[Federal Register Volume 78, Number 27 (Friday, February 8, 2013)]
[Notices]
[Pages 9389-9390]
[FR Doc No: 2013-02921]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2013-0025; FRL-9376-8]

Notice of Receipt of Pesticide Products; Registration
Applications To Register New Uses

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces receipt of applications to register new
uses for pesticide products containing currently registered active
ingredients pursuant to the provisions of section 3(c) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. This
notice provides the public with an opportunity to comment on the
applications.

DATES: Comments must be received on or before March 11, 2013.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the EPA Registration Number or EPA File Symbol of
interest as shown in the body of this document, by one of the following
methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: A contact person is listed at the end
of each registration application summary and may be contacted by
telephone, email, or mail. Mail correspondence to the Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001. As part of the mailing address, include the contact person's
name, division, and mail code.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Registration Applications

    EPA has received applications to register new uses for pesticide
products containing currently registered active ingredients. Pursuant
to the provisions of FIFRA section 3(c)(4), EPA is hereby providing
notice of receipt and opportunity to comment on these applications.
Notice of receipt of these applications does not imply a decision by
the Agency on these applications. For actions being evaluated under the

Agency's public participation process for registration actions, there
will be an additional opportunity for a 30-day public comment period on
the proposed decision. Please see the Agency's public participation Web
site for additional information on this process (http://www.epa.gov/pesticides/regulating/registration-public-involvement.html). EPA
received the following applications to register new uses for pesticide
products containing currently registered active ingredients:
    1. EPA Registration Numbers: 264-824 and 264-825. Docket ID Number:
EPA-HQ-OPP-2012-0876. Applicant: Bayer CropScience, 2 T.W. Alexander
Drive, P.O. Box 12014, Research Triangle Park, NC 27709. Active
ingredient: Prothioconazole Technical Fungicide [2-(2-1-
Chlorocyclopropyl)-3-(2-chlorophenyl-2-hydroxyproptyl)-1,2-dihydro-3H-
1,2,4-triazole-3-thione]. Product Type: Fungicide. Proposed Uses:
Bushberry (crop subgroup 13-07B), low growing berry subgroup, except
strawberry (crop subgroup 13-07H and cucurbit vegetables (crop group
9). Contact: Rosemary Kearns, RD,<PHONE_NUMBER>, email address:
<EMAIL_ADDRESS>    2. EPA Registration Number: 1001-87. Docket ID Number: EPA-HQ-OPP-
2013-0017. Applicant: Cleary Chemicals, LLC., 178 Ridge Road, Suite A,
Dayton, NJ 08810. Active ingredient: Tebuconazole. Product Type:
Fungicide. Proposed Uses: Turfgrass use on home lawns, sod and athletic
fields. Contact: Heather Garvie, RD,<PHONE_NUMBER>, email address:
<EMAIL_ADDRESS>    3. EPA Registration Number: 7969-278. Docket ID Number: EPA-HQ-OPP-
2013-0008. Applicant: BASF Corporation, 26 Davis Drive, P.O. Box 13528,
Research Triangle Park, NC 27709-3528. Active ingredient: Saflufenacil.
Product Type: Herbicide. Proposed Uses: Post-emergent applications to
rice. Contact: Bethany Benbow, RD,<PHONE_NUMBER>, email address:
<EMAIL_ADDRESS>    4. EPA Registration Numbers: 59639-35 and 59639-76. Docket ID
Number: EPA-HQ-OPP-2012-0899. Applicant: Valent U.S.A., 1600 Riveria
Avenue, Suite 200, Walnut Creek, California 94596. Active ingredient:
Fenpropathrin. Product Type: Insecticide. Proposed Use: Barley,
fruiting vegetable group 8-10, citrus fruit group 10-10, pome fruit
group 11-10, and berry subgroups 13-07 B, F & G. Contact: Olga Odiott,
RD,<PHONE_NUMBER>, email address<EMAIL_ADDRESS>    5. EPA Registration Numbers: 62719-437 and 62719-442. Docket ID
Number: EPA-HQ-OPP-2012-0912. Applicant: Dow AgroSciences LLC, 9330
Zionsville Road, Indianapolis, Indiana 46268. Active ingredient:
Methoxyfenozide. Product Type: Insecticide. Proposed Use: Herb subgroup
19A (except chives), dates, sorghum, peas and bean subgroup 6C (except
blackeyed and southern pea), fruiting vegetable group 8-10, pome fruit
group 11-10, berry subgroups 13-07 A, F & G, sugar apple, cherimoya,
atemoya, custard apple, llama, soursop, and biriba. Contact: Olga
Odiott, RD,<PHONE_NUMBER>, email address<EMAIL_ADDRESS>    6. EPA Registration Numbers: 62719-519, 62719-572, 62719-628,
62719-629, and 62719-630. Docket ID Number: EPA-HQ-OPP-2013-0015.
Applicant: Dow AgroSciences, 9330 Zionsville Road, Indianapolis, IN
46268. Active ingredient: Aminopyralid. Product Type: Herbicide.
Proposed Uses: Weed management in aquatic areas. Contact: Bethany
Benbow, RD,<PHONE_NUMBER>, email address<EMAIL_ADDRESS>    7. EPA Registration Numbers: 71049-2 and 71049-4. Docket ID Number:
EPA-HQ-OPP-2013-0011. Applicant: KIM-C1, LLC, 2547 W. Shaw Ave., Suite
116, Fresno, CA 93711. Active ingredient: Forchlorfenuron. Product
Type: Plant Growth Regulator. Proposed Uses: Almond; cherry, sweet fig;
pear; pistachio; plum; and prune. Contact: Cynthia Giles-Parker, RD,
(703) 305-7740, email address<EMAIL_ADDRESS>
List of Subjects

