 1  UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 FEB 15 2006 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM SUBJECT: Review of Product Characterization and Human Health Data for Modified Cry3A ( mCry3A) Bacillus thuringiensis insect control protein and maize ( Corn) Plants Derived from Event MIR604 ( EPA Reg. No. 67979 L) in support for a Permanent Exemption from Tolerances and Section 3 Registration, submitted by Syngenta Seeds, Inc.   Field Crops NAFTA.

TO: Mike Mendelsohn, Regulatory Action Leader Microbial Pesticides Branch, Biopesticides and Pollution Prevention Division ( 7511C)

FROM: Annabel Fellman, Environmental Protection Specialist [ signed] Microbial Pesticides Branch, Biopesticides and Pollution Prevention Division ( 7511C)

THROUGH: John L. Kough, Ph. D., Biologist [ signed] Microbial Pesticides Branch, Biopesticides and Pollution Prevention Division ( 7511C)

ACTION REQUESTED: To review additional product characterization, human health and analytical methods data submitted by Syngenta Seeds, Inc. Field Crops  NAFTA in support for section 3 registration and a permanent exemption from tolerances for Modified Cry3A insect control protein and maize ( Corn) Plants Derived from Event MIR604.

CONCLUSION: The product characterization, protein expression, toxicological and allergenicity data support the finding that there is a reasonable certainty of no harm to humans from the aggregate exposure to the residues of the mCry3A protein, including all anticipated dietary exposures and all other exposures for which there is reliable information.

* REVIEW DOES NOT CONTAIN CONFIDENTIAL BUSINESS INFORMATION*  2  DATA REVIEW RECORD: Active Ingredient: Modified Cry3A ( mCry3A) Bacillus thuringiensis insecticidal protein and the genetic material necessary for their production ( via pZM26) in transgenic maize ( corn) plants derived from Syngenta Seeds' transformation Event MIR604. Product Name: Event MIR604 Maize Plants Expressing Modified Cry3A Bacillus thuringiensis Protein Company Name: Syngenta Seeds, Inc.   Field Corps NAFTA ID No: 67979 Chemical Number: 006509 Decision Number: 343070 DP Barcode: 319746 MRID No:

465974 01 Independent Laboratory Validation of ELISA method for the Detection of mCry3A in Event MIR604 corn grain BACKGROUND: Syngenta synthetically modified a cry3A gene from Bacillus thuringiensis subsp. tenebrionis to optimize the gene for expression in maize ( corn) and to enhance its activity against the western corn rootworm ( WCRM; Diabrotica virgifera vigifera) and northern corn rootworm ( NCRM; D. longicornis barberi) ( Sekar et al., 1987). Syngenta's maize Event MIR604 corn plants were a result of a corn plant transformation with the synthetic modified cry3A gene, which provides resistance to these pests ( Chen, E. and Stacy, C., 2003). Transformation was conducted using immature maize embryos derived from a proprietary Zea mays line, via Agrobacterium mediated transformation. By this method, genetic elements within the left and right border regions of the transformation vector are efficiently transferred and integrated into the genome of the plant cell.

Event MIR604 maize also contains the pmi gene, which was introduced along with the mCry3A protein via the same pZM26 transformation vector. The gene represents the manA gene from Escherichia coli and encodes the enzyme phosphomannose isomerase ( PMI), which was employed as a selectable marker during the process of regenerating plant material following transformation ( Negrotto, et al., 2000). The PMI protein is a common enzyme involved in carbohydrate metabolism to allow for selection of transformants in cell culture, by only allowing transformed corn cells to utilize mannose as a sole carbon source, while corn cells lacking the pmi gene fail to grow. An existing permanent exemption from the requirement of a tolerance has been established for PMI in all crops when used as a plant incorporated protectant inert ingredient ( see 40 CFR 180.1252, effective May 14, 2004). This regulation eliminates the need to establish a maximum permissible level for residues in or on all plant commodities of phosphomannose isomerase and the genetic material necessary for its production in all plants when part of a plant incorporated protectant.

In the Federal Register of April 6, 2005 ( 70 FR 17323), the Agency established a temporary exemption from the requirement of a tolerance for Modified Cry3A and the genetic material  3  necessary for their production in corn which will expire October 15, 2006. In addition, EPA issued an experimental permit for the use Bt mCry3A protein and the genetic material necessary for their production ( via plasmid pZM26) in Event MIR604 corn and associated activities ( such as collection of field data; harvesting & processing of seed after last planting) on 575 acres of field corn. To support their requests for EUP and a temporary tolerance, Syngenta Seeds, Inc. submitted product characterization and protein expression analyses, toxicological and allergenicity data [ see memoranda from A. Fellman through J. Kough to M. Mendelsohn, dated 02/ 11/ 2005, 02/ 23/ 2005, 03/ 03/ 2005, and 05/ 31/ 2005]. The submitted study titles, conclusions, and their MRID numbers are provided ( see Table 1) in this report. The final study to complete data requirements for Section 3 registration for Modified Cry3A protein and the genetic material necessary for their production ( via plasmid pZM26) in Event MIR604 corn is reviewed in this report as well.

Permanent Exemption for the Requirement of a Tolerance ( 4F6838) EPA has established an exemption from tolerance requirements pursuant to FFDCA section 408( j)( 3) for Bacillus thuringiensis Cry3A delta endotoxin and the genetic material necessary for its production in potatoes, and this tolerance exemption has been reassessed and meets the 408( c)( 2) standard ( see 40 CFR 180.1147). An exemption from the requirement of a tolerance has been established for PMI in all crops when used as a plant incorporated protectant inert ingredient ( see 40 CFR 180.1252, effective May 14, 2004).

In the Federal Register of April 6, 2005 ( 70 FR 17323), the Agency established a temporary exemption from the requirement of a tolerance for Modified Cry3A and the genetic material necessary for their production in corn which will expire October 15, 2006. In addition, EPA issued an experimental permit for the use Bt mCry3A protein and the genetic material necessary for their production ( via plasmid pZM26) in Event MIR604 corn and associated activities ( such as collection of field data; harvesting & processing of seed after last planting) on 575 acres of field corn.

Syngenta Seeds, Inc.   Field Crops NAFTA has submitted a petition for a permanent exemption from the requirement of a tolerance pursuant to section 408( d)( 1) of the Federal Food, Drug, and Cosmetic Act with respect to the plant incorporated protectant modified Cry3A Bacillus thuringiensis insect control protein and the genetic material necessary for its production in all corn.

Previously submitted studies demonstrated the lack of toxicity of the mCry3A protein following acute oral high dose exposure to mice, rapid degradation of mCry3A upon exposure to simulated mammalian gastric fluid and the lack of significant amino acid sequence homology of the mCry3A protein to proteins known to be mammalian toxins or human allergens. Therefore, dietary exposure to mCry3A in corn is not anticipated to pose any harm for the U. S. population as stated in the memorandum from A. Fellman, through J. Kough, Ph. D., to M. Mendelsohn, dated May 31, 2005.

The only outstanding data gap identified in the May 31, 2005 memorandum was the submission of a validated analytical method for detection of mCry3A in corn. A new submission for the analytical method employing a monoclonal antibody is reviewed ( MRID No. 465974 01) in this report.  4  Preliminary Safety Assessment Section 408( c)( 2)( A)( i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance ( the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is A safe.@ Section 408( c)( 2)( A)( ii) of the FFDCA defines A safe @

to mean that A there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.@ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408( b)( 2)( C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to A ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . @

Additionally, section 408( b)( 2)( D) of the FFDCA requires that the Agency consider A available information concerning the cumulative effects of a particular pesticide's residues and other substances that have a common mechanism of toxicity.@ EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

Product Characterization Profile A mCry3A Bacillus thuringiensis ( Bt) insect control protein is produced in transgenic corn plants derived from transformation Event MIR604. A cry3A gene from Bt subsp. tenebrionis was recreated synthetically to optimize for expression in corn. Additional changes in this cornoptimized gene were made, such that the encoded mCry3A protein has enhanced activity against larvae of the western corn rootworm ( WCRM; Diabrotica virgifera vigifera) and northern corn rootworm ( NCRM; D. longicornis barberi). Introduced via transformation vector pZM26, a mcry3A specific probe, consisting of 1797 base pairs ( bp), was incorporated between an MTL promoter ( 2556 bp) from the Zea mays metallothionein like gene and a terminator sequence from the nopaline synthase ( NOS) gene of Agrobacterium tumefaciens used to provide a polyadenylation site. An Escherichia coli manA gene encoding a phosphomannose isomerase pmi gene ( 1176 bp) was incorporated between a promoter region from the Zea mays polyubiquitin gene ( ZmUbInt ( 1993 bp)) and the same NOS terminator sequence described above. This pmi gene, which was introduced along with the mCry3A protein via the same pZM26 transformation vector, encodes the enzyme phosphomannose isomerase ( PMI), which is employed as a selectable marker during the process of regenerating plant material following transformation. The PMI protein is a common enzyme involved in carbohydrate metabolism to allow for selection of transformants in cell culture, by only allowing transformed corn cells to utilize mannose as a sole carbon source, while corn cells lacking the pmi gene fail to grow.

