Page 1 of 12 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES February 17, 2004 MEMORANDUM SUBJECT: Tolerance Reassessment Decisions Completed by the Lower Toxicity Pesticide Chemical Focus Group FROM: Betty Shackleford, Associate Director Registration Division TO: Peter Caulkins, Associate Director Special Review and Reregistration Division Please find attached the Focus Group Decision Document for vanillin. The tolerance exemption for vanillin in 40 CFR 180.1001( d) is reassessed. The List classification of vanillin is confirmed as List 4A.

If you have any comments or questions, please contact Kathryn Boyle at 703 305 6304.

Attachment ( 1) Page 2 of 12 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES February 17, 2004 MEMORANDUM FROM: Kathryn Boyle, Chair Lower Toxicity Pesticide Chemical Focus Group Registration Division TO: Betty Shackleford, Associate Director Registration Division SUBJECT: Recommendation for Tolerance Reassessment The attached science assessment reviews the available information on vanillin. Vanillin assessments were previously performed by the World Health Organization ( WHO) in 1967 and the 1996 SIDS ( Screening Information Data Set) Report issued by the Organization for Economic Cooperation and Development ( OECD). Neither of these assessments directly addressed the use of vanillin as an inert ingredient in pesticide products. However, the amount of information on vanillin is extensive.

Vanillin ( or vanilla) has been widely used for many years as evidenced by a metabolism study that was reported in 1880. It is used as a flavoring in foods and beverages, and as a fragrance in cosmetics, personal care products, and perfumes. Vanillin is GRAS ( generally recognized as safe) under 21 CFR 182.90 and 21 CFR 182.60.

Based on its review and evaluation of the available information, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to residues of vanillin when used as an inert ingredient in pesticide products. The tolerance exemption in 40 CFR 180.1001( d) is reassessed. The classification as List 4A is confirmed. Page 3 of 12 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES January 29, 2004 Memorandum Subject: Vanillin: Science Assessment Document for Tolerance Reassessment.

CAS No.: 121 33 5 Chemical Class: substituted benzaldehyde 40 CFR: 180.1001 ( d)

From: Bentley C. Gregg, Ph. D., Risk Assessor Product Reregistration Branch Special Review and Reregistration Division ( 7508C)

Through: Linda Propst, Branch Chief Mark Perry, Team Leader Product Reregistration Branch Special Review and Reregistration Division ( 7508C)

To: Lower Risk Pesticide Chemical Focus Group Kathryn Boyle, Chair Registration Division ( 7505C)

Background:

Attached is the Lower Risk Pesticide Chemical Focus Group's science assessment for vanillin. This assessment summarizes available information on the uses, physical/ chemical properties, toxicological effects, exposure profile, and environmental fate and ecotoxicity for this inert ingredient substance. In performing this assessment, EPA has relied on a peer reviewed evaluation performed by a committee of the Food and Agriculture Organization of the World Health Organization ( WHO) and an Organization for Economic Cooperation and Development ( OECD) Screening Information Data Set ( SIDS) assessment, as well as TOXNET data and the results of ECOSAR modeling for the environmental fate and effects aspects of the assessment. Page 4 of 12 I. Executive Summary:

Vanillin is a substituted benzaldehyde. It has been classified by the U. S. Food and Drug Administration as Generally Recognized As Safe ( GRAS) for its use as a substance migrating to food from paper and paperboard products used in food packaging, as well as when used as a synthetic flavoring substance and adjuvant. An OECD SIDS assessment ( 1996) concluded that " almost every human globally is exposed to minute amounts of vanillin by ingestion."

Open literature studies and information from various assessments show that there are a number of toxicological studies with vanillin, and these data indicate that vanillin does not pose any serious health effects. Vanillin is rapidly metabolized, with its conjugated products readily excreted in the urine.

A WHO Joint Expert Committee on Food Additives Committee summary report ( 1967) concluded that for vanillin, " the metabolic fate of this flavouring is well established in man and animals," and that the " estimate of acceptable daily intake for man is 10 mg/ kg body weight."

Vanillin is soluble in water, and will remain in solution, since it is not likely to sorb to particulate matter or sediments. Vanillin is not likely to volatilize from water or from moist or dry soils. It has been found to be biodegraded in both aerobic and anaerobic conditions, and vanillin has been found to be relatively non toxic to aquatic plant and animal species.

Based on available information on vanillin, its expected use patterns, with its GRAS status and safe, long term history of use in food packaging and as synthetic flavoring substance and adjuvant, its use in commercially available, over the counter foods, and its use as a fragrance in perfumes, as well as its rapid metabolism and low degree of observed toxicity in humans and animals, the Lower Risk Pesticide Chemical Focus Group has determined that a screening level quantitative risk assessment is not required for vanillin.

II. Use Information:

The pesticidal and non pesticidal uses of vanillin are summarized briefly below.

Table 1. Use Pattern ( pesticidal inert ingredient)

Chemical Name PC Code 40 CFR Use Pattern ( Pesticidal) Current Inert List vanillin 800738 180.1001 ( d) Attractant 4A Vanillin also has an active ingredient PC Code, 115801, but there are no current end use products registered at this time. Page 5 of 12 Use Pattern ( non pesticidal):

Vanillin is generally recognized as safe ( GRAS) by the U. S. FDA when used as a substance migrating to food from paper and paperboard products used in food packaging ( 21 CFR 182.90), as well as GRAS when used as a synthetic flavoring substance and adjuvant ( 21 CFR 182.60). Vanillin has the following uses: as an additive ( flavoring agent) for food and beverages, as a fragrance ( in perfumes), and for intermediates for pharmaceuticals. According to the OECD SIDS assessment ( 1996), " Minor amounts [ of vanillin] are applied as skin care products, perfumes etc. The global use of vanillin in food and beverages imply [ sic] that almost every human globally is exposed to minute amounts of vanillin by ingestion."

