" 'Stop Sale, Use, or Removal' orders" from EPA

****!!!!**** {Broad range of foundational info} "A 70 kg person could safely ingest 0.05 mg of chlorite x 70 kg... per day"

**** (2007)

****!!!!**** "Notice to permanently exempt or proposing to permanently exempt certain class I and class II medical devices from the premarket notification requirement in section 510(k) of the Food, Drug, and Cosmetic Act, 21 U.S.C. 360(k). Under this notice, the Department is immediately making permanent the exemption of 7 class I device classes from the section 510(k) requirement and proposes to exempt an additional 84 class II and unclassified device classes from the same requirement on a permanent basis. These 91 devices were all subject a 510(k) waiving during the PHE."

****!!!!**** {Summary with well-divided reference sections} View osha standards for chlorine dioxide in WISER. "Vacated 1989 OSHA PEL TWA 0.1 ppm (0.3 mg/cu m); STEL 0.3 ppm (0.9 mg/cu m) is still enforced in some states."

{Safety standards for inhaled air} "TLV-TWA guidelines that are levels that should not be exceeded during any 8-hour workday of a 40- hour workweek" "TLV-STEL guidelines which are 15-minute exposure levels that should not be exceeded during a workday."

****!!!!****!!!** {Includes Fast Track Approvals, etc} "reports on New Drug Application (NDA)"

"intended for use in water and ice at an at-use concentration between 13 and 26 ppm. Any seafood that is intended to be consumed raw shall be subjected to a potable water rinse prior to consumption."

This web page provides resources to guide someone new to the pesticide registration process. It includes links to web pages where you can find more information as you get started.

******!!!!***This site provides resources for an individual or company wanting to register a pesticide active ingredient or pesticide product in the United States. Features: a manual (blue book), other guidance, and coordinated lists of requirements by pesticide type.

******!!!!**** TITLE 40—Protection of Environment CHAPTER I—ENVIRONMENTAL PROTECTION AGENCY SUBCHAPTER E—PESTICIDE PROGRAMS

Jan 2021

1994

"ensure OTC manufacturers have the flexibility to innovate, improve and meet the challenges of developing and sustaining current monographs."

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"CDER highlights key Web sites. Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics providers reporting."

{OSHA definition of "working life" number of years for chronic exposure limits} "The OSH Act requires OSHA to set the standard that most adequately protects employees against harmful workplace exposures for the period of their ‘‘working life’’ (29 U.S.C. 655(b)(5)). OSHA’s longstanding policy is to define ‘‘working life’’ as constituting 45 years; thus, it assumes 45 years of exposure when evaluating the risk of material impairment to health caused by a toxic or hazardous substance."

"EPA applications/systems, statutes/regulations, or other sources that track or regulate this substance. "

Explanation of requirements under FIFRA for importing and exporting pesticides.

"is misbranded if its labeling is false or misleading in any particular including both pesticidal and non-pesticidal claims... A false or misleading statement concerning the effectiveness of the product as a pesticide or device... A false or misleading statement about the value of the product for purposes other than as a pesticide or device;" "Claims as to the safety of the pesticide or its ingredients, including statements such as “safe,” “nonpoisonous,” “noninjurious,” “harmless” or “nontoxic to humans and pets” "net content shall be stated in terms of the largest suitable units" "shall be the average content unless explicitly stated as a minimum quantity" "The label bears a reference to the directions for use in accompanying leaflets or circulars, such as “See directions in the enclosed circular:”" "The directions for use shall include..." "“Not for sale or use after [date].”"

****!!!!**** "Refillable container. Refill this container with [common chemical name] only. Do not reuse this container for any other purpose.”

