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By Lisa M. Campbell and Lisa R. Burchi

On Thursday, April 30, 2015, the U.S. Environmental Protection Agency (EPA) issued interim guidance that it intends to clarify its toxicology data requirements for antimicrobial pesticides used on food contact surfaces.  In addition, EPA issued a letter to antimicrobial registrants that EPA states is intended “to summarize how the Agency has been implementing 158W with respect to existing registered antimicrobial pesticides, as well as new and pending antimicrobial pesticide applications.” 

The interim guidance is intended to satisfy a condition of the March 2, 2015, settlement agreement between EPA and the American Chemistry Council (ACC), which followed ACC’s July 2013 initiation of a legal challenge to the antimicrobial data requirements (subpart 158W of Title 40 of the Code of Federal Regulations) in the U.S. Court of Appeals in the District of Columbia.  The settlement agreement is discussed here. 

In the settlement, EPA agreed to issue, within 60 days of the Agreement becoming final, an interim guidance document explaining EPA’s interpretation of the 200 parts per billion (ppb) residue level above which additional toxicology testing would be required for indirect food uses. 

The interim guidance states with regard to the 200 ppb standard: 

No later than September 2, 2017, the Agency will propose a correction to 40 CFR Part 158W to make the rule’s language as it pertains to the 200 ppb level established in 40 C.F.R. § 158.2230(d) consistent with the U.S. Food and Drug Administration’s use of that same level. The proposal will be to clarify that the 200 ppb level established in the rule is based on total estimated daily dietary intake, and is not based on the amount of residue present on only a single commodity. The Agency is providing this interim guidance to registrants that the referenced 200 ppb level is based on total estimated daily dietary intake rather than on the amount of residue present on only a single commodity.

EPA states that this interpretation is consistent with the U.S. Food and Drug Administration’s (FDA) policy.  In general, if pesticide residues in food resulting from use on food contact surfaces are 200 ppb or less, EPA requires certain toxicology data.  If residues are greater than 200 ppb, additional data may be required, depending on other conditions such as test results.

Also in the settlement, EPA agreed to propose, within four months of the Agreement becoming final, a guidance document entitled Antimicrobial Pesticide Use Site Index (USI), and provide a 30-day comment period.  The USI guidance will provide descriptions of direct food uses, indirect foods uses, and nonfood uses.  The letter states the following regarding its development of the USI guidance:

The Agency is developing a guidance document called the Antimicrobial Pesticide Use Site Index (USI) that will serve as a compilation of existing use sites and will identify how each use site fits within the twelve use patterns established in 158W.  The guidance document will serve to assist prospective registrants with the application requirements by making it easier for them to identify which data are necessary to register their product(s). 

EPA’s letter also discusses the following regarding existing and pending antimicrobial pesticide applications:

  • EPA may find it necessary, “in the context of, but not limited to, the requirements in 158W,” to call in data as each active ingredient is evaluated under the Registration Review program.  EPA does not intend to conduct this generic evaluation for new products or applications to amend existing products that are covered in Pesticide Registration Improvement Extension Act (PRIA3) fee category Table 9 -- Antimicrobial Division -- New Products and Amendments.
  • During early implementation of the 158W requirements, EPA recognizes that not all new applications will have all the newly-required data.  EPA may thus find it appropriate to issue Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(c)(7) conditional registrations and set a deadline for the submission of the required data.
  • Any application submitted after July 8, 2013 (the effective date of the 158W requirements) must contain the required data or an adequate justification for any data requirements not submitted.  On the issue of timing, applicants should explain why any data are not yet submitted and when the data can be submitted.  Failure to submit required data or provide an adequate justification will result in EPA rejecting the application as incomplete under the 45/90 day preliminary technical screen under the Pesticide Registration Improvement Act (PRIA).

The settlement agreement and additional documents are available at http://www2.epa.gov/pesticide-registration/epa-data-requirements-registration-antimicrobial-pesticides-part-158w#interim and www.regulations.gov in docket EPA-HQ-OPP-2008-0110.  More information on antimicrobial policies and guidance is available here.


 

By Lisa M. Campbell and Lisa R. Burchi

The U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) have executed a Memorandum of Understanding (MOU) on Information Sharing regarding the sharing of data and other confidential information related to substances that may be present in human food, animal food and feed, animal drugs, and cosmetics. EPA and FDA state in the MOU that the sharing of such information will “open[] channels of communication between the agencies” and will “serve to facilitate [EPA and FDA’s] accomplishment[s] of their respective missions.” The MOU sets forth the safeguards to be implemented with regard to the sharing of confidential information to “protect against unauthorized use or disclosure of any non-public information shared or exchanged pursuant to this MOU.”

