CFAD v. Anacor, IPR2015-01776
`ANACOR EX. 2026 - 1/9
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`Pesticide
`Reregistration
`
`Use Profile
`
`United States
`Environmental Protection
`Agency
`
`Prevention, Pesticides
`And Toxic Substances
`(7508W)
`
`EPA-738-F-93-006
`September 1993
`
`R.E.D. FACTS
`
`Boric Acid
`
`All pesticides sold or used in the United States must be registered by
`EPA, based on scientific studies showing that they can be used without
`posing unreasonable risks to people or the environment. Because of
`advances in scientific knowledge, the law requires that pesticides which
`were first registered years ago be reregistered to ensure that they meet
`today's more stringent standards.
`In evaluating pesticides for reregistration, EPA obtains and reviews a
`complete set of studies from pesticide producers, describing the human
`health and environmental effects of each pesticide. The Agency imposes
`any regulatory controls that are needed to effectively manage each
`pesticide's risks. EPA then reregisters pesticides that can be used without
`posing undue hazards to human health or the environment.
`When a pesticide is eligible for reregistration, EPA announces this and
`explains why in a Reregistration Eligibility Decision (RED) document. This
`fact sheet summarizes the information in the RED document for boric acid
`and its sodium salts, which includes the seven active ingredients boric acid,
`sodium tetraborate decahydrate (borax decahydrate), sodium tetraborate
`pentahydrate (borax pentahydrate), sodium tetraborate (anhydrous borax),
`disodium octaborate tetrahydrate, disodium octaborate (anhydrous), and
`sodium metaborate.
`
`Pesticide products containing boric acid and its sodium salts are
`registered in the U.S. for use as insecticides, fungicides and herbicides. As
`insecticides, some act as stomach poisons in ants, cockroaches, silverfish
`and termites, while others abrade the exoskeletons of insects. As
`herbicides, some cause desiccation or interrupt photosynthesis in plants,
`while others suppress algae in swimming pools and sewage systems. As
`fungicides, several are wood preservatives which control decay-producing
`fungi in lumber and timber products.
`Boric acid and its sodium salts are used on several agricultural and
`many non-agricultural sites including residential, commercial, medical,
`veterinary, industrial, forestry and food/feed handling areas. They are
`marketed in many formulations including liquids, soluble and emulsifiable
`concentrates, granulars, powders, dusts, pellets, tablets, solids, paste, baits,
`and crystalline rods.
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`Regulatory
`History
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`Human Health
`Assessment
`
`The quantities of boric acid and its sodium salts applied as pesticides
`are modest compared to amounts used for other, non-pesticidal purposes.
`Further, boric acid, borax and boron-containing salts are ubiquitous in the
`environment. Boron occurs naturally in water, fruits, vegetables and forage
`crops, and is an essential nutrient for plants as well as an essential element
`for many organisms.
`
`Boric acid was first registered as a pesticide in the U.S. in 1948.
`Currently, 189 pesticide products are registered which contain boric acid or
`one of its sodium salts as an active ingredient.
`In February 1986, EPA issued two related documents dated November
`1985, the "Boric Acid and Boron Containing Salts Registration Standard"
`(NTIS #PB87-101903), and a General Registration Standard entitled,
`"Guidance for the Registration and Reregistration of End-Use Pesticide
`Products Containing the Insecticidal Uses of Boric Acid." About 43 boric
`acid products, used indoors for cockroach and silverfish control, were
`reregistered under the General Registration Standard. Producers of those
`products need only submit current labels and Confidential Statements of
`Formula for the products to remain reregistered.
`EPA has determined that, because they are of low toxicity and occur
`naturally, boric acid and its sodium salts should be exempted from the
`requirement of a tolerance (maximum residue limit) for all raw agricultural
`commodities. The Agency has established such exemptions and removed
`the previously established tolerances for residues of boric acid and certain
`derivatives in cotton seed and citrus fruits (please see 58 FR 44282); two
`other derivatives will be similarly exempted soon. Because boric acid is
`registered for crack and crevice use in food and feed handling
`establishments, the potential exists, though unlikely, for residues to occur in
`food. EPA therefore is establishing food and feed additive tolerances for
`boric acid and its sodium salts.