Hybridization patterns indicate that one full length copy of each of the mcry3A and pmi genes were integrated into the maize genome. Moreover, DNA sequencing revealed that there was a 44 and 43 bp truncation at the right and left break points of the T DNA insert, respectively, during the transformation process that resulted in MIR604. Therefore, the overall integrity of the insert and the contiguousness of the functional elements were confirmed.  5  The native Cry3A protein of Bt subsp. tenebrionis is a ca. 73 kDa polypeptide of 644 amino acids. By comparison, the mCry3A protein expressed in Event MIR64 corn is a ca. 67 kDa polypeptide of 598 amino acids. The amino acid sequence of the mCry3A protein corresponds to that of the native Cry3A protein, except: 1) Its N terminus corresponds to methionine 48 of the native protein; and 2) A cathepsin G protease recognition site has been introduced, beginning at amino acid residue 155 of the native protein. This cathepsin G recognition site has the sequence alanine alanine proline phenylalanie, and has replaced the amino acids valine 155, serine 156, and serine 157 in the native protein.

Toxicological Profile Consistent with section 408( b) ( 2) ( D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Data have been submitted demonstrating the lack of mammalian toxicity at high levels of exposure to the pure mCry3A protein. These data demonstrate the safety of the products at levels well above maximum possible exposure levels that are reasonably anticipated in the crops. This is similar to the Agency position regarding toxicity and the requirement of residue data for the microbial Bacillus thuringiensis products from which this plant incorporated protectant was derived ( See 40 CFR 158.740( b)( 2)( i)). For microbial products, further toxicity testing and residue data are triggered by significant acute effects in studies such as the mouse oral toxicity study, to verify the observed effects and clarify the source of these effects ( Tiers II and III).

An acute oral toxicity study was submitted for the mCry3A protein. The acute oral toxicity data submitted support the prediction that the mCry3A protein would be non toxic to humans. Male and female mice ( 5 of each) were dosed with 2,377 milligrams/ kilograms bodyweight ( mg/ kg bwt) of mCry3A protein. With the exception of one female in the test group that was euthanized on day 2 ( due to adverse clinical signs consistent with a dosing injury), all other mice survived the study, gained weight, had no test material related clinical signs, and had no test material related findings at necropsy.

When proteins are toxic, they are known to act via acute mechanisms and at very low dose levels ( Sjoblad, Roy D., et al. 1992). Therefore, since no effects were shown to be caused by the plant incorporated protectants, even at relatively high dose levels, the mCry3A protein is not considered toxic. Amino acid sequence comparisons showed no similarity between the mCry3A protein to known toxic proteins available in public protein data bases. According to the Codex Alimintarius guidelines, the assessment of potential toxicity also includes stability to heat ( FAO/ WHO Standards Programme, 2001). Further data demonstrate that mCry3A is inactivated against WCRM, when heated to 95 ° C for 30 minutes.

Since mCry3A is a protein, allergenic sensitivities were considered. Currently, no definitive tests for determining the allergenic potential of novel proteins exist. Therefore, EPA uses a  6  weight of the evidence approach where the following factors are considered: source of the trait; amino acid sequence similarity with known allergens; prevalence in food; and biochemical properties of the protein, including in vitro digestibility in simulated gastric fluid ( SGF), and glycosylation. Current scientific knowledge suggests that common food allergens tend to be resistant to degradation acid and proteases; may be glycosylated; and present at high concentrations in the food.

Data have been submitted that demonstrate that the mCry3A protein is rapidly degraded by gastric fluid in vitro. In a solution of simulated gastric fluid 1 mg/ mE mCry3A test protein mixed with simulated gastric fluid ( pH 1.2, containing 2 mg/ mL NaCl, 14 pL 6 N HC1, and 2.7 mg/ mL pepsin) resulting in 10 pepsin activity units/ jag protein ( complies with 2000 US Pharmacopoeia recommendations), complete degradation of detectable mCry3A protein occurred within 2 minutes. A comparison of amino acid sequences of known allergens uncovered no evidence of any homology with mCry3A, even at the level of 8 contiguous amino acids residues. Further data demonstrate that mCry3A is not glycoslylated, is inactivated when heated to 95 ° C for 30 minutes, and is present in low levels in corn tissue.

Therefore, the potential for the mCry3A protein to be a food allergen is minimal. As noted above, toxic proteins typically act as acute toxins with low dose levels. Therefore, since no effects were shown to be caused by the plant incorporated protectant, even at relatively high dose levels, the mCry3A protein is not considered toxic.

Aggregate Exposures In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other nonoccupational 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).

The Agency has considered available information on the aggregate exposure levels of consumers ( and major identifiable subgroups of consumers) to the pesticide chemical residue and to other related substances. These considerations include dietary exposure under the tolerance exemption and all other tolerances or exemptions in effect for the plant incorporated protectant chemical residue, and exposure from non occupational sources. Exposure via the skin or inhalation is not likely since the plant incorporated protectant is contained within plant cells, which essentially eliminates these exposure routes or reduces these exposure routes to negligible. Exposure via residential or lawn use to infants and children is also not expected because the use sites for the mCry3A protein are all agricultural for control of insects. Oral exposure, at very low levels may occur from ingestion of processed corn products and, potentially, drinking water.

However, oral toxicity testing done at a dose in excess of 2 gm/ kg showed no adverse effects. Furthermore, the expression of the modified Cry3A protein in corn kernels has been shown to be in the parts per million range, which makes the expected dietary exposure several orders of magnitude lower than the amounts of mCry3A protein shown to have no toxicity. Therefore,  7  even if negligible aggregate exposure should occur, the Agency concludes that such exposure would present no harm due to the lack of mammalian toxicity and the rapid digestibility demonstrated for the mCry3A protein.

Cumulative Effects Pursuant to FFDCA section 408( b)( 2)( D)( v), EPA has considered available information on the cumulative effects of such residues and other substances that have a common mechanism of toxicity. These considerations included the cumulative effects on infants and children of such residues and other substances with a common mechanism of toxicity. Because there is no indication of mammalian toxicity, resulting from the plant incorporated protectant, we conclude that there are no cumulative effects for the mCry3A protein.

Determination of Safety for U. S. Population, Infants and Children A. Toxicity and Allergenicity Conclusions The data submitted and cited regarding potential health effects for the mCry3A protein include the characterization of the expressed mCry3A protein in corn, as well as the acute oral toxicity, heat stability, and in vitro digestibility of the proteins. The results of these studies were determined applicable to evaluate human risk, and the validity, completeness, and reliability of the available data from the studies were considered.

Adequate information was submitted to show that the mCry3A protein test material derived from microbial cultures was biochemically and functionally similar to the protein produced by the plant incorporated protectant ingredients in corn. Microbially produced protein was chosen in order to obtain sufficient material for testing.

