15958 Federal Register / Vol. 68, No. 63 / Wednesday, April 2, 2003 / Rules and Regulations Commodity Parts per million Beet, sugar, molasses .............. 2.0 Beet, sugar, roots ..................... 0.5 Beet, sugar, tops ...................... 15.0 Grass, forage ............................ 10.0 Grass, hay ................................ 0.2 Spinach ..................................... 0.5 Sunflower, seed ........................ 0.5 Sunflower, meal ........................ 1.0 Tomato ...................................... 0.1 * * * * * [ FR Doc. 03   7800 Filed 4   1   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2002   0328; FRL   7286   9]

Bacillus pumilus GB 34; Exemption from the Requirement of a Tolerance AGENCY: Environmental Protection Agency ( EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of the Bacillus pumilus GB 34 when used as a seed treatment in or on soybeans and soybeans after harvest. Gustafson LLC submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act of 1996 ( FQPA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Bacillus pumilus GB 34.

DATES: This regulation is effective April 2, 2003. Objections and requests for hearings, identified by docket ID number OPP   2002   0328, must be received on or before June 2, 2003.

ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit IX. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Anne Ball, Biopesticides and Pollution Prevention Division ( 7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   8717; e mail address: ball. anne@ epa. gov.

SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:   Industry ( NAICS 111), e. g., crop production   Industry ( NAICS 112), e. g., animal production   Industry ( NAICS 311), e. g., food manufacturing   Industry ( NAICS 32532, e. g., pesticide manufacturing This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of This Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2002   0328. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr180_ 00. html, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http:// www. epa. gov/ opptsfrs/ home/ guidelin. htm. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search'' then key in the appropriate docket ID number.

II. Background and Statutory Findings In the Federal Register of December 31, 2001 ( 66 FR 67522) ( FRL   6813   8), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U. S. C. 346a( e), as amended by FQPA ( Public Law 104   170), announcing the filing of a pesticide tolerance petition ( PP 1F6344) by Gustafson LLC, 1400 Preston Road, Suite 400, Plano, TX 75093. This notice included a summary of the petition prepared by the petitioner Gustafson LLC. There were no comments received in response to the notice of filing. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of B. Pumilus GB 34.

III. Risk Assessment Section 408( c)( 2)( A)( i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance ( the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is `` safe.'' Section 408( c)( 2)( A)( ii) of the FFDCA defines `` safe'' to mean that `` there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408( b)( 2)( C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to `` ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....'' Additionally, section 408( b)( 2)( D) of the FFDCA requires that the Agency consider `` available information''

VerDate Jan< 31> 2003 11: 50 Apr 01, 2003 Jkt 200001 PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 02APR1. SGM 02APR1 15959 Federal Register / Vol. 68, No. 63 / Wednesday, April 2, 2003 / Rules and Regulations concerning the cumulative effects of a particular pesticide's residues and `` other substances that have a common mechanism of toxicity.'' EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