Vanillin is also known as vanillic aldehyde and vanilla. It is a substituted benzaldehyde, and its recognized chemical name is 4 hydroxy 3 methoxy benzaldehyde. Vanillin is produced naturally in vanilla beans; and synthetically primarily from the waste ( lignin) from the wood pulp industry, and also from eugenol or guaiacol, as well as from safrole. Vanillin is mainly utilized as an additive to food and beverages ( more than 60%), but considerable amounts are used for fragrances in perfumes ( 20 25%), while 5 10% is used for intermediates in pharmaceuticals.

Figure 1. Chemical Structure of Vanillin ( Source: ChemIDPlus; http:// toxnet. nlm. nih. gov/)

Table 2. Physical/ Chemical Properties of Vanillin ( from OECD SIDS assessment ( 1996))

Molecular formula C8H8O3 Molecular weight 152.15 Melting point 80 81 ° C Solubility in water 11,000 mg/ L at 30 ° C pH 4.3 ( 5% aqueous solution [ saturated solution])

Density/ Specific Gravity 1.056 g/ mL @ 19 ° C / 4 ° C Vapor Density 5.2 Estimated Octanol/ Water Partition Coefficient log Kow = 1.23  1.37 Physical state white or slightly yellow needles Page 6 of 12 Dissociation Constant pKa = 7.38 @ 25 ° C Vapor Pressure 1.2 x 10 4 mm Hg @ 25 ° C; 0.33 Pa Estimated Henry's Law constant 2.1 x 10 9 atm m3/ mole Estimated Soil Sorption Coefficient Koc = 130 Bioconcentration Factor 6.0 UV Absorption Spectrum absorbs light at wavelengths of 308 and 278 nm IV. Hazard Assessment:

Toxicological Profile:

Table 3. Summary of Acute Toxicity Data on Vanillin.

Test Species Results Oral LD50 rat 1580 mg/ kg  4200 mg/ kg ( 7 different studies)

guinea pig 1400 mg/ kg rabbit 3000 mg/ kg Dermal LD50 rat > 2000 mg/ kg rabbit > 5010 mg/ kg Eye Irritation rabbit slightly irritating, improving from 48 120 hrs, and no effects seen at 168 hrs Dermal Irritation rabbit no irritation guinea pig no signs of irritation Dermal Sensitization guinea pig Buehler Closed patch repeat exposure test: no signs of sensitization or allergy guinea pig Maximization test: Freunds complete adjuvance: positive allergic response guinea pig Freunds complete adjuvance with 10% acetone: weak sensitizer mouse Mouse ear swelling test: 50% vanillin in ethanol: no sensitization Vanillin is moderately toxic in acute oral toxicity studies, but essentially non toxic in the acute dermal toxicity study in the rat ( Table 3). While vanillin is slightly irritating to the eye, it is non irritating in dermal exposure tests. Dermal sensitization studies have shown both allergic and weak sensitizing results with vanillin, as well as results which were negative.

The OECD SIDS assessment ( 1996) reported results from dermal exposures with human volunteers. In primary irritation studies and in patch tests, no signs of irritation or sensitization Page 7 of 12 were observed. In maximization tests, human volunteers were exposed first to sodium lauryl sulfate, then to repeated 48 hour exposures to vanillin ( at 2 5% in petrolatum), and vanillin was negative, so it was " concluded to be non sensitizing in humans." However, in humans already sensitized to balsam of Peru, positive reactions were exhibited to vanillin, so the OECD SIDS assessment ( 1996) concluded that vanillin was " considered to be a secondary allergen."

There are no concerns for mutagenicity for vanillin. The mutagenicity studies cited in the OECD SIDS assessment ( 1996) include both in vivo and in vitro assays. All of the in vivo assays produced negative results for genetic toxicity as did the majority of the in vitro assays. Additionally, a two year oral feeding study in rats was negative for carcinogenicity, as well as any toxic effects, and repeated dose studies where reproductive parameters were measured also produced negative results.

The World Health Organization ( WHO) Joint Expert Committee on Food Additives ( JECFA) summary report ( 1967) reported that vanillin is converted to vanillic acid, mainly excreted ( in the urine) as free acid or the conjugated ethereal sulfate or glucurovanillic acid. Its metabolism is by the following pathway: vanillin first undergoes rapid conjugation, then slow oxidation to conjugated vanillic acid, some of which then becomes demethylated to conjugated protocatechuic acid, which is then further decarboxylated to conjugated catechol, with further complete oxidation then occurring by the opening of the aromatic ring between the C 3 and C 4 carbons. In another study in the rabbit, conjugated vanillic acid and conjugated protocatechuic acid were in equilibrium with the corresponding free acids, with all appearing in the urine, but there being no free vanillin excreted in the urine.

The JECFA summary report ( WHO 1967) also described results from four short term oral or feeding studies in the rat, and in general, no deleterious effects were reported. In addition, results were reported from a long term study in which groups of rats were fed 0, 0.5, 1.0, or 2.0% ( 0, 5000, 10,000, or 20,000 ppm, respectively) vanillin in their diets for 2 years without any deleterious effects being observed. On the basis of these studies, the JECFA summary report ( WHO 1967) concluded the following:

" The metabolic fate of this flavouring is well established in man and animals. The shortterm studies give conflicting results, but the long term study is used for evaluation. Evaluation: Level causing no toxicological effect: Rat. 2 per cent (= 20,000 ppm) in the diet, equivalent to 1000 mg/ kg body weight/ day. Estimate of acceptable daily intake for man: Unconditional acceptance: 0 10 mg/ kg body weight."

