would have on the ability of registrants to respond quickly to market changes and conditions, including the availability and price of technical and inert ingredients needed for formulations.
- One commenter had concerns with regard to the proposed changes to the inert ingredient disclosure statement, as EPA is “considering whether the notification method or the non-notification method is an appropriate avenue for industry requested inert disclosure based upon third-party vendor requirements.” The commenter stated that it “believes there is an approach that satisfies third-party vendors while minimizing the burden on the Agency’s resources,” and “a significant delay to this issue could have third-party vendor impacts.”
- Commenters also expressed disappointment with EPA’s notification delivery, stating that EPA “provided very little notice to Stakeholders of this major change in its policies regarding notification” and “as a result, many potentially affected registrants may overlook this change and fail to file comments on it.”
More information on this draft notice and other pesticide registration notice issues is available on our blog under key phrase Pesticide Registration Notice.
By Lynn L. Bergeson and Sheryl Lindros Dolan
On October 4, 2017, the U.S. Food and Drug Administration (FDA) announced the availability of final guidance that helps to clarify FDA and U.S. Environmental Protection Agency (EPA) jurisdiction over the regulation of mosquito-related products intended to function as pesticides, including those produced through the use of biotechnology. The notice was published in the Federal Register on October 5, 2017. 82 Fed. Reg. 46500. Guidance for Industry #236, “Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products” (Guidance), provides information for industry and other stakeholders regarding the regulatory oversight of articles, including substances, for use in or on mosquitoes (mosquito-related products). FDA states that it is providing the Guidance to clarify circumstances under which such products are regulated by FDA as new animal drugs under the Federal Food, Drug, and Cosmetic Act (FFDCA) and other circumstances under which such products are regulated by EPA as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Scope of Guidance
FDA notes that the Guidance is important in light of the public health urgency of countering the spread of mosquito-borne disease such as that caused by the Zika virus. While novel mosquito control technologies have gained greater attention, there has been confusion regarding FDA and EPA jurisdiction over such products. FDA, working collaboratively with EPA, is providing the Guidance to clarify the regulatory oversight of mosquito-related products. This includes, but is not limited to, those produced through biotechnology.
The Guidance includes the following examples of new animal drugs regulated by FDA:
- Products intended to reduce the virus/pathogen load within a mosquito, including reduction in virus/pathogen replication and spread within the mosquito and/or reduction in virus/pathogen transmissibility from mosquitoes to humans; and
- Products intended to prevent mosquito-borne disease in humans or animals.
Examples of pesticide products regulated by EPA are “[p]roducts intended to reduce the population of mosquitoes (for example, by killing them at some point in their life cycle, or by interfering with their reproduction or development).”
Guidance for Sponsors/Manufacturers of Products Intended for use on Mosquitoes
In the Guidance, FDA encourages sponsors of mosquito-related products, other than those that are “intended to prevent, destroy, repel, or mitigate mosquitoes by controlling a mosquito population,” to contact FDA early in the development process. FDA states that if a developer has a jurisdictional question, such as which agency or agencies would have oversight of a mosquito-related product that is expressly intended for both mosquito population control and human disease suppression, the developer may contact either or both agencies via the contacts listed. FDA and EPA will consult with each other on the jurisdictional question, “as is already common practice.” The agencies may suggest a joint meeting among EPA, FDA, and the sponsor to discuss appropriate pathways to market.
The guidance notes that FDA, EPA, and the U.S. Department of Agriculture (USDA) have committed to clarifying how the federal government intends to regulate genetically engineered insects as described in the September 2016 National Strategy for Modernizing the Regulatory System for Biotechnology Products. More information on the National Strategy is available in our September 21, 2016, memorandum White House Releases Proposed Update to the Coordinated Framework and National Strategy for Modernizing the Regulatory System for Biotechnology Products.
The new FDA guidance states that products intended to prevent mosquito-borne disease in humans or animals are regulated as new animal drugs subject to FDA jurisdiction, but products intended to control mosquito populations would be regulated by EPA as pesticides. That FDA and EPA are attempting to clarify their respective jurisdictions is appreciated. Potential commenters may wish to consider whether the guidance offers sufficient clarity for product development planning purposes. If “products intended to prevent mosquito-borne disease in humans or animals” are under FDA jurisdiction, the status of mosquito repellents currently registered by EPA that make claims about repelling mosquitoes that carry the Zika virus, the West Nile virus, or other viruses is unclear. Additionally, it would seem that the Oxitec mosquito is intended to reduce the mosquito population, among other goals. The Guidance is a good start, but further clarification likely will be needed to support emerging technologies.
More information is available in our memorandum FDA Guidance Addresses FDA and EPA Jurisdiction over Mosquito-Related Products.
By Sheryl Lindros Dolan and Heather F. Collins, M.S.
