Revisions To The 

 

SUPPLEMENT TO INTERIM FINAL REPORT 

(Bivalve molluscs) 

Of the 

Aquaculture Working Group 

Summer 2007 

In Response to Public Comments 

Summer 2008 

U.S. Department of Agriculture 

National Organic Program 

September 8, 2008
2

The National Organic Program Aquaculture Working Group 

Members 

Sebastian Belle 

Executive Director – Maine Aquaculture Association 

Robert A. Bullis, DVM 

Director – Animal Health and Regulatory Affairs, Advanced Bionutrition Corporation 

Ralph Elston, PhD 

President – AquaTechnics 

Rebecca Goldburg, PhD 

Senior Scientist – Environmental Defense 

Ronald W. Hardy, PhD 

Director – University of Idaho Aquaculture Research Institute 

John A. Hargreaves, PhD 

Associate Professor – Louisiana State University Agriculture Center 

George S. Lockwood 

Consultant and Task Force Chairperson 

Robert A. Mayo 

President - Carolina Classics Catfish, Inc. 

Christopher L. Nelson 

Vice President – Oyster Operations – Bon Secour Fisheries 

Bart Reid 

Owner – Permian Sea Shrimp Co. 

Albert G.J. Tacon, PhD 

Aquaculture Coordinator - University of Hawaii 

Kwamena K. Quagrainie, PhD 

Aquaculture Marketing Director, Purdue University 

Special Thanks 

to the following individuals for their contributions to the work 

of the Aquaculture Working Group: 

Valerie Frances – National Organic Program 

Rigoberto Delgado– National Organic Standards Board 

Kristina Ellor – National Organic Standards Board 

Kevin Engelbert – National Organic Standards Board 

Dan Giacomini – National Organic Standards Board 

Jennifer Hall – National Organic Standards Board 

Hubert J. Karreman – National Organic Standards Board 

Jeff Moyer – National Organic Standards Board 

Joseph Smillie – National Organic Standards Board 
3

Table of Contents 

Executive summary 4 

Introduction 5 

§ 205.2 Terms defined. 9 

§ 205.257 (a) Bivalve molluscs general. 9 

§ 205.257 (b) Organic system plan for bivalve production. 10 

§ 205.257 (c) Origin of bivalve molluscs. 12 

§ 205.257 (d) Bivalve mollusc forage production. 13 

§ 205.257 (e) Contamination indicators. 13 

§ 205.257 (f) Animal health care practices. 14 

§ 205.257 (g) Living conditions. 14 

§ 205.257 (h) Bivalve growing facilities. 15 

§ 205.257 (i) Harvesting bivalve shellfish. 16 

§ 205.257 (j) Handling and transport of bivalve molluscs. 17 
4

EXECUTIVE SUMMARY 

OVERVIEW 

The Aquaculture Working Group 

 In response to the growing interest in the certification of aquatic animals as organic, in 2005, the 

National Organic Standards Board (NOSB) and National Organic Program (NOP) announced the 

formation of an Aquatic Animal Task Force. This task force was to be comprised of two working groups; 

aquaculture and wild fisheries. 

 The Aquaculture Working Group (AWG) is a diverse group of experienced professionals 

consisting of representatives from universities, trade associations, aquaculture producers and suppliers, 

and environmental interests. Included in this group are present and former growers of bivalve molluscs 

and scientific experts in this field. With the submission of our Interim Final Report dated January 13, 

2006,1

 the AWG partially satisfied the objective established by the January 24, 2005, Federal Register 

notice (FR 70 3356) to develop draft organic production and handling standards for aquatic animals 

produced in aquaculture. 

 At that time, the Aquaculture Working Group was considering the adoption of standards for 

bivalve molluscan shellfish.. Due to complexities involved, the Working Group required additional time 

to prepare this supplemental proposal. Bivalve molluscs of interest include oysters, clams, mussels and 

scallops. 

 On July 9, 2007, AWG submitted its Supplement To Interim Final Report (Bivalve molluscs). 

This document was posted for public comments.2

 One comprehensive set of public comments was 

received dated November 8, 2007 from the Pacific Coast Shellfish Growers Association.3

 The AWG has 

carefully considered these comments, and has amended the Supplement accordingly. 

 As before, our decisions were guided by the Organic Food Production Act,4

 the Final Rule5

(including its Preamble6

), our Interim Final Report, the National Organic Standards Board Livestock 

Committee’s February 20, 2007, report Aquaculture Standards -- adopted by the NOSB on March 29, 

2007,7

 and the May 30, 2001, NOSB Aquatic Animal Task Force May 30, 2001 Recommendation on 

Operations that Produce Aquatic Animals.

8

 

 The AWG performed its work through conference calls and email exchanges. Formal public 

review of this document that includes revisions to our Interim Final Report will occur through normal 

NOSB processes involving public comment. 