IV. Toxicological Profile Consistent with section 408( b)( 2)( D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness, and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The Bacillus pumilus species was first described by Meyer and Gottheil in 1901. This naturally occurring species is one of the most numerous Bacillus sp. found on plant surfaces. The strain Bacillus pumilus GB 34 is a naturally occurring soil colonizer. The mode of action of the strain, an anti fungal agent, is to colonize the developing root system of the plant it is to protect, in this case the developing root system of the soybean plant. The organism Bacillus pumilus GB 34 then suppresses by competition, by the formation of a physical barrier, the continued formation of spores of the fungal diseases such as Rhizoctonia and Fusarium. Subsequently GB 34 colonizes the remaining fungal disease spores themselves, thereby destroying them. On the basis of Acute injection toxicity/ Pathogenicity tests on rats, Bacillus pumilus GB 34 does not appear to be toxic, infective, and/ or pathogenic in those mammals. Toxicity studies submitted in support of this tolerance petition are summarized below. More detailed analyses of these studies may be found in the specific Agency reviews of the studies. Waivers requested and granted are, as well, noted. Toxicity studies relating to the GB 34 Concentrate ( End Use Product) and GB 34 Technical ( Technical Grade Active Ingredient) are as follows: 1. Acute oral toxicity   i. GB 34 Concentrate. ( Submitted to determine the adequacy of data to support an EUP, GB 34 Concentrate, and here, bridged to support a section 3 registration of the microbial product) ( OPPTS 870.1100; OPP 152.30; Master record identification number ( MRID) 452940   01). Five male and five female young adult Sprague Dawley rats each received a single 5,000 milligrams/ kilogram ( mg/ kg) gavage dose of GB 34 Concentrate, previously diluted to a 40% weight/ weight ( w/ w) solution with distilled water at a dosing volume of 1 milliliter ( mL)/ 100 grams ( g). The rats were observed for morbidity, moribundity, and behavioral changes 1 and 3 hours after dosing and at least daily thereafter for 14 days. They were weighed on days 0, 7, and 14. At the end of the study, the rats were euthanized by CO2 inhalation and necropsied. No morbidity, moribundity, or effects on body weight were found following treatment of rats with 5,000 mg/ kg test material. Therefore, the Sprague Dawley rat oral lethal dose ( LD) 50 of GB 34 Concentrate for male, female, and male and female combined is > 5,000 mg/ kg, placing the test material in Toxicity Category IV. ii. Acute oral toxicity   GB 34 Technical. ( OPPTS 870.1100; OPP 152.30; MRID 454335   01 corrected as MRID 457225   01). Five male and five female Sprague Dawley rats each received a single 5,000 mg/ kg gavage dose of the GB 34 Technical, previously diluted to a 40% w/ w solution with distilled water, at a dosing volume of 1 mL/ 100 g. The rats were observed for morbidity, moribundity, and behavioral changes 1 and 3 hours after dosing and at least daily thereafter for 14 days. They were weighed on days 0, 7, and 14. At the end of the study, the rats were euthanized by CO2 inhalation and necropsied. No morbidity, moribundity, or effects on body weight were found following treatment of rats with 5,000 mg/ kg test material. Therefore, the Sprague Dawley rat oral LD 50 of GB 34 Technical for male, female, and male and female combined is > 5000 mg/ kg, placing the test material in Toxicity Category IV. 2. Acute dermal toxicity   GB 34 Concentrate and GB 34 Technical. (( OPPTS 870.1200 and OPPTS 885. 3100 ( Acute dermal toxicity/ Pathogenicity); OPP 152.31; waiver request, no MRID)). A waiver was requested and granted for a seed treatment use. The rationale for the waiver is that the rate of application of the product is 0.1 ounce ( oz.) per 100 pounds ( lbs.) of seed. The seed treatment is to take place in a commercial seed treatment facility in which there is no exposure to the general population. After germination of the treated seed, the habit of the bacterium is to inhabit the root system of the plant. There is expected to be minimal, if any, dermal exposure for the general population in a seed treatment use of the microbial pesticide. 3. Acute inhalation toxicity   GB 34 Concentrate and GB 34 Technical. (( OPPTS 870.1300 and OPPTS 885. 3150 ( Acute pulmonary toxicity/ Pathogenicity); OPP 152.32; waiver request, no MRID)). A waiver was requested and granted for a seed treatment use. The use of GB 34 is to be limited to that of a seed treatment which is to take place in a commercial seed treatment facility in which there is no potential inhalation exposure to the general population. The rate of application of the pesticide is 0.1 oz. per 100 lbs. of seed. The habit of the bacterium is to gravitate to the root system of the developing plant. For a seed treatment use of GB 34 there will most likely be a negligible, if any inhalation exposure. 4. Acute oral toxicity/ Pathgenicity   GB 34 Technical and GB 34 Concentrate. ( OPPTS 885.3050). A waiver was requested and granted for a seed treatment use. The rationales such as are the minimal increase of human oral exposure expected due to the low rate of application ( 0.1 oz. per 100 lbs. of seed), the minimal exposure to the general population since the seed treatment will take place in a commercial seed treating facility with mechanical treating equipment, and the results of the toxicity tests submitted to date ( see item 1. ii.) which do not indicate that this strain is toxic or infective. Moreover the results would suggest that the GB 34 strain does not express the 6,500 molecular weight toxin discussed in two papers. See item 7 below. In addition, the habit of the bacterium to gravitate to the root system of the developing plant makes it unlikely that any would be present in the above ground parts of the mature plant, thus minimizingthe potential for oral exposure for humans. 