    Environmental protection, Pesticides and pest.

    Dated: February 1, 2013.
Daniel J. Rosenblatt,
Acting, Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2013-02921 Filed 2-7-13; 8:45 am]
BILLING CODE 6560-50-P


Page 1 of 7 PROCESS FOR ASSESSING POTENTIAL RISKS TO ENDANGERED AND THREATENED SPECIES AND CONSULTATION WITH THE NATIONAL MARINE FISHERIES SERVICE AND THE U. S. FISH AND WILDLIFE SERVICE U. S. Environmental Protection Agency 2002 A. Consultation Procedures Regulations governing ESA

s section 7 consultation procedures pursuant to section 7 of ESA are codified in 50 CFR Part 402. A discussion of these regulations in reference to EPA

s registration and reregistration activities follows.

1. A " conference" is designed to identify potential problems between an agency action, such as pesticide registration, and a species proposed to be listed ( i. e., before it is listed) under ESA. There is also a more formal conference procedure ( 50 CFR 402.10 ( d) and ( e)), which follows the same basic procedures as a formal consultation, except that again the species is not yet listed. The EPA hopes to make use of formal conferences in the future, where appropriate, to provide more timely protection to listed species.

2. An " early consultation" attempts to identify potential conflicts between listed species and their critical habitats, and proposed actions prior to applying for the Federal pesticide registration. This type of consultation is conducted between the Federal agency, EPA, and FWS, but involves the registrant or applicant throughout the process. Pesticide registration has not used early consultation because the amount and quality of data needed from the registrant would be equivalent to that needed for registration, and the process would provide no benefit. Aspects of this consultation procedure ( i. e., early involvement of the applicant) can be useful in expediting public health emergency exemption consultations.

3. A " biological assessment" evaluates the potential effects of Federal action( s) on listed species. species that are proposed to be listed, and their critical habitats. The goal is to determine which species or habitats are likely to be adversely affected and to determine if consultation is necessary. Biological assessments are only required for major construction activities. An agency may request from FWS a list of species that may be in the area of concern. This process is only required within the biological assessment process but can be requested for any action. The FWS is to provide such a list to the agency within 30 days.

4. An " informal consultation" is an optional process between a Federal agency and FWS and is designed to assist the Federal agency in determining if formal consultation and/ or a conference are required.

5. A " formal consultation" is the process in which a Federal agency first determines if an agency action such as pesticide registration " may affect" a listed species or its critical habitat. If Page 2 of 7 " no effect" is determined, the process concludes. If there is a " may affect" determination, then the agency initiates formal consultation with FWS which describes ( ii the action, ( ii) the specific area( s) affected, ( iii) any species or critical habitats that may be affected. ( iv) how the action will impact the species or habitats. ( v) any cumulative effects, and ( vi) any other relevant information. The FWS then concludes the formal consultation within 90 days, unless extended by mutual agreement.

Within 45 days after the conclusion of the formal consultation, FWS issues a written finding called a Biological Opinion to the Federal agency. During this 45 day time period, the Federal agency may request a draft of the Opinion primarily to analyze the reasonable and prudent alternatives. This cannot extend the 45 day period by more than 10 days unless an extension is mutually agreed upon.