The acute oral toxicity data submitted supports the prediction that the mCry3A protein would be non toxic to humans. As mentioned above, when proteins are toxic, they are known to act via acute mechanisms and at very low dose levels ( Sjoblad, Roy D., et al. 1992). Since no effects were shown to be caused by mCry3A protein, even at relatively high dose levels ( 2,377 mg mCry3A/ kg bwt), the mCry3A protein is not considered toxic. This is similar to the Agency position regarding toxicity and the requirement of residue data for the microbial Bacillus thuringiensis products from which this plant incorporated protectant was derived. ( See 40 CFR 158.740( b)( 2)( i)). Moreover, mCry3A showed no sequence similarity to any known toxinand was inactivated by heat against WCRM.

Protein residue chemistry data for mCry3A were not required for a human health effects assessment of the subject plant incorporated protectant ingredients because of the lack of mammalian toxicity. However, data submitted demonstrated low levels of mCry3A in corn tissues with less than 2 micrograms mCry3A protein/ gram dry weight in kernels and less than 30 micrograms mCry3A protein/ gram dry weight of whole corn plant.

Since modified Cry3A is a protein, its potential allergenicity is also considered as part of the toxicity assessment. Data considered as part of the allergenicity assessment include that the modified Cry3A protein came from Bacillus thuringiensis which is not a known allergenic  8  source, showed no sequence similarity to known allergens, was readily degraded by pepsin, and was not glycosylated when expressed in the plant. Therefore, there is a reasonable certainty that modified Cry3A protein will not be an allergen.

Neither available information concerning the dietary consumption patterns of consumers ( and major identifiable subgroups of consumers including infants and children); nor safety factors that are generally recognized as appropriate for the use of animal experimentation data were evaluated. The lack of mammalian toxicity at high levels of exposure to the mCry3A protein, as well as the minimal potential to be a food allergen demonstrate the safety of the product at levels well above possible maximum exposure levels anticipated in the crop.

The genetic material necessary for the production of the plant incorporated protectant active ingredients are the nucleic acids ( DNA, RNA) which comprise genetic material encoding these proteins and their regulatory regions. The genetic material ( DNA, RNA) necessary for the production of mCry3A protein has been exempted under the blanket exemption for all nucleic acids ( 40 CFR 174.475).

B. Infants and Children Risk Conclusions FFDCA section 408( b)( 2)( C) provides that EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity.

In addition, FFDCA section 408( bfl2)( C) also 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 data base unless EPA determines that a different margin of safety will be safe for infants and children.

In this instance, based on all the available information, the Agency concludes that there is a finding of no toxicity for the mCry3A protein and the genetic material necessary for their production. Thus, there are no threshold effects of concern and, as a result, the provision requiring an additional margin of safety does not apply. Further, the provisions of consumption patterns, special susceptibility, and cumulative effects do not apply.

C. Overall Safety Conclusion There is a reasonable certainty that no harm will result from aggregate exposure to the U. S. population, including infants and children, to the mCry3A protein and the genetic material necessary for its production. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion because, as previously discussed, no toxicity to mammals has been observed, nor any indication of allergenicity potential for the plant incorporated protectant.

Other Considerations A. Endocrine Disruptors The pesticidal active ingredient is a protein, derived from sources that are not known to exert  9  an influence on the endocrine system. Therefore, the Agency is not requiring information on the endocrine effects of the plant incorporated protectant at this time.

B. Analytical Method( s) A method for extraction and ELISA analysis of mCry3A protein in corn has been submitted and found acceptable by the Agency.

C. Codex Maximum Residue Level No Codex maximum residue levels exist for the plant incorporated protectant Bacillus thuringiensis mCry3A protein and the genetic material necessary for its production in corn.

RECOMMENDATION: As previously noted, there is a reasonable certainty that no harm will result from aggregate exposure to the U. S. population, including infants and children, to the mCry3A protein and the genetic material necessary for its production. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. Therefore, the product characterization and human health data submitted are sufficient to support Section 3 registration and a permanent exemption from the requirement of a tolerance.

The data submitted for the ELISA method for determining mCry3A protein in Event MIR604 grain are classified as ACCEPTABLE and satisfies the EPA Residue Chemistry Guidelines OPPTS 860.1340( c)( 6) Residue Analytical Methods and PR Notice 96 1. However, the EPA's Analytical Method Laboratory located in Fort Meade ( Maryland) will have to independently validate Syngenta's ELISA protocol for accuracy, precision, and sensitivity.  10  Summaries of each review supporting the safety findings in the areas of product characterization, human toxicity, and allergenicity for this product are provided below.

Table 1. Previously submitted product characterization, toxicity, and allergenicity studies MRID Title Summary 461556 01 Review of Characterization and Safety of Modified Cry3A protein and maize ( corn) plants derived from Event MIR604 with comparison to native Cry3A protein The mCry3A protein contains 598 amino acids ( ca. 67 kDa), whereas the native Cry3A protein is ca. 73 kDa polypeptide of 644 amino acids. The amino acid sequence of the mCry3A protein corresponds to that of the native Cry3A protein, except: 1) Its Nterminus corresponds to methionine 48 of the native protein; and 2) A cathepsin G protease recognition site has been introduced, beginning at amino acid residue 155 of the native protein. The susceptibility of insect pest species and insecticidal properties, such as solubilization, proteolytic processing, receptor binding, and membrane pore forming properties, were also determined for mCry3A protein and differentiated with native Cry3A protein. The mCry3A protein has a similar spectrum of activity to the native Cry3A, but with enhanced toxicity to NCRW and WCRW.

Classification: Acceptable 461556 02 Molecular characterization of event MIR604 maize ( corn) expressing a modified Cry3A bacillus thuringiensis protein Corn Event MIR604 does not contain any of the backbone sequences from the transforming plasmid pZM26. Three nucleotide changes were identified, one in a regulatory region of the mCry3A gene and two in the pmi coding sequence. The mCry3A and pmi genes are closely linked.

Classification: Acceptable 461556 03 Characterization of modified Cry3A protein produced in event MIR604 derived maize ( corn) and comparison with modified Cry3A protein expressed in recombinant Escherichia coli This study evaluated the similarity of modified Cry3A ( mCry3A) insecticidal protein expressed in corn event MIR604 and mCry3A protein expressed in a recombinant E. coli test system. The mCry3A protein derived from corn event MIR604 and recombinant E. coli had the same approximate molecular weight ( ca. 67,700 Da.) based on mass spectral analysis ( from MRID 461556 06). The mCry3A protein from both sources was immunologically cross reactive with the same anti mCry3A antibody. Both proteins produced comparable toxicities toward Western Corn Rootworm larvae, based on LC50 values. There was no evidence of post translational glycosylation of mCry3A protein from either source. It was concluded that the mCry3A proteins from corn event MIR604 and from recombinant E. coli were substantially the same.

Classification: Acceptable  11  461556 04 Quantification of modified Cry3A and pmi proteins in transgenic maize ( corn) tissues, whole plants, and silage derived from transformation event MIR604 The plant extracts ( including leaves, roots, kernels, silk, pollen, silage, and whole plants) from inbred and hybrid corn lines derived from MIR604 field plants were quantitatively analyzed for mCry3A by ELISA. The magnitude of expression for tissue types was as follows in descending order: leaves, roots, silage, and kernels. All control tissues were negative for the expression of mCry3A. The mean extraction efficiency for mCry3A over all tissues ( except for pollen or silk tissue, where levels were too low to be determined) was 76.6%. Low, but quantifiable, levels of PMI protein were found in most of the Event MIR604 derived plant tissues analyzed including pollen. The mCry3A and PMI proteins were stably expressed in four backcross generations in leaf tissue analyzed at anthesis stage. Mean levels across all backcross generations were ca. 11.8  15.5 µ g/ g dry weight and 1.1  1.3 µ g/ g dry weight for mCry3A and PMI proteins, respectively.