5. Primary eye irritation   i. GB 34 Concentrate. (( Submitted to determine the adequacy of data to support an EUP, GB 34 Concentrate, and here, bridged to support a section 3 registration of the microbial product) ( OPPTS 870.2400; OPP 152.35; MRID 452940   02)). Three male and three female young adult New Zealand white rabbits were used in the experiment. Prior to test material instillation, both eyes were treated with 2% fluorescein and examined under ultraviolet ( UV) light for ocular abnormalities. The test material, 0.1 mL ( equivalent to 0.05   0.07 g), was instilled into the everted lower lid of the right eye and the upper and lower lids held closed for 1 second. The contralateral eye served as control. The eyes were examined and scored acording to the VerDate Jan< 31> 2003 11: 50 Apr 01, 2003 Jkt 200001 PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 02APR1. SGM 02APR1 15960 Federal Register / Vol. 68, No. 63 / Wednesday, April 2, 2003 / Rules and Regulations Draize method 1, 24, 48 and 72 hours after test material instillation. The 24 hour examination also included a fluorescein staining examination for corneal effects. All rabbits survived the study. All rabbits developed slight conjunctival irritation that cleared within 48 hours of treatment. No corneal opacity or iritis were noted. GB 34 Concentrate was minimally irritating to the eye and is placed in Toxicity Category IV. ii. Primary eye irritation   GB 34 Technical. ( OPPTS 870.2400; OPP 152.35; MRID 454335   02, corrected as 457225   02). Three male and three female young adult New Zealand white rabbits were, prior to test, treated in both eyes with 2% fluorescein and then examined under UV light for ocular abnormalities. The test material, in the amount of 0.1 mL, was instilled into the everted lower lid of the right eye and the upper and lower lids were held closed for 1 second. The contralateral eye served as control. The eyes were examined and scored according to the Draize method 1, 24, 48 and 72 hours after test material instillation. The 24 hour examination also included a fluorescein staining examination for corneal effects. All rabbits developed moderate conjunctival irritation that cleared up within 72 hours of treatment. No corneal opacity or iritis or nonocular effects were noted. The GB technical test substance was mildly irritating to the eye and is placed in Toxicity Category III. 6. Primary dermal irritation   i. GB 34 Concentrate. ( Submitted to determine the adequacy of data to support an EUP for GB 34 Concentrate, and here, bridged to support a section 3 registration of the microbial product) ( OPPTS 870.2500; OPP 152.34; MRID 452940   03). Three male and three female young adult New Zealand white rabbits were received for the study. The fur on the dorso lumbar area of each rabbit was clipped. The rabbits were given a single 0.5 g dose of test material applied under a under a 1 inch x 1 inch 4 ply gauze pad on a 6 cm2 clipped site. The gauze pad is then secured and Elizabethan collars were placed on the animals. Four hours later these were removed and the sites wiped with a moistened towel. The application sites were observed for dermal irritation 1, 24, 48, and 72 hours after patch removal. In addition the rabbits were observed at least daily for clinical signs of toxicity during the 72   hour study period. All rabbits survived the study. No dermal irritation was observed on any rabbit at any site. Based on the study GB 34 Concentrate is nonirritating to the New Zealand white rabbit and is placed in Toxicity Category IV. ii. Primary dermal irritation   GB 34 Technical. ( OPPTS 870.2500; OPP 152.34; MRID 454335   03 corrected as MRID 457225   03). Three male and three female New Zealand albino rabbits were prepared by clipping the dorsal area and the trunk. Only healthy animals without preexisting skin irritation had been selected for the test. The test substance in the amount of 0.5 g was placed on a 1 inch x 1 inch, 4 ply gauze pad which was applied and secured on each rabbit. After 4 hours exposure to the test substance, the pads were removed and the test sites gently wiped with water and towel to remove any residual test substance. Individual dose sites were scored according to the Draize scoring system at approximately 1, 24, 48 and 72 hours after patch removal. The animals were observed for signs of gross toxicity and behavioral changes at least once daily during the test period. All animals appeared active and healthy. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behavior. No dermal irritation was noted at any test site during the study. Under the conditions of the study, the GB 34 Technical is classified as non irritating to the skin and placed in Toxicity Category IV. 7. Acute injection toxicity/ Pathogenicity   GB 34 Technical. ( Submitted to determine the adequacy of data to support an EUP for GB 34, and here, bridged to support a section 3 registration of the microbial product) ( OPPTS 885.3200; OPP 152.33; MRID 453416   01). A total of 39 male and 39 female rats were used in the tests. The results showed: i. Mortality. No deaths were observed in any of the dosed or control groups prior to scheduled sacrifice. ii. Body and organ weights. Overall, both male and female rats gained weight for the duration of the study, demonstrating the continued health of the animals. iii. Clinical Observation. Overall, both male and female rats showed no abnormal clinical signs. iv. Gross necropsy. No significant signs of abnormalities were seen except for a laceration on the left shoulder of a test substance treated male rat. An enlarged spleen was seen in one test substance treated male rat on day The conclusion in the Data Evaluation report was that Bacillus pumilus GB 34 does not appear to be toxic, infective, and/ or pathogenic in rats, when dosed at 1 x 107 cfu/ animal. This test supports the requirements for both the TGAI ( the technical) and the end use product ( the concentrate). A hypersensitivity study, or dermal sensitization study ( OPP 152.36) is not required for registration of this product since the routes of use will not result `` in repeated human contact by inhalation or dermal routes'' as specified in footnote iii of the table in 40 CFR 158.740( c). Use of the product is limited to that of a seed treatment which takes place in a commercial facility using mechanical seed treatment equipment. An Immune response study is not required for registration of this product because the Acute I. V., I. C., or I. P. Injection toxicity/ Pathogenicity study, ( OPPTS guideline 885.3200/ OPP 153.33) submitted to determine the adequacy of data to support an EUP for GB 34, and here bridged support a section 3 registration of the microbial product, serves to address the endpoint of immune response. This injection study examines the normal functioning of the immune system when faced with the potentially most challenging exposure to this microbial pesticide active ingredient: Direct injection into the bloodstream. If the test animal is able to withstand and survive the introduction of such a large number of microbes, bypassing the normal protective barriers of the skin, the pulmonary macrophages and the gastrointestinal lymphoid tissues, then the immune system is functioning normally. The normal functioning of the immune system implies that it can recognize the introduced microbes as foreign and can clear them from the blood and other exposed organs. After the active ingredient, Bacillus pumilus GB 34 was intravenously injected into the test animals ( rats), no deaths, adverse clinical signs or significant findings upon necropsy were seen 35 days after the injection. ( See item 7). The requirement for Tier II and Tier III data was not triggered because of the results of Tier I data which had been submitted or waived.

