10 - COMMENTS (273-277) - VOL1 ISSUE2 (DO NOT DELETE) 7/9/2010 1:00 PM CITE AS: 1 HASTINGS. SCI. AND TECH. L.J. 269 ARIAD PHARMACEUTICALS, INC. V. ELI LILLY AND COMPANY —- F.3d ——, 2009 WL 877642, C.A.Fed. (Mass.), April 03, 2009 (NO. 2008-1248) STATEMENT OF THE FACTS Defendant-Appellant Eli Lilly and Company (“Lilly”) appeals the district court’s ruling that the patent a
Mvoai.comWild Crop, Greenhouse, and Apiary Guidelines
Wild Crop, Greenhouse, and Apiculture Products - General Points .1Wild Crop Products.1 Product Identification.2Description of the Supervised Area .2Management and Oversight by Supervisory Agencies .2Non-contamination.2Inspection.3Sustainability .3Record Keeping .3 Definitions .3Apiculture practice.3Handling Standards for Organic Apiculture Products: .6 NOSB Guidelines for Greenhouse Production.10 Definitions .10Greenhouse Production Systems.10 Wild Crop, Greenhouse, and Apiculture Products - General Points Detailed guidelines do not yet exist for apiculture, greenhouse, or wild crop production in theNOP standards. However the organic production, processing, and labeling of these productsmust follow all the NOP standards as provided in the MVOAI Standards manual. UntilUSDA publishes more detailed standards for such production methods, the followingguidelines may be useful. These are suggested guidelines only.
Wild Crop Products
Wild products are produced in natural environments that are not generally subject to localimpact, pollution or its detrimental influences. Wild products may be harvested from land orwater ecosystems.
Wild products are not cultivated and managed by humans except for their harvest. Harvestmethods used to collect wild products must maintain the target crop’s capacity for continuedself-propagation, as well as for the flourishing of the populations of non-target species, andthe ecosystem as a whole.
The sole management tool allowed for wild systems is adjustment of harvest levels andmethods, based on monitoring of population levels. Wild products are exempt from certification regulations that require active organic management such as crop rotation andfertilization. Because wild crop products come from natural environments they may be usedas ingredients in organically processed products.
All wild harvested species proposed for certification must be clearly identified. The operatorshould provide MVOAI information on the populations (historic, current, and projected) ofeach variety proposed for certification.
The operator should submit and utilize information on the life cycles of all species targetedfor harvest to allow a firm understanding of continued population maintenance, growthrequirements, and population fluctuations.
Description of the Supervised Area
The boundaries of the wild-harvested area must be clearly defined and, if applicable,differentiated from the boundaries of the harvest area. Maps must be used to show the harvestarea as well as all other regions that the target organism inhabits throughout its life cycle.
Maps must include topography, human developments, and other items ofgeological/geographical significance.
Management and Oversight by Supervisory Agencies
The wild-crop operator must supply information on how the area is monitored and/ormanaged by governmental bodies or other supervisory agencies that are in control of thearea, if applicable. The same should be provided for privately owned land. The frequency ofmonitoring/research activities by the supervisory body must also be reported.
All regulations pertaining to the use of the area as well as any indirect impacts upon it byhumans must be described or referenced. Information on mechanisms used for enforcementof these regulations must also be included.
The operator must present all required licenses or permits for harvest to MVOAI, along withan explanation of the responsibilities associated with holding such licenses as well as thefrequency of their issuance. Specific use agreements between the party to be certified and thesupervisory authority for the area must also be submitted.
An analysis of the potential for contamination of the supervised area must be submitted alongwith documentation supporting the conclusions of the analysis. All direct and indirect humanimpacts on the supervised zone must be described as thoroughly as possible. Factors notlinked to human-related impacts that can adversely affect the safety of the product for consumption by humans must also be documented and reported. The operator must submit aplan for ongoing monitoring of the supervised area to confirm that no contamination occurs.
Any information regarding pollution of the target species’ habitat must be reported toMVOAI.
All harvested areas to be certified, as well as other areas that the target species inhabitsduring its life span, must be capable of being inspected.
The operator must submit anticipated harvest schedules for the current year and a minimumof 1 additional year. The operator must demonstrate that harvesting techniques are consistentwith maintenance of a sustained population of the target species. When fluctuations of thetarget specie’s population occur (as reflected by changes in harvest levels), the operator mustdemonstrate that the ecosystem as a whole, as well as the specie’s population, is beingadequately monitored.
The record keeping system for wild harvest products must be capable of completely trackingthe chain of custody for all certified products, from the point of sale back to the original areaof harvest.