In the more recent OECD SIDS assessment ( 1996), various other repeated dose oral toxicity studies were also reviewed, with only no adverse effects levels ( NOAELs) having been reported in most studies, except for one, unpublished study. On the basis of these various studies, the OECD SIDS assessment ( 1996) utilized an NOAEL of 50,000 ppm ( 2500 mg/ kg/ day) from the 1 year study.

Table 4. Results of Repeated Dose Feeding Studies Reported in OECD SIDS assessment ( 1996) Page 8 of 12 Species Duration Dosing Levels Results Reported rat 27 weeks 1000 ppm ( 50 mg/ kg/ day) no adverse effects were observed rat 16 weeks 10,000 ppm ( 500 mg/ kg/ day) no adverse effects were observed male rats 1 year 20,000 or 50,000 ppm ( 1000 or 2500 mg/ kg/ day, respectively) no adverse effects were observed male rats 26 weeks 1000, 5000 or 10,000 ppm ( 50, 250, or 500 mg/ kg/ day, respectively) no adverse effects were observed rats 91 days 3000, 10,000, or 50,000 ppm ( 150, 500, or 2500 mg/ kg/ day) NOAEL: 3,000 ppm ( 150 mg/ kg/ day); LOAEL: 10,000 ppm ( 500 mg/ kg/ day). 1 dogs 26 27 weeks 0, 25, or 100 mg/ kg/ day in caps no particular toxicity was observed 1 Included in this table because the data were cited in the OECD SIDS assessment ( 1996); however, that assessment stated that " this study is unpublished, but the information has been taken from a citation in 1963. The design and the details of the study are unknown, thus, the other studies seem more reliable."

Special Considerations for Infants and Children: At this time, there is no concern for vanillin to have potential sensitivity to infants and children. Although no developmental or reproductive studies were identified, the Agency does not believe there are concerns for adverse effects in infants or children, given the widespread historical use of vanillin in food products to which pregnant women and children have been exposed without adverse effects. Thus, a safety factor analysis has not been used to assess the risk. For the same reasons, the additional tenfold safety factor is unnecessary, and has been removed.

V. Exposure Assessment:

Exposure to vanillin may occur through its FDA approved GRAS uses in food packaging and as a food additive, when used as a synthetic flavoring substance and adjuvant, as well as its use as a fragrance in cosmetics. Vanillin has been used as a food additive for many years; in fact, one of the first scientific studies on vanillin was concerning its metabolism, having been reported in the 19th century, in 1880 ( Preusse, 1880, as cited in the OECD SIDS assessment ( 1996)). In addition, the production volume of vanillin is sufficiently high that the Agency considers it to be a High Production Volume ( HPV) chemical. Based on the extensive and long standing use of vanillin in many types of foods ( approved FDA uses), the potential exposures to the substance as a result of use in pesticide products are expected to be minimal. Therefore, a screening level quantitative exposure assessment has not been conducted.

VI. Risk Characterization: Page 9 of 12 Taking into consideration all available information on vanillin, including its designations by FDA as GRAS, the information compiled in a WHO summary report, and an OECD SIDS assessment, as well as its long term use as a flavoring agent in foods and as a fragrance in perfumes, it is concluded that the use of vanillin as an inert ingredient in pesticide products is unlikely to pose a significant hazard to the general public or any population subgroup. Vanillin is readily metabolized, and in long term feeding studies, it showed no adverse effects and produced no evidence of carcinogenic potential, with no toxicological effects observed in the rat at 20,000 ppm ( 2%) in the diet ( equivalent to 1000 mg/ kg bw/ day), so the WHO summary report estimate of the acceptable daily intake in humans was 10 mg/ kg bw. As a result, OPP is recommending a qualitative approach to assessing human health risks from exposure to vanillin.

VII. Environmental Fate/ Ecotoxicity/ Drinking Water Considerations:

HSDB in TOXNET discusses the environmental fate of vanillin. This information from HSDB has been supplemented with predictive modeling, based on structure activity relationships ( Meylan and Howard, 1998).

Based on its moderate K oc ( 130 L/ g) and low K ow ( 1.37) values, vanillin is classified as highly mobile in soil ( McCall et al. [ undated]). It has the potential to slowly volatilize from dry soil surfaces, based on its vapor pressure of about 1.2 x 10 4 mm Hg. Vanillin has been observed to be completely degraded from pasture soil in 12.5 days, but with an initial lag period of 4 days. Overall half lives in acclimated systems would range from days for primary degradation to weeks for ultimate degradation ( mineralization), based on the ready biodegradability model ( Meylan and Howard, 2000). Due to the lack of hydrolyzable functional groups, abiotic degradation of vanillin in the soil would not be expected to be an important fate process.

Vanillin is very soluble in water ( 11,000 mg/ L). Based on its K oc and K ow values, vanillin would not be expected to adsorb to suspended solids or sediments in water. Volatilization from water would not be expected to be an major fate process for vanillin, based on its Henry's Law constant ( 2.1 x 10 9 atm m3). The dissociation constant for vanillin ( pKa: 7.4) suggests that in waters in the range of environmentally relevant pHs, it would exist partly in an ionized form. Based on its low K ow and low estimated Bioconcentration Factor ( 6), there is a low potential for bioconcentration in aquatic animals. The rapid biodegradation of vanillin in soil under aerobic conditions suggests that aerobic biodegradation in water would be an important fate process. Under anaerobic test conditions, vanillin was 72% degraded in 42 days, with a lag time of 12 days, in a closed bottle serum test using settled domestic sewage seed. Vanillin is not expected to undergo hydrolysis in the environment due to the lack of hydrolyzable functional groups.