V. Aggregate Exposures Section 408( b)( 2)( D)( vi) of the FFDCA directs EPA to consider available information concerning aggregate exposures to consumers ( and major identifiable subgroups of consumers) from the pesticide residue in food and all other non occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings ( residential and other indoor uses).

A. Dietary Exposure Bacillus pumilus GB 34 is a naturally occurring soil microorganism which VerDate Jan< 31> 2003 11: 50 Apr 01, 2003 Jkt 200001 PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 02APR1. SGM 02APR1 15961 Federal Register / Vol. 68, No. 63 / Wednesday, April 2, 2003 / Rules and Regulations inhabits the root system of plants and acts as an antifungal agent. Review of the available toxicology data submitted in support of registration indicate that it is non toxic and non pathogenic to animals and humans. In its proposed use as a soybean seed treatment, it is not foreseen to contribute any or more than a negligible amount of dietary exposure. 1. Food. The product is used only as a seed treatment and the organism inhabits the roots of the plants, in this case the soybean plant roots. The use of products which contain B. pumilus GB 34 is not anticipated to result in more than negligible, if any, any dietary exposure from food for humans. To date there have been no reports of any hypersensitivity incidents or reports of any known adverse reactions in humans resulting from exposure to B. pumilus GB 34. 2. Drinking water exposure. There is expected to be only insignificant or minimal human exposure to the organism in drinking water from its use in the treatment of seeds, its only use proposed. The treatment of seeds is expected to take place in a commercial seed treatment facility. The farmer then plants the seeds in the soil. Since the organism is non toxic and nonpathogenic to humans, even if small amounts would seep into the ground water, there is expected to be no adverse effect on humans.

B. Other Non Occupational Exposure The possibility for non dietary exposure to residues of this B. pumilus pesticide for the general population, including infants and children, is unlikely because the only proposed use site is in an agricultural setting, as a treatment on soybean seeds. Since the seed treatment is to take place in a commercial seed treating facility where mechanical treating equipment is used, it is not expected that dermal or inhalation exposure to residues will occur in the general population, including infants and children. Bacillus pumilus GB 34 is a ubiqutous bacterium commonly found in soil, water, air and decomposing plant tissue and which acts as an antifungal agent. The bacteria typically occur at 106 to 107 colony forming units ( CFU's) per gram of soil. It is not known to be pathogenic or toxic to any animal or plant species. The added soil density from the proposed seed treatment use rates represents a very small proportion of the naturally occurring bacilli in the soil and therefore is not expected to add substantially to the effects of the naturally occurring Bacillus. VI. Cumulative Effects Section 408( b)( 2)( D)( v) of the FFDCA requires the Agency to considered the cumulative effect of exposure to B. pumilus GB 34 and to other substances that have a common mechanism of toxicity. These considerations include the possible cumulative effects of such residues on infants and children. B. pumilus does not appear to be toxic or pathogenic to humans. Thus, there is no indication that the bacteria we consider here share any common mechanisms of toxicity ( metabolic mechanisms) with other substances.

VII. Determination of Safety for U. S. Population, Infants and Children There is reasonable certainty that no harm will result from aggregate exposures to residues of B. pumilus GB 34, in its use as a seed treatment, to the U. S. population, including infants and children. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. As discussed previously, there is probably no potential for harm, from this bacterium in its use as a seed treatment via dietary exposure since the organism is non toxic and nonpathogenic to animals and humans. The Agency has arrived at this conclusion based on the very low levels of mammalian toxicity ( no toxicity at the maximum doses tested, Toxicity Categories III and IV). Moreover no inhalation or dermal exposure is expected. FFDCA section 408( b)( 2)( C) provides that EPA shall apply an additional ten fold margin of exposure ( safety) for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA determines that a different margin of exposure ( safety) will be safe for infants and children. Margins of exposure ( safety) are often referred to as uncertainty ( safety) factors. In this instance, based on all the available information, the Agency concludes that the bacterium, B. pumilus GB34, is nontoxic to mammals, including infants and children. Because there are no threshold effects of concern, the provision requiring an additional margin of safety does not apply. As a result, EPA has not used a margin of exposure ( safety) approach to assess the safety of B. pumilus GB 34.

VIII. Other Considerations A. Endocrine Disruptors EPA is required under FFDCA section 408( p) to develop a screening process to determine whether pesticide chemicals ( and any other substance that may have an effect that is cummulative to an effect of a pesticide chemical) `` may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effects effect as the Administrator may designate.'' Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee ( EDSTAC), EPA determined that there was a scientific basis for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of potential effects in wildlife. For pesticide chemicals EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program ( EDSP). When the appropriate screening and/ or testing protocols being considered under the Agency's Endocrine Disruptor Screening Program have been determined, B. pumilus GB 34 may be subjected to additional screening and/ or testing to better characterize any effects related to endocrine disruption. Based on the weight of the evidence of available data, no endocrine systemrelated effects have been identified for B. pumilus GB 34.

B. Analytical Method( s) The Agency proposes to establish an exemption from the requirement of a tolerance without any numerical limitation. Accordingly, the Agency has concluded that analytical methods are not needed for enforcement purposes related to B. pumilus GB 34.

C. Codex Maximum Residue Level There are no Codex Maximum Residue Levels nor any tolerances or exemptions issued for B. pumilus GB 34 outside the United States.

IX. Objections and Hearing Requests Under section 408( g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue VerDate Jan< 31> 2003 11: 50 Apr 01, 2003 Jkt 200001 PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 02APR1. SGM 02APR1 15962 Federal Register / Vol. 68, No. 63 / Wednesday, April 2, 2003 / Rules and Regulations to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408( g) of the FFDCA provides essentially the same process for persons to `` object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408( d) of the FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP   2002   0328 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before June 2, 2003. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections ( 40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector ( 40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk ( 1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. You may also deliver your request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is ( 703) 603   0061. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it `` Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement `` when in the judgment of the Administrator such a waiver or refund is equitable and not contrary to the purpose of FFDCA section 408( m).'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at ( 703) 305   5697, by e mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit IX. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 1. Mail your copies, identified by docket ID number OPP   2002   0328, to: Public Information and Records Integrity Branch, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 1. You may also send an electronic copy of your request via e mail to: oppdocket epa. gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/ 8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues( s) in the manner sought by the requestor would be adequate to justify the action requested ( 40 CFR 178.32).