***!!!!*** "it is unlawful “to detach, alter, deface, or destroy, in whole or in part, any labeling required [under FIFRA].” Putting the copied mixing directions on another product is considered labeling and must be done in a registered establishment and in accordance with the registration of the product to which the sticker is added" "the warehouse where the labeling is taking place must be registered as a pesticide producing establishment" "distributor must complete a signed Notice of Supplemental Distribution of a Registered Pesticide Product (EPA form 8570-5), however, the form can contain more then one brand name" "A distributor may not place a tag or sticker to a product " "container the unlabeled pesticides are shipped in must bear the label of the registered product." "The other substances you list may be both registered for pesticidal use or available unregistered for non-pesticidal uses. While the Agency does regulate the ***sale and distribution of unregistered pesticides, it does not regulate the ***personal use of unregistered pesticides. The personal use of products that are not registered pesticides – such as ammonia, ***bleach, kerosene, gasoline – may be dangerous, but it is not a violation of FIFRA." "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." "At a minimum, the front panel must contain the following information: Restricted Use Product statement (if applicable)... Product Name, Brand or Trademark... Ingredient Statement... Keep Out of Reach of Children Statement... Signal Word... First Aid (or referral statement... Skull & Crossbones Symbol and the word Poison (if applicable)... In addition, generally the net weight or contents also appears on the front panel." "Agency recommends that the shipping container be labeled with enough information for emergency personnel" "minimum requirements for booklet labels" "Generally, it is not acceptable to print the required label items only on the "blister card"" "Because the strips themselves are the pesticide product, they do not need to be individually labeled because 40 CFR 156.10(a)(4) requires labels to be securely attached to the immediate container of the product and not the product itself." "EPA does not have requirements for statements included on such a technical bulletin [marketing brochure] that is not a part of the labeling. However, it must not have claims that differ from the product label." "All states, under individual state laws, require that pesticides be registered in their state before they can be sold and distributed" "skin sensitization procedures state the highest nonirritating dose be used for the... tests" "It is not permissible to list a specific application rate on the distributor product labeling when the application rates on the registered primary product appear in a range." "Agency may determine a product is a pesticide, and therefore requires a registration, regardless of the product's label claims." "Suggestive terms such as "should," "may" or "recommend" may be confusing " "The language "For Industrial/Institutional/Commercial Use Only" does not prohibit a product's sale to consumers for household use." "labeling an empty container as described does not have to be done in a registered establishment [although other FIFRA requirements may apply if container is later filled before sale]" "If, however, the MSDS accompanies the pesticide at any time, it is considered labeling and must not conflict with the labeling EPA has approved" "pesticide being exported" "advises against directions for use that call for use of more than the net content" "do-it-yourself store would have to register as a producing establishment" "if the kit is considered anything more than the combination of separately named products (i.e., when the kit is marketed with its own distinct name), the kit must be registered" "states cannot require labeling different from the federally-approved label" "If you buy a product from a company and repackage it to smaller quantities for resale, how do you use the parent company's label" "TIf the individual items bear an abbreviated label, they must refer to further directions on the outer container" "Such stickering must occur at a registered establishment and be recorded per the requirements of 40 CFR Part 167." "for minimum risk pesticide... the term “antibacterial” is considered to be an impermissible public health claim, whereas the term “antimicrobial” is not." "Products that are exempt from Federal regulation under FIFRA Section 25(b) are still subject to state regulation" "certain food or food-like fragrances and/or graphics on an antimicrobial label could make the product attractive to children" "The picture or image cannot be in conflict with any label text." "may correct labels by adding stickers... The sticker must be applied in a registered establishment, the relabeling must be reported" "importing a substance for research and development" "If a product is manufactured as a topical antiseptic on human skin, (regulated by FDA) and also as a hard surface disinfectant (regulated by EPA), can the uses be combined on a single label...?" "Certain categories of products... need not be registered unless they contain a pesticidal claim... Deodorizers, bleaches, and cleaning agents..." "products for use against microorganisms intended for use on or in living animals are not subject to EPA regulation. They instead are within the jurisdiction of FDA" "The term “anti-bacterial” is also considered to be a public health claim which would require efficacy data" "label or immediate container must bear the establishment number of the establishment where the final production step occurred" "the label of a pesticide manufactured only for export does not need to be approved by EPA" "If the approved label(s) is visible through the outer packaging (e.g. visible through shrink-wrap), or if the outer packaging is an exact replica of the approved label(s), EPA does not need to review the kit label... when the kit is marketed with its own distinct name), the kit must be registered" "Intent for a pesticidal purpose is considered on a case-by-case basis and the Agency may determine a product is a pesticide, and therefore requires a registration, regardless of the product's label claims."

2018 June. "Like acidified sodium chlorite and hypochlorous acid, CDO gas has the added potential to offer handling operations a material that has strong antimicrobial properties on irregular surfaces, may reduce water use, and appears compatible with the fundamental principles of organic production."

****** "A product should be approved by EPA to inactivate at least one large or one small non-enveloped virus to be eligible for use against an enveloped emerging viral pathogen." "viral families in the ***small non-enveloped subgroup: (1) Picornaviridae, (2) Parvoviridae, (3) Caliciviridae, (4) Astroviridae, and (5) Polyomaviridae.... ***large non-enveloped subgroup: (1) Adenoviridae, (2) Reoviridae, and (3) Papillomaviridae... ***enveloped subgroup: (1) Arenaviridae, (2)Bornaviridae, (3) Bunyaviridae, (4) Coronaviridae, (5) Filoviridae, (6) Flaviviridae, (7) Hepadnaviridae, (8) Herpesviridae, (9) Orthomyxoviridae, (10) Paramyxoviridae, (11) Poxviridae, (12) Retroviridae, (13) Rhabdoviridae, and (14) Togaviriedae."