If any vanillin should enter the atmospheric compartment of the environment, its vapor pressure being 1.2 x 10 4 mm Hg, it is expected to exist solely as a vapor. Vapor phase vanillin would be degraded in the atmosphere by reactions with photochemically produced hydroxyl radicals, with estimated half life values on the order of 14 hours. Vanillin also has a potential to photolyze directly, but the kinetics of the potential photolysis are unknown. Page 10 of 12 Vanillin is relatively non toxic in tests with various aquatic species, based on the data in the OECD SIDS assessment ( 1996) ( Table 5). The LC 50 values to the fathead minnows indicate that vanillin is relatively non toxic in short term acute tests, but there were no data available for chronic toxicity to fish. Results were reported for longer term exposures with Daphnia; after 13 days exposure to 100 mg/ L, all the Daphnia became immobilized, with the immobilization EC 50 for the period from 13 to 21 days estimated to be 75 mg/ L.

Table 5. Summary of Ecotoxicity Data ( Source: OECD SIDS assessment ( 1996))

Organism ( Species name) Toxicity data ( LC50, unless indicated) at respective time period:

Fathead minnow ( Pimephales promelas) 1 hr: 173  370 mg/ L 24 hr: 100  131 mg/ L 48 hr: 68.3  123 mg/ L 72 hr: 57  123 mg/ L 96 hr: 57  123 mg/ L Water flea ( Daphnia sp.) 24 hr EC50: 180 mg/ L 21 day reproduction study: EC50 for reproduction: 16 mg/ L measured ( 24 mg/ L nominal) NOEC for reproduction: 5.9 mg/ L measured ( 10 mg/ L nominal) LOEC for reproduction: 10 mg/ L measured ( 18 mg/ L nominal)

Green algae ( Scenedesmus obliquus) ( Chlorella variegata) only 1 test concentration, 2 mg/ L: reduced growth after 3 days, but no effect was observed after 7, 14, and 21 days exposure ( identical results reported for both species of green algae).

Diatoms ( Gomphonema parvulum)

( Nitzschia palea) with both species, only 1 test concentration, 2 mg/ L: No growth after 3 days, and reduced growth after 7, 14, and 21 days.

Unaffected at 3 days, reduced growth at 7 days, and growth was normalized again after 14 and 21 days.

Blue green algae ( Cylinderospermum licheneniforme) ( Mycrocystis aeruginosa) only 1 test concentration, 2 mg/ L: " no effect was seen" after 3, 7, 14, and 21 days exposure ( identical results reported for both species of blue green algae).

Green algae ( Chlorella vulgaris) after 80 hr exposure to 152 mg/ L, 50% growth reduction; after 160 hr exposure to 152 mg/ L, growth inhibition was 30%; no effects were observed at 15 mg/ L or 1.5 mg/ L.

earthworm ( Eisenia foetida) soil concentrations of 0, 0.1, 1, 4, and 8% for 42 day exposure period: 4% was lowest concentration which significantly reduced growth rate, and cause death of 80% of worms; thus, NOEC value reported to be 10 g/ kg soil dry weight (= 1%), and LOEC was 40 g/ mg soil dry weight (= 4%), at which concentration, the mortality of worms was 80%.

VIII. Cumulative Exposure: Page 11 of 12 Section 408( b)( 2)( D)( v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider " available information" concerning the cumulative effects of a particular pesticide's residues and " other substances that have a common mechanism of toxicity."

EPA does not have, at this time, available data to determine whether vanillin has a common mechanism of toxicity with other substances. Unlike other pesticide substances for which EPA has followed a cumulative risk approach, based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to vanillin and any other substances, and vanillin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that vanillin has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http:// www. epa. gov/ pesticides/ cumulative/.

References:

McCall, P. J., D. A. Laskowski, R. L. Swann, and H. J. Dishburger. [ Undated.] " Measurements of Sorption Coefficients of Organic Chemicals on their use in Environmental Fate Analysis." Agricultural Products Department, Dow AgroChemicals USA, Midland, MI. P104 ( 89 109).

Meylan, W. and P. Howard. 1998. ECOSAR Class Program, Version 0.99d. Syracuse Research Corporation, Syracuse, N. Y. For: U. S. Environmental Protection Agency, Office of Pollution Prevention and Toxics, Washington, D. C.

Meylan, W. and P. Howard. 2000. Estimation Program Interface, Version 3.10. Syracuse Research Corporation, Syracuse, N. Y. For: U. S. Environmental Protection Agency, Office of Pollution Prevention and Toxics, Washington, D. C.

Organization for Economic Cooperation and Development ( OECD) Screening Information Data Sets ( SIDS) for High Production Volume Chemicals. Processed by United Nations Environment Programme ( UNEP) Chemicals as a contribution to the Inter Organization Programme for the Sound Management for Chemicals ( IOMC). Volume 5, Part 2. Introduction. 4 pp. Available at http:// www. inchem. org/ documents/ sids/ sids/ sids5b01. htm. ( MRID No. 461082 01). VANILLIN. SIDS INITIAL ASSESSMENT PROFILE. Dated 20.08.96 [ August 20, 1996]. OECD Screening Information Data Sets ( SIDS). 117 pp. Available at http:// www. inchem. org/ documents/ sids/ sids/ sids5b06. htm. ( MRID No. 461082 02).

