        ENVIRONMENTAL PROTECTION AGENCY
        40 CFR Part 180
        [OPP-2004-0413; FRL-7691-9]
        Lignosulfonates; Exemptions from the Requirement of a Tolerance

          AGENCY:
          Environmental Protection Agency (EPA).

          ACTION:
          Proposed rule.

          SUMMARY:
          The Agency is proposing to establish 44 exemptions from the requirement of a tolerance for  residues of various lignosulfonate chemicals in or on raw agricultural commodities when used as inert ingredients in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest, or to animals under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). This regulation eliminates the need to establish a maximum permissible level for residues of these lignosulfonate chemicals.

          DATES:
          Comments, identified by docket identification (ID) number OPP-2004-0413, must be received on or before April 18, 2005.

          ADDRESSES:
          Submit your comments, identified by docket ID number OPP-2004-0413, by one of the following methods:
          • Federal eRulemaking Portal: http://www.regulations.gov/.  Follow the on-line instructions for submitting comments.
          • Agency Website: http://www.epa.gov/edocket/.  EDOCKET, EPA's electronic public docket and comment system, is EPA's preferred method for receiving comments.  Follow the on-line instructions for submitting comments.
          • E-mail: Comments may be sent by e-mail to opp-docket@epa.gov, Attention: Docket ID Number OPP-2004-0413.
          • Mail:  Public Information and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, Attention: Docket ID Number OPP-2004-0413.
          • Hand delivery:  Public Information and Records Integrity Branch (PIRIB), Office of  Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID Number OPP-2004-0413.   Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information.

            Instructions: Direct your comments to docket ID number OPP-2004-0413.  EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http://www.epa.gov/edocket/, 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 EDOCKET, regulations.gov, or e-mail.  The EPA EDOCKET and the regulations.gov websites are “anonymous access” systems, 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 EDOCKET or regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public 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. For additional information about EPA's public docket visit EDOCKET on-line or see the Federal Register of May 31, 2002 (67 FR 38102) (FRL-7181-7).

            Docket: All documents in the docket are listed in the EDOCKET index at http://www.epa.gov/edocket/.  Although listed in the index, some information is not publicly available, i.e., 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 electronically in EDOCKET or in hard copy at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S. Bell St.,  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.

          FOR FURTHER INFORMATION CONTACT:

          Princess Campbell, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8033; e-mail address: campbell.princess@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 32532).

        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 Access Electronic Copies of this Document and Other Related Information?
        In addition to using EDOCKET (http://www.epa.gov/edocket/), 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 on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
        C.  What Should I Consider as I Prepare My Comments for EPA?
        1. Submitting CBI.  Do not submit this information to EPA through EDOCKET, regulations.gov, or e-mail.  Clearly mark the part or all of the information that you claim to be CBI.  For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI.  In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
        2. Tips for preparing  your comments.  When submitting comments, remember to:

        i. Identify the rulemaking by docket ID number and other identifying information (subject heading, Federal Register date, and page number).
        ii. 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.
        iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
        iv. Describe any assumptions and provide any technical information and/or data that you used.
        v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
        vi. Provide specific examples to illustrate your concerns, and suggest alternatives.
        vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
        viii. Make sure to submit your comments by the comment period deadline identified.
        II.  Background
        A.  What Action is the Agency Taking?
        The Agency is proposing to establish 44 tolerance exemptions for various lignosulfonate chemicals.  Currently, there are seven tolerance exemptions for lignosulfonate chemicals.  In 40 CFR 180.910 and 180.930, the exemption reads: Lignosulfonate, ammonium, calcium, magnesium, potassium, sodium, and zinc salts.  The Agency intends to remove this single exemption, and split the exemption into separate chemical entries.  There are also in 40 CFR 180.910 and 930, exemptions for oxidized pine lignin, sodium salt with a limitation of 2% in the formulation.  As part of the proposed actions, the limitation will be removed.  The exemptions for pine lignin in 40 CFR 180.910 and 180.930 will be revised to include the Chemical Abstracts Service Registry Number (CAS No.) and a different naming convention.  In 40 CFR 180.910 the exemption for ethoxylated lignosulfonic acid, sodium salt will be revised in a similar manner.
        In part, this action is based on two pesticide petitions (PP 6E4673 and 6E4674) from  LignoTech USA Inc., 100 Hwy. 51 South, Rothschild, WI 54474.  LignoTech requested exemptions from the requirement of a tolerance for sulfite liquors and cooking liquors, spent, oxidized; and lignosulfonic acid, sodium salt, oxidized,  when used as inert ingredients in pesticide formulations.  The petitioner requested that 40 CFR 180.1001(c) and (e) (newly redesignated as 180.910 and 180.930) be amended by establishing these  exemptions from the requirement of a tolerance.

        EPA on its own initiative, under section 408(e) of FFDCA, 21 U.S.C. 346a(e), is proposing to amend several existing tolerance exemptions and to establish several new tolerance exemptions for  various lignosulfonate chemicals on raw agricultural commodities when used in pesticide formulations  as inert ingredients (surfactants or related adjuvants to surfactants) applied to growing crops, or to raw agricultural commodities after harvest and when applied to animals. The 22 lignosulfonate chemicals, (a total of 44 exemptions), that the Agency is proposing to exempt from the requirement of a tolerance are listed in the Table 1 of this unit.

            Table 1.—Lignin and Lignosulfonate Chemicals Proposed for Tolerance Exemption

            Chemical
            Chemical formula
            CAS No.

            Lignosulfonic acid
            C213H246O88S64

            8062-15-5

            Lignosulfonic acid, ammonium salt
            C213H258N4O88S4

            8061-53-8

            Lignosulfonic acid, calcium salt
            C213H242Ca2O88S4

            8061-52-7

            Lignosulfonic acid, magnesium salt
            C213H242Mg2O88S4

            8061-54-9

            Lignosulfonic acid, sodium salt
            C213H242Na4O88S4

            8061-51-6

            Lignosulfonic acid, potassium salt
            C213H242K4O88S4

            37314-65-1

            Lignosulfonic acid, zinc salt
            C213H242O88S4Zn2

            57866-49-6

            Lignosulfonic acid, ammonium sodium salt

            166798-73-8

            Lignosulfonic acid, ammonium magnesium salt

            123175-37-1

            Lignosulfonic acid, ammonium calcium salt

            12710-04-2

            Lignosulfonic acid, calcium magnesium salt

            55598-86-2

            Lignosulfonic acid, calcium sodium salt

            37325-33-0

            Lignosulfonic acid, sodium salt sulfomethylated
            C214H242Na6O94S6

            68512-34-5

            Lignin alkali reaction products with disodium sulfite and formaldehyde
            C213H248Na2O83S2

            105859-97-0

            Lignin alkali reaction products with formaldehyde and sodium bisulfite
            C213H248Na2O83S2

            68512-35-6

            Ethoxylated lignosulfonic acid, sodium salt
            C217H250Na4O90S4

            68611-14-3

            Lignin, alkali, oxidized, sodium salt
            C213H237Na5O81

            68201-23-0

            Lignin

            9005-53-2

            Lignin, alkali
            C213H245Na6O76

            8068-05-1

            Lignosulfonic acid, sodium salt, polymer with HCHO and phenol
            C229H256Na3O90S4

            37207-89-9

            Sulfite liquors and cooking liquid, spent, oxidized
            C225H253CaNaO113S7

            68514-09-0

            Lignosulfonic acid, sodium salt oxidized
            C212H230Na4O88S4

            68855-41-4

        B.  What is the Agency's Authority for Taking this Action?
        This proposed rule is issued under section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170).  Section 408(e) of FFDCA authorizes EPA to establish, modify, or revoke tolerances, or exemptions from the requirement of a tolerance for residues of pesticide chemicals in or on raw agricultural commodities and processed foods.
        III. Human Health Assessment
        Consistent with section 408(b)(2)(D) of 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 nature of the toxic effects caused by lignosulfonate chemicals are discussed in this unit.
        A. Description of Lignosulfonate Materials