X. Statutory and Executive Order Reviews This final rule establishes an exemption from the tolerance requirement under section 408( d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget ( OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104   4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations ( 59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104   113, section 12( d) ( 15 U. S. C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408( d) of the FFDCA, such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the VerDate Jan< 31> 2003 11: 50 Apr 01, 2003 Jkt 200001 PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 02APR1. SGM 02APR1 15963 Federal Register / Vol. 68, No. 63 / Wednesday, April 2, 2003 / Rules and Regulations distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408( n)( 4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

XI. Congressonial Review Act The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a `` major rule'' as defined by 5 U. S. C. 804( 2).

List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: March 12, 2003. James Jones, Acting Director, Office of Pesticide Programs.

 Therefore, 40 CFR chapter I is amended as follows:

PART 180   [ AMENDED]

 1. The authority citation for part 180 continues to read as follows:

Authority: 21 U. S. C. 321( q), 346( a) and 371.

 2. Section 180.1224 is added to subpart D to read as follows:

§ 180.1224 Bacillus pumilus GB 34; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of the microbial pesticide Bacillus pumilus GB 34 when used as a seed treatment in or on soybeans and soybeans after harvest. [ FR Doc. 03   7638 Filed 4   1   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0079; FRL   7297   8]

Modified Acrylic Polymers; Revision of Tolerance Exemption AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This regulation revises an existing exemption from the requirement of a tolerance for modified acrylic polymers when used as an inert ingredient in a pesticide chemical formulation, including antimicrobial pesticide chemical formulations if such is used in accordance with good agricultural or manufacturing practices. Alco Chemical submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act of 1996 ( FQPA) requesting the revisions to the existing exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of modified acrylic polymers.

DATES: This regulation is effective April 2, 2003. Objections and requests for hearings, identified by docket ID number OPP   2003   0079, must be received on or before June 2, 2003. ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit XI. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Treva Alston, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   8373; e mail address: alston. treva@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:   Crop production ( NAICS code 111)   Animal production ( NAICS code 112)   Food manufacturing ( NAICS code 311)   Pesticide manufacturing ( NAICS code 25532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number VerDate Jan< 31> 2003 14: 46 Apr 01, 2003 Jkt 200001 PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 02APR1. SGM 02APR1


[Federal Register: October 29, 2008 (Volume 73, Number 210)]
[Rules and Regulations]
[Page 64197-64199]
[DOCID:fr29oc08-6]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2003-F-0398] (formerly Docket No. 2003F-0048]

Food Additives Permitted in Feed and Drinking Water of Animals;
Methyl Esters of Conjugated Linoleic Acid (Cis-9, Trans-11 and Trans-
10, Cis-12-Octadecadienoic Acids)

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the
regulations for food additives permitted in feed and drinking water of
animals to provide for the safe use of methyl esters of conjugated
linoleic acid (cis-9, trans-11 and trans-10, cis-12 octadecadienoic
acids) as a source of fatty acids in swine diets. This action is in
response to a food additive petition filed by BASF Corp. (BASF), 100
Campus Dr., Florham Park, NJ.

DATES:  This rule is effective October 29, 2008. Submit written or
electronic objections and requests for a hearing by December 29, 2008.
See section V of this document for information on the filing of
objections.

ADDRESSES:  You may submit objections and a request for a hearing,
identified by Docket No. FDA-2003-F-0398, by any of the following
methods:
    Electronic Submissions
    Submit electronic objections in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
    Written Submissions
    Submit written objections in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of objections, FDA is no longer
accepting objections submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic objections by using

the Federal eRulemaking Portal, as described previously in the
ADDRESSES portion of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN
number has been assigned) for this rulemaking. All objections received
may be posted without change to http://www.regulations.gov, including
any personal information provided. For additional information on
submitting objections, see the ``Objections and Hearing Requests''
heading of the SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
objections received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.

FOR FURTHER INFORMATION CONTACT: Michaela G. Alewynse, Center for
Veterinary Medicine (HFV-228), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register of March 11, 2003 (68
FR 11567), FDA announced that a food additive petition (animal use)
(FAP 2250) had been filed by BASF, 100 Campus Dr., Florham Park, NJ
07932. The petition proposed to amend the food additive regulations to
provide for the safe use of methyl esters of conjugated linoleic acid
(cis-9, trans-11 and trans-10, cis-12 octadecadienoic acids) as a
source of fatty acids in swine diets. The notice of filing provided for
a 60-day comment period on the petitioner's environmental information.
No comments have been received.

II. Conclusion

    FDA concludes that the data establish the safety and utility of
methyl esters of conjugated linoleic acid (cis-9, trans-11 and trans-
10, cis-12-octadecadienoic acids) for use as proposed with modification
and that the food additive regulations should be amended as set forth
in this document.