TOXNET. Department of Health and Human Services, National Institutes of Health, U. S. Page 12 of 12 National Library of Medicine, Specialized Information Services. Databases: Hazardous Substances Data Bank ( HSDB) and Chemical Carcinogenesis Research Information System ( CCRIS) and Genetic Toxicology ( Mutagenicity) ( GENE TOX). Vanillin ( CAS Registry Number 121 33 5). Available at http:// www. toxnet. nlm. nih. gov.

World Health Organization ( WHO). 1967. Toxicological Evaluation of Some Flavouring Substances and Non Nutritive Sweetening Agents. 125. Vanillin. International Programme on Chemical Safety, Food and Agriculture Organization Nutrition Meetings Report Series No. 44A. 4 pp. Available at http:// www. inchem. org/ documents/ jecfa/ jecmono/ v44aje34. htm. ( MRID No. 461081 01).


ICR SUPPORTING STATEMENT OUTLINE
Part A

1. Identification of the Information Collection

1(a) Title of the Information Collection
Recordkeeping for Institutional Dual Use Research of Concern (iDURC) Policy Compliance
EPA ICR Number 2530.03, OMB Control No. 2080-0082

1(b) Short Characterization/Abstract

The White House Office of Science and Technology Policy issued the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (iDURC Policy) in September 2014. The purpose of the Policy is to identify Dual Use Research of Concern (DURC) and implement risk mitigation measures where applicable. DURC applies to life science research that provides knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, material, or national security.

Institutions subject to the iDURC Policy are those within the United States that (1) receive funding from the U.S. Government to conduct or sponsor life sciences research and (2) conduct or sponsor research that involves one or more of the 15 agents or toxins identified in the iDURC Policy, even if the research is not supported by U.S. Government funding. Institutions outside of the United States that receive U.S. Government funding to conduct or sponsor research that involves one or more of the 15 agents or toxins identified in the iDURC Policy are also subject to the Policy. The iDURC Policy requires that institutions subject to the Policy provide education and training on DURC for individuals conducting life sciences research with one or more of the 15 agents or toxins identified in the iDURC Policy. It is also required that they maintain education and training records for the term of the research grant or contract. The policy states that records must be saved for three years after its completion, but no less than eight years, unless a shorter period is required by law or regulation.

EPA is submitting an information collection request for the requirement of institutions in maintaining these training records. EPA's Office of Research and Development may choose to collect these records to ensure Policy compliance.

2. Need for and use of the Collection
2(a) Need/Authority for Collection

The White House Office of Science and Technology Policy issued the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (iDURC Policy) on September 2014. It became effective on September 24, 2015 (79 Federal Register 57589). All federal departments and agencies are required to implement this Policy. The iDURC Policy requires institutions to maintain training records for individuals conducting life sciences research with one or more of the 15 agents or toxins identified in the Policy. The goal of this collection is to ensure that all personnel involved in conducting life sciences research with one or more of the 15 agents or toxins identified in the iDURC Policy understands what DURC is, how to mitigate risk, and how to communicate research findings in a responsible manner through the use of training and education.

2(b) Practical Utility/Users of the Data

The iDURC Policy requirement for training records helps institute a culture of responsibility for individuals conducting life science research with one or more of the 15 agents or toxins identified in the Policy.

3. Non duplication, Consultations, and Other Collection Criteria
3(a) Non duplication

Training information requested from institutions under this ICR is required by the iDURC Policy, which is being implemented by all federal department and agencies. There are no other sources available to collect this information.

3(b) Public Notice Required Prior to ICR submission to OMB

To comply with the 1995 Amendments to the Paperwork Reduction Act (PRA), EPA is soliciting public comment on this ICR for a 60-day period before it is submitted to OMB. EPA published a notice in the Federal Register (FR) requesting comment on the estimated respondent burden and other aspects of this ICR (ICR 2530.02). This notice is included in Appendix A. Before submission to OMB, EPA will consider any comments received and determine if any adjustments are needed to the burden and cost calculations or to the supporting statement for this ICR. Comments received, and EPA's responses will be included in Appendix D. An additional Federal Register notice will be published when this ICR is submitted to OMB. The public comment period for this additional notice will be 30 days.

3(c) Consultations
This ICR renewal includes the issuance of an FR Notice that will be collecting comments from the public with regard to the requirement of maintaining training records in accordance with the iDURC Policy and its burden estimates. Additionally, the White House Office of Science and Technology Policy and the National Institutes of Health co-hosted a public workshop in July 2015 to engage stakeholders on the implementation of the iDURC Policy. This workshop had an attendance of nearly 200 individuals either in-person or via webcast. Overall, there was recognition by stakeholders that threats of DURC exist. Several institutions indicated that all staff were required to do training as part of their annual training. Training frequency and length is determined by each institution as well as the means by which it is recorded. Some institutions expressed worry about the added workload without any financial support through the policy.

3(d) Effects of Less Frequent Collection

The iDURC Policy requirement for training records helps institute a culture of responsibility for individuals conducting life science research with one or more of the 15 agents or toxins identified in the Policy. A less frequent collection of these training records may result in non-compliance with the Policy by EPA and/or U.S. Government funded institutions. Non-compliance with the Policy could potentially result in the release of knowledge, information, products, or technologies that could be directly misapplied and pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, material, or national security.

3(e) General Guidelines

These reporting or recordkeeping requirements do not violate any of the regulations promulgated by OMB under 5 CFR Part 1320, Section 1320.5.

3(f) Confidentiality

This information is required to be withheld from the public pursuant to Section 107(a) of the Ethics in Government Act of 1978. Agency personnel shall not publicly release the information contained therein.

If EPA chooses to collect this information, the designated official will store it on the EPA DURC SharePoint Site, which is only accessible to those that have privileges to the site. EPA does not intend to publish or make public any of the information that may be collected through this information request.