`In developing this RED, the active ingredient sodium metaborate was
`added from another reregistration case. Also, this RED originally was to
`have included boric oxide as an active ingredient. However, since no
`registered products currently contain that active ingredient, it is not
`included.
`
`Human Toxicity
`The toxicity of boric acid and its six sodium salts are expected to be
`similar. Information on the effects of these boron-related compounds in
`humans, supplemented by data from laboratory animal studies, were used by
`EPA to evaluate their toxicity.
`Boric acid generally is of moderate acute toxicity, and has been placed
`in Toxicity Category III for most acute effects including oral and
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`dermal toxicity, and eye and skin irritation. Sodium tetraborate (anhydrous
`borax) products have been placed in Toxicity Category I indicating a high
`degree of acute toxicity for eye irritation effects.
` A subchronic borax feeding study using dogs resulted in blood and
`metabolism disorders as well as effects to the testes, endocrine system, brain
`weight, and size ratios among various organs and glands.
`In chronic oncogenicity studies using mice, rats and beagle dogs, boric
`acid and borax were found not to be carcinogenic; however, testicular
`effects and decreases in body weight resulted at high dose levels. EPA has
`classified boric acid as a "Group E" carcinogen, indicating that it shows
`"evidence of noncarcinogenicity" for humans.
`In reproductive and developmental toxicity studies using rats, mice
`and rabbits, maternal liver and kidney effects and decreased weight gain as
`well as decreased fetal body weights were observed. In two studies, at the
`highest dose levels, no litters were produced. Prenatal mortality occurred at
`the highest dose levels in the rabbit study. Boric acid does not cause
`mutagenicity.
`Dietary Exposure
`Tolerances were established for residues of boron resulting from the
`use of boric acid and its sodium salts on cottonseed (30 ppm) and citrus
`fruits, postharvest (8 ppm) (please see 40 CFR 180.271.) EPA's review of
`new toxicology studies raised no concerns. Further, boron occurs naturally
`in fruits and vegetables at much higher levels (200 to 300 ppm in red
`cabbage). Therefore, the Agency is exempting these compounds from the
`requirement of a tolerance and revoking the existing tolerances. EPA is
`establishing food/feed additive regulations to cover the use of boric acid
`salts for crack and crevice treatments at food and feed handling
`establishments (please see 58 FR 44282, and a soon-to-be-issued Federal
`Register notice).
`Occupational and Residential Exposure
`Boric acid and its sodium salts are applied both indoors and outdoors,
`in residential, commercial, medical, veterinary and industrial areas, in food
`handling establishments, in swimming pools and sewage systems, in lakes,
`ponds and reservoirs, and in treating wood. Depending on the use site,
`boric acid may be applied using aircraft, a spreader, airblower, power
`duster, squeeze applicator, aerosol can or knife/spatula. The potential for
`dermal and inhalation exposure exists among applicators and people
`reentering treated areas.
`As a prudent measure to reduce any potential risks to handlers, EPA is
`requiring that all products containing boric acid and its sodium salts (except
`products for residential use) bear personal protective equipment (PPE) re-
`quirements. These must consist of at least the use of a long-sleeved shirt,
`long pants, shoes, socks and chemical-resistant gloves.
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`Environmental
`Assessment
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`If end-use product labeling already bears PPE requirements that are more
`protective than these items, the more protective requirements must be
`retained.
`The Worker Protection Standard (WPS) for Agricultural Pesticides
`(40 CFR 156 and 170) established an interim restricted-entry interval (REI)
`of 12 hours for boric acid and its sodium salts. EPA is retaining this REI
`for uses within the scope of the WPS, as a prudent risk mitigation measure
`to protect workers. During the REI, workers may enter treated areas only
`under the few narrow exceptions allowed in the WPS.
`Human Risk Assessment
`Dietary risk is not a concern with boric acid and its sodium salts since
`no direct food uses are registered and tolerances have been revoked. Appli-
`cators and others in treatment areas may be exposed to boric acid and its
`sodium salts during or after application. However, there is no reasonable
`expectation that these pesticide uses may constitute a hazard or risk to
`people involved in, or near to, handling or application activities. Proper
`care and adhering to label directions and precautions should reduce exposure
`and any associated risk.