        Lignin is an extremely complex naturally occurring phenolic polymer that is primarily made of three phenolic alcohols: Coniferyl, p-coumaryl, and synapyl alcohols. These alcohols are cross-linked to each other via a variety of different chemical bonds.  The structure of lignin is somewhat undefined.  However, it is lignin that supplies the strength and rigidity to the cell wall of plants.  Lignin is the glue-like substance that binds the cellulose fibers together. The lignin group of compounds makes up the second most abundant class of chemicals found in plants.  Cellulose is the most abundant.  According to information available on the internet (http://www.chem.vt.edu/chem-dept/helm/3434WOOD/notes1/lignin.html), the ratio of the alcohols determines the rigidity or flexibility of the plant's cell wall. “p-Coumaryl alcohol is a minor component of grass and forage type lignins.  Coniferyl alcohol is the predominant lignin monomer found in softwoods.....Both coniferyl and sinapyl alcohols are the building blocks of hardwood lignin.”  The lignin content of softwoods are on the order of 26-32% and of hardwoods 20-28%.
        To make pulp and paper, various processes are used to release the cellulose, by removing the lignin from plant cells, by destroying the chemical bonds within the lignin. These processes produce by-products which are different in composition from the original lignin polymer.  In one such process lignin reacts with sulfur dioxide to form lignosulfonic acid.    Lignosulfonates can also be produced as the sodium, potassium, calcium, magnesium, zinc, or ammonium salts.  Using other chemical processes lignosulfonate chemicals that have been oxidized or ethoxylated can be manufactured.
        B.  Previous Agency Action
        On March 27, 1996, EPA's OPP published in the Federal Register (61 FR 13476) (FRL-5355-6) a proposed rule to establish tolerance exemptions for oxidized pine lignin, sodium salt (CAS No. 68201-23-0).  In that proposed rule the Agency described its review and evaluation of various toxicity data as follows: “The toxicological data show that pine lignin, sulfonated pine lignin as well as oxidized pine lignin or lignosulfonates are of very low acute toxicity (LD50
          > 2 to > 5 g/kg in rats......Pine lignin is classified as toxicity category IV in a skin irritation and eye irritation studies.”  The final rule establishing the tolerance exemption for oxidized pine lignin published in the Federal Register of June 19, 1996 (61 FR 31037) (FRL-3575-9).
        C.  Internet Search for Publicly Available Information
        The Agency through its Interagency Agreement with the Department of Energy's Oakridge National Laboratory conducted an extensive literature search.  Over 20 publicly available websites, such as International Programme on Chemical Safety (IPCS), National Toxicological Program (NTP), National Library of Medicine's TOXNET, Agency for Toxic Substances and Disease Registry (ATSDR), and Organization for Economic Co-operation and Development (OECD), were searched using both names and CAS Nos. as search terms.  It should be noted that these are reliable compilations of toxicity data. The search revealed little information for these compounds in the public literature.  Table 2 of this unit summarizes the information that was retrieved.  All of the following studies were conducted using lignosulfonic acid, sodium salt.

            Table 2.—Toxicity Data for Lignosulfonic acid, Sodium Salt (CAS No. 8061-51-6)

            Species
            Study type
            Results

            Rat/Wistar
            16-Week oral toxicity
            NOAEL = 2.83 male (M) 2.42 female (F) gram/kilogram/day (g/kg/day)LOAEL = 10.02 (M) 9.99 (F) g/kg/day based on statistically significant decreases in body weight, RBC (erythrocytes), Hb (hemoglobin), and hematocrit; significantly significant increases in total leucocyte count; absolute and relative liver, spleen, and kidney weights in males

            Rat/Wistar
            Acute oral toxicity in male and female rats
            LD50
              > 40 g/kg

            Rabbit
            21/28-Day dermal toxicity
            non irritating to skin in rabbits

            Guinea pig (albino)
            Repeated dose toxicity (1-5 weeks)
            NOAEL was not determinedLOAEL = 1.740 g/kg/day based on ulceration of the colon in 50% of test animals

              Salmonella typhimurium strains TA98, TA100, TA1535, TA1537
            Gene mutation
            Non-mutagenic—Ames with and without activation

        D. Information from the Petitioner
        The information submitted in the two petitions (6E4673 and 6E4674) by LignoTech consisted of the following:

            Table 3.—Toxicity Information

            Chemical description
            Study

            Pine lignin, sodium salt
            Acute oral rat; LD50 is greater than 2 g/kg

            Sulfonated pine lignin, sodium salt
            Acute oral rat; LD50 is greater than 2 g/kg

            Oxidized pine lignin, sodium salt
            Acute oral rat; LD50 is greater than 5 g/kg

            Carboxylated lignosulfonate, calcium salt
            Acute oral rat; LD50 is greater than 5 g/kg

            Oxidized lignosulfonate, sodium salt
            Acute oral rat; LD50 is greater than 5 g/kg

            Oxidized lignosulfonate, sodium salt
            Skin irritation; not irritating

            Oxidized lignosulfonate, sodium salt
            Eye irritation; not irritating

        The petitioner supplied only the information in this unit, not the studies or source from which the information was extracted.  Therefore, the Agency cannot review and evaluate any of this information.  According to the petitioner, lignosulfonates are generally recognized as having low aquatic, avian, and mammalian toxicities.  Sulfite liquors and cooking liquors are the raw materials obtained from the sulfite pulping of wood chips, with the main component of these liquors being sodium lignosulfonate, a derivative of the natural-occurring polymer, lignin.
        E. Structure Activity Relationship (SAR) Assessment

        The Agency traditionally begins its evaluation process for inert ingredients by searching publicly available databases.  However, the Agency believes that for certain chemicals it is possible to assess the chemical's toxicity with other evaluation tools which can include expert scientific judgement. Even if literature searches do not yield much toxicity data, given these other tools, the Agency believes that it is still possible to determine a “ reasonable certainty of no harm.”
        SAR analysis is a useful tool for predicting toxicity and thus identifying chemicals which may present specific risk concerns and/or for which the value of generating additional data would be low.  This analysis utilizes the chemical's structural similarity to other chemicals for which data are available. A discussion on the SAT process in the Office of Pollution Prevention and Toxics (OPPT) follows.
        SAR assessments have been performed by OPPT for over 25 years. Under section 5 of the Toxic Substances Control Act (TSCA), the Agency must make a determination  to restrict the manufacture or importation of the chemical within 90 days of the submission of a pre-manufacturing notice (PMN). The Agency must  make either a “...may present an unreasonable risk to human health or the environment...” finding or show that the chemical “....is or will be produced in substantial quantities, and such substance either enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance...”.  However, section 5 of TSCA does not require any toxicity testing as a prerequisite for submission of  PMNs. Thus, toxicological data are usually not available for review by the Agency. In response to the lack of toxicity data, and the mandated time frames, the Agency has relied on expert assessments to predict a chemical's toxicity.
        For human health, the SAR process can be used to assess absorption and metabolism, mutagenicity, carcinogenicity, developmental and reproductive effects, neurotoxicity, system effects, immunotoxicity, sensitization, and irritation.  This is a qualitative assessment using terms such as good, not likely, poor, moderate, or high. To judge the validity of these assessments, EPA examined the method in the Project on the Evaluation of (Quantitative) Structure Activity Relationships (EPA 743-R-94-001).  Given only chemical structure information, the Structure Activity Team (SAT) in  OPPT assessed 140 chemicals using their SAR assessment process.  The results of their assessments were then compared to the “base set” data that the European Union (EU) had received on each chemical.  The results indicated that the SAR assessments were “on target” 90% of the time for aquatic toxicity, and roughly 80% of the time for human health effects.  For human health, the approximately 20% that were not “on target” were overestimates.
        The SAT consists of expert scientists who evaluate the potential environmental fate, human health, and environmental hazards of these new chemicals.  The scientific disciplines represented on the SAT are: Chemistry, environmental fate, ecotoxicity, absorption/metabolism, mutagenicity, carcinogenicity, developmental/reproductive toxicity, neurotoxicity, acute toxicity, and subchronic/chronic toxicity.
        Thus, after an in-depth literature search revealed that there was not extensive information available on the lignosulfonates, OPP decided to utilize the SAT's expertise to evaluate/identify the potential risks to human health posed by the lignosulfonates, and the environmental fate, health, and environmental hazards of the lignosulfonates, while considering the information on lignosulfonic acid, sodium salt. The SAT process begins by verifying the chemical identity and structures of the requested chemicals and then estimating (modeling) the physical/chemical properties of the chemicals, if measured data are not available.
        Table 4 of this unit contains an excerpt of the information on the physical/chemical properties which were used by the SAT to make the determination.  (Information on all of the physical/chemical properties considered by the SAT is contained in paper format only in EDOCKET OPP-2004-0413).