Classification: Acceptable 461556 05 Characterization of modified Cry3A test substance mCry3A 0102 and certificate of analysis This study characterized test material MCRY3A 0102, a microbially produced protein preparation containing a modified Cry3A ( mCry3A) protein. The purity of mCry3A in the test material was shown to be ca. 90.3% by weight using SDS PAGE analysis. Western blot analysis of the test material showed a single immunoreactive band corresponding to the predicted molecular weight of ca. 67,700 Da. The test material was insecticidally active and had a 144 hour LC50 of 1.4 µ g/ mL diet ( 95% confidence interval: 0.7  2.2 µ g/ mL) against Western corn rootworm ( WCRW) larvae. Two forms of mCry3A were found in the test material, designated mCry3A SF and mCry3A LF, respectively, and were both insecticidally active against WCRW. On this basis, and taking into account the high degree of structural homology ( 97.4% amino acid identity), the two forms of mCry3A in test material MCRY3A 0102 were considered to be equivalent. The test material was re analyzed ca. 9 months after its initial characterization and found to be substantially stable when stored at  20 ° C.

Classification: Acceptable 461556 06 Further Characterization of Modified Cry3A Test Substance MCRY3A 0102 The test material, MCRY3A 0102, containing mCry3A protein was shown, by SDS PAGE and MALDI TOF mass spectrometry, to contain two closely related components in a ratio of ca. 2: 3. The lesser of the two components, with the lower molecular weight, corresponded to the intended mCry3A protein with 598 amino acids. The other component contained the same 598 amino acids as the first component but also contained an additional 16 amino acids at the N  terminal end of the protein. The identity of the two components was conclusively determined by peptide mapping using tandem ( MS/ MS) mass spectrometry and by MALDI TOF mass spectrometry of the intact proteins. The molecular weight data showed the two proteins to have masses of 67,519 and 69,138 Da.

Classification: Acceptable  12  461556 07 In vitro digestibility of modified Cry3A protein ( mCry3A 0102 and IAPMIR604 0103) under simulated mammalian gastric conditions The susceptibility of mCry3A protein to proteolytic degradation was evaluated in simulated gastric fluid ( SGF) containing pepsin. Modified Cry3A protein from transgenic corn and recombinant E. coli ( test material MCRY3A 0102) was readily degraded in SGF. The data support a conclusion that mCry3A protein expressed in transgenic plants will be readily digested as conventional dietary protein under typical mammalian gastric conditions.

Classification: Acceptable 461556 08 Effect of temperature on the stability of modified Cry3A protein ( mCry3A 0102) At 95 ° C mCry3A protein was completely inactivated against WCRM. At 4 ° C, 25 ° C, and 37 ° C there was little or no effect on mCry3A bioactivity, while at 65 ° C there was some reduction in the bioactivity.

Classification: Acceptable 461556 09 Analysis for the presence of modified Cry3A protein in wet and dry milled fractions, corn oil and corn chips from corn ( maize) event MIR604 Among the wet milled fractions, the medium fiber ( 0.46 µ g mCry3A/ g), fine fiber ( 0.26 µ g mCry3A/ g), and gluten meal ( 0.24 µ g mCry3A/ g) fractions yielded quantifiable amounts of mCry3A. Among the dry milled fractions the highest concentrations were found in the flaking grits ( 2.12 µ g mCry3A/ g), the corn hulls ( 1.42 µ g mCry3A/ g), and the coarse grit ( 0.92 µ g mCry3A/ g) fractions. Levels of mCry3A found in the other dry milled fractions, including fine grits, corn meal, corn cone and corn flour, were between 0.32 and 0.69 µ g mCry3A/ g. Although the concentration of mCry3A protein measured in the flour used to prepare the corn chips was 0.32 µ g mCry3A / g, no mCry3A protein was detected in the corn chips. Similarly, mCry3A protein was not detectable in oil, whereas the starting material, flaking grits, contained 2.12 µ g mCry3A/ g.

Classification: Acceptable 461556 10 Acute oral toxicity study of modified Cry3A protein ( mCry3A 0102) in the mouse MCRY3A 0102 was not acutely toxic to mice. There was no evidence of toxicity at 2,632 mg MCry3A 0102/ kg body weight, representing ca. 2,377 mg mCry3A protein/ kg body weight. The estimated LD50 value for pure mCry3A protein in male and female mice was > 2,377 mg/ kg body weight, the single dose used.

Classification: Acceptable 461556 11 Modified Cry3A protein as expressed in transgenic maize event MIR604: assessment of amino acid homology with known toxins The National Center for Biotechnology Information ( NCBI) GenBank Database ( NCBI, 2003) containing all publicly available protein sequences was queried for proteins with amino acid sequences having significant homology to mCry3A protein and that were toxins. The query found no significant amino acid homology between any protein toxin and the mCry3A protein.

Classification: Acceptable  13  461556 12 Modified Cry3A protein as expressed in transgenic maize event MIR604: assessment of amino acid homology with known allergens No significant similarity was found between any of the mCry3A 80 amino acid peptides and any entries in the SBI Allergen Database. Also, there were no alignments of eight or more contiguous amino acids between the mCry3A protein and any of the proteins in the allergen database. Overall, the mCry3A protein showed no significant amino acid homology to any known or putative allergenic protein.

Classification: Acceptable 465974 01 Analytical Method for the Detection of the Plant Incorporated Protectant Modified Cry3A Protein in Event MIR604 Corn Grain and Independent, Third Party Validation of Said Method An ELISA method to quantify modified Cry3A ( mCry3A) protein in corn tissues was validated by an independent third party laboratory ( EnvironLogix, Inc.) using grain from Event MIR604, which contains mCry3A, and 25 other commercially available transgenic and non transgenic corns which do not contain mCry3A. The average mCry3A LOD for three different lots of reagents tested was 5.5 ± 4.6 ppb, which established the sensitivity of the ELISA assay at approximately 25%. In a ground grain assay, the mean mCry3A protein detected was 159.1 ± 70.2 ng/ g fresh weight with a coefficient of variation (% CV) of 44.1%. However, the data submitted showed: less than optimal LOD; low sensitivity; high standard deviations; the % CV exceeding the recommended value ( 20%); anomalous frequency of false positives in the non MIR604 corn ( both transgenic and conventional) as well as false negatives in the MIR604 corn; and unexpected cross reactivity with other Cry3Bb1 samples.

Classification: Supplemental 461556 13 Phosphomannose Isomerase as expressed in transgenic maize event MIR604: assessment of amino acid homology with known toxins Two nucleotide changes were discovered in the pmi gene sequence inserted in corn Event MIR604. This resulted in two changes in the PMI protein; valine 61 was replaced by alanine, and glutamine 210 was replaced by histidine. These substitutions have not resulted in any apparent functional change in the PMI protein. The NCBI GenBank Database containing all publicly available protein sequences was queried for proteins with amino acid sequences having significant homology to this modified PMI protein that were toxins. The query found no significant amino acid homology between any protein toxin and the PMI protein expressed in corn Event MIR604.

Classification: Acceptable 464252 01 Phosphomannose Isomerase as expressed in transgenic maize event MIR604: assessment of amino acid homology with known allergens No significant similarity was found between any of the PMI 80 amino acid peptides and any entries in the SBI Allergen Database. However, in the eight or more contiguous amino acids homology search, there was an alignment between the PMI protein and a recently identified allergen,   parvalbumin from Rana species CH2001 ( a frog of Indonesian origin). However, a serum screening concluded that there is no cross reactivity between PMI and serum IgE ( obtained from an allergic individual who displayed food induce anaphylaxis from   parvalbumin). Bovine serum albumin was also tested as an internal check. The observed low degree of sequence identity between MIR604 PMI and   parvalbumin is not biologically relevant.

Classification: Acceptable  14  465974 01 Independent Laboratory Validation of Monoclonal based ELISA method for the Detection of mCry3A in Event MIR604 corn grain A monoclonal based enzyme linked immunosorbent assay ( ELISA) method was developed by Syngenta to detect modified Cry3A ( mCry3A) protein expressed in MIR604 seed and leaf tissues. An independent, third party laboratory ( EnvironLogix, Inc.) utilized the assay methodology, Event MIR604 seed, negative isoline seed, and three lots of mCry3A monoclonal antibody for validation of assay protocol, sensitivity and cross reactivity, according to the USDA GIPSA directive. The assay sensitivity was estimated at 1 positive Event MIR604 kernel in 999 non MIR604 kernels ( 0.1%), which was based on a minimum of 120 ground seed samples ( with a LOD of 0.33 ppb for seed material). The average quantification was 2.07 ppb ( ng/ g fresh weight corn). No cross reactivity with other commercial, conventional and transgenic corn was detected with the exception of products expressing the Cry3Bb1 protein. Moreover, extraction efficiency was determined at 59% for ground seed and 75% for leaf tissue.