`
`Environmental Fate
`No new environmental fate data are required for reregistration of
`boric acid and its sodium salts because only relatively small amounts of
`boric acid are used as pesticides, and significant amounts of boron are
`present naturally in soil and water. Surface soil contains relatively high
`levels of boron. Boron salts occur naturally in low concentrations in most
`unpolluted waterways (both surface water and seawater). In some areas,
`boron occurs in surface waters in concentrations that have been shown to be
`toxic to commercially important plants.
`Ecological Effects
`Available studies indicate that technical boric acid is practically
`nontoxic to birds, fish and aquatic invertebrates, and relatively nontoxic to
`beneficial insects. The boric acid rights-of-way herbicide use pattern poses
`a potential risk to aquatic invertebrates, including some that are endangered.
`However, risk probably is mitigated by the practice of limiting treatment to
`small strips of land, thereby limiting the amount of contaminated runoff into
`adjacent aquatic environments.
`Boric acid's noncrop herbicidal use also may harm endangered or
`threatened plants. EPA is requiring three phytotoxicity studies (seed
`germination, seedling emergence and vegetative vigor) to assess these risks.
`EPA is deferring endangered species labeling requirements until the Agency
`publishes the Endangered Species Protection Program plan and guidance for
`registrants. Labeling will refer users to county bulletins for area-specific
`use limitations.
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`Additional Data
`Required
`
`Product Labeling
`Changes Required
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`Ecological Effects Risk Assessment
`EPA's concerns regarding risks to birds, fish and wildlife species are
`minimal. Boric acid's limited outdoor use patterns, low toxicity, and
`natural presence in terrestrial and aquatic environments are mitigating
`factors for any potential risk to nontarget organisms.
`
`EPA is requiring three phytotoxicity studies to further assess the risks
`of boric acid and its sodium salts to non-target plants and endangered plant
`species. However, these studies are not part of the target data base and do
`not affect the reregistration eligibility of boric acid and related active
`ingredients. The Agency also is requiring product-specific data including
`product chemistry, acute toxicity and efficacy studies, revised Confidential
`Statements of Formula, and revised product labeling for reregistration.
`EPA already has reregistered all 43 boric acid products covered by the
`General Registration Standard. For these products, only current labeling
`and Confidential Statement of Formulas must be submitted to ensure that
`they still meet the criteria set forth in that document.
`
`The labeling of all end-use products containing boric acid and its
`sodium salts must comply with EPA's current pesticide labeling
`requirements. In addition:
`þ Compliance with Worker Protection Standard (WPS) - Any product
`whose labeling permits use in the production of an agricultural plant on any
`farm, forest, nursery or greenhouse must comply with the labeling require-
`ments of:
`• PR Notice 93-7, "Labeling Revisions Required by the Worker
`Protection Standard (WPS)," and
`• PR Notice 93-11, "Supplemental Guidance for PR Notice 93-7."
`Unless specifically directed in the RED, all statements required by these two
`PR Notices must appear on product labeling exactly as instructed in the
`Notices. Labels must be revised by April 21, 1994, for products distributed
`or sold by the primary registrant or supplementally registered distributors,
`and by October 23, 1995, for products distributed or sold by anyone.
`þ Personal Protective Equipment (PPE) Requirements
`Products NOT Primarily Intended for Home Use
`The PPE requirement for handlers of all end-use products except those
`intended primarily for home use is:
`"Applicators and other handlers must wear:
`--Long-sleeved shirt and long pants
`--Chemical-resistant or waterproof gloves*
`--Shoes plus socks
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`* The glove statement is that established through the instructions in
`Supplement Three of PR Notice 93-7."
`Registrants must compare the PPE requirements in this section with
`those on their product labeling, and retain the more protective PPE.
`Products Primarily Intended for Home Use
`No new PPE requirements need to be added. However, any PPE
`requirements on current product labeling must be retained.
`þ Entry Restrictions
`Products NOT Primarily Intended for Home Use
`þ Uses Within the Scope of the WPS: A 12-hour restricted entry
`interval (REI) is required for all uses within the scope of the WPS,
`except on products intended primarily for home use. The PPE for
`early entry should be that required for applicators of boric acid and its
`sodium salts, except that the requirement for an apron or respirator is
`waived. Registrants should insert this REI and PPE into the
`standardized statements required by PR Notice 93-7.