3(g) Sensitive Questions

None of the information collected by this action results in or requests sensitive information of any nature.

4. The Respondents and the Information Requested

4(a) Respondents/NAICS Codes

NAICS Codes
The iDURC Policy states that institutions subject to the Policy are those within the United States that both receive funding from the U.S. Government to conduct or sponsor life sciences research and conduct or sponsor research that involves one or more of the 15 agents or toxins identified in the iDURC Policy, even if the research is not supported by U.S. Government funding. Institutions outside of the United States that receive U.S. Government funding to conduct or sponsor research that involves one or more of the 15 agents or toxins identified in the iDURC Policy are also subject to the Policy. Institutions that do not receive U.S. Government funding for life sciences research, but conduct life sciences research that has potential to generate knowledge, information, products, or technologies that could be used in a manner that results in harm, are not subject to oversight as articulated in the Policy; however, they are strongly encouraged to implement internal oversight procedures consistent with the culture of shared responsibility and notify the National Institutes of Health (NIH) of any research that is determined to be DURC. NIH will refer the notification to the appropriate agency based upon the nature of the research. The North American Industry Classification System (NAICS) code for Research and Development in the Physical, Engineering and Life Sciences is code 54171.

Respondents

4(b) Information Requested

 Data items, including record keeping requirements

Per iDURC Policy, the research institution is required to store training records for the term of the research grant or contract plus three years after its completion, but no less than eight years, unless a shorter period is required by law or regulation. EPA may contact the institution via email requesting these records to ensure Policy compliance. Additional information is found in section 5(b).

(ii) Respondent Activities

The U.S. Government developed a compendium of tools to assist investigators and research institutions in the implementation of DURC oversight, including training and education on DURC. Institutions may wish to address dual use topics in existing courses on research ethics or the responsible conduct of research. Per iDURC Policy, institutions may require additional record keeping and should designate an individual responsible for maintaining documentation. Institutions should ensure that all individuals involved in research subject to iDURC Policy have completed this training and provided records of such training to the institution.

5. The Information Collected - Agency Activities, Collection Methodology, and Information Management

5(a) Agency Activities
To comply with the iDURC Policy, the Agency may incur activities associated with this information collection, which could consist of analyzing, evaluating, summarizing, and/or reporting on the training records from institutions subject to the iDURC Policy.

5(b) Collection Methodology and Management

Information collected from institutions subject to the iDURC Policy must be useful, accurate, reliable, and retrievable. Institutions must comply with the practices and procedures outlined in the Policy, which includes ensuring data quality. Non-compliance with the iDURC Policy may result in suspension, limitation, or termination of U.S. Government funding, or loss of future U.S. Government funding opportunities for the non-compliant U.S. Government-funded research project and of U.S. Government funds for other life sciences research at the institution.

If necessary, the designated official from EPA may collect the information via email and store it on the DURC SharePoint Site. The EPA DURC SharePoint Site is listed as For Official Use Only, and access to the site is managed by EPA's Office of Homeland Security. EPA does not intend to publish or make public any of the information that may be collected through this information request.

5(c) Small Entity Flexibility

This collection of information is not reasonably expected to impact small businesses or other small entities. For research institutions in low-resource environments outside of the U.S. that receive U.S. Government funds, EPA may consider serving as the implementing Institutional Review Entity, as the funding Agency, thereby providing the necessary oversight and compliance with the iDURC Policy.

5(d) Collection Schedule

Institutions subject to the iDURC Policy should certify that they will comply with the Policy at the time of seeking or receiving EPA funding. These institutions must notify the U.S Government funding agency within 30 calendar days of any research that involves one or more of the 15 agents and one or more of the 7 experiments, including whether it meets or does not meet the definition of DURC. Principal Investigators must ensure that laboratory personnel (i.e. those under the supervision of laboratory leadership, including graduate students, postdoctoral fellows, research technicians, laboratory staff, and visiting scientists) conducting life sciences research with one or more of the 15 agents or toxins identified in the iDURC Policy have received education and training on DURC. These training records must be maintained by the institution for the term of the research grant or contract plus three years after its completion, but no less than eight years, unless a shorter period is required by law or regulation. EPA may choose to collect these records to ensure compliance with the Policy at any time.

6. Estimating the Burden and Cost of the Collection

6(a) Estimating Respondent Burden
The mean hourly wage for life, physical and social science occupations is listed in the Bureau of Labor Statistics' website: https://www.bls.gov/oes/current/oes_nat.htm#19-0000. The mean hourly wage for this occupation group is $35.76.

It is estimated that each respondent will take 30 minutes to complete the training and complete recordkeeping activities. The estimated labor cost for life, physical and social science occupations is $35.76, which is multiplied by the standard overhead factor of 1.6, producing a loaded wage rate of $57.21 (rounded to $58). Approximately 40 respondents could be requested to submit recordkeeping statements annually. These are one-time activities for the life of the research grant/contract. Multiplying the estimated number of respondents (40) by the estimated respondent labor cost ($58) by the number of hours (.50), we estimate the total dollar burden estimate for this ICR to be $1,160 annually. The grand total for all 3 years is estimated to be $3,480.

6(b) Estimating Respondent Costs

 Estimating Labor Costs

                             Respondent Activities
                          Burden Hours per Respondent
Burden for Respondent ($35.76 per labor hour multiplied by 1.6 for overhead equals $58)
                        Number of Respondents per Year
                        Total Respondent Cost per Year
Education & Training
                                      .33
                                   (20 min)
                                      $19
                                      40
                                     $760
Recordkeeping for Training
                                      .17
                                   (10 min)
                                      $10
                                      40
                                     $400
Total
                                   .5 hours
                                      $29
                                      40
                                    $1,160

Annual Cost for Respondents

 (ii) Estimating Capital and Operations and Maintenance Costs

There are no capital or operations and maintenance costs.