The Biological Opinion should include a summary of the information on which the consultation is based, and a discussion of the effects of the action on the listed species or critical habitats, including a FWS determination on whether the action is likely to jeopardize the continued existence of a species or result in the destruction or adverse modification of critical habitat. Incidental take of species for which there is a " may affect" but is not likely to be jeopardized, will be identified. If possible, FWS will identify reasonable and prudent alternatives to the action, such as modification of the use of the pesticide, that the agency or registrant can take to avoid jeopardy. In addition, the Biological Opinion will identify ( i) the amount or extent, if any, of acceptable incidental take of the species, ( ii) reasonable and prudent measures to the action that will minimize the impact. ( iii) terms and conditions to implement the reasonable and prudent measures, and ( iv) procedures to handle or dispose of species taken. The FWS can also provide conservation recommendations that the agency may or may not consider.

Issuance of the Biological Opinion terminates the formal consultation process. If the Federal agency cannot comply with a Biological Opinion, it may apply for an exemption under section 7 of ESA.

6. A " reinitiation of consultation" is required if ( i) incidental take is exceeded, ( ii) new information is obtained which may affect the assessment( s) of species or critical habitats in a manner not previously considered, ( iii) the action is subsequently modified and causes an effect to the species or habitat not previously considered, and ( iv) new species or critical habitats have been designated that may be affected by the action.

B. The EPA

s " May Affect" Determinations Ecological risk from pesticide use is a function of toxicity and environmental exposure ( Ref. 1). This Unit summarizes risk assessment procedures used by EPA and indicates how these standard procedures are adapted for determining whether a pesticide " may affect" listed species. The EPA evaluates data and risks in a tiered fashion. The first risk evaluation is based upon laboratory toxicity and environmental fate data, If the initial evaluation indicates a significant Page 3 of 7 concern, then EPA requests registrants to supply additional laboratory and/ or field data in order to refine the risk assessment.

1. Toxicity evaluations. Data used in assessing toxicity include acute and chronic test data. For acute toxicity, EPA evaluates LC5O and LD5O tests, which are submitted in response to EPA data requirements ( 40 CFR Part 158). The LC5O is the statistically derived estimate of the concentration ( median lethal concentration) that would cause mortality to 50 percent of the test population. in contrast, the LD5O is the statistically derived estimate of the single dose ( median lethal dose) that would cause mortality to 50 percent of the test population. Both tests are conducted with surrogate species that are used to evaluate the potential risk to other species.

To assess acute toxicity of pesticides to birds, EPA guidelines require one LD5O study for an upland game bird ( preferably bobwhite quail) or waterfowl ( preferably mallard duck) and one LC5O study for each species. To assess toxicity to aquatic species ( fish and invertebrates), EPA requires LC5O studies on a warm water species ( preferably bluegill sunfish), a cold water species ( preferably rainbow trout), and an invertebrate ( preferably Daphnia magna). Toxicity to nontarget mammals is initially assessed by considering LD5O data for laboratory rats, which EPA requires to evaluate pesticide hazards to humans. Typically, EPA requires data on honeybees to address the risks to beneficial insects. In situations where additional, scientifically valid, toxicity data related to acute effects in wildlife and aquatic organisms are available EFED will consider them in establishing the toxicity endpoint for risk assessment. It is EFED's policy to conduct risk assessments using the acute lethal endpoint from the most sensitive species tested.

The acute toxicity data described above are basic requirements that are generally available for all pesticides with outdoor uses. For some kinds of pesticide uses, or where these basic data warrant additional data, EPA may require higher tier testing. Higher tier acute data may include toxicity to estuarine fish, invertebrates, and oyster embryo larvae; and oyster shell deposition studies. Chronic toxicity data are all higher tier and may include data or avian reproductive effects, fish early life stage toxicity, chronic toxicity to mammals and to freshwater fishes, estuarine fishes, and invertebrates. The chronic toxicity endpoints commonly considered by EFED include frank effects on reproduction such as numbers of offspring produced and their survival as well a growth effects. Rarely are data from field studies, aquatic pond studies, or secondary toxicity studies available, although such data recently have been required for some pesticides. The EPA validates all data using its Standard Evaluation Procedures ( Refs 2 through 24).

For assessment of potential effects to plants, EFED may request toxicity data regarding seedling emergence and vegetative vigor in a variety of terrestrial plants as well as plant growth studies for aquatic plants. Effects endpoints for terrestrial plants are established for the most sensitive tested dicot and monocot plants and are set at the no observed adverse effect concentration ( NOAEC) or EC05 values if NOAEC values are unavailable.