            Table 4.—Comparison of Chemical/Physical Properties for Lignosulfonic Acid Sodium Salt and Sodium Salt Oxidized (Obtained from the SAT)

            Chemical
            Physical state
            Boiling point
            Water solubility (g/Liter (L))
            Vapor pressure
            Molecular weight

            Lignosulfonic acid, sodium salt
            Solid

              >500

              >500

              <0.000001
            10,000

            Lignosulfonic acid, sodium salt, oxidized
            Solid

              >500

              >500

              <0.000001
            10,000

        The information used by the SAT indicate that these are high molecular weight, polymeric-type materials.   After determining the physical /chemical properties, the SAT divided the 16 chemicals into 3 groups. Group 1 consisted of: Lignosulfonic acid, ammonium salt; lignosulfonic acid, calcium salt; lignosulfonic acid, magnesium salt; lignosulfonic acid, sodium salt; and lignosulfonic acid, potassium salt.
        The SAR conclusions for Group 1 are as follows:
        Absorption is nil for all routes based on the physical/chemical properties.  There is concern for irritation and possible corrosion to the GI (gastorintestinal) tract based on data provided for sodium lignosulfonate (guinea pig 14-28 day oral drinking water LOEL = 1.7 g/kg/day with colonic ulceration.  No pH values were provided for the lignosulfonic acid or its salts; therefore, SAT members made the assumption that the free acid would have a very low pH value and that the salts could have high pH values depending on the amount of and the manner in which the counter-ion reacted or complexed with the acid.  Based on this assumption there is a concern for irritation to skin, eyes, and lungs.  There is also concern for lung toxicity if inhaled based on potential lung overload for high molecular weight polymers.  The SAT determined that Group 1 lignosulfonates are of low-moderate concern for human health effects.

        Group 2 consisted of lignosulfonic acid, zinc salt.  The SAT's human health assessment for lignosulfonic acid, zinc salt are identical to Group 1's with the following addition.  The inclusion of zinc in the lignosulfonate polymer results in concerns for developmental toxicity and immunotoxicity at high doses, as well as concerns for asthma and mutagenicity.  However, the SAT determined that lignosulfonic acid, zinc salt is also of low-moderate concern for human health effects.
        Group 3 consisted of: Lignin, alkali reaction products with disodium sulfite and formaldehyde; lignin, alkali reaction products with formaldehyde and sodium bisulfite;ethoxylated lignosulfonic acid, sodium salt; lignin, alkali oxidized, sodium salt; lignin, alkali; lignosulfonic acid, sodium salt, polymer with formaldehyde and phenol; sulfite liquors and cooking liquors, spent, oxidized; lignosulfonic acid, sodium salt, oxidized; and lignosulfonic acid.  The SAT's human health assessment for this group of lignosulfonate chemicals was identical to the SAT determinations for Group 1.
        F.  Data obtained via the High Production Volume (HPV) Challenge Program

        The test plan for spent pulping liquor (CAS No. 66071-92-9) was submitted to OPPT on January 29, 2001 by the American Forest & Paper Association (AF&PA).  (See http://www.epa.gov/chemrtk/afpa/c12936.pdf/) On February 21, 2003, the final data summary was submitted.  (See http://www.epa.gov/chemrtk/afpa/c12936fds.pdf/)  While spent pulping liquor is not proposed for tolerance exemption in this document, it is noted that one of the chemicals proposed for tolerance exemption is spent liquors and cooking liquid, spent, oxidized.  AF&PA noted in their data summary, that spent pulping liquor is very alkaline in nature, with a pH ranging from 11.5 to 13.5.  The composition varies, but includes pulping chemicals, cellulose, hemicellulose, and lignin.  Given the high pH, testing could be performed on only very dilute solutions, so the only toxicity testing described in the submission are two mutagenicity tests.  The results of the bacterial reverse mutation test indicated that spent pulping liquor is non-mutagenic in that test.  In a chromosomal aberration assay with Chinese hamster ovary cells (in vitro), spent pulping liquor was clastogenic with and without activation. Concentrations of 2,500 ug/mL with activation and 5,000 μg/mL without activation  were judged overtly toxic to the cultures.
        G. Conclusions

        The toxicity data available to the Agency indicate that the lignosulfonates are of very low toxicity.  The oral acute LD50s supplied by the petitioner are all greater than 2 g/kg.  The toxicological data located in the public literature is for sodium lignosulfonate.  Repeated dose studies retrieved from open literature  indicate NOAELs and LOAELs expressed as g/kg/day instead of the usual unit in most toxicity studies reviewed by the Agency of milligram (mg)/kg/day.  There is some very unsubstantiated information that lignosufonate materials given to rats before, during, and after mating at doses as high as 1,500 mg/kg/day did not cause adverse effects on reproduction or offspring.  But at a dose level of 500 mg/kg/day there were histopathological changes in the lymph nodes of the mothers.  Given the quality and quantity of information available, OPP needed additional information to complete its assessment of the lignosulfonate chemicals.
        As a group, the SAR assessments did not identify any concerns for mutagenicity or carcinogenicity for the lignosulfonate chemicals.  Based on the physical/chemical properties, and particularly on the large molecular weights of the lignosulfonate chemicals, the SAT believes that when considered as a group, the lignosulfonates are not absorbed via any route.  This is due to the fact, that generally, polymer-type materials such as lignosulfonates of these higher molecular weights would be poorly absorbed through the intact gastrointestinal tract or through intact human skin.
        As a group, one of the health concerns for lignosulfonate chemicals is for inhalation to the deep lung (a lung overload effect), which could occur if lignosulfonate chemicals were to be used either as a powder or as an aerosol.  Other concerns identified by the SAT are for irritation to skin, eyes, and lungs, which was based on the assumption that some of these chemicals could have a low  pH and therefore display effects consistent with those of an acid.  The lung and irritation effects are adequately handled through acute end-product testing to determine any needed personal protective equipment.
        The lignosulfonic acid, zinc salt was judged to be of more concern than any of the other lignosulfonate salts.  According to the SAT, the inclusion of zinc can result in concerns for developmental toxicity and immunotoxicity at high doses, as well as concerns for asthma and mutagenicity.  However, zinc is also a needed nutrient.
        Counter-ions such as calcium, potassium, sodium, magnesium, and zinc are required for proper functioning of human biological systems.  Thus, the human body does have an effective means of processing them.  Zinc is an essential element in the nutrition of man.  It functions as an integral part of numerous enzymes.  The daily intake for an adult ranges from 14 to 20 mg/day.  The recommended dietary allowance (RDA) for adult men and women is 15 mg/day; however, the amount of zinc needed by the body changes throughout life.  The Food and Nutrition Board of the United States evaluated zinc dietary allowances and recommended zinc as follows: 2 mg for infants 0.5 years, 5 mg for 0.5-1.0 years, 10 mg for children 1-10 years, 15 mg for men and women 11-51+ years, 20 mg for pregnant women, and 25 mg for lactating women.  Deficiencies of zinc can cause illness.  Given the incorporation of zinc into a polymeric-type high molecular weight chemical, which is then not well-absorbed by the human body, it is unlikely that the high doses of zinc at which adverse effects are possible would be reached.  Without the concerns for the zinc counter-ion, as a group the SAT judged that there were no structural similarities of lignosulfonate chemicals to any known developmental toxicants.
        IV.  Aggregate Exposures
        In examining aggregate exposure, section 408 of FFDCA directs EPA to consider available information concerning exposures 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

        Several of the lignosulfonates have applications in food and animal feed products.  Monographs describing purity requirements and analytical procedures for both lignosulfonic acid, calcium salt and lignosulfonic acid, sodium salt are published in the Fourth Edition of the Food Chemicals Codex.  Various salts of lignosulfonic acid have been approved by FDA as secondary direct food additives, components of adhesives, components of paper and paperboard, and adjuvants for glue.  Lignosulfonate chemicals can also be used as a pelletizing agent or binder in processed animal feed items.  Therefore, animals can consume lignosulfonates as part of their feed mix, and then these animals are consumed by humans.   Thus, there is on-going human dietary exposure.
        B.  Drinking Water