(iii) Capital/Start-up Operating and Maintenance (O&M) Costs

There are no capital/startup operating and maintenance costs.

(iv) Annualizing Capital Costs

There are no annualized capital costs.

(c) Estimating Agency Burden and Cost

                        Information Collection Activity
                                 Annual Hours
                                 Annual Costs
Analyzing, Evaluating, Summarizing, and/or Reporting on Training Records
                                      0.5
                                    $26.50

The Agency estimates that it would require 30 minutes for one staff member to review and evaluate training records performed by a GS-11 employee. The annual salary for a GS-11, Step 1 in Washington, DC is $69,581. The hourly rate including benefits is $53.52 ($33.45 hourly rate x 1.6 multiplier).

6(d) Estimating the Respondent Universe and Total Burden and Costs

See 6(a) and 6(b).

6(e) Bottom Line Burden Hours and Cost Tables

EPA estimates a total of 40 respondents would be required to take training and maintain records of that training for the duration of this ICR. On average, EPA has funded five research projects per year that involve one or more of the 15 agents or toxins identified in the iDURC Policy through a contract/grant mechanism. Previous consultations with Project Officers determined that there are about 6-8 respondents per research project. The total cost annually will be $1,160, and $3,480 over the life of 3 years.

 Respondent Tally

              Bottom-Line Annual Burden and Cost for Respondents
                 Respondent Activities to Complete the Survey
                            Burden Hours/Respondent
                           Number of Hours per Year
Burden for Respondent ($23.60 per labor hour multiplied by 1.6 for overhead equals $38)
                        Number of Respondents Per Year
                              Total Cost Per Year
Total Per Year
                                      .5
                                      20
                                      $29
                                      40
                                    $1,160
3 Years
                                      1.5
                                      60
                                      $29
                                      120
                                    $3,480

 The Agency Tally

                   Bottom-Line Annual Agency Burden and Cost

                       Agency Hours for Each Respondent
                           Number of Hours Per Year
                              Labor Cost Per Year
                          Total Agency Cost Per year
Agency Total
                                      .5
                                      20
                                     $530
                                     $530
3 Years
                                      1.5
                                      60
                                    $1,590
                                    $1,590

(iii) Variations in the Annual Bottom Line

We do not anticipate major variations in the annual bottom line burden hours and costs for the respondents or the Agency.

6(f) Reasons for Change in Burden

There is a decrease of 52 burden hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This decrease is due to an adjustment in estimates to account for the number of hours required to perform recordkeeping duties.

6(g) Burden Statement

The annual public reporting and recordkeeping burden for this collection of information is estimated to average of .33 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjusting the existing ways to comply with any previously applicable applications and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit, or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket Number EPA-HQ-2016-0010, which is available for online viewing at www.regulations.gov, or in person viewing at the Office of Environmental Information Docket in the EPA Docket Center (EPA/DC), EPA William Jefferson Clinton West Building, Room 3334, 1301 Constitution Avenue, NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m.  -  4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is<PHONE_NUMBER>, and the telephone number for the Office of Environmental Information Docket is<PHONE_NUMBER>. An electronic version of the public docket is available at www.regulations.gov. This site can be used to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17[th] Street, NW, Washington, D.C. 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID Number EPA-HQ-2016-0010, OMB Control No. 2080-NEW in any correspondence.


[Federal Register Volume 80, Number 248 (Monday, December 28, 2015)]
[Notices]
[Pages 80785-80787]
[FR Doc No: 2015-32644]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2015-0629]

Collection of Information Under Review by Office of Management
and Budget; OMB Control Number: 1625-0003

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding an Information Collection Request (ICR),
abstracted below, to the Office of Management and Budget (OMB), Office
of Information and Regulatory Affairs (OIRA), requesting an extension
of its approval for the following collection of information: 1625-0003,
Boating Accident Report. Our ICR describe the information we seek to
collect from the public. Review and comments by OIRA ensure we only
impose paperwork burdens commensurate with our performance of duties.

DATES: Comments must reach the Coast Guard and OIRA on or before
January 27, 2016.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2015-0629] to the Coast Guard using the Federal
eRulemaking Portal at http://www.regulations.gov. Alternatively, you
may submit comments to OIRA using one of the following means:
    (1) Email<EMAIL_ADDRESS>    (2) Mail: OIRA, 725 17th Street NW., Washington, DC 20503,
attention Desk Officer for the Coast Guard.
    (3) Fax:<PHONE_NUMBER>. To ensure your comments are received in a
timely manner, mark the fax, attention Desk Officer for the Coast
Guard.
    A copy of the ICR is available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
Commandant (CG-612), Attn: Paperwork Reduction Act Manager, U.S. Coast
Guard, 2100 2nd Street SW., Stop 7710, Washington, DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection. The Coast Guard invites comments on whether
this ICR should be granted based on the Collection being necessary for
the proper performance of Departmental functions. In particular, the
Coast Guard would appreciate comments addressing: (1) The practical
utility of the Collection; (2) the accuracy of the estimated burden of
the Collection; (3) ways to enhance the quality, utility, and clarity
of information subject to the Collection; and (4) ways to minimize the
burden of

the Collection on respondents, including the use of automated
collection techniques or other forms of information technology. These
comments will help OIRA determine whether to approve the ICR referred
to in this Notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG-2015-0629], and must be received by January 27,
2016.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at http://www.regulations.gov and
can be viewed by following that Web site's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    OIRA posts its decisions on ICRs online at http://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice
of Action on each ICR will become available via a hyperlink in the OMB
Control Number: 1625-0003.