III. Public Disclosure

    In accordance with Sec.  571.1(h), the petition and the documents
that FDA considered and relied upon in reaching its decision to approve
the petition are available for inspection at the Center for Veterinary
Medicine by appointment with the information contact person. As
provided in Sec.  571.1(h), the agency will delete from the documents
materials that are not available for public disclosure before making
the documents available for inspection.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.32(r) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment, nor an environmental impact statement is required.

V. Objections and Hearing Requests

    Any person who will be adversely affected by this regulation may
file with the Division of Dockets Management (see ADDRESSES) written or
electronic objections by (see DATES). Each objection must be separately
numbered, and each numbered objection must specify with particularity
the provision of the regulation to which objection is made and the
grounds for the objection. Each numbered objection on which a hearing
is requested must state that a hearing is requested. Failure to request
a hearing for any particular objection will constitute a waiver of the
right to a hearing on that objection. Each numbered objection for which
a hearing is requested must include a detailed description and analysis
of the specific factual information intended to be presented in support
of the objection in the event that a hearing is held. Failure to
include such a description and analysis for any particular objection
will constitute a waiver of the right to a hearing on the objection.
Three copies of all documents must be submitted and must be identified
with the docket number found in brackets in the heading of this
document. Any objections received in response to the regulation may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.

List of Subjects in 21 CFR Part 573

    Animal feeds, Food additives.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 573 is
amended as follows:

PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF
ANIMALS

0
1. The authority citation for 21 CFR part 573 continues to read as
follows:

    Authority: 21 U.S.C. 321, 342, 348.

0
2. Add Sec.  573.637 to read as follows:

Sec.  573.637  Methyl esters of conjugated linoleic acid (cis-9, trans-
11 and trans-10, cis-12-octadecadienoic acids).

    The food additive, methyl esters of conjugated linoleic acid (cis-
9, trans-11 and trans-10, cis-12 octadecadienoic acids), may be safely
used in swine feed in accordance with the prescribed conditions:
    (a) The food additive is manufactured by the reaction of refined
sunflower oil with methanol to produce fatty acid methyl esters, which
then undergo conjugation to yield methyl esters of octadecadienoic
acid. The additive consists of not less than 28 percent methyl ester of
cis-9, trans-11-octadecadienoic acid, and not less than 28 percent
methyl ester of trans-10, cis-12-octadecadienoic acid with the sum of
the other methyl esters of octadecadienoic acid not to exceed 4
percent. The additive shall contain not less than 35 percent of other
fatty acid esters composed of oleic acid, palmitic acid, stearic acid,
linoleic acid, and other associated acid esters.
    (b) The additive is used or intended for use in the feed of growing
and finishing swine as a source of fatty acids at levels not to exceed
0.6% in the finished feed.
    (c) The additive meets the following specifications:
    (1) Free methyl alcohol not to exceed 0.015%.
    (2) Insoluble impurities not to exceed 0.1%.
    (3) Moisture not to exceed 0.5%.
    (4) Unsaponifiable matter not to exceed 1.0%.
    (d) To assure safe use of the additive, in addition to the other
information required by the act:
    (1) The label and labeling of the additive and any feed premix
shall bear the following:
    (i) The name of the additive.
    (ii) A statement to indicate that methyl esters of conjugated
linoleic acid (cis-9, trans-11 and trans-10, cis-12 octadecadienoic
acids) must not be added to vitamin or mineral premixes.
    (2) The label and labeling of the additive, any feed premix, or
complete feed prepared therefrom shall bear adequate directions for
use.

    Dated: October 23, 2008.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. E8-25719 Filed 10-28-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 76, Number 173 (Wednesday, September 7, 2011)]
[Notices]
[Pages 55381-55384]
[FR Doc No: 2011-22843]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2011-0718; FRL-8886-9]

FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: There will be a 3-day meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
consider and review scientific conclusions supporting EPA's FIFRA
Section 6(b) Notice of Intent to Cancel Twenty Homeowner Rodenticide
Bait Products.

DATES: The meeting will be held on November 29, 2011, through December
1, 2011, from approximately 8:30 a.m. to 5 p.m.
    Comments. The Agency encourages that written comments be submitted
by November 15, 2011, and requests for oral comments be submitted by
November 22, 2011. However, written comments and requests to make oral
comments may be submitted until the date of the meeting, but anyone
submitting written comments after November 15, 2011, should contact the
Designated Federal Official (DFO) listed under FOR FURTHER INFORMATION
CONTACT. For additional instructions, see Unit I.C. of the
SUPPLEMENTARY INFORMATION.
    Nominations. Nominations of candidates to serve as ad hoc members
of FIFRA SAP for this meeting should be provided on or before September
21, 2011.
    Webcast. This meeting may be webcast. Please refer to the FIFRA
SAP's Web site, http://www.epa.gov/scipoly/SAP for information on how
to access the webcast. Please note that the webcast is a supplementary
public process provided only for convenience. If difficulties arise
resulting in webcasting outages, the meeting will continue as planned.
    Special accommodations. For information on access or services for
individuals with disabilities, and to request accommodation of a
disability, please contact the DFO listed under FOR FURTHER INFORMATION
CONTACT at least 10 days prior to the meeting to give EPA as much time
as possible to process your request.