Aquaculture Working Group 

George S. Lockwood, Chair 

September 8, 2008 

 

1

 http://www.ams.usda.gov/nop/TaskForces/AATFInterimFinalReport.pdf 

2

 http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5062437&acct=nopgeninfo 3

 http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5065080 4

 http://agriculture.senate.gov/Legislation/Compilations/AgMisc/OGFP90.pdf 5

 http://www.ams.usda.gov/nop/NOP/standards.html 

6

 http://www.ams.usda.gov/nop/NOP/standards/FullText.pdf 

7

 http://www.ams.usda.gov/nosb/CommitteeRecommendations/March_07_Meeting/Livestock/AquacultureRec.pdf 

8

 http://www.ams.usda.gov/nosb/lscommRMR/recommendations/aquatic_animals.html 
5

INTRODUCTION 

 Developing organic standards for bivalve molluscs involves special considerations. Bivalves are 

farmed on seafloor parcels, and in the water column above, that are owned by the producer or on public 

owned seafloor parcels, and waters above, leased to the producer by a public body, rather than on 

privately owned farmland. Different states have different means for leasing publicly owned water bottoms 

or areas, and the water columns above, but practically all coastal states lease public water bottoms or 

areas , and their waters, to private entities. 

 Wild bivalves are not considered for organic certification. 

 Farmed bivalves typically consume wild feed (microalgae and other seston) that they filter from 

natural waters, rather than feed which is prepared for them. As a result, we drew on several different 

organic production systems in drafting organic standards for molluscs. These included: a) harvest of wild 

crops and kelp from relatively unmanaged lands or waters; b) honey production where bees forage from a 

relatively wide area that is usually not entirely managed by organic producers; and c) organic production 

of poultry and mammals. 

This document, Revisions To The Supplement To Interim Final Report (Bivalve molluscs) of the 

Aquaculture Working Group Summer 2007 in Response to Public Comments Summer 2008, is submitted 

to NOSB for consideration for their recommendation to the National Organic Program as an amendment 

to the Final Rule to allow the organic certification of bivalve molluscs under certain conditions. Based 

upon public comments, private comments, and internal AWG considerations, the original bivalve 

proposal of Summer 2007 has been extensively modified. 

BACKGROUND INFORMATION 

 The Recommendations of Operations that Produce Aquatic Animals of May 30, 2001, include 

the following relative to considerations of organic bivalve molluscs: 

MOLLUSC PRODUCTION

In considering the mollusc production as a complete system, the Task Force concludes that there 

is insufficient compatibility with the requirements of the OFPA to warrant the development of certification standards for such systems. The Task Force concludes that mollusc producers are not 

called upon to make a sufficient number of the management decision imposed by the statute nor 

could certification standards create significant differentiation between organic and nonorganic 

operations. 

 The Preamble to the Final Rule considers: 

Crop Production - Changes Based on Comments

 (8) Greater Rigor in the Wild Harvest Production Organic System Plan. A number of 

commenters stated that the wild-crop harvesting practice standard was insufficiently descriptive 

and that the proposed rule failed to apply the same oversight to wild harvest operations as it did to 

those producing crops and livestock. Some commenters maintained that the proposed rule did not 

require a wild harvest producer to operate under an approved organic system plan. These commenters proposed specific items, including maps of the production area that should be required in 

a wild harvest operation's organic system plan. One commenter recommended that the definition 

for "wild crop" be modified to allow the harvest of plants from aquatic environments. 
6

 We amended the practice standard for wild-crop harvesting to express the compliance requirements more clearly. Wild-crop producers must comply with the same organic system plan requirements and conditions, as applicable to their operation, as their counterparts who produce 

crops and livestock. Wild harvest operations are production systems, and they must satisfy the 

general requirement that all practices included in their organic system plan must maintain or improve the natural resources of the operation, including soil and water quality. We modified the 

practice standard to emphasize that wild harvest production is linked to a designated site and expect that a certifying agent would incorporate mapping and boundary conditions into the organic 

system plan requirements. Finally, we changed the definition of "wild crop" to specify that harvest 

takes place from a "site" instead of "from land," thereby allowing for aquatic plant certification. 

 Bivalve molluscs grown in the ocean forage upon natural phytoplankton (microalgae that are wild 

aquatic plants) and other seston. In view of the above, and with other considerations discussed below, 

AWG established criteria for the proposed standards for organic bivalve molluscs. 

THIS PROPOSAL 

 Organic system plan. We propose that operators of organic bivalve mollusc farms develop 

organic system plans that include maps of mollusc production areas as well as maps of zones of forage 

production. A wide variety of management considerations must be included in the organic system plan. 

 Organic honey and kelp. Some certifiers of organic honey operations require growers to obtain 

affidavits from adjacent land owners within the bee forage area that they do not use pesticides and other 

prohibited substances. In the case of wild kelp harvested from the ocean, the harvester of this wild aquatic 

plant crop must demonstrate that there are no discharges of prohibited substances nearby that could 

contaminate the kelp. 

 Organic certification of honey bees and marine kelp provides valuable precedents for wild food 

sources for organic production. 