2. Environmental exposure. Data used for the exposure assessment of a pesticide include ( 1) its physical/ chemical properties; ( 2) environmental fate data, including data on persistence; ( 3) Page 4 of 7 label information such as application sites, rates, methods, and timing; ( 4) bioconcentration; and ( 5) factors related to the species themselves, such as their biology, ecology, and distribution. Occasionally, field residue data applicable to non target species are available.

The exposure assessment has two components. The first component is the determination of the EECs that may result from use of the pesticide according to label directions. The second is a determination of whether non target species are expected to be exposed to the EEC.

The EPA uses various models to determine EECs to evaluate the risk to aquatic species. Whenever possible. actual field study or residue data also are reviewed. The models used include ( a) a water model, ( b) a simple drift model, ( c) a simple runoff model, and ( d) a computer runoff and exposure simulation model. Computer based models include the Pesticide Root Zone Model coupled with the Exposure Analysis Modeling System ( EXAMS).

To determine EECs for listed terrestrial species, EPA estimates residues on food items consumed by the species. Estimated residues, primarily on plants and insects, are based mainly on the work of Hoerga and Kenaga ( 1972) and Fletcher et al. ( 1994). These works are a compendium of measured pesticide residue values for several types of vegetable material, such as long and short range grasses; leaves and leafy crops; forage crops; pods containing seeds; and fruit ( cherries, peaches, grapes, citrus). Residues are given on the basis of a pesticide application rate of lb/ A and then adjusted for the label rate. The estimates represent upper bound expected residues for day zero ( immediately after application). When possible, actual validated residue data also are considered.

In estimating the environmental concentrations, EPA also considers the formulation of the product, such as liquid, granular, or fumigant formulations. The available validated pesticide and environmental fate data are used in the computer based models to provide more accurate assessments from multiple applications, as identified on the label. Specific scenarios have been developed for runoff from specific crop sites, as well as environmental concentrations in a pond or headwater stream environment. Data, such as water chemistry data, are often insufficient to accurately run the more sophisticated computer based models. The EPA is attempting to develop additional scenarios to address additional use sites, different application methods ( aerial, ground, etc.), cropping practices ( no till, strip crop, rotation, etc.), application techniques ( band, infurrow side dressing, etc.), and integrated pest management practices so that alternatives can be identified that will protect listed species.

3. Risk assessment. In assessing the risk to non target species in general, EPA compares the toxicity information with the EEC and then determines the likelihood that non target organisms will actually be exposed. Comparisons of LC5O or LD50 values with EECs indicate whether additional data may be required or that a particular pesticide may warrant restricted use classification if actual exposure may occur. When evaluating impacts to federally listed species, EPA does not rely solely on the LC5O or LD5O end points since some listed species may not be able to withstand even the loss of a few individuals in the population. much less 50 percent. Page 5 of 7 Therefore, more stringent criteria have been developed to provide greater protection for populations of listed species, whose numbers in many instances are dangerously low. Thus, criteria were developed to determine the environmental concentrations at which a pesticide A " may affect" a listed species. These criteria were developed for mammals, birds, and aquatic organisms as follows:

mammals B EEC equal to or greater than 1/ 5th the lowest mammalian acute oral LD1O or LC1O, or 1/ 10th the lowest LD5O or LC5O;

birds B EEC equal to or greater than 1/ 5th the lowest avian acute oral LD1O or subacute dietary LC1O or 1/ 10th the lowest LD5O or LC5O; and aquatic organisms B EEC equal to or greater than 1/ 10th the lowest aquatic LC1O, or 1/ 20th the lowest aquatic LC5O. Terrestrial plant criteria are set at an EEC equivalent to the EC05 or the NOAEC, depending upon toxicity data availability.

When the above criteria are exceeded for any relevant taxa, the magnitude of the potential impact is determined by calculating a hazard ratio, which is the ratio of the EEC ( based on a specific application rate) over the toxicity criteria. Any hazard ratio of one or greater confirms that a " may affect" situation exists, since the predicted residues in the environment are equal to or exceed the amount of the pesticide that could be hazardous to the species. Higher hazard ratios indicate a greater magnitude of concern.

For most currently registered pesticides, ecological impacts from acute toxicity are more likely than those from chronic toxicity. However, EPA also considers information related to subchronic and chronic risks, reproductive effects, and bioaccumulation factors. The laboratory test data ( e. g., chronic feeding, life cycle, oncogenicity, or reproductive studies) on no effect levels or no observable effect levels ( NOEL) and/ or effect levels are compared with estimated or actual field residues. When these residues are in excess of the NOEL for appropriate surrogates of listed species, EPA considers there is a potential that the pesticide may affect a species and therefore, conducts more in depth assessments.

