Cloning Recommendation before the National Organic Standards Board

Re: Docket No. AMS-TM-07-0032; TM-07-05, Notice of Meeting of the National
Organic Standards Board [Federal Register: March 12, 2007 (Volume 72, Number 47)
Page 10971-10973], National Organic Standards Board Cloning Recommendation.

Dear Ms. Frances:

The Biotechnology Industry Organization (BIO) provides the following comments on the
above referenced docket. BIO represents more than 1,100 biotechnology companies,
academic institutions, state biotechnology centers and related organizations across the
United States and 31 other nations. BIO members are involved in the research and
development of healthcare, agricultural, industrial and environmental biotechnology
products. BIO appreciates the opportunity to comment on the Cloning Recommendation
currently under consideration by the National Organic Standards Board (the NOSB or the
Board).

BIO members provide industry leadership for the ethical application of animal
biotechnology to improve animal and human well-being. The industry seeks to improve
global food supply and quality through the application of animal cloning, and thereby to
provide solutions to issues important to humankind—hunger and health.

The USDA National Organic Program (NOP) provided a statement on January 31, 2007,
stating that cloning technology is prohibited under NOP regulations. Despite that
statement, a recommendation is currently before the Board to formalize the exclusion of
the use of cloning technology as a production method under the NOP. We respectfully
oppose the recommendation and offer the following general and specific comments.
General Comment Somatic Cell Nuclear Transfer (SCNT) and other forms of animal cloning are an assisted reproductive technology (ART), which fall on a continuum of breeding methods used
today in animal agriculture, including artificial insemination, embryo transfer and in vitro
fertilization, all of which are allowed under the NOP. Animal cloning allows farmers and
ranchers to produce healthy, productive animals and healthful foods for human
consumption. Animal cloning allows for rapid distribution of the best genetics from
proven animals to provide consistent, healthful, and safe meat and milk for human
consumption.

A clone is a genetically identical twin to a donor animal, which naturally exhibits
desirable traits. Progeny (offspring) of clones are not clones; they are sexually produced
from the mating of one or more animal clones, after undergoing a normal gestation period
and birthing process.

Based on all available scientific information, animal cloning technology is shown to be
safe and produces safe food. On December 28, 2006, the U.S. Food and Drug
Administration (FDA) stated in its science-based draft Risk Assessment (FDA, CVM.
2006. Animal Cloning: A Draft Risk Assessment, http://www.fda.gov/cvm/Documents/Cloning_Risk_Assessment.pdf ) that edible
products from healthy clones and progeny of clones pose no additional food consumption
risks relative to corresponding products from other animals. FDA agrees with the
National Academy of Sciences (2002 Animal Biotechnology: Science-Based Concerns.
www.nap.edu/books/0309084393/html/), which concluded that “The products of
offspring of clone(s)…were regarded as posing no food safety concern because they are
the result of natural matings,” and “In summary there is no current evidence that food
products derived from adult somatic cell clones or their progeny present a food safety
concern.”

The U.S. companies that provide cloning technology for agricultural animals are leaders
in the production of healthy livestock clones. This industry has continuously improved
the technology, collaborated in research, been transparent with federal agencies in
providing all data, and openly provided information about the animals and the technology
to many different stakeholder groups.

Specific Comments

1) The Organic Foods Production Act of 1990 (7 USC §6501 to 6522)
Livestock clones and their progeny can be raised in accordance with the Organic Foods
Production Act (OFPA), specifically 7 USC §6502 Definitions, §6504 National standards
for organic production, and §6509 Animal production practices and materials.
In particular, 7 USC §6509 Animal production practices and materials, Breeder stock,
states that breeder stock may be purchased from any source if such stock is not in the last
third of gestation. Since breeder stock may be purchased from any source, livestock
clones and their progeny could be breeder stock and meet the statutory requirements, as
defined in the Act. In fact, cloned animals will be used primarily for breeding purposes
with only nominal amounts winding up in the food supply after the animal’s useful
breeding life.