 Process not safety. Bivalve molluscs forage upon marine seston, principally microalgae. On 

occasion this seston can include human pathogens. Food safety is the jurisdiction of the U.S. Food and 

Drug Administration and not U.S. Department of Agriculture and its National Organic Program. The 

organic claim is a process claim, not a food safety claim. 

 Therefore, our proposal does not include efforts to improve on the U.S. National Shellfish 

Sanitation Program, a bivalve food safety program. [See: http://www.cfsan.fda.gov/~ear/nss2-toc.html ] 

However, all possible inputs into zones of forage production are important since prohibited substances 

may be included in these inputs. We have therefore developed criteria based upon the Sanitary Survey 

required under NSSP for delineating zones of forage production and propose that the organic system plan 

identify potential sources of prohibited substances that flow into such zones, including but not limited to 

sewage and farmed animal manure. Sewage is a source of contamination of a wide range of substances, 

some prohibited, not just human pathogens. 

 Zone of forage production. Our proposal includes the delineation of the zone of forage 

production. To accomplish this we originally propose that hydraulic modeling investigations provide 

information about how shoreline currents influence the zone of forage production, and where water 

exchanges might be important considerations. 

 We have replaced hydraulic modeling requirements with inclusion of the NSSP Sanitary Survey 

that is actually a government mandated modeling program. With this, we propose that organic certifica-
7

tion be prohibited for waters that receive sewage and other point discharges, waters with adjacent land 

activities involving prohibited substances, and waters where marinas, boats, and similar activities 

influence the zone of forage production. 

 Use of sewage indicator organisms. While the use of sewage indicator organisms for microbial 

food safety concerns is not appropriate in this context , we propose their use as indicators of other forms 

of man-made contamination. Sewage discharges, both human and storm runoff, in many cases are the 

principle source of prohibited substances flowing into the zone. Therefore, requiring the certified grower 

to monitor for indicator organisms on a regular basis is proposed. 

 Origin of livestock-hatchery seed. From the background documents, it is clear that organic 

system plans must demonstrate managed farming systems. Obtaining bivalve mollusc seed from the wild 

involves low levels of system management, while obtaining seed from hatcheries requires greater 

management effort. These proposed standards require that bivalve molluscs be raised in discrete 

populations that are proactively managed consistent with requirements in the Act for origin of terrestrial 

livestock and poultry. Even if some molluscs such as mussels are not now hatchery produced in some 

areas of the country, the technology and capability to do this is well established. 

 Environmental considerations. A clear mandate articulated in the Preamble to the Final Rule is 

that all practices included in the organic system plan must maintain or improve the natural resources of 

the operation. We therefore propose numerous conditions on growing and harvesting that are intended to 

protect other forms of life on the ocean floor and surrounding areas. Moreover, a healthy bivalve farm 

substantially reduces water turbidity from microalgae and other seston. This reduction can be environmentally beneficial where turbidity results from increased flows of nutrients and organic matter from 

human activities. 

 Differentiation from conventional bivalve production. The proposed regulations provide for 

substantial differentiation from conventional bivalve aquaculture in many respects. In order to prevent 

inclusion of prohibited substances, bivalve growing areas and zones of forage production are delineated, 

frequently monitored, and managed. Certain materials for facilities are prohibited. Special attention is 

provided to assure a minimum of environmental disturbance from bivalve growing and harvest activities. 

 Revisions in this document The criteria in developing these revisions have been maintained. 

They include demonstrating a managed system, preventing prohibited substances from contaminating 

bivalve aquatic animals, and minimizing disruption to the environment. 

 In developing these revisions, AWG spend considerable effort considering the substitution of the 

NSSP Sanitary Survey for the hydraulic modeling required in the Summer 2007 proposal. Considerable 

effort was also spent in developing standards for burrowing molluscs such as clams. These animals reside 

in the substrate and efforts were directed to develop standards that minimize disruption to the biota in the 

substrate, as well as on and above the seafloor, and to nearby wildlife. 

 Another area of concern is the sediment plume that develops when harvesting molluscs on the 

seabed such as oysters, as well as when harvesting burrowing molluscs, such as clams, from the substrate. 

In establishing a maximum plume density of 200 mg/L we were guided by the work of Wilber and 

Clarke.9

 

9

 Wilber, Dara H and Douglas G Clarke. 2001. Biological Effects of Suspended Sediments, North American Journal 

of Fisheries Management 21:855-875. 
8

 Public comments One comprehensive public comment document was received that addressed 

23 concerns. One private comment received addressed sediment plume and hand raking of clams. In 

addition, members of AWG carefully reviewed each proposed paragraph in this document in terms of 

meeting our established criteria, clarity, workability, and the ability of growers and certifiers to clearly 

understand these provisions for preparing organic system plans. 

RESPONSES TO PUBLIC COMMENTS RECEIVED

 The first comment in the comprehensive public comment paper received sought that the proposed 

standards should “not allow wild-harvested, unmanaged systems, to be included in these standards.” In 

the AWG proposed standards, bivalve shellfish from wild, unmanaged systems are proscribed from 

organic certification. 