Apiculture Standards Guidance
§ 205.2 Definitions
Apiculture definition. The management and production of honey bees and queens andtheir products including but not limited to honey, beeswax, pollen, royal jelly, propolis,and bee venom.
Forage zone. Land surrounding bee colonies that provides bees with water, nectar,honeydew, pollen, and propolis.
§ 205.240 Apiculture practice standard
(a) Products from an apiculture operation that are to be sold, labeled, or represented asorganic must be from hives which have been under continuous organic management for noless than 270 days prior to the removal of the products from the hive. If a prohibitedmaterial has been used in or on the hive prior to the 270-day transition, the producer mustreplace the hive’s foundation with foundation made from organic wax and remove thoseproducts to be sold as organic, prior to the start of the transition period.
(b) A producer of organic apiculture products must develop an organic apiculture plan inaccordance with the provisions in § 205.201. In addition, the organic apiculture plan must: (1) Contain a map of the forage zone that shows the location of the hives, thelocation of organic and wild land, and the location of all non-organic areas; (2) Describe the quantity of organic and/or wild forage to be provided per colony,including the type or types of forage, approximate bloom period, forage density,competing species density, honeybee colony density, colony health, colonystrength, topography, and climatic conditions; (3) Describe the water sources available in the forage zone; (4) List all sanitary landfills, incinerators, sewage treatment facilities, powerplants, golf courses, towns or cities, land to which prohibited materials areapplied, and all other sources of potential contamination located in the foragezone; and (5) For split operations, list and describe the management practices used toprevent commingling and contamination, including measures to preventcommingling resulting from bee drift and robbing.
(c) A producer of organic apiculture products must maintain records in accordance with §205.103 and § 205.236(c).
(d) The producer must maintain hives on land that is managed in accordance with theprovisions in § 205.202 through 205.206 or § 205.207. (e) The producer must provide bees with forage that is managed in accordance with theprovisions in § 205.202 through 205.206 or § 205.207. (f) The producer of an organic apiculture operation may: (1) Allow bees from their operation to forage on non-organically managed landwhen adequate forage from organically managed land and/or land that is managedin accordance with § 205.207, as defined by the operation’s organic apicultureplan, has been provided; and (2) Provide supplemental feed from organic honey, organic sugar syrup, and/orpollen substitutes and supplements that are allowed under 205.603, Except, That,the producer must not provide organic sugar syrup less than 30 days prior to theharvest of honey to be sold, labeled, or represented as organic.
(g) The producer of an organic apiculture operation must not: (1) Maintain colonies in an area where land to which prohibited materials, aslisted in § 205.105, are applied, or where another source of contamination islocated less than 4 miles (6.4 kilometers) from the apiary, as described in theoperation's organic apiculture plan.
(h) Approved hive construction materials: (1) Hives must be made of natural materials, including wood and metal.
(2) Outside hive surfaces may be painted with non-lead based paints.
(3) Plastic foundation may be used if dipped in organic beeswax and mounted in awooden frame.
(i) The producer must establish and maintain preventive health care practices, including: (1) Selection of bee stocks, hive densities, and colony locations appropriate tosite-specific conditions and resistant to prevalent diseases and pests; (2) Introduction of replacement bees which are from organic sources or from non-organic sources, Provided, That the replacement bees are managed organically forat least 60 days prior to the removal of organic apiculture products from the hive; (3) Maintenance of adequate supplies of honey and pollen in the hive, includingleaving hives with reserves of honey and pollen sufficient for the colony tosurvive the dormancy period; (4) Use of foundation wax not contaminated with diseases or pests; (5) Destruction of equipment and bees contaminated with disease or pests; (6) Use of management methods or modified equipment to control pests anddiseases; (7) Use of therapeutic applications of non-synthetic materials to control pests,parasites, and diseases, Provided, That such materials are not prohibited under §205.604; and (8) Use of therapeutic applications of synthetic materials, Provided, That suchmaterials are allowed under § 205.603.
(1) Accept the presence of pests, parasites, or disease without initiating efforts to restorethe health of the colony; (2) Use synthetic materials not listed as allowed under § 205.603; (3) Use non-synthetic materials prohibited under § 205.604; (4) Use lumber treated with synthetic materials not listed as allowed under § 205.603 ornon-synthetic materials prohibited under § 205.604 for hive construction materials; (5) Use synthetic materials or non-synthetic materials prohibited under § 205.604 in beesmokers; (6) Annually destroy bee colonies following honey flows; (7) Rotate hives between organic and non-organic management; or (8) Sell apiculture products as organic if they contain a residue of a prohibited materialgreater than 5 percent of the Environmental Protection Agency’s tolerance for thespecific material, pursuant to § 205.671.
Handling Standards for Organic Apiculture Products:
§ 205.273 Handling organic apiculture products.