Secondary hazards are associated with acute and chronic toxicity relating to bioaccumulation of a pesticide in the food chain and body residues of target or non target organisms consumed by organisms higher in the food chain. Again, estimated or actual residues In food items are correlated with diet of the non target organisms and compared with the acute and chronic toxicity values.

In evaluating the risk from pesticide use, EPA also considers other information. For example, toxicity to non target insects, such as honey bees, is important because pollination can be critical to certain listed plants. Any reports of pesticide incidents involving non target species, even if they are not listed species, also are considered. Page 6 of 7 Finally, effects on listed species

habitats and food supply are also considered. For example, the Everglade snail kite feeds specifically on the apple snail. Therefore, any disruption of the apple snail's habitat from pesticides or pesticide toxicity to the apple snail itself may adversely affect the Everglade snail kite. Also, herbicide disruptions of animal and plant community balance also could adversely impact the habitat or micro habitat of listed species. For example, herbicides are unlikely to be directly toxic to the valley elderberry longhorn beetle, but they may destroy the elderberry trees in which the beetle lives. On occasion, pesticide use may be beneficial to some species

habitats by reversing adverse plant competition trends that have been exacerbated by other human activities, such as exotic introductions and wildfire control.

When all the data are evaluated, if a " may affect determination" is made, EPA assembles all of the relevant information and/ or references, along with any reasonable and prudent alternatives that are known, and sends it to FWS requesting consultation, per the Services regulations. The species and pesticides included in this request are only those where a " may affect determination" was made.

Following receipt of the request for consultation, FWS prepares the Biological Opinion and determines if the use is likely to pose jeopardy to the continued existence of a species, if the use will result in the destruction or adverse modification of critical habitat of a species or if incidental take is anticipated and provisions are necessary to minimize these impacts. A " may affect determination" by EPA may not result in a jeopardy determination by FWS or result in any anticipated incidental take.

C. Threshold Application Rate Estimates Some pesticides ( e. g., certain ones that have been subject to Special Review) have been evaluated enough

that the application rates that would result in a " may affect" determination are already known. For other pesticides, EPA will first screen them to determine if the highest application rate would result in a " may affect" determination. Pesticides that do not exceed the " may affect" criteria are dropped from further analysis. For pesticides that do exceed the criteria at the highest application rate, EPA then will determine the EEC that would result from an application rate of 1 pound active ingredient per acre ( lb ai/ A) for various combinations of application methods and formulation types ( and environments, where appropriate) of a pesticide. Typically, EPA then will compare the resulting EEC

s to toxicity to obtain a hazard ratio.

A hazard ratio of " 1" or greater indicates that the EEC has met or exceeded our " may affect" criteria. If using 1 lb ai/ A application rate results In a hazard ratio of less than one ( indicating the " may affect" criteria has not been met at that rate), the ratio allows EPA to calculate the highest application rate that would still not result in a " may affect" determination, which may be compared with product label rates.

This is accomplished by multiplying the 1 lb ai/ A application rate by the reciprocal of the hazard ratio. For example, if the hazard ratio is 1/ 5 based on a 1 lb ai/ A application rate, the Page 7 of 7 application rate which would result in a " may affect" determination would be 1 lb ai/ A x 5/ 1 or 5 lb ai/ A. The same procedure applies even if the hazard ratio is greater than 1. However, the application rate derived in the latter case might not be a rate specified on the label, in which case all label use rates would result in a " may affect" to listed species.

U. S. Environmental Protection Agency. 1986. Hazard Evaluation Division Standard Evaluation Procedure, Ecological Risk Assessment Fletcher, J. S., J. E. Nellesson and T. G. Pfleeger. 1994. Literature Review and Evaluation of the EPA Food Chain ( Kenaga) Nomogram, an Instrument for Estimating Pesticide Residues on Plants. Environ. Tox. and Chem. 13( 9): 1383 1391. Hoerger, F. and E. E. Kenaga. 1972. Pesticide Residues on Plants: Correlation of Representative Data as a Basis for Estimation of Their Magnitude in the Environment. IN: F. Coulston and F. Corte, eds., Environmental Quality and Safety: Chemistry, Toxicology, and Technology. Vol I. Georg Thieme Publishers, Stuttgart, West Germany, pp. 9 28.