On September 29, 2017, the U.S. Environmental Protection Agency (EPA) announced the availability of two final test method Standard Operating Procedures (SOP) for evaluating the efficacy of antimicrobials against spores of Clostridium difficile (C. diff):
EPA also released regulatory guidance for test criteria and pesticide claims for these products, specifically “Methods and Guidance for Testing the Efficacy of Antimicrobial Products Against Spores of Clostridium difficile on Hard Non-Porous Surfaces.” EPA states that these test methods and guidance “provide a framework for registrants who seek to make a claim for antimicrobial pesticide products to control C. difficile spores on hard, non-porous surfaces.”
C. diff is an anaerobic, spore-forming bacterium and a frequent cause of hospital-acquired infections. The spores survive on hard surfaces such as glass, metals, and plastics that are commonly found in health-care settings. Hospitals and other health care facilities often use antimicrobial pesticides to reduce the number of spores on environmental surfaces. Registrants seeking antimicrobial product registrations with claims to control C. diff will need to carefully review these documents as they consider the efficacy data that EPA will likely require to support these claims, as well as the claims that can be made and supported for these products.
EPA MLB SOP MB-28 describes the test methodology for producing and storing standardized spore suspensions of C. diff based on ASTM E2839, Standard Test Method for Production of C. difficile Spores for Use in Efficacy Evaluation of Antimicrobial Agents (ASTM International). A spore suspension should be developed and qualified according to EPA MLB SOP MB-28 before an efficacy evaluation can be performed using method EPA MLB SOP MB-31. EPA MLB SOP MB-31 describes a quantitative method intended for evaluating the sporicidal efficacy of liquid disinfectants against spores of C. diff on inanimate, hard, non-porous surfaces.
EPA solicited comments on the clarity of the test method SOPs and the regulatory guidance in December 2016. EPA received comments from 12 entities. The primary areas of comment included the following:
- Test carrier interaction;
- Additional method validation;
- Verification testing;
- Soil load;
- Use of a standard setting organization to publish test methods;
- Proposed revisions to the guidance document; and
- Proposed revisions to the standard operating procedures.
EPA revised the drafts to incorporate suggested changes. EPA posted its response to those comments in Docket No. EPA-HQ-OPP-2016-0753-0026.
Some of the changes to the guidance document based on submitted comments include clarifying:
- Three batches of test product should be tested on independent test days;
- The inclusion of the three-part soil load is used for all test, control, and test system control carriers; and
- The current document supersedes the previous 2014 guidance document.
The new guidance proposes updated standard label claims and special instructions that are intended to provide greater clarity to the user community.
EPA’s response to comments and other documents associated with this action are available in Docket No. EPA-HQ-OPP-2016-0753 at www.regulations.gov. The methods and guidance also are found on EPA’s Antimicrobial Testing Methods & Procedures Developed by EPA's Microbiology Laboratory webpage, at the Methods tab as Method IDs MB-28 and MB-31, and at the Guidance tab as Sporicidal Claims Against Clostridium difficile.
C. diff is widely recognized as one of the most common causes of healthcare-acquired infection. C. diff infections, spread by transmission of bacterial spores, have proven difficult to prevent. EPA’s new guidance and test methods are intended to clarify the efficacy standards that pesticide products claiming to reduce C. diff spores must meet, as well as the associated claims that can be made. This guidance should bring more clarity to pesticide registrants seeking to register such products and to healthcare facilities in their identification of registered pesticide products that may help them to reduce C. diff spores and thus help with prevention efforts.
By J. Brian Xu, M.D., Ph.D., DABT®
On September 29, 2017, the Ministry of Agriculture of China (MOA) issued the final revisions to Data Requirements on Pesticide Registration (MOA Proclamation No. 2569). The revisions will become effective on November 1, 2017, under the new Regulation on Pesticide Administration (RPA) and Pesticide Registration Management Measures (MOA Order No. 3, 2017). The draft revisions to Data Requirements on Pesticide Registration were initially released for public comment on June 30, 2017. The new Data Requirements include 10 chapters and 14 annexes and a category of pesticides for specialty minor crops has been added. More information on China’s new pesticide regulations is available in our blog under key word China.
MOA Order No. 3, 2017 requires chemistry and toxicology tests to be completed in laboratories located in China approved by the MOA or overseas laboratories that have a mutual recognition agreement with the relevant Chinese Authority. The new Data Requirements on Pesticide Registration do not provide any additional information about the acceptance of data generated in overseas laboratories.
It remains unclear whether, for example, for literature or data prepared in a foreign language, entire study reports/articles, or only summaries, must be translated into Chinese. In addition, the final revision of Data Requirements on Pesticide Registration deletes the category of “Pesticides for Overseas Uses Only” that was set forth in the draft revision of Data Requirements on Pesticide Registration.
The new RPA, MOA Order No. 3, 2017, and the Data Requirements on Pesticide Registration significantly change the registration requirements and the registration process for pesticides in China. These new requirements, and the many ambiguities they contain, will likely extend the time for obtaining registrations and impose additional challenges on manufacturers to overcome, particularly foreign manufacturers who wish to bring pesticide products to the Chinese market.