EPA and FDA’s decision to share information will have a direct impact on companies with substances that have pesticidal and non-pesticidal applications. As noted in an example in the MOU, an antimicrobial food wash that can also be a labeled pesticide for other uses could have data submitted to FDA demonstrating that the product’s use is safe and does not adulterate food and data submitted to EPA demonstrating that the pesticide will not cause unreasonable adverse effects on the environment. Companies that have submitted information to EPA and FDA should be mindful of the potential that such information could be shared between the agencies, and consider whether additional safeguards or data compensation protection may be needed.
 


 

By Lisa M. Campbell and Lisa R. Burchi

On March 2, 2015, the United States Environmental Protection Agency (EPA) and the American Chemistry Council (ACC) executed a settlement agreement (Agreement) following the ACC’s petition for judicial review of EPA’s antimicrobial pesticide data requirements final rule issued on May 8, 2013 (78 Fed. Reg. 26936). The judicial review proceeding was held in abeyance while settlement discussions were pursued between EPA and ACC for this final rule, entitled “Data Requirements for Antimicrobial Pesticides.”

In the settlement, EPA agreed to propose, within four months of the Agreement becoming final, a guidance document entitled Antimicrobial Pesticide Use Site Index (USI), and provide a 30-day comment period. The USI guidance will provide descriptions of direct food uses, indirect foods uses, and nonfood uses.

In addition, EPA agreed to issue, within 60 days of the Agreement becoming final, an interim guidance document explaining EPA’s interpretation of the 200 parts per billion (ppb) residue level above which additional toxicology testing would be required for indirect food uses. Then, within two years and six months of the Agreement becoming final, EPA agreed to propose a correction to the final rule that “will make the language of the Final Rule as it pertains to the 200 ppb level established in 40 C.F.R. § 158.2330(d) consistent with the U.S. Food and Drug Administration’s use of that same level by making clear that the 200 ppb level established in the Final Rule is based on total estimated daily dietary intake, and is not based on the amount of residue present on only a single commodity.”
  

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By Lisa M. Campbell and Lisa R. Burchi


On February 27, 2015, the California Department of Pesticide Regulation (DPR) released California Notice 2015-3, entitled Concurrent Submission of Pesticide Products to the Department of Pesticide Regulation and the U.S. Environmental Protection Agency. In this Notice, DPR describes the four types of applications that may be submitted concurrently to DPR and to the U.S. Environmental Protection Agency (EPA), the procedure applicants should follow to request concurrent submission, and how DPR will process such requests.

This notice supersedes California Notice 2005-10, and there are some changes. For example, Notice 2015-3 now includes a process for an applicant to seek concurrent submission when the application is not one of the four specified types for which concurrent submission is permitted. Under this new procedure, the applicant must send a letter requesting approval to the Pesticide Registration Branch Chief before submitting an application to DPR and provide the following: (1) a statement that the product/amendment is not yet federally registered or accepted; (2) a request for concurrent acceptance of the application; and (3) justification with supporting documentation for the concurrent submission request (e.g., no other effective alternatives available for a specific pest problem). In addition, regarding data submissions with an application, DPR now states clearly: “All data and information required by California statutes and regulations, including all data and information submitted to U.S. EPA, must still be submitted with your California registration request.”
 


 

By Lisa R. Burchi

The European Commission (EC) Standing Committee on Plants, Animals, Food and Feed has issued a guidance document entitled Draft Guidance Document on the Interpretation of the Transitional Measures for the Data Requirements for Chemical Active Substances and Plant Protection Products according to Regulation (EU) No. 283/2013 and Regulation (EU) No. 284/2013. Following the adoption in 2009 of Regulation (EC) No. 1107/2009 concerning the placing of plant protection products (PPP), additional regulations were adopted to establish the necessary data requirements for active substances and PPPs. In 2013, Regulation (EU) No. 283/2013 (amended by Regulation (EU) No. 1136/2014) updated the data requirements for active substances, while Regulation (EU) No. 284/2013 updated data requirements for products. These Regulations include transitional measures to explain when certain applications can rely upon former data requirements and when the updated data requirements must be satisfied.

The Guidance provides two charts describing the transitional measures for: (1) applications for approval, renewal, or approval or amendment of approval of Active Substances; and (2) applications for authorization, renewal of authorization, or amendment of authorization of Plant Protection Products. Each chart describes the type of application at issue and the resulting data requirements. For authorization applications, the Guidance divides the types of applications and resulting data requirements into four active substances categories: (1) AIR-2 active substances; (2) AIR-3 active substances/substances not yet renewed; (3) new active substances; and (4) mixtures.

The Guidance was developed to assist EU Member States in consistently applying and interpreting these transitional measures. Many of the data requirement decisions depend on the type of active substances and whether an application is submitted before or after December 31, 2015, so companies considering or planning to submit applications should review the Guidance carefully to determine what data requirements may be applicable.
 


 
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