Guidance and Reference Materials

Trade-off benefits of options for various approaches. Japan promoted incremental innovation (which introduces product patents & maintains reasonable drug prices, without discouraging innovation by domestic firms--coordinated policy instruments, i.e. narrow patent scope, adequate patentability, and cross-licensing). India’s new patent policy demonstrates that developing countries may want to shorten the exclusivity period on new drugs by, inter alia, raising the hurdle on patentability (which will strengthen the competitiveness of domestic firms in global generics markets, but may reduce incentives to invest in incremental innovation in domestic markets).

"Do FIFRA 2(ee) recommendations generally include rate of application requirements or is the user bound by label directions? LC09-0276; 8.13.09. A FIFRA 2(ee) recommendation may be made for a number reasons, one being the application of the pesticide at less than the label dosage, concentration or frequency. An applicator may apply the product at the use dilution listed on the label or at a lesser use dilution listed in the 2(ee) recommendation. An applicator has the option of applying at less than the use dilution listed on the label unless the label specifically prohibits such dilution. Note that for antimicrobial pesticides targeted against human pathogens, it is unlawful for any person selling or distributing these products to advertise uses permitted by FIFRA 2(ee)" "Section 2(ee) allows the use of a pesticide against any target pest not specified on the labeling as long as the site is identified on the label and there are no other label restrictions that would preclude use against the pest." "Persons may not make claims under section 2(ee) for antimicrobial pesticide products targeted against microbial human pathogens."

These policies and guidance resources are intended to assist companies that want to register an antimicrobial pesticide.

Antimicrobial pesticides are substances or mixtures of substances used to destroy or suppress the growth of harmful microorganisms such as bacteria, viruses, or fungi on inanimate objects and surfaces.

EPA ExpoBox is a toolbox for exposure assessors. Its purpose is to provide a compendium of exposure assessment and risk characterization tools that will present comprehensive step-by-step guidance and links to relevant exposure assessment data bases

OMB No.2070-0060; 2070-0174. This form is designed for reporting the ingredients used in the formulation of a pesticide product. It must be completed and submitted with each applicationfor new registration of a pesticide and application for amended registration if the revision involves a formula change.

"A cceptable efficacy data that supports claims for hospital/health care disinfection may be cited in the DCI response to support broad-spectrum disinfection claims"

"RfD is generally expressed mg/kg/day. RfD = NOAEL (or LOAEL or BMDL) / UFs" "(RfC), is used to assess inhalation risks for mg/m3" "This page provides the step-by-step instructions to how the EPA conducts a human health risk assessment with additional links to models, tools, databases and related products." "When there are alternative procedures having significant biological support, the Agency encourages assessments to be performed using these alternative procedures, if feasible, in order to shed light on the uncertainties in the assessment"

Product Performance Test Guideline, OCSPP 810.2000 "Examples of situations which do require the submission of confirmatory data:.. Identical Product Formulations. a formulation which is identical to a registered product that has complete supporting efficacy data, and the two products are not produced by the same manufacturer using the same production process. The chemical composition, label claims, and directions for use are identical in substance to those of the original registration, and specific references to the supporting data developed for the identical product are cited by the applicant. In this case, confirmatory data **are** needed to verify that the change in manufacturer (production process) does not impact the efficacy of the final product.""Failure of performance of registered formulations and claims is reportable" "Dilution of Products for Testing–Hard Water Guidance"

2020. Changes to the EPA safety assessment processes to include political review of proposed limits for human safety, rather than just review by scientists.

CDRH Databases: a listing of databases on a variety of topic of interest for CDRH stakeholders.

*****

If a suitable commercially available EPA-registered disinfectant is not available, only then may a suitable disinfectant approved for use under FIFRA section 18 (i.e., a Section 18 disinfectant) be used according to its Section 18 label.

{}Includes Potential Disinfectants to Use Against Foreign Animal Disease Agents in Farm Settings}

Emergency Exemptions: In some situations, a particular pathogen may not be listed on the product label of an EPA-registered disinfectant. In these cases, Section 18 of FIFRA authorizes EPA to grant exemptions to Federal agencies or States to use unregistered pesticides for a limited time, if EPA determines that emergency conditions exist. If granted, such exemptions would allow the use of non-registered pesticides or the “off-label” uses of a registered pesticide for a specified time period.

Electrostatic Spray Application Directions for Use to Antimicrobial Product Registrations. Products intended for use against the SARS-CoV-2, the novel human coronavirus that causes COVID-19

Unapproved prescription drugs pose significant risks to patients because they have not been reviewed by FDA for safety, effectiveness or quality.

"Once a product is registered by the EPA it can only make claims for what it has been tested for... also true... can only be used per label directions for the applications on the label of the product. A disinfectant can also be considered a ‘broad spectrum’ disinfectant meaning it has been tested against all three categories of bacteria, fungi and viruses. Specific bacteria, fungi and viruses must be tested to make this claim." "Cleaners on the other hand are not regulated or tested by the EPA for product registration... The EPA does have a list of ingredients it approves for use as cleaners, so they do regulate some aspects of cleaners to ensure their safety" "At no time can a ‘cleaner’ ever use the word ‘removes biofilm’." "it comes down to wordsmithing and how well you can label your products to not use any phrases that EPA does not allow on non-registered products."It does not depend on the surface being cleaned (porous, non-porous, water lines etc.) but it depends on the label and if the product is making claims.""The end user would be in jeopardy if it is using a registered product off label or not as intended based on usage label directions that brought harm to its animals. " "When mislabeling of a product like that occurs the EPA always goes after the manufacturer or distributor selling the product and NOT the end user. " "It has been stated in presentations and articles over the last couple of years from some companies that ALL products used to clean water lines without animals present must be EPA registered. It has also been stated that if you use a product that is not EPA registered to clean lines without animals present that you are violating federal law and could be fined and even incur jail time if found guilty for these "crimes"...

Grants for research and development, etc

****Grants for small businesses for COVID-19 development of technologies & products.

{Relaxes procedural sequences}

*****FDA recognizes the professional judgment of veterinarians, and permits the extralabel use of drugs by veterinarians under certain conditions.