ADDRESSES: The meeting will be held at the Environmental Protection
Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA 22202.
    Comments. Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2011-0718, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2011-0718. If your comments contain any

information that you consider to be CBI or otherwise protected, please
contact the DFO listed under FOR FURTHER INFORMATION CONTACT to obtain
special instructions before submitting your comments. EPA's policy is
that all comments received will be included in the docket without
change and may be made available on-line at http://www.regulations.gov,
including any personal information provided, unless the comment
includes information claimed to be Confidential Business Information
(CBI) or other information whose disclosure is restricted by statute.
Do not submit information that you consider to be CBI or otherwise
protected through regulations.gov or e-mail. The regulations.gov Web
site is an ``anonymous access'' system, which means EPA will not know
your identity or contact information unless you provide it in the body
of your comment. If you send an e-mail comment directly to EPA without
going through regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the docket and made available on the Internet. If you submit
an electronic comment, EPA recommends that you include your name and
other contact information in the body of your comment and with any disk
or CD-ROM you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.
    Nominations, requests to present oral comments, and requests for
special accommodations. Submit nominations to serve as ad hoc members
of FIFRA SAP, requests for special seating accommodations, or requests
to present oral comments to the DFO listed under FOR FURTHER
INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: Joseph E. Bailey, DFO, Office of
Science Coordination and Policy (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may,
however, be of interest to persons who are or may be required to
conduct testing of chemical substances under the Federal Food, Drug,
and Cosmetic Act (FFDCA), FIFRA, and the Food Quality Protection Act of
1996 (FQPA). Since other entities may also be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the DFO
listed under FOR FURTHER INFORMATION CONTACT.

 B. What should I consider as I prepare my comments for EPA?

    When submitting comments, remember to:
    1. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    2. Follow directions. The Agency may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
    3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    6. Provide specific examples to illustrate your concerns and
suggest alternatives.
    7. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    8. Make sure to submit your comments by the comment period deadline
identified.

 C. How may I participate in this meeting?

    You may participate in this meeting by following the instructions
in this unit. To ensure proper receipt by EPA, it is imperative that
you identify docket ID number EPA-HQ-OPP-2011-0718 in the subject line
on the first page of your request.
    1. Written comments. The Agency encourages that written comments be
submitted, using the instructions in ADDRESSES, no later than November
15, 2011, to provide FIFRA SAP the time necessary to consider and
review the written comments. Written comments are accepted until the
date of the meeting, but anyone submitting written comments after
November 15, 2011, should contact the DFO listed under FOR FURTHER
INFORMATION CONTACT. Anyone submitting written comments should bring 30
copies to the meeting for distribution to the FIFRA SAP.
    2. Oral comments. The Agency encourages that each individual or
group wishing to make brief oral comments to FIFRA SAP submit their
request to the DFO listed under FOR FURTHER INFORMATION CONTACT no
later than November 22, 2011, in order to be included on the meeting
agenda. Requests to present oral comments will be accepted until the
date of the meeting and, to the extent that time permits, the Chair of
FIFRA SAP may permit the presentation of oral comments at the meeting
by interested persons who have not previously requested time. The
request should identify the name of the individual making the
presentation, the organization (if any) the individual will represent,
and any requirements for audiovisual equipment (e.g., overhead
projector, 35 mm projector, chalkboard). Oral comments before the FIFRA
SAP are limited to approximately 5 minutes unless prior arrangements
have been made. In addition, each speaker should bring 30 copies of his
or her comments and presentation slides for distribution to the FIFRA
SAP at the meeting.
    3. Seating at the meeting. Seating at the meeting will be open and
on a first-come basis.
    4. Request for nominations to serve as ad hoc members of the FIFRA
SAP for this meeting. As part of a broader process for developing a
pool of candidates for each meeting, FIFRA SAP staff routinely solicits
the stakeholder community for nominations of prospective candidates for
service as ad hoc members of the FIFRA SAP. Any interested person or
organization may nominate qualified individuals to be considered as
prospective candidates for a specific meeting. Individuals