        To assess the presence of the lignosulfonate chemicals in drinking water, two reviews are available. A review performed by OPP determined that the various salts of  lignosulfonic acid are soluble to very highly water soluble depending on the cation.  Once in water dissociation of the cation is expected depending on pH.  These lignosulfonates are not expected to be mobile in terrestrial environments, moving equally with the water and sediment phase to surface water.  Ground water migration is not likely.  Once in water, the dissociated cation and anion are likely to remain in dissolution.  The available information suggest that lignosulfonates may be persistent in aquatic environment of low microbial activity and much less persistent in environments with ample microbial activity.
        The SAR assessment performed by OPPT determined that as a group the lignosulfonates were of low concern for exposure via drinking water.  Though the time for complete aerobic degradation is predicted to be months, the lignosulfonates are strongly adsorbed to soils and sediments due to their high-molecular weights.  This strong binding minimizes the availability of these chemicals for migration to ground water supplies and thus reduces the potential for residues of lignosulfonates to be present in drinking water.
        C.  Other Non-Occupational
        Lignosulfonates have many uses in industrial applications.  According to the Lignin Institute website, lignosulfonates can be used as an adhesive (a binder), a dispersant to prevent the clumping and settling of undissolved particles in suspensions, an emulsion stabilizer, and as a sequestrant for water treatments for boilers and cooling systems.  Lignosulfonates are used for dust control and surface stabilization on roads.
        V.  Cumulative Effects
        Section 408(b)(2)(D)(v) of  FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

        Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding for any of the lignosulfonate chemicals.  As a group,  the lignosulfonates do not appear to produce any toxic metabolite produced by other substances.  For the purposes of this tolerance action, therefore, EPA has not assumed that any of the lignosulfonate chemicals have a common mechanism of toxicity with other substances.  For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's OPP concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.
        VI.  Determination of Safety
        The available data from the open literature describes chemicals which exhibit effects at doses that are in the grams per kilogram per day. Additionally,  the Agency's understanding of the polymeric nature of these chemicals indicates nil absorption, and there is a finding of low-moderate concern for human health from the SAR assessments.  Based on all of the available information, EPA concludes that these lignosulfonate chemicals do not pose an appreciable risk under reasonably foreseeable circumstances.  Accordingly, EPA finds that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to these lignosulfonate chemicals.
        Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database unless EPA concluded that a different margin of safety will be safe for infants and children. The SAR assessments did not indicate any concerns for developmental toxicity for the lignosulfonate chemicals, other than for the zinc counter-ion.  Given the incorporation of zinc into a polymeric-type high molecular weight chemical, which is then not well-absorbed by the human body, it is unlikely that the high doses of zinc at which adverse effects can occur would be reached.  Due to the expected low oral toxicity due to the nil absorption of the lignosulfonates, a safety factor analysis has not been used to assess the risk.  For the same reasons, the additional tenfold safety factor for the protection of infants and children is unnecessary.
        VII.   Other Considerations
        A. Endocrine Disruptors
        FQPA requires EPA to develop a screening program to determine whether certain substances, including all pesticide chemicals (both inert and active ingredients), “may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect...”  EPA has been working with interested stakeholders to develop a screening and testing program as well as a priority setting scheme.  As the Agency proceeds with implementation of this program, further testing of products containing lignosulfonate chemicals for endocrine effects may be required.
        B. Analytical Method
        An analytical method is not required for enforcement purposes since the Agency is proposing exemptions from the requirement of a tolerance without any numerical limitation.
        C. Existing Tolerances
        Currently, there are seven tolerance exemptions for lignosulfonate chemicals.  In 40 CFR 180.910: Ethoxylated lignosulfonic acid, sodium salt; lignosulfonate, ammonium, calcium, magnesium, potassium, sodium, and zinc salts; oxidized pine lignin, sodium salt; pine lignin .   There are also in 40 CFR 180.930: Lignosulfonate, ammonium, calcium, magnesium, potassium, sodium, and zinc salts; oxidized pine lignin, sodium salt; and pine lignin. The Agency is proposing to revise these tolerances.
        D. International Tolerances
        The Agency is not aware of any country requiring a tolerance for any of the lignosulfonate chemicals nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time.
        VIII.  Conclusions
        Based on the Agency's review and evaluation of the available information on the toxicity of lignosulfonate chemicals and considering the SAR assessments, EPA concludes that there is a reasonable certainty of no harm from aggregate exposure to residues of these 22 lignosulfonate chemicals.  The Agency finds that exempting these 22 lignosulfonate chemicals from the requirement of a tolerance will be safe.
        IX.  Statutory and Executive Order Reviews

        This proposed rule establishes 32 exemptions from the requirement for a tolerance under section 408(d) of  FFDCA. 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 proposed rule has been exempted from review under Executive Order 12866 due to its lack of significance, this proposed rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This proposed 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). The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental organizations. After considering the economic impacts of this proposed rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. Establishing an exemption from the requirement of a pesticide tolerance (or, expanding and consolidating a tolerance exemption, as is proposed), is in effect, the removal of a regulatory restriction on pesticide residues in food and thus such an action will not have any negative economic impact on any entities, including small entities. 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 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 proposed 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 FFDCA. For these same reasons, the Agency has determined that this proposed 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 proposed 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 proposed rule.

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

          Dated: February 5, 2005.
          Lois Rossi,
          Director, Registration Division, Office of Pesticide Programs.

        Therefore, it is proposed that 40 CFR chapter I be amended as follows:

          PART 180—[AMENDED]

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

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

          § 180.910
          [Amended]
          2. Section 180.910 is proposed to be amended by removing the following entries from the table: Ethoxylated lignosulfonic acid, sodium salt; lignosulfonate, ammonium, calcium, magnesium, potassium, sodium, and zinc salts; oxidized pine lignin, sodium salt; and pine lignin.
          3. Section 180.910 is proposed to be amended by adding alphabetically the following entries to the table to read as follows:

          § 180.910
          Inert ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance.

            Inert ingredients
            Limits
            Uses

            *    *    *    *    *    *    *

            Lignin (CAS No.9005-53-2)

            surfactant, related adjuvants of surfactants

            Lignin, alkali (CAS No. 8068-05-1)

            Surfactant, related adjuvants of surfactants

            Lignin, alkali, oxidized, sodium salt (CAS No. 68201-23-0)

            Surfactant, related adjuvants of surfactants

            Lignin alkali, reaction products with disodium sulfite and formaldehyde (CAS  No. 105859-97-0)

            Surfactant, related adjuvants of surfactants

            Lignin alkali, reaction products with formaldehyde and sodium bisulfite (CAS No. 68512-35-6)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid (CAS . No. 8062-15-5)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, ammonium calcium salt (CAS  No. 12710-04-2)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, ammonium magnesium salt (CAS  No. 123175-37-1)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, ammonium salt (CAS  No. 8061-53-8)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, ammonium sodium salt (CAS  No. 166798-73-8)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, calcium magnesium salt (CAS  No. 55598-86-2)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, calcium salt (CAS  No. 8061-52-7)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, calcium sodium salt (CAS  No. 37325-33-0)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, ethoxylated, sodium salt (CAS  No. 68611-14-3)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, magnesium salt (CAS  No. 8061-54-9)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, potassium salt (CAS No. 37314-65-1)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, sodium salt (CAS  No. 8061-51-6)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, sodium salt, oxidized (CAS No. 68855-41-4)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, sodium salt, polymer with HCHO and phenol (CAS No. 37207-89-9)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, sodium salt, sulfomethylated (CAS  No. 68512-34-5)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, zinc salt (CAS  No. 57866-49-6)

            Surfactant, related adjuvants of surfactants

            *    *    *    *    *    *    *

            Sulfite liquors and cooking liquid, spent, oxidized (CAS No. 68514-09-0)

            Surfactant, related adjuvants of surfactants

            *    *    *    *    *    *    *

          § 180.930
          [Amended]
          4. Section 180.930 is proposed to be amended by removing the following entries from the table:  Lignosulfonate, ammonium, calcium, magnesium, potassium, sodium, and zinc salts; oxidized pine lignin, sodium salt; and pine lignin.
          5. Section 180.930 is proposed to be amended by adding alphabetically the following entries to the table to read as follows:

          § 180.930
          Inert ingredients applied to animals; exemptions from the requirement of a tolerance.