(a) A handler of organic apiculture products must develop an organic handling plan inaccordance with the provisions in § 205.201.
(b) A handler of organic apiculture products must maintain records in accordance with §205.103.
(c) An operation which handles organic apiculture products must implement GoodManufacturing Practices and be in compliance with all handling requirements of §205.270 through § 205.272.
(d) Primary handlers of organic apiculture products must not: (1) Add water to honey to decrease the honey’s viscosity; (2) Use fine mesh filters or diatomaceous earth to separate seed crystals from honey; (4) Heat or handle organic apiculture products using kerosene heaters or any heatingsystem which introduces petroleum fumes into the room; or (5) Control stray bees or other insects using synthetic insecticides, repellants, orfumigants, unless such materials are allowed under § 205.605.
Addendum I: Definition of Honey and Honey Products (FOR REFERENCE ONLY) Approved by the US National Honey Board June 15, 1996 Honey is the substance made when the nectar and sweet deposits from plants are gathered,modified and stored in the honeycomb by honey bees.
The definition of honey stipulates a pure product that does not allow for the addition of any othersubstance. This includes, but is not limited to, water or other sweeteners.
As a natural product, the composition of honey is highly variable.
Comb honey: Honey presented in its original comb or portions thereof.
Extracted honey: Honey removed from the comb and presented in several forms, as defined inthe United States Department of Agriculture Standards for Grades: (1) liquid, (2) crystallized orgranulated, or (3) partially crystallized. This is commonly known, and referred throughout thedocument, as "honey." IV. Designation of Honey Sources - the source of honey determines many of the attributes ofhoney, e.g., aroma, flavor, color and composition.
Floral: Indicates the primary flowers from which bees gathered nectar to produce the honey.
Non-Floral: Indicates primary sources other than flowers such as extra-floral nectaries andhoneydew.
Geographic Origin: The name of an area of production (state, region) may be included, providedthe honey has been produced entirely within that area. Blends containing honey of foreign originmust be labeled to indicate their origin(s), in accordance with the Code of Federal Regulations(CFR).
1. Blended Honey: A homogeneous mixture of two or more honeys differing in floral source,color, flavor, density or geographic origin.
2. Churned Honey: See whipped honey.
4. Crystallized Honey: Honey in which part of the natural glucose content has spontaneouslycrystallized from solution as the monohydrate. Also called "Granulated Honey." 5. Filtered Honey: Honey processed by filtration to remove extraneous solids and pollen grains.
6. Honey Fondant: See whipped honey.
7. Organic Honey: Honey produced, processed, and packaged in accordance with State andFederal regulations on honey and organic products, and certified by a State Department ofAgriculture or an independent organic farming certification organization.
8. Raw Honey: Honey as it exists in the beehive or as obtained by extraction, settling or strainingwithout adding heat.
8a. Commercially Raw Honey: Honey as obtained by minimum processing. This product is oftenlabeled as raw honey.
Notes: 1) Storage or exposure to either ambient (environmental) or applied (deliberately added)heat influences the character of honey. 2) Enzymatic activity, antimicrobial properties, microbialquality, color and chemical composition are all influenced by heat and storage. 3) There are aninfinite number of time and temperature combinations that will affect the raw state of honey. 4)The definition of "minimum" processing can be set by purchasing standards.
10. Strained Honey: Honey which has been passed through a mesh material to remove particulatematerial (pieces of wax, propolis, other defects) without removing pollen.
11. Whipped Honey: Honey processed by controlled crystallization, to a smooth spreadableconsistency. Also called "Cremed Honey," "Spun® Honey," "Whipped Honey," "ChurnedHoney," "Candied Honey" or "Honey Fondant." Current U.S. Standards for Grades of Extracted Honey and Comb Honey (CFR Title 7, Part 52,sections 1391-1405) are herein incorporated by reference. The grading of extracted honeyincludes factors such as color, clarity, absence of defects, moisture, flavor and aroma.
The official methods of analysis for honey of the Association of Official Analytical ChemistsInternational are herein incorporated by reference (AOAC 1995, 16th edition, section 44.4).
Suggested Amendments to the National List: (For reference only) Clients wishing or needing
to use the suggested additions below in their operation should contact MVAOI for
The NOSB Apiculture Task Force gathered information on materials currently used by apicultureoperations and materials currently allowed by certifying agents. The Task Force proposes thatthe following materials be reviewed for possible inclusion on the National List, § 205.603.
In the table below, the name of the material appears in the first column. The S/N code in thesecond column stands for synthetic/natural. The third column contains information and notes onhow and why the material is used. The information in this column may be helpful to constructannotations on use of the material.