 The original Supplement of Summer 2007 proposed the delineation of a zone of forage 

production. To accomplish this we proposed that hydraulic modeling investigations provide information 

about how shoreline currents influence the zone of forage production, and where water exchanges might 

be important considerations. 

 Once the hydraulic zone of influence (HZI) was established, we proposed that organic certification be prohibited for waters that receive sewage and other point discharges, waters with adjacent land 

activities involving prohibited substances, and waters where marinas, boats, and similar activities 

influence the zone of forage production. 

 A comment was received that under the National Shellfish Sanitation Program, shellfish growing 

areas are monitored and frequently disallowed due the potential for contamination. Since the Food Drug 

Administration and the National Shellfish Sanitation Program address food safety concerns, and for other 

reasons, the AWG proposal is not concerned with food safety per se. Of concern, however, is the 

potential for contamination by prohibited substances, such as industrial and agricultural chemicals. As is 

explained in the Supplement, certain monitoring techniques in the AWG proposal are modeled after NSSP 

requirement since these techniques also allow the assessment of contamination by prohibited substances. 

 The commenter also claimed that the monitoring program is redundant with the legal requirements under NSSP, and that the proposed organic standards should specify such matters as frequency of 

monitoring and which indicators are to be monitored. In response, AWG has attempted to make these 

factors clear in this proposal. This proposal requires considerable more producer management than under 

NSSP. 

 The AWG Supplement contained a section on Origin of livestock-hatchery seed, that proposes 

“From the background documents, it is clear that organic system plans must demonstrate managed 

farming systems. Obtaining bivalve mollusc seed from the wild involves low levels of system management, while obtaining seed from hatcheries requires greater management effort. Even if some molluscs 

such as mussels are not now hatchery produced in some areas of the country, the technology and 

capability to do this is well established.” 

 The commenter stated “This requirement will effectively eliminate vast growing areas around the 

country that have managed systems for collecting natural-set spat on cultch. Furthermore, you can not 

prevent wild seed from setting on the managed farm area. If high levels of system management is indeed 

the criteria, then natural spat collection should not be summarily disallowed. In fact, under the strict 

regulations imposed by the NSSP, seed CAN be produced even in prohibited areas, but it must be grown 

out for a minimum of 6 months in an approved area. “ 

 It is the proposal of AWG that organic certification be limited to highly managed bivalve growing 

systems, and not include vast growing areas around the country. AWG does not believe that the collection 
9

of wild shellfish larvae represents the degree of management for which AWG has the burden to 

demonstrate. In this revised proposal, certain wild-set bivalve shellfish would be allowed under certain 

conditions for a limited time. 

REVISED PROPOSED STANDARDS 

For Organic Bivalve Molluscs 

In order to provide further clarity to the proposed bivalve standard, additions have been 

made to Terms Defined for Specific pathogen free and Submerged Aquatic Vegetation; 

§ 205.2 TERMS DEFINED 

HACCP. Hazard Analysis Critical Control Point, a mandatory program for seafood processors under the 

U.S. Food and Drug Administration and the National Oceanic and Atmospheric Administration. The 

program requires the analysis and management of critical processing variables that impact upon the 

healthiness and safety of seafood products. 

NSSP. National Shellfish Sanitation Program operated under jurisdiction of the U.S. Food and Drug 

Administration and designated state and foreign shellfish control authorities. 

Bivalves. The term “bivalve” applies to bivalve molluscs including oysters, clams, mussels, and scallops. 

Gastropod molluscs, such as abalone and conch, and cephalopods, such as octopus and squid, are not 

included. 

Seed, juvenile or spat. The stage of development after the larval, free-swimming stage, which, having 

developed an eye spot, foot, and gills, settles onto a suitable substrate (on shell, for example). This life 

state is also sometimes referred to as “spat.” 

Specific pathogen free. Hatchery bivalve seed must be certified free of reportable shellfish infectious 

disease agents in accordance with applicable state and/or federal regulations pertaining to the location of 

origin and use.

Submerged aquatic vegetation (SAV). A collective term that describes rooted macrophytes, including 

marine angiosperms, such as the true sea grasses, and freshwater macrophytic algae. Submerged aquatic 

vegetation provides food and shelter for juvenile estuarine and marine organisms and improves water 

quality by causing the sedimentation of suspended matter and the removal of dissolved nutrients through 

primary productivity. 

Bivalve Molluscs In this section, (a)(6) has been added. 

§ 205.257 BIVALVE MOLLUSCS

(a) Bivalve molluscs general: 

(1) Except as otherwise provided, all provisions of § 205.250 through § 205.259, Aquaculture, and § 205.600 through § 205.604, National List, in this subsection apply to bivalves. 

(2) An organic bivalve producer must maintain records to preserve the identity of all organically managed bivalves and edible and non-edible products to assure reliable traceability 

from growing area to market. 