2) 7 CFR Part 205.2 Terms defined
a) The cloning recommendation before the Board would characterize SCNT and
other methods of animal cloning as methods used to genetically modify organisms
or influence their growth and development. SCNT and other methods of animal
cloning do not genetically modify organisms, nor do they influence the growth
and development of organisms. Therefore, they should not be considered
excluded methods.
b) The original definition of “Excluded Methods” as provided in the NOP amended
proposed rule (65 Fed. Reg. 13,512 (March 13, 2000)), was specifically inserted
to prohibit the intentional use of recombinant DNA technology. There is no
recombinant DNA technology involved in the process of cloning; no genes are
inserted or changed. Cloning simply produces a genetic twin. Therefore, the
recommendation is inconsistent with the intent and purpose of the definition of
Excluded Methods.
c) ARTs are not excluded under the NOP. It is a scientific fact that SCNT and other
forms of cloning are ARTs. Other ARTs, such as in vitro fertilization, artificial
insemination, and tissue culture are not excluded methods. Therefore the
recommendation creates inconsistencies in how ARTs are treated under the NOP,
and the inclusion of SCNT as an excluded method is inconsistent with similar
organic production practices.

ARTs, such as artificial insemination, embryo transfer, and in vitro fertilization, are
widely used in the livestock industry including organic production. It is estimated that 75
percent of milk and 80 percent of pork is produced from the use of artificial insemination,
which includes milk and pork labeled organic under the NOP. The use of embryo
transfer has been valuable in capturing the desirable traits of superior females. In vitro
fertilization is increasingly being used in production of superior animals eventually used
as founder sires. These ARTs have been successfully practiced in the agriculture sector,
including organic production. Cloning is simply another ART, a fact supported by the
FDA (FDA, CVM. 2006. see previous citation), which will continue to improve the
health of agricultural animals that produce safe meat and milk.

3) Progeny of Clones
BIO interprets that the proposed amendment to the definition of Excluded Methods does
not exclude progeny of clones, or the products thereof, from organic production practices.
Progeny of clones are not clones. Without prejudice to our position that cloning should
be allowed under the NOP, if the NOSB disagrees with that position, progeny of clones
and products thereof certainly should be allowed in organic production practices.
Livestock clones, because of their highly desirable traits and genetic merit, will be the
superior founder breeding animals for organic production. They are produced through
sexual reproduction under normal conditions of gestation and parturition and therefore
are compatible with organic production. FDA has concluded that progeny of clones are
not clones (FDA, CVM. 2006. see previous citation), which is in agreement with the

National Academy of Sciences (National Academies. 2002. see previous citation).
Offspring of clones, born under normal conditions of sexual reproduction, gestation and
parturition, and which may be raised according to the requirements of the OFPA and the
NOP regulations, should be allowed under the NOP to produce animal food products and
be labeled in accordance with the NOP.

7 CFR Part 205.236 Origin of Livestock (3) Breeder Stock specifically allows that
breeder stock may be brought from a non-organic operation onto an organic operation.
Therefore, progeny of animals produced by SCNT should be allowed to be used as
breeders for organic livestock. There is nothing restricting the kinds of “non-organic”
breeders that can be brought into an organic production facility. An animal from a nonorganic
farm, even one that had been produced by SCNT, could convert to producing
offspring that would be in compliance with the organic standards. Thus, food products
derived from those offspring would meet all the NOP regulatory requirements and
labeling them as such should be legal.

Conclusion

The Organic Foods Production Act does not prohibit the use of assisted reproductive
technologies in organic production. BIO does not support the proposed amendment,
which would exclude one type of assisted reproductive technology, SCNT (or other
methods of animal cloning), from the NOP. Further, BIO does not support exclusion of
animal clones or their progeny from organic production. Just as with other forms of
assisted reproductive technologies, organic livestock producers should have the option to
select the best genetics and reproductive technology, including SCNT, which result in an
organic food product consistent with the NOP.

BIO appreciates this opportunity to comment on the cloning recommendation currently
before the Board. We look forward to further deliberation, and would be pleased to work
with the Board and USDA to provide further input or clarification of our comments or on
the cloning technology, as needed.

Sincerely,

Barbara P. Glenn, Ph. D.
Managing Director, Animal Biotechnology
Food & Agriculture Section