            Inert ingredients
            Limits
            Uses

            *    *    *     *      *    *    *

            Lignin (CAS No. 9005-53-2)

            Surfactant, related adjuvants of surfactants

            Lignin, alkali (CAS No. 8068-05-1)

            Surfactant, related adjuvants of surfactants

            Lignin, alkali, oxidized, sodium salt (CAS No. 68201-23-0)

            Surfactant, related adjuvants of surfactants

            Lignin alkali, reaction products with disodium sulfite and formaldehyde (CAS No. 105859-97-0)

            Surfactant, related adjuvants of surfactants

            Lignin alkali, reaction products with formaldehyde and sodium bisulfite (CAS No. 68512-35-6)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid (CAS No. 8062-15-5)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, ammonium calcium salt (CAS No. 12710-04-2)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, ammonium magnesium salt (CAS No. 123175-37-1)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, ammonium salt (CAS No. 8061-53-8)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, ammonium sodium salt (CAS No. 166798-73-8)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, calcium magnesium salt (CAS No. 55598-86-2)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, calcium salt (CAS No. 8061-52-7)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, calcium sodium salt (CAS No. 37325-33-0)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, ethoxylated, sodium salt (CAS No. 68611-14-3)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, magnesium salt (CAS No. 8061-54-9)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, potassium salt (CAS No. 37314-65-1)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, sodium salt (CAS No. 8061-51-6)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, sodium salt, oxidized (CAS No. 68855-41-4)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, sodium salt, polymer with HCHO and phenol (CAS No. 37207-89-9)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, sodium salt, sulfomethylated (CAS No. 68512-34-5)

            Surfactant, related adjuvants of surfactants

            Lignosulfonic acid, zinc salt (CAS No. 57866-49-6)

            Surfactant, related adjuvants of surfactants

            *     *    *    *     *     *     *

            Sulfite liquors and cooking liquid, spent, oxidized (CAS No. 68514-09-0)

            Surfactant, related adjuvants of surfactants

            *    *    *    *     *     *     *

      [FR Doc. 05-2986 Filed 2-15-05; 8:45 am]
      BILLING CODE 6560-50-S


        DEPARTMENT OF TRANSPORTATION
        Federal Motor Carrier Safety Administration
        [Docket No. FMCSA-2016-0050]
        49 CFR Parts 393 and 395
        Hours of Service of Drivers; Parts and Accessories: ArcelorMittal Indiana Harbor, LLC, Application for Exemptions

          AGENCY:
          Federal Motor Carrier Safety Administration (FMCSA), DOT.

          ACTION:
          Notice of application for exemptions; request for comments.

          SUMMARY:
          FMCSA announces that it has received an application from ArcelorMittal Indiana Harbor, LLC (ArcelorMittal) requesting exemptions for our regulations. The first exemption request is for ArcelorMittal's employee-drivers with commercial driver's licenses (CDLs) who transport steel coils between their production and shipping locations on public roads. ArcelorMittal requests this exemption to allow its employee-drivers to work up to 16 hours per day and be allowed to return to work with less than the mandatory 10 consecutive hours off duty. ArcelorMittal also requests exemptions in parts of our regulations for its coil carriers that do not meet all of the vehicle requirements in sections of our regulations. FMCSA requests public comment on ArcelorMittal's application for exemptions.

          DATES:
          Comments must be received on or before April 21, 2016.

          ADDRESSES:
          You may submit comments identified by Federal Docket Management System Number FMCSA-2016-0050 by any of the following methods:
          • Federal eRulemaking Portal: www.regulations.gov. Follow the online instructions for submitting comments.
          • Mail: Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Avenue SE., West Building, Ground Floor, Room W12-140, Washington, DC 20590-0001.
          • Hand Delivery or Courier: West Building, Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
          • Fax: 1-202-493-2251.

            Instructions: All submissions must include the Agency name and docket number. For detailed instructions on submitting comments and additional information on the exemption process, see the Public Participation heading below. Note that all comments received will be posted without change to www.regulations.gov, including any personal information provided. Please see the Privacy Act heading below.

            Docket: For access to the docket to read background documents or comments received, go to www.regulations.gov, and follow the online instructions for accessing the dockets, or go to the street address listed above.

            Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.

            Public participation: The Federal eRulemaking Portal is available 24 hours each day, 365 days each year. You can obtain electronic submission and retrieval help and guidelines under the “help” section of the Federal eRulemaking Portal Web site. If you want us to notify you that we received your comments, please include a self-addressed, stamped envelope or postcard, or print the acknowledgement page that appears after submitting comments online.

          FOR FURTHER INFORMATION CONTACT:

          Ms. Pearlie Robinson, FMCSA Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards; Telephone: 202-366-4325. Email: MCPSD@dot.gov. If you have questions on viewing or submitting material to the docket, contact Docket Services, telephone (202) 366-9826.

        SUPPLEMENTARY INFORMATION:
        I. Public Participation and Request for Comments
        FMCSA encourages you to participate by submitting comments and related materials.
        Submitting Comments
        If you submit a comment, please include the docket number for this notice (FMCSA-2016-0050), indicate the specific section of this document to which the comment applies, and provide a reason for suggestions or recommendations. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.
        To submit your comment online, go to www.regulations.gov and put the docket number, “FMCSA-2016-0050” in the “Keyword” box, and click “Search.” When the new screen appears, click on “Comment Now!” button and type your comment into the text box in the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party and then submit. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the facility, please enclose a stamped, self-addressed postcard or envelope. FMCSA will consider all comments and material received during the comment period and may grant or not grant this application based on your comments.
        Viewing Comments and Documents

        To view comments, as well as documents mentioned in this preamble as being available in the docket, go to www.regulations.gov and insert the docket number, “FMCSA-2016-0050” in the “Keyword” box and click “Search.” Next, click “Open Docket Folder” button and choose the document listed to review. If you do not have access to the Internet, you may view the docket online by visiting the Docket Management Facility in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., e.t., Monday through Friday, except Federal holidays.
        II. Legal Basis

        FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant exemptions from certain parts of the Federal Motor Carrier Safety Regulations. FMCSA must publish a notice of each exemption request in the Federal Register (49 CFR 381.315(a)). The Agency must provide the public an opportunity to inspect the information relevant to the application, including any safety analyses that have been conducted. The Agency must also provide an opportunity for public comment on the request.