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard has published the 60-day notice (80 FR 45670, July 31,
2015) required by 44 U.S.C. 3506(c)(2). That Notice elicited five
comments.
    Comment #1: Mark Brown: Mr. Brown is the Boating Law Administrator
in Oklahoma. He suggests that before the Boating Accident Report (BAR)
is updated, items incorporated in the proposed rulemaking on Accident
Reporting be included. The BAR form is approved by OMB on a triennial
basis, and that approval expires soon. We are seeking to renew the
approval of the BAR form based on the current accident reporting
requirements. The proposed rulemaking to which the commenter refers
will likely change the requirements for accident reporting if it is
adopted. However, since the proposed rulemaking on Accident Reporting
is still being developed and no final resolution has been determined,
we cannot use any potential changes that the accident reporting
rulemaking may propose. Therefore the BAR will remain as is. If the
accident reporting rulemaking proposes changes to accident reporting
requirements that will necessitate changes to the BAR form, those
changes will be incorporated in the rulemaking and will be submitted to
OMB for its approval.
    Comment #2: Clifford Inn: Mr. Inn represents a State and enters
data into the Boating Accident Report Database (BARD). He's suggesting
adding an additional field under the existing ACCIDENT DETAILS to allow
a field for the registration number of another vessel (the 2nd in an
accident involving two vessels). Although, a good suggestion, it is our
feeling that the BAR need not be changed at this time as there are
other means when inserting into BARD to do what Mr. Inn suggests.
    Comments #3: National Association of State Boating Law
Administrators (NASBLA): NASBLA represents the recreational boating law
officials in the 50 states and six territories. They claim that at this
time, two factors limit their ability to respond to this Notice in a
more comprehensive and meaningful way. Firstly, they claim that
terminology may change depending on the results of a notice of proposed
rulemaking on Accident Reporting. However, until the notice of proposed
rulemaking is published and finalized, no changes will be made to the
BAR as explained under COMMENT #1. The next iteration of the BAR may
need changes if the rulemaking, when finalized, makes it appropriate.
Secondly, they refer to another Federal Register notice (docket number
USCG-2015-0753) dealing with the updating of the Boating Accident
Manual (COMDTINST M16782.1). However, this ICR must go on, in spite of
any problems the COMDTINST may encounter. They further state that
commenting on this particular docket would not be particularly useful
and might even be rendered obsolete by the time the Federal Register
Notice regarding BAR form changes is issued. As such, no changes will
be made to the BAR ICR as a result of these comments.
    Comment #4. Connecticut Department of Energy & Environmental
Protection: Connecticut supports an extension of the currently approved
collection: 1625-0003, Boating Accident Report. However, they also feel
the forms may need to be updated to ensure conformity with terminology
and other changes to the casualty report content authorized in the
final rule and consistent with COMDINST M16782.1. However, as stated in
the response to NASBLA, the BAR will not be changed at this time.
    Comment #5. Ohio Department of Natural Resources: Ohio's comments
are consistent with those of the National Association of State Boating
Law Administrators (ID: USCG-2015-0629-0004) and as such the comments
above relative to NASBLA's submission apply to Ohio.
    After considering all the above comments, no changes have been made
to the collection for the reasons explained in the responses to the
comments.

Information Collection Request

    1. Title: Boating Accident Report.
    OMB Control Number: 1625-0003.
    Summary: The Coast Guard Boating Accident Report form is the data
collection instrument that ensures compliance with the implementing
regulations and Title 46 U.S.C. 6102(b) that requires the Secretary to
collect, analyze and publish reports, information, and statistics on
marine casualties.
    Need: Title 46 U.S.C. 6102(a) requires a uniform marine casualty
reporting system, with regulations prescribing casualties to be
reported and the manner of reporting. The statute requires a State to
compile and submit to the Secretary (delegated to the Coast Guard)
reports, information, and statistics on casualties reported to the
State. Implementing regulations are contained in Title 33, Code of
Federal Regulations, SUBCHAPTER S--BOATING SAFETY, PART 173--VESSEL
NUMBERING AND CASUALTY AND ACCIDENT REPORTING, Subpart C--Casualty and
Accident Reporting and Part 174--STATE NUMBERING AND CASUALTY REPORTING
SYSTEMS, Subpart C--Casualty Reporting System Requirements, and Subpart
D--State reports.
    States are required to forward copies of the reports or
electronically transmit accident report data to the Coast Guard within
30 days of their receipt of the report as prescribed by 33 CFR 174.121
(Forwarding of casualty or accident reports). The accident report data
and statistical information obtained from the reports submitted by the
state reporting authorities are used by the Coast Guard

in the compilation of national recreational boating accident
statistics.
    Forms: CG-3865, Recreational Boating Accident Report; CG-3865-SP,
Reporte Del Accident En Barcos De Recreaci[oacute]n (Spanish Version).
    Respondents: Federal regulations (33 CFR 173.55) require the
operator of any uninspected vessel that is numbered or used for
recreational purposes to submit an accident report to the State
authority when:
    (1) A person dies; or
    (2) A person is injured and requires medical treatment beyond first
aid; or
    (3) Damage to the vessel and other property total $2,000 or more,
or there is a complete loss of the vessel; or
    (4) A person disappears from the vessel under circumstances that
indicate death or injury.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated annual burden remains 2,500
hours a year.

    Authority:  The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: December 21, 2015.
Thomas P. Michelli,
 Deputy Chief Information Officer, U.S. Coast Guard.
[FR Doc. 2015-32644 Filed 12-24-15; 8:45 am]
 BILLING CODE 9110-04-P