`• Sole Active Ingredient Products: Must be revised to adopt
`the entry restrictions set forth in this section, and any conflicting
`entry restrictions on current labeling must be removed.
`• Multiple Active Ingredient Products: Registrants must
`compare the entry restrictions set forth in this section to the
`entry restrictions on their current labeling and retain those which
`are more protective. A specific time period in hours or days is
`considered more protective than "until sprays have dried" or
`"dusts have settled."
`þ Uses Not Within the Scope of the WPS: No new entry restrictions
`must be added. However, any entry restrictions on current product
`labeling must be retained.
`Products Primarily Intended for Home Use
`No new entry restrictions need to be added. However, any entry
`restrictions on current product labeling must be retained.
`þ Products Under the General Boric Acid Registration Standard
`Labels must comply with the format labels issued with the Standard.
`Five copies of current labeling must be submitted.
`þ Products Not Under the General Registration Standard
`Labels must bear the following Environmental Hazards statements, if
`appropriate:
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`þ Terrestrial Food and Feed Use and Non-Crop Products
`"Do not apply directly to water, or to areas where surface water
`is present or to intertidal areas below the mean high-water mark.
`Do not contaminate water when disposing of equipment
`washwaters or rinsate."
`þ Indoor Use Products with Effluent
`"Do not discharge effluent containing this product into lakes,
`streams, ponds, estuaries, oceans or other waters unless in
`accordance with the requirements of a National Pollutant Dis-
`charge Elimination System (NPDES) permit and the permitting
`authority has been notified in writing prior to discharge. Do not
`discharge effluent containing this product to sewer systems
`without previously notifying the sewage treatment plant
`authority. For guidance, contact your State Water Board or
`Regional Office of the EPA."
`Labels with uses on carpets and floors to combat fleas, cockroaches,
`ants and silverfish must bear the following under Directions for Use:
`þ Use Restrictions
`"Children and pets should not be in treatment area until after
`application is completed. Do not treat pets with this product.
`Avoid contamination of feed and foodstuff. Avoid
`contamination of ornamental plants."
`þ Carpets
`"Apply to dry surfaces only. Apply directly on carpets where
`pets frequently traffic or sleep. Work powder deeply into fibers
`and mat with a broom or rug rake. Any powder visible after
`application must be brushed into carpet fibers or removed."
`þ Upholstery
`"Remove loose cushions. Apply along creases and into corners
`and furniture wells. Do not apply product to exposed fabric.
`Any product visible after application must be removed."
`
`Regulatory
`Conclusion
`
`The use of currently registered pesticide products containing boric
`acid and its sodium salts in accordance with approved labeling will not pose
`unreasonable risks or adverse effects to humans or the environment.
`Therefore, all uses of these products are eligible for reregistration. These
`products will be reregistered once the required product-specific data,
`Confidential Statements of Formula and revised labeling are received and
`accepted by EPA.
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`For More
`Information
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`Boric acid products that already have been reregistered under the
`General Registration Standard will remain reregistered as long as current
`labeling and Confidential Statements of Formula are submitted, and demon-
`strate that these products still meet the criteria set forth in the Standard.
`Boric acid products which also contain other active ingredients will be
`reregistered only after the other active ingredients are determined to be
`eligible for reregistration.
`
`EPA is requesting public comments on the Reregistration Eligibility
`Decision (RED) document for boric acid and its sodium salts during a 60-
`day time period, as announced in a Notice of Availability published in the
`Federal Register. To obtain a copy of the RED document or to submit
`written comments, please contact the Pesticide Docket, Public Response and
`Program Resources Branch, Field Operations Division (7506C), Office of
`Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
`703-305-5805.
`Following the comment period, the boric acid RED document will be
`available from the National Technical Information Service (NTIS), 5285
`Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
`For more information about EPA's pesticide reregistration program,
`the boric acid and its sodium salts RED, or reregistration of individual
`products containing these active ingredients, please contact the Special
`Review and Reregistration Division (7508W), OPP, US EPA, Washington,
`DC 20460, telephone 703-308-8000.
`For information about the health effects of pesticides, or for assistance
`in recognizing and managing pesticide poisoning symptoms, please contact
`the National Pesticides Telecommunications Network (NPTN). Call toll-
`free 1-800-858-7378, between 8:00 am and 6:00 pm Central Time, Monday
`through Friday.
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