CLASSIFICATION: ACCEPTABLE The monoclonal assay antibody based commercial ELISA detection assay ( tested by EnviroLogix, Inc.) satisfies the EPA Residue Chemistry Guidelines OPPTS 860.1340( c)( 6) Residue Analytical Methods and PR Notice 96 1. However, the EPA's Analytical Method Laboratory located in Fort Meade ( Maryland) will have to independently validate Syngenta's ELISA protocol for accuracy, precision, and sensitivity.

REFERENCES Chen, E. & Stacy, C. ( 2003) Modified Cry3A toxins and nucleic acid sequences coding therefore. WO Patent No. 03/ 018810.

Food and Agriculture Organization of the United Nations and World Health Organization. ( 2003). Foods Derived from Biotechnology. Codex Alimentarius. Sec. 4, No. 38, pg. 16.

Negrotto, et al. ( 2000) The use of phosphomannose isomerase as a selectable marker to recover transgenic maize plants ( Zea mays L. via Agrobacterium transformation. Plant Cell Reports, 19: 798 803.

Sekar et al. ( 1987) Molecular cloning and characterization of the insecticidal crystal protein gene of Bacillus thuringiensis var. tenebrionis. Proc. Natl. Acad. Sci. USA 8: 7036 7040.

Sjoblad, R. D., McClintock, J. T., and Engler, R. ( 1992) A Toxicological Considerations for Protein Components of Biological Pesticide Products,@ Reg. Toxicol. Pharmacol. 15( 1): 3 9.


[Federal Register Volume 81, Number 246 (Thursday, December 22, 2016)]
[Notices]
[Page 93950]
[FR Doc No: 2016-30801]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4206-DR; Docket ID FEMA-2016-0001]

Soboba Band of Luise[ntilde]o Indians; Amendment No. 1 to Notice
of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster for the
Soboba Band of Luise[ntilde]o Indians (FEMA-4206-DR), dated January 27,
2015, and related determinations.

DATES: Effective Date: November 30, 2016.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated November 30, 2016, the President amended the cost-sharing
arrangements regarding Federal funds provided under the authority of
the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42
U.S.C. 5121 et seq. (the ``Stafford Act''), in a letter to W. Craig
Fugate, Administrator, Federal Emergency Management Agency, Department
of Homeland Security, under Executive Order 12148, as follows:

    I have determined that the damage to the lands associated with
the Soboba Band of Luise[ntilde]o Indians resulting from severe
storms, flooding, and mudslides during the period of December 4-6,
2014, is of sufficient severity and magnitude that special cost
sharing arrangements are warranted regarding Federal funds provided
under the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford Act'').
    Therefore, I amend my declaration of January 27, 2015, to
authorize Federal funds for all categories of Public Assistance at
90 percent of total eligible costs.
    This adjustment to the cost sharing applies only to Public
Assistance costs and direct Federal assistance eligible for such
adjustments under the law. The Robert T. Stafford Disaster Relief
and Emergency Assistance Act specifically prohibits a similar
adjustment for funds provided for the Hazard Mitigation Grant
Program (Section 404). These funds will continue to be reimbursed at
75 percent of total eligible costs.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2016-30801 Filed 12-21-16; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Rules and Regulations]
[Pages 35833-35834]
[FR Doc No: 2015-15315]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2014-0457; Airspace Docket No. 14-AWP-4]

Establishment of Class E Airspace; Cloverdale, CA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action establishes Class E airspace at Cloverdale
Municipal Airport, Cloverdale CA. to accommodate Area Navigation (RNAV)
Global Positioning System (GPS) standard instrument approach procedures
at Cloverdale Municipal Airport. This action enhances the safety and
management of IFR operations at the airport.

DATES: Effective 0901 UTC, August 20, 2015. The Director of the Federal
Register approves this incorporation by reference action under title 1,
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order 7400.9 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.9Y, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed on line at http://www.faa.gov/airtraffic/publications/. The Order is also available for
inspection at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15. For further
information, you can contact the Airspace Policy and ATC Regulations
Group, Federal Aviation Administration, 800 Independence Avenue SW.,
Washington, DC 29591; telephone:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Richard Roberts, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the

agency's authority. This rulemaking is promulgated under the authority
described in Subtitle VII, Part A, Subpart I, Section 40103. Under that
section, the FAA is charged with prescribing regulations to assign the
use of airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it establishes controlled airspace at Cloverdale Municipal
Airport, Cloverdale, CA.

History

    On September 2, 2014 the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to establish Class E airspace
extending upward from 700 feet above the surface at Cloverdale
Municipal Airport, Cloverdale, CA. (79 FR 51919). Interested parties
were invited to participate in this rulemaking effort by submitting
written comments on the proposal to the FAA. No comments were received.
    Class E airspace designations are published in paragraph 6005, of
FAA Order 7400.9Y, dated August 6, 2014, and effective September 15,
2014, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.9Y, airspace Designations and
Reporting Points, dated August 6, 2014, and effective September 15,
2014. FAA Order 7400.9Y is publicly available as listed in the
ADDRESSES section of this final rule. FAA Order 7400.9Y lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 establishes Class E airspace extending upward from 700 feet
above the surface at Cloverdale, CA, with a segment that extends 6.3
miles south of the airport. Controlled airspace is needed for the RNAV
(GPS) standard instrument approaches and departures at the airport.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore, (1) is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71:

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment:

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for Part 71 continues to read as follows:

     Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Y,
Airspace Designations and Reporting Points, dated August 6, 2014, and
effective September 15, 2014, is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

AWP CA E5 Cloverdale, CA [New]

Cloverdale Municipal Airport, CA
    (lat. 38[deg]46'34'' N., long. 122[deg]59'33'' W.)
    That airspace extending upward from 700 feet above the surface
within a 3.5-mile radius of Cloverdale Municipal Airport and 2 miles
either side of the 152[deg] radial from the 3.5-mile radius to 6.3
miles south of the airport.

    Issued in Seattle, Washington, on June 15, 2015.
Christopher Ramirez,
Acting Manager, Operations Support Group, Western Service Center.
[FR Doc. 2015-15315 Filed 6-22-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 238 (Thursday, December 11, 2014)]
[Notices]
[Pages 73696-73697]
[FR Doc No: 2014-29068]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2006-24278; FMCSA-2006-25854; FMCSA-2008-0355; FMCSA-
2010-0203; FMCSA-2011-0089]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

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

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

-----------------------------------------------------------------------

SUMMARY: FMCSA announces its decision to renew the exemptions from the
Epilepsy and Seizure Disorders requirement in the Federal Motor Carrier
Safety Regulations for 9 individuals. FMCSA has statutory authority to
exempt individuals from the Epilepsy and Seizure Disorders requirement
if the exemptions granted will not compromise safety. The Agency has
concluded that granting these exemption renewals will provide a level
of safety that is equivalent to or greater than the level of safety
maintained without the exemptions for these commercial motor vehicle
(CMV) drivers.

DATES: This decision is effective December 1, 2014. Comments must be
received on or before January 12, 2015.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) numbers: Docket No. [Docket No. FMCSA-2006-
24278; FMCSA-2006-25854; FMCSA-2008-0355; FMCSA-2010-0203; FMCSA-2011-
0089], using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line 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., Washington, DC, between 9 a.m. and
5 p.m., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number for this notice. Note that DOT posts all comments
received without change to http://www.regulations.gov, including any
personal information included in a comment. Please see the Privacy Act
heading below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The Federal Docket Management System (FDMS) is
available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement
page that appears after submitting comments on-line.

C. 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.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the Epilepsy and Seizure Disorders requirements in 49 CFR
391.41(b)(8), which applies to drivers of CMVs in interstate commerce,
for a two-year period if it finds ``such exemption would likely achieve
a level of safety that is equivalent to or greater than the level that
would be achieved absent such exemption.'' The procedures for
requesting an exemption (including renewals) are set out in 49 CFR part
381.