nominated for this meeting should have expertise in one or more of the
following areas: Ecotoxicology and Wildlife Biology (including
assessment of poisoning incidents and case evaluation of mortality);
Toxicology/Pharmacology of Rodenticides; Veterinarian Science
(including pet poisoning incident surveillance); Human Poisoning
Surveillance; and Rodent Biology and Control. Nominees should be
scientists who have sufficient professional qualifications, including
training and experience, to be capable of providing expert comments on
the scientific issues for this meeting. Nominees should be identified
by name, occupation, position, address, and telephone number.
Nominations should be provided to the DFO listed under FOR FURTHER
INFORMATION CONTACT on or before September 21, 2011. The Agency will
consider all nominations of prospective candidates for this meeting
that are received on or before this date. However, final selection of
ad hoc members for this meeting is a discretionary function of the
Agency.
    The selection of scientists to serve on the FIFRA SAP is based on
the function of the panel and the expertise needed to address the
Agency's charge to the panel. No interested scientists shall be
ineligible to serve by reason of their membership on any other advisory
committee to a Federal department or agency or their employment by a
Federal department or agency except the EPA. Other factors considered
during the selection process include availability of the potential
panel member to fully participate in the panel's reviews, absence of
any conflicts of interest or appearance of lack of impartiality,
independence with respect to the matters under review, and lack of
bias. Although financial conflicts of interest, the appearance of lack
of impartiality, lack of independence, and bias may result in
disqualification, the absence of such concerns does not assure that a
candidate will be selected to serve on the FIFRA SAP. Numerous
qualified candidates are identified for each panel. Therefore,
selection decisions involve carefully weighing a number of factors
including the candidates' areas of expertise and professional
qualifications and achieving an overall balance of different scientific
perspectives on the panel. In order to have the collective breadth of
experience needed to address the Agency's charge for this meeting, the
Agency anticipates selecting approximately 10 ad hoc scientists.
    FIFRA SAP members are subject to the provisions of 5 CFR part 2634,
Executive Branch Financial Disclosure, as supplemented by the EPA in 5
CFR part 6401. In anticipation of this requirement, prospective
candidates for service on the FIFRA SAP will be asked to submit
confidential financial information which shall fully disclose, among
other financial interests, the candidate's employment, stocks and
bonds, and where applicable, sources of research support. The EPA will
evaluate the candidates financial disclosure form to assess whether
there are financial conflicts of interest, appearance of a lack of
impartiality or any prior involvement with the development of the
documents under consideration (including previous scientific peer
review) before the candidate is considered further for service on the
FIFRA SAP. Those who are selected from the pool of prospective
candidates will be asked to attend the public meetings and to
participate in the discussion of key issues and assumptions at these
meetings. In addition, they will be asked to review and to help
finalize the meeting minutes. The list of the FIFRA SAP members
participating at this meeting will be posted on the FIFRA SAP Web site
at http://epa.gov/scipoly/sap or may be obtained from the OPP
Regulatory Public Docket at http://www.regulations.gov.

 II. Background

A. Purpose of FIFRA SAP

    FIFRA SAP serves as the primary scientific peer review mechanism of
EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) and is
structured to provide scientific advice, information and
recommendations to the EPA Administrator on pesticides and pesticide-
related issues as to the impact of regulatory actions on health and the
environment. FIFRA SAP is a Federal advisory committee established in
1975 under FIFRA that operates in accordance with requirements of the
Federal Advisory Committee Act. FIFRA SAP is composed of a permanent
panel consisting of seven members who are appointed by the EPA
Administrator from nominees provided by the National Institutes of
Health and the National Science Foundation. FIFRA, as amended by FQPA,
established a Science Review Board consisting of at least 60 scientists
who are available to the SAP on an ad hoc basis to assist in reviews
conducted by the SAP. As a peer review mechanism, the FIFRA SAP
provides comments, evaluations and recommendations to improve the
effectiveness and quality of analyses made by Agency scientists.
Members of the FIFRA SAP are scientists who have sufficient
professional qualifications, including training and experience, to
provide expert advice and recommendation to the Agency.

 B. Public Meeting

    The EPA's 2008 Risk Mitigation Decision for Ten Rodenticides (RMD)
concluded more than a decade of Agency review of commensal
rodenticides. The RMD concluded that registrants of commensal
rodenticide products needed to adopt certain risk mitigation measures
in order to meet the FIFRA registration standard of not causing
unreasonable adverse effects on the environment. In 2008, EPA gave
registrants of commensal rodenticide bait products 3 years to research,
develop, and register new consumer/homeowner products that adopted
these risk mitigation measures designed to greatly reduce child, pet,
and non-target wildlife exposure to rodenticides. The Agency intends to
propose a Notice of Intent to Cancel (NOIC) for 20 consumer/homeowner
rodenticide products for which registrants have refused to voluntarily
adopt the risk mitigation measures. The Agency will be seeking advice
and recommendations from the SAP on the following scientific issues
associated with the proposed NOIC:
     EPA's evaluation of human and pet incidents of accidental
exposure to rodenticides.
     EPA's evaluation of ecological incidents of accidental
exposure to rodenticides.
     The differences in uptake and clearance of first-
generation anticoagulant rodenticides, non-anticoagulant rodenticides,
and second-generation anticoagulant rodenticides, in target and non-
target wildlife.
     EPA's ecological risk assessments for rodenticides,
including ecological risks of first-generation anticoagulant
rodenticides, non-anticoagulant rodenticides, and second-generation
anticoagulant rodenticides.
     The differences in secondary ecological exposure between
first-generation anticoagulant rodenticides, non-anticoagulant
rodenticides, and second-generation anticoagulant rodenticides.

C. FIFRA SAP Documents and Meeting Minutes

    EPA's background paper, related supporting materials, charge/
questions to the FIFRA SAP, FIFRA SAP composition (i.e., members and ad
hoc members for this meeting), and the meeting agenda will be available
by late October. In addition, the Agency may provide additional
background

documents as the materials become available. You may obtain electronic
copies of these documents, and certain other related documents that
might be available electronically, at http://www.regulations.gov and
the FIFRA SAP homepage at http://www.epa.gov/scipoly/sap.
    The FIFRA SAP will prepare meeting minutes summarizing its
recommendations to the Agency within 90 days after the meeting. The
meeting minutes will be posted on the FIFRA SAP Web site or may be
obtained from the OPP Regulatory Public Docket at http://www.regulations.gov.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: August 30, 2011.
Frank Sanders,
Director, Office of Science Coordination and Policy.
[FR Doc. 2011-22843 Filed 9-6-11; 8:45 am]
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