For apicultural use to disinfect empty combs which have beenexposed to European foulbrood, Nosema, or the protozoan-caused Amoeba Disease.
For apicultural use to control wax moth.
For apicultural use to control tracheal mites including: menthol,cinnamon, eucalyptus, spearmint, wintergreen, thyme, andcamphor. These materials may be used after the last honeyharvest of the season and must be discontinued 30 days beforethe addition of honey supers.
For apicultural use to control Varroa mites. This material maybe used after the last honey harvest of the season and must bediscontinued 30 days before the addition of honey supers.
For apicultural use to control Varroa mites.
For apicultural use to control Varroa mites. This material maybe used after the last honey harvest of the season and must bediscontinued 30 days before the addition of honey supers.
discontinued 30 days before the addition of honey supers.
For apicultural use. Only for treatment of American foulbrood (AFB) in apiaries in which the disease has been diagnosed; beekeepers may not make routine, prophylactic applications ofoxytetracyline in apiaries in which there has been noconfirmation of the presence of AFB.
(Note: Included for discussion purposes becauseoxytetracycline calcium complex is on the National List forcrop production. Although terramycin is commonly used tocontrol bee diseases, no antibiotics are allowed for other typesof organic livestock. If allowed, an extended withdrawal periodor re-transition of the hive should be considered prior tocollection of organic apiculture products.) For apicultural use to control tracheal mites. This material may be used after the last honey harvest of the season and must bediscontinued 30 days before the addition of honey supers.
(Note: Some certifiers have allowed vegetable shorteningmixed with sugar to form a patty. It is included here for review,but may not need to appear on the list, since it is a naturalmaterial, and may be used by definition. Since it ends up beingeaten by the bees, it is assumed that the shortening would haveto be from organic sources. If the shortening is used as anexcipient, the Task Force is unclear as to whether theshortening must be organic or if it must appear on the list.) NOSB Guidelines for Greenhouse Production Definitions
A Greenhouse may be defined as an enclosed structure used to grow organic crops,annual seedlings or planting stock used in organic production.
Greenhouse Production Systems
(a) Greenhouse operations must meet all applicable requirements of subparts B(205.103 – 205.105) and C (205.200 – 205.206) except that: (1) The producer operating a greenhouse with crops grown in containers isexempt from requirements of 205.202, 205.203(a) and 205.205. In addition, theproducer is exempt from the crop rotation and cover cropping requirements insection 205.203(b). The production environment must prevent contact between organically produced crops and prohibited substances as listed in 205.105throughout the entire production period.
(2) The producer of an in-ground permanent soil greenhouse system can seek anexemption from the crop rotation requirements of sections 205.203, and 205.205-205.206 provided that effective alternative strategies for developing andmaintaining plant and soil health are established and approved by the certifyingagent.
(b) The use of potting mixtures containing prohibited materials is not allowed.
(c) Producers may use artificial light sources (d) Plants and soil shall not be in direct contact with wood treated with prohibitedmaterials that is used for greenhouse structures or frames of raised beds.
(e) If a producer is growing both organic and non-organic greenhouse crops, the producermust comply with the provisions of 205.201(a)(5) to prevent commingling andcontamination.
(f) Organic and non-organic crops can be grown within the same structure if thefollowing conditions are met: 1. An impermeable wall shall separate organic and non-organic production sites ifprohibited pesticides are applied to the non-organic crop at a time when theorganic crop is present.
2. Adequate provisions must be made to prevent contamination of organic cropswhen producers alternate between organic and non-organic production duringdifferent times of the year.
3. The ventilation system must ensure that prohibited materials do not drift to theorganic production area.
4. Separate watering systems must be established if prohibited fertilizers and/orpesticides are injected within the watering system.
5. Producers must insure that no contamination occurs to the organic crop throughcross-pollination with crops produced through genetic engineering.
6. Soil mixing machines and other equipment used for non-organic cropproduction must be thoroughly cleaned prior to use in organic production, exceptthat pesticide sprayers used in conventional production can not be used fororganic production purposes; .
7. Adequate physical facilities, as determined by the certifying agent, shallseparate organic and non-organic crops and production materials in storage,production or holding areas.
8. Organic and non-organic crops and production areas must be conspicuouslylabeled.
APD PROVIDERS / SUPPORT COORDINATORS JOINT MEETING Thursday, November 17, 2011 9:30 A.M. 401 NW 2ND AVENUE, SUITE N-1011, MIAMI, FL 33128 AGENDA ITEM ISSUE / DISCUSSION ACTION / FOLLOW UP Meeting began at 9:40 a.m. Area Administrator Ms. Evelyn Alvarez welcomed I. CALL TO ORDER everyone and requested that all phones be silenced to avoid interruptions. Special Anno