        The Agency reviews safety analyses and public comments submitted, and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305). The decision of the Agency must be published in the Federal Register (49 CFR 381.315(b)) with the reasons for denying or granting the application and, if granted, the name of the person or class of persons receiving the exemption, and the regulatory provision from which the exemption is granted. The notice must also specify the effective period and explain the terms and conditions of the exemption. The exemption may be renewed (49 CFR 381.300(b)).
        III. Request for Exemption
        Under 49 CFR 395.3(a)(2), a property-carrying commercial motor vehicle (CMV) driver is prohibited from operating a CMV after having been on duty for 14 consecutive hours following 10 or more consecutive hours off duty. Once an individual has reached the end of this 14 consecutive-hour period, he or she cannot drive a CMV again without taking a minimum of 10 consecutive hours off duty.
        ArcelorMittal (USDOT 1098829) operates a steel plant that is located in East Chicago, Indiana, its principal place of business. The plant currently encompasses an area which has several public roadways that run through its present location. Steel coils produced in one portion of the plant require driver-employees to travel on public roadways at two points to move the coils to another portion of the plant for further processing or for shipment to customers. Both points are controlled intersections, having either traffic lights or a combination of traffic lights and signs in the area, where the vehicles cross. The first public road the CMVs cross is Riley Road. The crossing is controlled by a traffic signal in both directions. The distance traveled at this crossing is 80 feet in length. The average number of crossings at this intersection is 24 per day. The second crossing is at Dickey Road and 129th Street. The distance traveled at this crossing is .2 miles. The trucks cross 129th Street 24 times per day.
        All employee-drivers are required to hold CDLs and adhere to the regulations that apply to CMV drivers. Specialized equipment and trailers are used to move steel coils due to the size of the coils. The tractors maximum speed is 30-35 miles per hour, but when moving a fully loaded trailer the maximum speed is 15 miles per hour.
        Trailer beds are configured in such a way as create a cradle to hold the steel coils in place on the bed of the trailer. The trailers have a bed height of 68 inches, and bed width of 114 inches. The trailers maximum height is 14 feet.
        The tractors and trailer in combination unloaded have a gross combination weight of 77,000 pounds. When fully loaded the gross combination vehicle weight is 263,171 pounds. Additionally, the trailers have off-road tires. These types of tires are necessary to operate both inside and outside the plant safely, given the type of roadway surface inside the plant area and the weight of the loads. These vehicles have many of the same features of a typical tractor and trailer, but do not meet all of the parts and accessories requirements in 49 CFR part 393.
        When employee-drivers move these vehicles, they are fully marked as an “oversize load” and have flags on the front of the tractor. The driving of these vehicles amounts to 10 percent of the employee-drivers total work day. ArcelorMittal contends that none of these employee-drivers work more than 16 hours per day and advises that a 16-hour work day is the exception, not the rule.
        According to ArcelorMittal, the current hours-of-service (HOS) regulations create problems for employee-drivers as these employees typically work an 8-hour shift plus overtime while employees in the production and shipping areas work 12-hour shifts. Employee-drivers must go home under the current arrangement leaving a 4-hour gap between production and the driver's schedule, creating a possible shortage of coils for shipping or processing. ArcelorMittal asserts that the limited amount of employees used to drive the CMVs make it difficult to schedule when the vehicles move. ArcelorMittal anticipates only 3 of the 24 crossings at each noted intersection would occur after the 14th hour on-duty.
        ArcelorMittal requests an exemption from 49 CFR part 395 for its employee-drivers. Under a waiver of the HOS regulations, employee-drivers would be able to follow the same schedule as the employees in the production and shipping areas. ArcelorMittal could then minimize the chances of possible shortages of coils for shipping or processing. ArcelorMittal advises that it would ensure all employee-drivers would not work more than 16 hours per shift, would receive 8 hours off duty between shifts, and would not be allowed to drive more than 10 percent of their total work day.
        ArcelorMittal also requests exemptions for its coil carriers from certain sections in 49 CFR part 393 as follows: The heavy hauler trailer definition in § 393.5; the height of rear side marker lights in § 393.11 Table 1—Footnote 4; the tire loading restrictions in § 393.75(f); and the coil securement requirements in § 393.120. As previously noted, the vehicles used to transport steel coils have many of the same features of a typical tractor and trailer, but do not meet all of the parts and accessories requirements in 49 CFR part 393.
        According to ArcelorMittal, its equipment was designed for in-facility use and very limited road use. Public roadways are crossed due to operational necessity. ArcelorMittal advises that they have never had an issue at the crossings mentioned with their equipment or drivers. The coils are well-secured in the vehicles with the cradle design of their trailers. The time it would take to secure the coils per the regulations would be longer than the transit time it takes to move the coils from part of the plant to another.
        ArcelorMittal asserts that it has taken additional precautions to make sure the public roadway crossings are at the shortest points and only at controlled intersections. ArcelorMittal ensures all lights are properly working on both the tractor and trailer. They also flag and mark the vehicles as “oversize” loads. Trailers have conspicuity tape down the entire side to make them more visible to other traffic. ArcelorMittal believes that the additional precautions ensure a level of safety that is equivalent to or exceeds the level of safety achieved by following the regulations.
        ArcelorMittal acknowledges in its application that these drivers would still be subject to all of the other applicable Federal regulations. This includes qualification of drivers, controlled substance and alcohol testing and inspection, and maintenance and repair of vehicles.
        Included in ArcelorMittal's application are illustrations of the plant's location, public roads crossed, and pictures of the tractors and trailers used to transport the steel coils. A copy of ArcelorMittal's application for the exemptions is available for review in the docket for this notice.

          Issued on: March 16, 2016.
          Larry W. Minor,
          Associate Administrator for Policy.

      [FR Doc. 2016-06391 Filed 3-21-16; 8:45 am]
      BILLING CODE 4910-EX-P


        DEPARTMENT OF TRANSPORTATION
        National Highway Traffic Safety Administration
        49 CFR Part 571
        [Docket No. NHTSA 2006-24342]
        Federal Motor Vehicle Safety Standards

          AGENCY:
          National Highway Traffic Safety Administration (NHTSA), DOT.

          ACTION:
          Denial of Petitions for Rulemaking and Defect Determination.

          SUMMARY:
          This document denies a petition for rulemaking and defect determinations submitted by Mr. James E. Hofferberth to prevent the installation by States of seat belts in large school buses and declare school buses equipped with seat belts to be safety defects. After reviewing the petition, NHTSA concludes that there is no justification for changing its longstanding position that States may require seat belts at passenger seating positions in large public school buses. We also conclude that there is no basis to declare that school buses equipped with seat belts have safety-related defects, or to recall existing school buses installed with seat belts. The petitioner did not provide any data that NHTSA has not considered in the past.

          FOR FURTHER INFORMATION CONTACT:
          For legal issues: Ms. Dorothy Nakama, Office of the Chief Counsel, phone (202) 366-2992.
          For technical issues: Mr. Charles R. Hott, Office of Crashworthiness Standards, NVS-113, phone (202) 366-0247.
          You can reach both of these officials at the National Highway Traffic Safety Administration, 400 Seventh St., SW., Washington, DC 20590.

        SUPPLEMENTARY INFORMATION:
        On April 26, 2005, NHTSA received a petition from Mr. James E. Hofferberth to preempt and prevent the installation of seat belts in large school buses (gross vehicle weight rating greater than 4,536 kg (10,000 pounds) (also called “full-sized school buses” by the petitioner) and declare school buses equipped with seat belts defective. He petitioned to:
        1. Preempt, prevent and preclude the possibility of the installation of seat belts or safety belts in full sized school buses.
        2. Declare school buses equipped with seat belts or safety belts as defective relative to safety and order that all such vehicles be recalled and repaired immediately to full compliance with letter and intent of the applicable motor vehicle safety standard.
        3. Initiate criminal, civil or any alternative punitive action available to [the Secretary of Transportation] under the law against any individual or organization that ordered or performed the installation of seat belts or safety belts in school buses.
        4. Require that any device installed in full sized school buses be proven to neither reduce the overall safety of children of all relevant sizes and ages during transportation related to school activities with due consideration to all factors affecting that safety nor preclude or diminish in any way the safety provision of the motor vehicle safety standards related to school buses.
        In his petition, Mr. Hofferberth stated his belief that several State and local governments have enacted or are considering requirements for seat belts or safety belts in full sized school buses, that full sized school buses are subject to established Federal motor vehicle safety standards (FMVSS), that installation of seat belts or safety belts in full sized school buses overrides or precludes the effectiveness of the safety features required in full sized school buses, and that the installation of seat belts or safety belts in full sized school buses creates an unnecessary and unacceptable risk of injury and fatality to school bus passengers.
        He also submitted supplemental information and analysis on November 16, 2005 1
          . He reviewed cited tests in the agency's April 2002 report to Congress, “School Bus Safety: Crashworthiness Research,” and concluded that abdominal injury measurements, which he alleged were not included in the report to Congress, for lap and shoulder belted occupants were between 1.6 and 2.3 times higher than for comparable unbelted occupants. For lap belted occupants, he stated that the abdominal injury measurements were between 2.9 and 5.6 times higher than for comparable unbelted occupants, and that these loadings of the belted occupants were well above the threshold of serious to fatal injury. He stated that abdominal loading of the unbelted child was 135 pounds, and this type of loading is substantially less injurious than when belts are used to apply the loads, and would not be likely to cause serious abdominal injury. He believed that the increases in injury severity for belted occupants are consistent with “seat belt syndrome” and provided a bibliography of various research reports and articles on the subject.