(3) Offshore bivalve growing areas must be under organic management for at least three 

years before production can be certified organic. 
10

(4) All applicable laws, regulations and procedures of national and local governments, including NSSP, HACCP, and environmental laws and regulations, must be obeyed. 

(5) Bivalves that are removed from a certified operation and subsequently managed on a 

non-certified operation may not be sold, labeled or represented as organically produced. 

(6) Depuration of bivalve molluscs for the purpose of eliminating or reducing amounts of 

prohibited substances is prohibited. 

 Organic system plan for bivalve production. In response to public and internal 

comments, AWG has substantially modified (b) to exclude the requirement for the determination 

of the Hydraulic Zone of Influence. Upon careful review, AWG found that the Sanitary Survey 

required under NSSP that applies to all bivalve shellfish growing areas accomplishes the same 

purpose. Therefore, (b) has been modified to read: 

(b) Organic system plan for bivalve production: 

A producer of organic bivalve molluscs must develop an organic system plan in accordance with 

the provisions of§ 205.201. The organic system plan for bivalve production must include: 

(1) A map of the growing area that indicates the boundaries of organically managed areas, 

adjacent natural areas, and non-organically managed areas that may influence the operation, and water circulation patterns. The location of all industrial or domestic point 

sources of contamination must be included on the map. The map also must include locations of beds of eel grass, submerged aquatic vegetation, and other ecologically sensitive 

flora and fauna. 

(2) The Sanitary Survey for the operation as required under NSSP. 

(3) For bivalve molluscs that forage on pelagic wild microalgae and other seston, the organic 

system plan must include an approximate delineation of the zone of production for forage 

consumed by the farmed bivalve molluscs. This must be at least the area included in the 

NSSP Sanitary Survey. This area is expected to be at lease as large as the area in the sanitary survey. 

(4) The Sanitary Survey must be reviewed and updated if necessary at least annually by the 

grower and supplemented with particular attention given to possible contamination by 

any one or more prohibited substances from any source. It must include the identification 

and location of all point and non-point sources of prohibited substances and other potential contaminants, such as pesticides, herbicides, and heavy metals. Point and non-point 

sources can be from urban, residential, industrial and agricultural areas that may pollute 

the area of natural forage production and the bivalve growing facility. This may include 

domestic waste (including municipal sewage treatment plants and private septic tanks), 

agricultural contamination from farms, feedlots, slaughterhouse operations, and crop 

spraying, and all forms of industrial discharges that could impact the growing waters. The 

plan must include the distance from the bivalve growing site to any point or identified 

area from which there is a significant risk of contamination. The required Sanitary Survey 

shall be further supplemented whenever there is a material change. 

(5) The Sanitary Survey supplement must include a representative range of meteorological 

and oceanographic typical conditions that might be expected over a ten year period. Identification or quantification of extreme climatic conditions, such as hurricanes and floods, 
11

that could affect the zone of forage production must be considered in the organic system 

plan with plans for dealing with such events. 

(6) The Organic System Plan must include plans for action for events that trigger any form of 

pollution contribution to the area of the Sanitary Survey. 

(7) Documentation of environmental conditions in the zone of forage production, including 

water quality and land use in contiguous watersheds. Documentation shall include affidavits from contiguous agricultural and industrial users that prohibited substances have not 

been applied during the past three years. 

(8) A description of a water quality monitoring program including the parameters measured, 

frequency of measurement, and location of sampling stations. 

(9) A description of the procedures used for the culture and harvest of bivalve molluscs, including materials used for rafts, nets, or other structures. 

(10) A description of measures that will be implemented to minimize impacts of culture operations on ocean ecosystems and wildlife, including discussions of: 

i. the impacts of farm structures (if any), growing practices, and harvest methods. 

ii. benthic deposition. 

iii. estimates of nutrient flows, including recycling of nutrients from anthropogenic 

sources and adequacy of wild forage in the water column. 

iv. predator control methods. 

v. species that use the habitat, including those designated as threatened or endangered. If threatened or endangered species are present, the plan must indicate 

how culture and harvest activities are in compliance with applicable laws that 

protect such species. 

(11) A description of biosecurity practices to prevent to the occurrence and spread of diseases 

or parasites. 

(12) A waste management plan that provides for: 

i. reuse, recycling and proper disposal of nets, ropes, waste shell, grade-outs and 

dead-stock. 

ii. composting or recycling of waste biological materials, including shells, to the extent practicable. 

iii. control of offensive odors. 

(13) A schedule for surveillance and methods of removing accidentally released culture materials or equipment from beaches or natural waters adjacent to the culture site; 

(14) A process for the resolution or mitigation of complaints, conflicts, and other multistakeholder issues. 