Exemption Decision

    This notice addresses 9 individuals who have requested renewal of
their exemptions in accordance with FMCSA procedures. FMCSA has
evaluated these applications for renewal on their merits and decided to
extend each exemption for a renewable two-year period. They are:

Daniel Forth (NY)
Steven L. Hunsaker (ID)
Henrietta M. Ketcham (NY)
Shane Klementis (NY)
Robin L. Sherwood (ID)
Wayne C. Sorensen (MN)
Michael W. Thomas (KS)
Paul C. Warren (ME)
John B. Yates (WV)

    These exemptions are extended subject to the driver maintaining a
stable treatment regimen and remaining seizure-free during the 2-year
exemption period. The exempted drivers must submit a physician
statement from their treating physician attesting to the stability of
treatment and that the driver has remained seizure-free. The driver
must undergo an annual medical examination by a medical examiner, as
defined by 49 CFR 390.5, following the FCMSA's regulations for the
physical qualifications for CMV drivers. The exemption will be
rescinded if: (1) The person fails to comply with the terms and
conditions of the exemption; (2) the exemption has resulted in a lower
level of safety than was maintained before it was granted; or (3)
continuation of the exemption would not be consistent with the goals
and objectives of 49 U.S.C. 31136(e) and 31315.

Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. In accordance with 49
U.S.C. 31136(e) and 31315, each of the 9 applicants has satisfied the
entry conditions for obtaining an exemption from the Epilepsy and
Seizure Disorder requirements (71 FR 60606; 72 FR 44916; 73 FR 75165;
75 FR 38599; 76 FR 18822). Each of these 9 applicants has requested
renewal of the exemption and has submitted evidence showing that they
have maintained a stable treatment regimen and remained seizure-free
during the 2-year exemption period. The exempted drivers must submit a
physician statement from their treating physicians attesting to the
stability of treatment and that the driver has remained seizure-free.
The driver must undergo an annual medical examination by a medical
examiner, as defined by 49 CFR 390.5, following the FCMSA's regulations
for the physical qualifications for CMV drivers. In addition to
evaluating the medical status of each applicant CDLIS and MCMIS were
searched for crash and violation data on the 9 applicants. For non-CDL
holders, the Agency reviewed the driving records from the State
licensing agency. These factors provide an adequate basis for
predicting each

driver's ability to continue to drive safely in interstate commerce.
Therefore, FMCSA concludes that extending the exemption for each
renewal applicant for a period of two years is likely to achieve a
level of safety equal to that existing without the exemption.

Request for Comments

    FMCSA will review comments received at any time concerning a
particular driver's safety record and determine if the continuation of
the exemption is consistent with the requirements at 49 U.S.C. 31136(e)
and 31315. However, FMCSA requests that interested parties with
specific data concerning the safety records of these drivers submit
comments by January 12, 2015.
    FMCSA believes that the requirements for a renewal of an exemption
under 49 U.S.C. 31136(e) and 31315 can be satisfied by initially
granting the renewal and then requesting and evaluating, if needed,
subsequent comments submitted by interested parties. As indicated
above, the Agency previously published notices of final disposition
announcing its decision to exempt these 9 individuals from the Epilepsy
and Seizure Disorders requirement in 49 CFR 391.41(b)(8). The final
decision to grant an exemption to each of these individuals was made on
the merits of each case and made only after careful consideration of
the comments received to its notices of applications. The notices of
applications stated the medical condition of each applicant for an
exemption from the Epilepsy and Seizure requirements. That information
is available by consulting the above cited Federal Register
publications.
    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315, FMCSA will take immediate steps to revoke the
exemption of a driver.

Submitting Comments

    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 that FMCSA
can contact you if there are questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov and
in the search box insert the docket numbers FMCSA-2006-24278; FMCSA-
2006-25854; FMCSA-2008-0355; FMCSA-2010-0203; FMCSA-2011-0089 and click
the search button. When the new screen appears, click on the blue
``Comment Now!'' button on the right hand side of the page. On the new
page, enter information required including the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. If you submit your comments by mail or
hand delivery, submit them in an unbound format, no larger than 8\1/2\
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. We will
consider all comments and material received during the comment period.

Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
notice, or to submit your comment online, go to http://www.regulations.gov and in the search box insert the docket number
FMCSA-2006-24278; FMCSA-2006-25854; FMCSA-2008-0355; FMCSA-2010-0203;
FMCSA-2011-0089 and click ``Search.'' Next, click ``Open Docket
Folder'' and you will find all documents and comments related to this
document.

    Issued on: December 4, 2014.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2014-29068 Filed 12-10-14; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 81, Number 52 (Thursday, March 17, 2016)]
[Rules and Regulations]
[Pages 14395-14398]
[FR Doc No: 2016-05988]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2016-0002; Internal Agency Docket No. FEMA-8423]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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SUMMARY: This rule identifies communities where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP) that are scheduled for suspension on the effective dates
listed within this rule because of noncompliance with the floodplain
management requirements of the program. If the Federal Emergency
Management Agency (FEMA) receives documentation that the community has
adopted the required floodplain management measures prior to the
effective suspension date given in this rule, the suspension will not
occur and a notice of this will be provided by publication in the
Federal Register on a subsequent date. Also, information identifying
the current participation status of a community can be obtained from
FEMA's Community Status Book (CSB). The CSB is available at http://www.fema.gov/fema/csb.shtm.

DATES: The effective date of each community's scheduled suspension is
the third date (``Susp.'') listed in the third column of the following
tables.

FOR FURTHER INFORMATION CONTACT: If you want to determine whether a
particular community was suspended on the suspension date or for
further information, contact Patricia Suber, Federal Insurance and
Mitigation Administration, Federal Emergency Management Agency, 500 C
Street SW., Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
Federal flood insurance that is not otherwise generally available from
private insurers. In return, communities agree to adopt and administer
local floodplain management measures aimed at protecting lives and new
construction from future flooding. Section 1315 of the National Flood
Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale
of NFIP flood insurance unless an appropriate public body adopts
adequate floodplain management measures with effective enforcement
measures. The communities listed in this document no longer meet that
statutory requirement for compliance with program regulations, 44 CFR
part 59. Accordingly, the communities will be suspended on the
effective date in the third column. As of that date, flood insurance
will no longer be available in the community. We recognize that some of
these communities may adopt and submit the required documentation of
legally enforceable floodplain management measures after this rule is
published but prior to the actual suspension date. These communities
will not be suspended and will continue to be eligible for the sale of
NFIP flood insurance. A notice withdrawing the suspension of such
communities will be published in the Federal Register.
    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard Areas (SFHAs) in these communities.
The date of the FIRM, if one has been published, is indicated in the
fourth column of the table. No direct Federal financial assistance
(except assistance pursuant to the Robert T. Stafford Disaster Relief
and Emergency Assistance Act not in connection with a flood) may be
provided for construction or acquisition of buildings in identified
SFHAs for communities not participating in the NFIP and identified for
more than a year on FEMA's initial FIRM for the community as having
flood-prone areas (section 202(a) of the Flood Disaster Protection Act
of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against
certain types of Federal assistance becomes effective for the
communities listed on the date shown in the last column. The
Administrator finds that notice and public comment procedures under 5
U.S.C. 553(b), are impracticable and unnecessary because communities
listed in this final rule have been adequately notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
    National Environmental Policy Act. This rule is categorically
excluded from the requirements of 44 CFR part 10, Environmental
Considerations. No environmental impact assessment has been prepared.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended,
Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless
an appropriate public body adopts adequate floodplain management
measures with effective enforcement measures. The communities listed no
longer comply with the statutory requirements, and after the effective
date, flood insurance will no longer be available in the communities
unless remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the

Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

    Accordingly, 44 CFR part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for part 64 continues to read as follows:

    Authority:  42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.