            1 For a full copy of Mr. Hofferberth's supplemental information, please refer to dms.dot.gov (Docket Number 24342).

        Mr. Hofferberth argued that the modification of standard seats to accommodate belt loading increased the head, neck and chest injury readings for all unbelted occupants and degraded the level of safety performance provided by standard seats designed for use with the compartmentalization requirements of FMVSS No. 222.
        The petitioner stated that section 103(d) of the National Traffic and Motor Vehicle Safety Act (recodified at 49 U.S.C. 30103(b)) provides that no “State or political subdivisions [sic] of a State shall have any authority either to establish or continue in effect, with respect to any motor vehicle or item of motor vehicle equipment any motor vehicle [sic] safety standard applicable to the same aspect of [performance of such vehicle or item of] equipment which is not identical to the Federal standard.” It was his opinion that the “aspect” which overlaps the “motor vehicle or item of motor vehicle equipment” regulated by FMVSS No. 222 is the level of injury protection provided by the school buses and the compartmentalization restraint equipment and performance required by FMVSS No. 222. Therefore, he argued that FMVSS No. 222 preempts all State and local requirements relating to the installation of belt restraints in full size school buses, and that the use of belt restraints installed in full size school buses should be prohibited until such time as the belts can be removed or otherwise rendered inoperable.
        Analysis of the Petition for Rulemaking
        The agency has conducted a review of the rulemaking petition in accordance with 49 CFR Section 552.6. We are denying the petition, based on that review.
        NHTSA is responsible for establishing Federal motor vehicle safety standards (FMVSSs) to reduce the number of fatalities and injuries from motor vehicle crashes, including those involving school buses. NHTSA also works with the States on school bus safety and occupant protection programs. New school buses must meet safety standards for various aspects of school bus safety, including the passenger crash protection requirements of FMVSS No. 222. Rather than requiring passenger seat belts on large school buses, FMVSS No. 222 provides crash protection through a concept called “compartmentalization.” Children are compartmentalized in a protective envelope consisting of strong, closely-spaced seats that have energy-absorbing seat backs. Through compartmentalization, children are protected without the need to buckle up.

        Currently, there are four States that require seat belts in all school buses. New York, New Jersey and Florida require lap belts, and California requires lap and shoulder belts in all school buses. NHTSA does not maintain a record of local school boards that also may require seat belts on buses. However, a University of South Florida (USF) study 2
           revealed that many districts might require such systems even though it is not mandatory in their State. At the time of the USF study, only New York required seat belts in all school buses.

            2 “To Belt or Not To Belt, Experiences of School Districts that Operate Large School Buses Equipped with Seat Belts,” Final Report, August 1994, Center for Urban Transportation Research, College of Engineering, University of South Florida.

        Federal preemption of State motor vehicle safety standards is governed by Section 30103(b) of 49 U.S.C. 30101 et seq. (the “Vehicle Safety Act”). Section 30103(b)(1) states:

          When a motor vehicle safety standard is in effect under this chapter [49 USCS §§ 30101 et seq.], a State or a political subdivision of a State may prescribe or continue in effect a standard applicable to the same aspect of performance of a motor vehicle or motor vehicle equipment only if the standard is identical to the standard prescribed under this chapter [49 USCS §§ 30101 et seq.]. However, the United States Government, a State, or a political subdivision of a State may prescribe a standard for a motor vehicle or motor vehicle equipment obtained for its own use that imposes a higher performance requirement than that required by the otherwise applicable standard under this chapter [49 USCS §§ 30101 et seq.].

        NHTSA has previously addressed the preemption issue raised by the petitioner 3
          . A State law that requires seat belts on all large school buses conflicts with FMVSS No. 222 and is preempted. However, the last sentence of § 30103(b) permits a State to prescribe a standard for school buses obtained for its own use that imposes a higher performance requirement than that required by the otherwise applicable FMVSS. (We have interpreted the phrase “vehicles procured for (the State's) own use” to include public school buses and those under contract to transport children to and from public school. However, school buses purchased by private schools would not be included). Thus, as the last sentence of § 30103(b) makes clear, States are free to require seat belts on school buses which the State purchases for its own use.

            3 Denial of Petition for Rulemaking, September 10, 1981 46 FR 4571, interpretation letter to Mr. Martin Chauvin, February 20, 1987.

        NHTSA has permitted the co-existence of seat belts with compartmentalization requirements on large school buses since the beginning of FMVSS No. 222. NHTSA published the final rule establishing FMVSS No. 222 on January 28, 1976 (41 FR 4016). This regulation became effective for all newly manufactured school buses on and after April 1, 1977. In the rulemaking leading to the 1976 final rule, four notices of proposed rulemaking (NPRM) were published.4
           Throughout the course of that rulemaking, the issue of requiring seat belts and/or belt anchorages on large school buses was extensively contemplated. Although the agency decided not to require the belts or anchorage systems, the agency clearly intended to allow State and local jurisdictions the choice of installing seat belts. For example 5
          , in the October 1975 NPRM, the agency confirmed State and local jurisdictional choice to install belts when it stated (46 FR at 45171):

            4 February 22, 1973 (38 FR 4776), July 30, 1974 (39 FR 27586), April 23, 1975 (40 FR 17855) and October 8, 1975 (40 FR 47141).

            5 See also April 23, 1975 NPRM, in which NHTSA proposed (but subsequently did not adopt) a provision for built-in seat belt anchorages in addition to compartmentalization requirements stating that it “finds it desirable to allow local school boards the option of installing belts, if they decide the additional protection is worth the extra expense.”

          A greater measure of protection may be obtained [over compartmentalization alone] if a particular end user chooses to use the anchorages by installation of seat belts together with a system to assure that seat belts are worn, properly adjusted, and not misused. School bus users are free to choose whether or not to install belts.

        NHTSA has consistently construed the FMVSS as not preempting State requirements concerning seat belts in large school buses where there is no showing that those requirements adversely impact compliance with the FMVSS. Seat belts on large school buses can be considered to satisfy the “higher performance” threshold of the last sentence of § 30103(b) because, when properly worn, they can supplement compartmentalization by restraining passengers in crashes other than frontal crashes, e.g., in rollovers. In its 1999 report on seat belts on large school buses, the National Transportation Safety Board (NTSB) 6
           concluded that the compartmentalization requirement for school buses in FMVSS No. 222 is incomplete because it does not protect school bus passengers in rollovers or in lateral impacts from large vehicles, because in such accidents passengers do not always remain completely within the seating compartment. Despite the NTSB conclusion, NHTSA has not found that a sufficient safety need exists with respect to those non-frontal crashes to warrant requiring seat belts on large school buses.7
           However, we have always permitted States to choose to require the safety devices over and above the Federal requirements in the school buses they purchase.

            6 NTSB/SIR-99/04, Highway Safety Report, Bus Crashworthiness Issues, September 1999, National Transportation Safety Board.

            7 In its 1987 report on the crashworthiness of large, post-April 1, 1977 school buses, NTSB concluded that passengers in the cases studied would have received no net benefit from lap belt use, and that most of the severe injuries and fatalities were due to passengers being seated directly in the impact zone (NTSB/SS-87/01, Safety Study, Crashworthiness of Large Post-standard School Buses, March 1987, National Transportation Safety Board). Likewise, the National Academy of Sciences (NAS) concluded that the overall potential benefits of requiring seat belts on large school buses are insufficient to justify a Federal requirement for mandatory installation. Special Report 222, Improving School Bus Safety, National Academy of Sciences, Transportation Research Board, Washington, DC, 1989. NAS also stated that the funds used to purchase and maintain seat belts might better be spent on other school bus safety programs and devices that could save more lives and reduce more injuries.

        NHTSA's April 2002 report to Congress 8

           found that the addition of lap belts slightly raised the potential risk for head injury. However, these were severe frontal impacts that were studied for the report. Conversely, lap belts have been on large school buses for over 30 years without any documented injuries resulting from the use of the seat belt restraint systems.9
           We cannot make a determination, based on the results of limited testing with belt restraints in a severe frontal condition that showed performance only slightly reduced from that of compartmentalization, that the addition of seat belts in large school buses reduces overall occupant protection.

            8 School Bus Safety: Crashworthiness Research, National Highway Traffic Safety Administration, April 2002.

            9 Crash data show that there are approximately 26,000 school bus crashes annually, involved in frontal, side, rear, and rollover collisions.

        As for abdominal loading, NHTSA does not know the basis for the petitioner's conclusions regarding the significance of the dummy abdominal measures. The abdominal measurements made in these tests were for comparative research purposes, have not been biomechanically validated, and have no injury criteria associated with them. This was discussed on page 43 of the report to Congress.
        School buses constitute a very safe form of transportation. A recent NAS study 10

           shows that there are about 815 school transportation fatal injuries per year. Only 2 percent are associated with school buses, compared to 22 percent due to walking/bicycling, and 75 percent from passenger car transportation. Every year, approximately 450,000 public school buses travel about 4.3 billion miles to transport 23.5 million children to and from school and school-related activities. The school bus occupant fatality rate of 0.2 fatalities per 100 million vehicle miles traveled (VMT) is much lower than the rates for passenger cars (1.46 per 100 million VMT) or light trucks and vans (1.3 per 100 million VMT). These results reflect the safety record of large school buses that, for the most part, are not being fitted with any seat belts at passenger seating positions.