 A public comment sought to eliminate consideration of offensive odors as required in 

(b)(12)(iii) as not relevant with organic management. AWG does not concur and proposes that 

control of offensive odors be included in the Organic System Plan. 
12

 Origin of bivalve molluscs. In (c) the public commenter sought to eliminate the 

requirement that all seed be hatchery produced and proposed standards for natural spat collection. As a result of this comment and further consideration by AWG, (c) has been modified to 

allow wild collection under certain conditions for a limited time period. As developed in the 

Supplement, AWG has the burden to demonstrate that the proposed regulations for organic 

certification are for a highly managed system. Therefore, (c) now reads: 

(c) Origin of bivalves molluscs: 

(1) The use of hatchery produced seed is required. 

i. However, where commercially available seed in not available in the same 

geographic region, or where the use of hatchery seed would preclude commercial production of market sized animals, the collection of larvae or natural 

set seed from the ocean is allowed for a period of seven years from the date 

these regulations are adopted, under the following conditions: 

(A) wild seed only can be collected from wild animals that are actively managed by the appropriate government resource management agency to 

ensure sustainable wild populations. The organic system plan must include provisions that consider and control the impacts of wild seed collection activities and methods to monitor those impacts. 

(B) wild seed collection methods must not compromise the ecological integrity of the aquatic ecosystem in which they are being used. 

(C) the organic system plan must include provisions to minimize overset of 

wild seed. 

Prior to the expiration of this exemption period, a reevaluation shall be made of whether to extend this exemption for specific species where the use of hatchery seed would 

preclude commercial production of market sized animals. 

(2) Production of triploid bivalves is prohibited by § 205.251 Origin of aquaculture animals, 

paragraph (e).

 A comment was received that (c)(2) be amended to allow triploidy. AWG responds that 

polyploidy is prohibited under § 205.251 Origin of aquaculture animals that controls this section 

for bivalve molluscs. 

Bivalve mollusc forage production. Based upon private comments, AWG proposes that 

(d)(3) be amended to also provide for major pollution impacts. 

(d) Bivalve mollusc forage production: 

(1) Bivalves grown in onshore ponds, tanks, and other containers may be supplied organic 

aquatic plants produced under § 205.258 Farmed aquatic plants. 

(2) Bivalves may forage on wild microalgae and other seston at locations classified by appropriate government authorities under the NSSP as “remote”, or “approved” subject to 

specific provisions of these standards. Bivalves grown at locations that are not classified, 

or classified as “conditionally approved,” “restricted,” “conditionally restricted,” or “prohibited” may not be sold, labeled or represented as organically produced. 
13

(3) In the event of an emergency closure ordered by a state shellfish control authority for environmental reasons, the waters under organic production must remain closed for an additional seven days after these waters are reopened by that authority and testing by the 

grower after reopening determines that requirements under (e) Contamination indicators 

are satisfied. In the event of a closure due to major pollution impacts, including sewage 

or chemical spills, closure shall extend until at least 14 days after the waters are reopened 

by the shellfish control authority and testing by the grower determines that requirements 

under (e) are satisfied. 

 Contamination indicators: The public commenter seeks to exempt small farm sites and 

require sampling for only those sites that are larger than two acres. AWG recommends that the 

provisions of (e) apply to all farm sites seeking organic certification. In addition, the public 

commenter sought clarification of sampling procedures. AWG has amended (e) to further define 

and clarify sampling procedures, methods and criteria. 

(e) Contamination indicators: 

(1) Measuring fecal coliforms as an indicator for contamination by prohibited substances is 

required. 

(2) In addition to monitoring by government agencies for indicator organisms required under 

NSSP, the organic system plan must include monitoring by the producer for microbial 

indicators of possible contamination by prohibited substances for each site with periodic 

testing of seawater. Monitoring must be site specific with specifications determined by 

the initial site analysis in the Sanitary Survey and ongoing evaluation of potential contamination. The organic system plan must consider historical information and must be updated annually. 

(3) The annual review of the organic system plan shall consider incorporating new technologies for monitoring contamination when new technologies become available and can be 

used with reliable and consistent interpretation. 

(4) Locations for sample stations must be identified in the organic system plan and indicated 

on the site map. There must be at least two sampling stations for each farm site. At least 

one station must be located near the boundary of the farm closest to any potential source 

of contamination. Additional sample stations must be utilized where potential sources of 

contamination exist near other boundaries of the farm site. 

(5) Periodic sampling and testing for fecal coliform indicators must occur at least twice each 

month at approximately two week intervals with records maintained for at least five 

years. All stations must be sampled within the same 12 hour period, or within the same 

tidal cycle, whichever is shorter. Sampling and testing should be conducted using standard industry protocols and may include multiple samples per station. At least twice each 

year a third party independent FDA certified laboratory must verify at least one set of 

samples. 

(6) Harvesting of bivalves is allowed from the farm site when fecal coliform water sample 

testing results for each sampling event indicate a geometric mean or median for all stations that does not exceed 14 bacteria cells per 100 ml. This determination can be made 

by most probable number (MPN) or membrane filter methods. When the geometric mean 

or median exceed 14 bacteria cells per 100 ml of seawater, bivalves may not be harvested 
14

for organic sale until sample results are 14 bacteria cells per 100 ml or less. Should two 

consecutive sampling dates indicate an geometric mean or median of greater than 14 

bacteria cells per 100 ml then harvesting for organic sale must be suspended until two 

consecutive sample dates, separated by at least 24 hours, yield consecutive acceptable 

(≤14 bacteria cells per 100ml) results. 