Sec.  64.6  [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

----------------------------------------------------------------------------------------------------------------
                                                 Effective date
                                                 authorization/
                                   Community    cancellation of    Current effective map   Date certain  federal
       State and location             No.        sale of flood             date            assistance no longer
                                                  insurance in                              available in SFHAs
                                                   community
----------------------------------------------------------------------------------------------------------------
           Region III

Pennsylvania:
    Adamstown, Borough of,             420541  December 4, 1973,  April 5, 2016.........  April 5, 2016.
     Lancaster County.                          Emerg; January
                                                16, 1981, Reg;
                                                April 5, 2016,
                                                Susp.
    Akron, Borough of,                 422461  December 31,       ......do..............   Do.
     Lancaster County.                          1975, Emerg;
                                                December 16,
                                                1980, Reg; April
                                                5, 2016, Susp.
    Bart, Township of,                 421761  June 10, 1975,     ......do..............   Do.
     Lancaster County.                          Emerg; January
                                                16, 1981, Reg;
                                                April 5, 2016,
                                                Susp.
    Brecknock, Township of,            421762  July 9, 1975,      ......do..............   Do.
     Lancaster County.                          Emerg; April 1,
                                                1981, Reg; April
                                                5, 2016, Susp.
    Caernarvon, Township of,           421763  April 29, 1975,    ......do..............   Do.
     Lancaster County.                          Emerg; May 19,
                                                1981, Reg; April
                                                5, 2016, Susp.
    Christiana, Borough of,            420542  July 30, 1975,     ......do..............   Do.
     Lancaster County.                          Emerg; April 15,
                                                1981, Reg; April
                                                5, 2016, Susp.
    Clay, Township of,                 421764  April 29, 1975,    ......do..............   Do.
     Lancaster County.                          Emerg; December
                                                16, 1980, Reg;
                                                April 5, 2016,
                                                Susp.
    Colerain, Township of,             421765  September 17,      ......do..............   Do.
     Lancaster County.                          1975, Emerg;
                                                January 16,
                                                1981, Reg; April
                                                5, 2016, Susp.
    Columbia, Borough of,              420543  March 9, 1973,     ......do..............   Do.
     Lancaster County.                          Emerg; January
                                                6, 1982, Reg;
                                                April 5, 2016,
                                                Susp.
    Conestoga, Township of,            420544  April 24, 1973,    ......do..............   Do.
     Lancaster County.                          Emerg; March 18,
                                                1980, Reg; April
                                                5, 2016, Susp.
    Conoy, Township of,                420545  July 6, 1973,      ......do..............   Do.
     Lancaster County.                          Emerg; June 4,
                                                1980, Reg; April
                                                5, 2016, Susp.
    Denver, Borough of,                420546  August 22, 1973,   ......do..............   Do.
     Lancaster County.                          Emerg; April 15,
                                                1981, Reg; April
                                                5, 2016, Susp.
    Drumore, Township of,              421766  July 7, 1975,      ......do..............   Do.
     Lancaster County.                          Emerg; April 15,
                                                1981, Reg; April
                                                5, 2016, Susp.
    Earl, Township of,                 421767  January 13, 1975,  ......do..............   Do.
     Lancaster County.                          Emerg; December
                                                16, 1980, Reg;
                                                April 5, 2016,
                                                Susp.
    East Cocalico, Township of,        420547  April 24, 1974,    ......do..............   Do.
     Lancaster County.                          Emerg; March 16,
                                                1981, Reg; April
                                                5, 2016, Susp.
    East Donegal, Township of,         421768  August 30, 1974,   ......do..............   Do.
     Lancaster County.                          Emerg; January
                                                16, 1980, Reg;
                                                April 5, 2016,
                                                Susp.
    East Drumore, Township of,         421769  August 27, 1975,   ......do..............   Do.
     Lancaster County.                          Emerg; April 15,
                                                1981, Reg; April
                                                5, 2016, Susp.
    East Earl, Township of,            421770  October 18, 1974,  ......do..............   Do.
     Lancaster County.                          Emerg; September
                                                4, 1987, Reg;
                                                April 5, 2016,
                                                Susp.
    East Hempfield, Township           420548  June 6, 1973,      ......do..............   Do.
     of, Lancaster County.                      Emerg; September
                                                28, 1979, Reg;
                                                April 5, 2016,
                                                Susp.
    East Lampeter, Township of,        421771  September 6,       ......do..............   Do.
     Lancaster County.                          1974, Emerg;
                                                December 16,
                                                1980, Reg; April
                                                5, 2016, Susp.
    East Petersburg, Borough           420549  September 27,      ......do..............   Do.
     of, Lancaster County.                      1974, Emerg;
                                                September 5,
                                                1979, Reg; April
                                                5, 2016, Susp.
    Eden, Township of,                 421772  July 7, 1980,      ......do..............   Do.
     Lancaster County.                          Emerg; December
                                                16, 1980, Reg;
                                                April 5, 2016,
                                                Susp.
    Elizabeth, Township of,            421773  July 31, 1975,     ......do..............   Do.
     Lancaster County.                          Emerg; September
                                                28, 1979, Reg;
                                                April 5, 2016,
                                                Susp.
    Elizabethtown, Borough of,         420550  May 15, 1973,      ......do..............   Do.
     Lancaster County.                          Emerg; April 17,
                                                1978, Reg; April
                                                5, 2016, Susp.
    Ephrata, Borough of,               420551  April 17, 1973,    ......do..............   Do.
     Lancaster County.                          Emerg; April 1,
                                                1981, Reg; April
                                                5, 2016, Susp.
    Ephrata, Township of,              421208  May 20, 1974,      ......do..............   Do.
     Lancaster County.                          Emerg; May 19,
                                                1981, Reg; April
                                                5, 2016, Susp.
    Fulton, Township of,               421774  July 11, 1975,     ......do..............   Do.
     Lancaster County.                          Emerg; April 15,
                                                1981, Reg; April
                                                5, 2016, Susp.
    Lancaster, City of,                420552  May 12, 1972,      ......do..............   Do.
     Lancaster County.                          Emerg; September
                                                28, 1979, Reg;
                                                April 5, 2016,
                                                Susp.
    Lancaster, Township of,            420553  March 9, 1973,     ......do..............   Do.
     Lancaster County.                          Emerg; December
                                                18, 1979, Reg;
                                                April 5, 2016,
                                                Susp.