            10 Special Report 269, “The Relative Risks of School Travel: A National Perspective and Guidance for Local Community Risk Assessment,” Transportation Research Board of the National Academies, 2002.

        The petitioner believes that the dollars spent installing belts on large school buses could be more effectively spent purchasing additional buses to transport more children in the safest means available (in school buses). On our Web site information about seat belts in large school buses 11
          , NHTSA does advise consideration of the overall safety consequences of bus purchasing decisions, to ensure that seat belt restraints are worn properly, and that no child is left seeking a less safe form of transportation. At the same time, the agency concludes that there is no justification for changing its longstanding position that States may order seat belts at passenger seating positions in large public school buses. For these reasons, and since the petitioner did not provide any data that NHTSA has not considered in the past, the agency is denying the rulemaking petition.

            11 Http://www.nhtsa.dot.gov: click Traffic Safety tab: click School Buses under Browse Topics menu: click Seat Belts On School Buses

        Analysis of the Petition for Defect Determination
        The agency has conducted a technical review of the defect petition in accordance with 49 CFR 552.6. The Office of Defects Investigation (ODI) reviewed its databases for reports and complaints related to alleged problems with school buses equipped with seat belts. That review did not reveal any reports or complaints that would warrant opening a safety-related defects investigation. Moreover, the petitioner has not presented any data or argument that supports his basis for concluding that seat belts may pose an unreasonable risk to the safety of occupants of those buses. Based on ODI's review and lack of data to the contrary, the agency believes that there is insufficient data to warrant NHTSA commencing a defect investigation and is denying the petition.

          Authority:
          49 U.S.C. 322, 30111, 30115, 30117, 30118, and 30162; delegation of authority at 49 CFR 1.50 and 501.8.

          Issued on: July 10, 2006.
          Stephen R. Kratzke,
          Associate Administrator for Rulemaking.
          Daniel C. Smith,
          Associate Administrator for Enforcement.

       [FR Doc. E6-11136 Filed 7-13-06; 8:45 am]
      BILLING CODE 4910-59-P


        DEPARTMENT OF COMMERCE
        National Oceanic and Atmospheric Administration
        50 CFR Part 665
        RIN 0648-AX76
        Fisheries in the Western Pacific; Community Development Program Process

          AGENCY:
          National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

          ACTION:
          Notice of availability of fishery ecosystem plan amendments; request for comments.

          SUMMARY:
          NMFS announces that the Western Pacific Fishery Management Council (Council) proposes to amend the fishery ecosystem plans (FEPs) for American Samoa, Hawaii, Marianas, and western Pacific Pelagics. If approved by the Secretary of Commerce (Secretary), the amendments would establish requirements and procedures for reviewing and approving community development plans for access to western Pacific fisheries. The intent of the amendments is to promote the participation of island communities in fisheries that they have traditionally depended upon, but may not have the capabilities to support continued and substantial participation in, possibly due to economic, regulatory, or other constraints.

          DATES:
          Comments on the amendments must be received by July 20, 2010.

          ADDRESSES:
          Comments on the amendments, identified by 0648-AX76, may be sent to either of the following addresses:

          • Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal www.regulations.gov; or
          • Mail: Mail written comments to William L. Robinson, Regional Administrator, NMFS, Pacific Islands Region (PIR), 1601 Kapiolani Blvd, Suite 1110, Honolulu, HI 96814-4700.

          Instructions: Comments must be submitted to one of these two addresses to ensure that the comments are received, documented, and considered by NMFS. Comments sent to any other address or individual, or received after the end of the comment period, may not be considered. Comments will be posted for public viewing after thecomment period has closed. All comments received are a part of the public record and will generally be posted to www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.) submitted voluntarily by the commenter may be publicly accessible. Do not submit confidential business information, or otherwise sensitive or protected information. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous). Attachments to electronic comments will be accepted in Microsoft Word or Excel, WordPerfect, or Adobe PDF file formats only.

          Copies of the amendments (which are identical for all four FEPs) containing background information on the issue are available from www.regulations.gov and from the Council, 1164 Bishop St., Suite 1400, Honolulu, HI 96813, tel 808-522-8220, fax 808-522-8226, or web site www.wpcouncil.org.

          FOR FURTHER INFORMATION CONTACT:
          Jarad Makaiau, NMFS PIR Sustainable Fisheries, 808-944-2108.

        SUPPLEMENTARY INFORMATION:
        This document is also available at www.gpoaccess.gov/fr.
        Section 305(i)(2) of the Magnuson-Stevens Act authorizes the Council and the Secretary, through NMFS, to establish a community development program for western Pacific fisheries. The intent of the program is to provide western Pacific communities access to fisheries that they have traditionally depended upon, but may not have the capabilities to support continued and substantial participation in, possibly due to economic, regulatory, or other constraints.
        In 2002, NMFS announced the eligibility criteria for participating in the program (67 FR 18512; April 16, 2002). To participate in the program, communities are required to develop and submit a development plan, but there is currently no mechanism to solicit, review, and approve these plans. To address this issue, the Council developed and submitted to NMFS for review, amendments to the FEPs for American Samoa, Hawaii, the Mariana Archipelago, and western Pacific Pelagics to establish such a mechanism. The amendments are identical for each FEP.
        To be eligible for the community development program, a community must:
        1. Be located in American Samoa, Guam, Hawaii, or the Northern Mariana Islands (collectively, the western Pacific);

        2. Consist of community residents descended from aboriginal people indigenous to the western Pacific area who conducted commercial or subsistence fishing using traditional fishing practices in the waters of the western Pacific;
        3. Consist of individuals who reside in their ancestral homeland;
        4. Have knowledge of customary practices relevant to fisheries of the western Pacific;
        5. Have a traditional dependence on fisheries of the western Pacific;
        6. Are experiencing economic or other constraints that prevent full participation in the western Pacific fisheries and, in recent years, have not had harvesting, processing or marketing capability sufficient to support substantial participation in fisheries in the area; and
        7. Develop and submit a community development plan to the Council and NMFS.
        Each community development plan must contain the following information:
        1. A statement of the purpose and goals of the plan;
        2. A description of, and justification for, the proposed fishing activity;
        3. The location of the proposed fishing activity;
        4. The species to be harvested, directly and incidentally;
        5. The gear type(s) to be used;
        6. The frequency and duration of the proposed fishing activity; and
        7. A statement describing the degree of involvement by the indigenous community members including the name, address, telephone and other contact information of each person who would conduct the proposed fishing activity, and a description of how the community and or its members meet each of the eligibility criteria.
        If a vessel is to be used by the community to conduct fishing activities, the plan must include the vessel name and official number (USCG documentation, state, territory, or other registration number), length, displacement, fish holding capacity, any valid federal fishing permit number, and the name and contact information of the owner(s) and operator(s).
        The amendments would require the Council to review each plan to ensure that it meets the intent of Section 305(i)(2) of the Magnuson-Stevens Act and contains all of the required information. If the Council finds these requirements are met, the Council would then forward the plan to the NMFS Regional Administrator for review.

        The Regional Administrator would review each plan to ensure it is consistent with the FEPs, Magnuson-Stevens Act, and other applicable laws. NMFS would then publish a notice in the Federal Register to solicit public comment on the plan and associated environmental review documents. Within 90 days after the close of the public comment period, the Regional Administrator would notify the applicant in writing of the decision to approve or disapprove the community development plan. If the plan is approved, the Regional Administrator would publish a notice in the Federal Register describing the plan's authorized activities. The Regional Administrator may attach limiting terms and conditions to the authorization for proper management and monitoring of the fishing activity, including, but not limited to, catch and trip limits, times and places where fishing may or may not be conducted, vessel monitoring system, observers, and/or reporting requirements.
        Public comments on the proposed amendments must be received by July 20, 2010 to be considered by NMFS in the decision to approve, partially approve, or disapprove the amendments. A proposed rule to implement the measures recommended in the amendment has been prepared for Secretarial review and approval. NMFS expect to publish and request public comment on the proposed rule in the near future.

          Authority:
          16 U.S.C. 1801 et seq.

          Dated: May 17, 2010.
          James P. Burgess,
          Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.

      [FR Doc. 2010-12283 Filed 5-20-10; 8:45 am]
      BILLING CODE 3510-22-S