Methods for determination of fecal coliform indicator organisms are described in the U.S. 

Food and Drug Administration Guide for the Control of Molluscan Shellfish, 2005 (or 

subsequent editions), IV. GUIDANCE DOCUMENTS, II-Growing Areas, .10 Approved 

National Shellfish Sanitation Program Laboratory Tests. [

http://www.cfsan.fda.gov/~ear/nss3-42j.html ]. 

Animal health care practices: The public commenter sought to restrict (f) to hatchery 

seed to recognize their proposed allowance of wild set bivalves. AWG has modified (f) to read: 

 (f) Animal health care practices: 

Hatchery bivalve seed must be certified to be 

(1) Free of reportable shellfish infectious disease agents according to applicable State and 

Federal regulations. 

(2) Handling and growing area management practices must minimize the occurrence and 

spread of diseases and parasites. 

(3) Biosecurity measures must protect against entry of new pathogens, parasites or pests, or 

their spread. Such biosecurity measures must be specified a specific biosecurity or health 

section of the organic system plan. 

(4) Saline and freshwater dipping, rinsing or spraying may be employed to destroy 

shell parasites, predators or bacteria.

 Living conditions The public commenter sought to insert the words “owned or 

leased” in (g)(3)(ii). AWG believes the language is clear as written. Also sought was the 

allowance of certain unspecified chemicals. AWG points out that under § 205.601 or § 205.603, 

National List, it is possible to allow listed chemicals to be employed in organic production under 

certain conditions. AWG has modified (g) and (h) to now read: 

(g) Living conditions: 

(1) Bivalves must be under continuous organic management from the time seed is placed in a 

certified growing area. All product labeled organic must achieve at least 95 percent of its 

biomass while under organic management. 

(2) Sites must provide appropriate rates of water exchange with sufficient tidal currents to 

assure a good supply of food for bivalve crops while maintaining a healthy environment 

for other marine organisms. 

(3) Bivalves shall be stocked at densities and total numbers that: 

i. optimize the health and growth of the bivalves. 

ii. do not result in changes to the benthos except in the farm site. 

iii. do not remove quantities of plankton or microorganisms from the water sufficient 

to cause damage in ecosystems on or adjacent to the farm. 
15

(4) The producer must assure adequate protection of bivalves from predators with a pest 

management plan for each location. Where possible, the plan should provide for pest removal without using lethal means of predator control. The use of quicklime (CaO), biocides, pesticides, herbicides, and other chemical toxins are prohibited to control or eliminate predators and other nuisance organisms unless allowed under § 205.601 or § 

205.603. 

(5) Removal of biofouling, pests, or predators using benign means including hand removal 

and hose washing of bivalves in a manner that minimizes environmental impacts from the 

discharge of fouling organisms and sediment is allowed.

Bivalve growing facilities There were no comments received relative to facilities, and 

AWG has no changes to propose other then the addition of (6)(ii). 

(h) Bivalve growing facilities: 

(1) Bivalves may be grown in integrated production systems with other organically raised 

aquatic animals, such as finfish. 

(2) Bivalve growing areas must be geographically defined. The farm must have exclusive 

rights to manage and harvest bivalves in each defined area. Bivalves grown on public 

grounds that are not leased for private use cannot be certified organic. 

(3) Bivalves may be grown on the substrate, or in off-bottom containers, including bags on 

racks, lantern nets, trays, or on long-lines, poles or other bags or containers which employ off-bottom methods. Rafts and other floating structures for suspending bivalves in 

the water column may be employed. 

(4) Structures used for raising bivalves may not contain lumber treated with arsenate or other 

synthetic anti-foulants or preservatives, or any non-synthetic substances prohibited under 

205.604, except as provided in 205.603. 

(5) Burrowing bivalves such as clams may be grown in the substrate. 

(6) Farms that grow bivalves must include in their organic system plan specific and measurable steps that will be taken to minimize environmental impacts of farm practices. Such 

steps may include but not are not limited to: 

i. minimize disturbance of the benthic sediments during seeding and harvest of subtidal leases by using only shallow draft vessels during high tide. 

ii. subtidal leases with fine bottom sediments must be harvested with the least disruptive 

mechanical or manual harvesting method that are practicable and must comply with 

(i)(4). 

(7) The seafloor of non-private growing areas cannot be altered with dikes, or leveling. 

 Harvesting bivalve shellfish The public commenter seeks to allow inter-tidal mechanical dredging. The amended (i) below allows inter-tidal harvesting under certain conditions. (i)(4) 

has been changed to specify sediment values found to be acceptable in scientific literature. A 

comment urged further consideration of harvesting Geoduck clams with the allowance of the use 

of hydraulic water jets for harvesting Geoduck clams. AWG has amended (i)(6) to allow use of 
16

hydraulic jets for Geoduck clam harvesting.. After considerable review, various parts of (i) have 

been modified to allow harvesting of Geoduck clams consistent with the minimization of 

environmental disturbance. The public commenter and a private commenter sought the allowance of hand raking of clams. (i)(11) has been amended to allow for hand raking under certain 

conditions. 