    Leacock, Township of,              420958  December 17,       ......do..............   Do.
     Lancaster County.                          1973, Emerg;
                                                March 1, 1978,
                                                Reg; April 5,
                                                2016, Susp.
    Lititz, Borough of,                420554  October 6, 1972,   ......do..............   Do.
     Lancaster County.                          Emerg; October
                                                15, 1980, Reg;
                                                April 5, 2016,
                                                Susp.
    Little Britain, Township           421775  June 16, 1975,     ......do..............   Do.
     of, Lancaster County.                      Emerg; April 15,
                                                1981, Reg; April
                                                5, 2016, Susp.
    Manheim, Borough of,               420555  April 19, 1973,    ......do..............   Do.
     Lancaster County.                          Emerg; March 2,
                                                1983, Reg; April
                                                5, 2016, Susp.
    Manheim, Township of,              420556  July 5, 1973,      ......do..............   Do.
     Lancaster County.                          Emerg; August
                                                15, 1979, Reg;
                                                April 5, 2016,
                                                Susp.
    Manor, Township of,                420557  April 19, 1973,    ......do..............   Do.
     Lancaster County.                          Emerg; March 18,
                                                1980, Reg; April
                                                5, 2016, Susp.
    Marietta, Borough of,              420558  July 5, 1973,      ......do..............   Do.
     Lancaster County.                          Emerg; February
                                                1, 1980, Reg;
                                                April 5, 2016,
                                                Susp.
    Martic, Township of,               421146  April 11, 1974,    ......do..............   Do.
     Lancaster County.                          Emerg; January
                                                16, 1980, Reg;
                                                April 5, 2016,
                                                Susp.
    Millersville, Borough of,          420559  November 11,       ......do..............   Do.
     Lancaster County.                          1974, Emerg;
                                                December 15,
                                                1978, Reg; April
                                                5, 2016, Susp.
    Mount Joy, Borough of,             420561  May 22, 1974,      ......do..............   Do.
     Lancaster County.                          Emerg; October
                                                15, 1981, Reg;
                                                April 5, 2016,
                                                Susp.
    Mount Joy, Township of,            421776  September 20,      ......do..............   Do.
     Lancaster County.                          1974, Emerg;
                                                September 16,
                                                1981, Reg; April
                                                5, 2016, Susp.
    Mountville, Borough of,            420560  August 5, 1975,    ......do..............   Do.
     Lancaster County.                          Emerg; July 16,
                                                1981, Reg; April
                                                5, 2016, Susp.
    Paradise, Township of,             421777  January 13, 1975,  ......do..............   Do.
     Lancaster County.                          Emerg; May 19,
                                                1981, Reg; April
                                                5, 2016, Susp.
    Penn, Township of,                 421778  February 5, 1975,  ......do..............   Do.
     Lancaster County.                          Emerg; September
                                                2, 1981, Reg;
                                                April 5, 2016,
                                                Susp.
    Pequea, Township of,               421779  January 24, 1975,  ......do..............   Do.
     Lancaster County.                          Emerg; September
                                                30, 1980, Reg;
                                                April 5, 2016,
                                                Susp.
    Providence, Township of,           421780  December 13,       ......do..............   Do.
     Lancaster County.                          1974, Emerg;
                                                September 30,
                                                1981, Reg; April
                                                5, 2016, Susp.
    Quarryville, Borough of,           420563  September 25,      ......do..............   Do.
     Lancaster County.                          1974, Emerg;
                                                January 16,
                                                1981, Reg; April
                                                5, 2016, Susp.
    Rapho, Township of,                421781  June 25, 1975,     ......do..............   Do.
     Lancaster County.                          Emerg; February
                                                16, 1983, Reg;
                                                April 5, 2016,
                                                Susp.
    Sadsbury, Township of,             421782  July 30, 1975,     ......do..............   Do.
     Lancaster County.                          Emerg; January
                                                16, 1981, Reg;
                                                April 5, 2016,
                                                Susp.
    Salisbury, Township of,            421783  May 20, 1975,      ......do..............   Do.
     Lancaster County.                          Emerg; April 15,
                                                1981, Reg; April
                                                5, 2016, Susp.
    Strasburg, Borough of,             427790  N/A, Emerg;        ......do..............   Do.
     Lancaster County.                          December 18,
                                                2006, Reg; April
                                                5, 2016, Susp.
    Strasburg, Township of,            421784  May 27, 1975,      ......do..............   Do.
     Lancaster County.                          Emerg; February
                                                4, 1981, Reg;
                                                April 5, 2016,
                                                Susp.
    Upper Leacock, Township of,        421785  June 19, 1975,     ......do..............   Do.
     Lancaster County.                          Emerg; November
                                                3, 1978, Reg;
                                                April 5, 2016,
                                                Susp.
    Warwick, Township of,              421786  July 2, 1975,      ......do..............   Do.
     Lancaster County.                          Emerg; November
                                                19, 1980, Reg;
                                                April 5, 2016,
                                                Susp.
    West Cocalico, Township of,        421787  August 5, 1974,    ......do..............   Do.
     Lancaster County.                          Emerg; April 15,
                                                1981, Reg; April
                                                5, 2016, Susp.
    West Donegal, Township of,         421788  June 5, 1975,      ......do..............   Do.
     Lancaster County.                          Emerg; July 16,
                                                1981, Reg; April
                                                5, 2016, Susp.
    West Earl, Township of,            420959  November 2, 1973,  ......do..............   Do.
     Lancaster County.                          Emerg; May 19,
                                                1981, Reg; April
                                                5, 2016, Susp.
    West Hempfield, Township           421789  August 30, 1974,   ......do..............   Do.
     of, Lancaster County.                      Emerg; September
                                                5, 1979, Reg;
                                                April 5, 2016,
                                                Susp.
    West Lampeter, Township of,        420566  July 9, 1973,      ......do..............   Do.
     Lancaster County.                          Emerg; January
                                                2, 1981, Reg;
                                                April 5, 2016,
                                                Susp.

           Region IV

Kentucky:
    Bullitt County,                    210273  April 11, 1989,    ......do..............   Do.
     Unincorporated Areas.                      Emerg; July 1,
                                                1991, Reg; April
                                                5, 2016, Susp.
    Hillview, City of, Bullitt         210384  N/A, Emerg;        ......do..............   Do.
     County.                                    November 24,
                                                2009, Reg; April
                                                5, 2016, Susp.
    Lebanon Junction, City of,         210304  February 23,       ......do..............   Do.
     Bullitt County.                            1978, Emerg;
                                                July 16, 1987,
                                                Reg; April 5,
                                                2016, Susp.
    Shepherdsville, City of,           210028  June 7, 1976,      ......do..............   Do.
     Bullitt County.                            Emerg; January
                                                2, 1987, Reg;
                                                April 5, 2016,
                                                Susp.

           Region VII

Kansas:
    Geary County,                      200579  January 8, 1979,   ......do..............   Do.
     Unincorporated Areas.                      Emerg; February
                                                4, 1988, Reg;
                                                April 5, 2016,
                                                Susp.
    Junction City, City of,            200112  April 15, 1975,    ......do..............   Do.
     Geary County.                              Emerg; September
                                                29, 1978, Reg;
                                                April 5, 2016,
                                                Susp.
    Nebraska: Clarkson, City           310359  December 5, 1977,  ......do..............   Do.
     of, Colfax County.                         Emerg; December
                                                18, 1986, Reg;
                                                April 5, 2016,
                                                Susp.
    Colfax County,                     310426  March 31, 1978,    ......do..............   Do.
     Unincorporated Areas.                      Emerg; February
                                                1, 1987, Reg;
                                                April 5, 2016,
                                                Susp.
    Howells, Village of, Colfax        310380  May 22, 1978,      ......do..............   Do.
     County.                                    Emerg; June 2,
                                                1981, Reg; April
                                                5, 2016, Susp.
    Leigh, Village of, Colfax          310386  August 25, 1975,   ......do..............   Do.
     County.                                    Emerg; July 1,
                                                1987, Reg; April
                                                5, 2016, Susp.
    Richland, Village of,              310502  N/A, Emerg; March  ......do..............   Do.
     Colfax County.                             4, 2014, Reg;
                                                April 5, 2016,
                                                Susp.
    Rogers, Village of, Colfax         315497  November 30,       ......do..............   Do.
     County.                                    1990, Emerg;
                                                September 17,
                                                1992, Reg; April
                                                5, 2016, Susp.
    Schuyler, City of, Colfax          310046  August 30, 1974,   ......do..............   Do.
     County.                                    Emerg; March 5,
                                                1990, Reg; April
                                                5, 2016, Susp.

          Region VIII

North Dakota:
    Bowman, City of, Bowman            380012  September 16,      ......do..............   Do.
     County.                                    1975, Emerg;
                                                July 4, 1988,
                                                Reg; April 5,
                                                2016, Susp.
    Bowman County,                     380355  April 3, 1978,     ......do..............   Do.
     Unincorporated Areas.                      Emerg; September
                                                30, 1987, Reg;
                                                April 5, 2016,
                                                Susp.
    Gascoyne, City of, Bowman          380677  April 8, 1987,     ......do..............   Do.
     County.                                    Emerg; September
                                                30, 1987, Reg;
                                                April 5, 2016,
                                                Susp.
    Scranton, City of, Bowman          380014  August 27, 1975,   ......do..............   Do.
     County.                                    Emerg; September
                                                30, 1987, Reg;
                                                April 5, 2016,
                                                Susp.

           Region IX

California:
    San Diego, City of, San            060295  January 29, 1971,  ......do..............   Do.
     Diego County.                              Emerg; August
                                                15, 1983, Reg;
                                                April 5, 2016,
                                                Susp.
----------------------------------------------------------------------------------------------------------------
*-do- = Ditto.
Code for reading third column: Emerg.--Emergency; Reg.--Regular; Susp.--Suspension.

    Dated: February 11, 2016.
Roy E. Wright,
Deputy Associate Administrator, Federal Insurance and Mitigation
Administration, Department of Homeland Security, Federal Emergency
Management Agency.
[FR Doc. 2016-05988 Filed 3-16-16; 8:45 am]
 BILLING CODE 9110-12-P