(i) Harvesting bivalve shellfish: 

(1) Harvest methods must cause minimal impact to the substrate, benthos, and to organisms 

that live on the ocean bottom and in bottom sediments. Impacts must be minimal to assure sustainability of habitat. Where possible, mitigation measures must be employed. 

(2) For all methods of harvest the organic system plan must include an assessment of the potential for incidental kill of non-farmed species that occupy the farming habitat and a plan 

to minimize the occurrence of such incidental kill 

(3) Manual harvest of bivalves by divers using self contained breathing apparatus (SCUBA) 

or surface supplied air is permitted. Diving activities within the United States must comply with either State or Federal regulations, whichever is applicable. Diving activities in 

foreign jurisdictions must comply with pertinent diving regulations established by the 

United States Occupational Safety and Health Administration. 

(4) The density of the sediment plume created during subtidal harvest operations cannot exceed 200 mg/liter dry weight of settable solids at any point ten meters away or greater.

(5) Dredges or other mechanical methods employed to harvest bivalves must scrape farmed 

animals from the benthic surface and minimize penetration into the substrate to no more 

than the depth of the market sized bivalves being harvested. Sediment penetration must 

only be by a harvesting bar, blade or tooth, with the body of the dredge held off the bottom by sled runners or by other means to ensure that the dredge does not penetrate the 

substrate. 

(6) The use of hydraulic water jets for harvesting of farmed Geoduck clams is allowed as 

long as requirements in (1) and (4) are met. The use of hydraulic water jets for intertidal 

harvesting of other burrowing molluscs is prohibited. 

(7) Suction devices and hydraulic escalator harvesters are prohibited for harvesting burrowing molluscs. 

(8) Harvesting of molluscs is not allowed within 100 feet of beds of submerged aquatic vegetation or other light-sensitive aquatic ecosystems, known spawning areas of fish, or ecologically sensitive habitats. These areas must be shown on the site map.

(9) Equipment for harvesting non-burrowing seafloor surface dwelling bivalves that creates a 

negative water pressure above the substrate to sweep the animals into the dredge without 

the dredge penetrating the substrate is allowed. With this dredge design, the equipment 

must held off the bottom by sled runners or other means to assure that the apparatus does 

not penetrate the substrate. 

(10) The organic system plan must include a description of the design of dredges and other 

harvest equipment employed including drawings or photographs. 

(9) Clams and other burrowing molluscs that grow in the substrate in intertidal areas may be 

hand dug with particular care to minimize disruption of the seabed. Harvest must occur 
17

during periods of beach exposure at low tide to minimize the distribution of marine sediments. 

(10) Intertidal harvest of clams or other substrate dwelling shellfish may be accomplished with 

tractor driven or self-propelled harvesting machines. Mechanical harvesting equipment must be designed and operated to minimize disturbance of the substrate through the 

use of low weight equipment with low pressure tires that are designed to minimize loading on the substrate. This equipment must have a total weight of less than 3,000 pounds 

including the weight of operators. In no case shall substrate loadings exceed 10 pounds 

per square inch for any tire. This calculation shall be made in the field by dividing the 

weight of the harvester carried by each tire by the horizontal contact area of the tire on 

the substrate determined by multiplying the contact width by the contact length of the tire 

impression in the substrate. Tracked crawler equipment meeting these specifications also 

may be employed. 

(11) Hand raking of clams is allowed, provided that the maximum density of the silt plume 

does not exceed 200 mg/liter dry weight of settable solids at any point ten meters away or 

greater.

 Handling and transport of bivalve molluscs The public commenter questions the 

purpose of (j)(2). This provision eliminates a practice called soaking, a condition where bivalve 

meats after harvest add substantial mass and volume thereby changing the quality of this 

product. The public commenter also sought the elimination in the earlier draft of a proposed 

condition that the provisions of (j)(3) extend to retailers. AWG concurs that producers have 

little, or no, control of certified products once they reach the retail level and has removed this 

proposed condition. 

(j) Handling and transport of bivalve molluscs: 

(1) All national and local regulations controlling the disposal of processing wastewater must 

be obeyed. 

(2) After shucking and during packing exposure to fresh water shall not exceed 20 minutes. 

(3) Packing materials and controls must conform to NSSP requirements throughout shipping, and distribution. 

(4) Packing date must be clearly marked on the retail sales container as well as estimated 

shelf-life or “sell by” and the product must conform to local, state or federal standards 

pertinent to shelf-life and quality. 

(5) Placing bivalves in waters of lower salinity after harvest for purposes of increasing 

weight or volume (“soaking”) is prohibited. Placing bivalves in waters of greater salinity 

for purposes of improving taste (“salting”) is allowed with the provision that the lease or 

facility used for this practice has been under continuous organic management.