Loading...
You are viewing a DELETED record.
This record information is displayed for reference purpose only and should be not used.
This document has been updated. This is not the latest published version. Click here to view the latest version of the record.
Risk Assessment generated by an independent or non-regulatory process
(IRA)
last updated: 30 May 2019
ASSESSORS' CONSOLIDATED REPORT OF MONSANTO'S CORN MON88017 FOR FOOD, FEED AND OR PROCESSING
EN
04 Jan 2018
-
- Competent National Authority: | BCH-CNA-PH-46524-5 This document has been updated. This is not the latest published version. Click here to view the latest version of the record.Competent National Authority:Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesPhone: +632 920-3986, +632 924-1278 local 2802,Fax: +632 920-3986,Email: osec.da@gmail.com,Website: http://www.da.gov.ph, -
Competent National Authority:Department of Health ()San Lazaro Compound, Sta. CruzManila,
, PhilippinesPhone: +632 651 7801; +623 651 7800,Fax: +632 743 1829,Email: etona@co.doh.gov.ph,Website: http://www.doh.gov.ph, -
Competent National Authority:Department of Environment and Natural Resources ()Visayas AvenueQuezon City,
1100, PhilippinesPhone: +632 925-2329, +632 920-4352,Fax: +632 920-4301,Email: osec@denr.gov.ph,Website: http://www.denr.gov.ph, http://www.pawb.gov.ph,
-
Person:Ms. Ma. Lorelei U. AgbagalaSupervising Agriculturist, Post Entry QuarantineEconomic GardenLos Banos, Laguna
4030, PhilippinesPhone: +63 49 536 1678,Fax: +63 49 536 1678,Email: lorelieu5@gmail.com,Website: http://bpi.da.gov.ph,Related OrganizationBureau of Plant Industry (BPI)Government agency (National/Federal)Economic GardenLos Banos, Laguna
4030, PhilippinesPhone: +63 49 536 1678,Fax: +63 49 536 1678,Email: lorelieu5@gmail.com,Website: http://bpi.da.gov.ph,
-
MON-88Ø17-3 - YieldGard™ VT™ Rootworm/RR2™ Maize| Monsanto | Resistance to diseases and pests (Insects, Coleoptera (beetles)), Resistance to herbicides (Glyphosate)
DENR Observations:
1. The effect of the regulated article on the environment depends largely on the
viability of the product to be utilized for direct use. lf the article is transported in a nonviable form, there is no danger to the environment;
2. Due to the absence of a specified Environmental Management Plan (EMP) by the
traders/importers, the Committee would like to recommend that it be added to the
requirements for the issuance of an import permit by the Bureau of Plant lndustry (BPl)
(Article Vlll, Section 26 of JDC No,1 s.2016);
DOH Observation:
1. On the description of the phases or stages of the biotechnology project, Monsanto
Philippines Inc. claimed that Corn MON88017 does not pose greater risks to human when
brought to loading/unloading, transport, storage or processing.
2. On the risk to Health Matrix (Integration of the health consequence rating with incident
potential rating), the Monsanto Philippines, Inc. rated the activities of the phases of project
a very low incident/exposure potential rating.
3. Scientific pieces of evidences from provided references i.e. literatures show that
regulated article applied for direct use is as safe as its conventional counterpart and shall
not pose any significant risk on human health, animal health and on the environment.
EN
1. The effect of the regulated article on the environment depends largely on the
viability of the product to be utilized for direct use. lf the article is transported in a nonviable form, there is no danger to the environment;
2. Due to the absence of a specified Environmental Management Plan (EMP) by the
traders/importers, the Committee would like to recommend that it be added to the
requirements for the issuance of an import permit by the Bureau of Plant lndustry (BPl)
(Article Vlll, Section 26 of JDC No,1 s.2016);
DOH Observation:
1. On the description of the phases or stages of the biotechnology project, Monsanto
Philippines Inc. claimed that Corn MON88017 does not pose greater risks to human when
brought to loading/unloading, transport, storage or processing.
2. On the risk to Health Matrix (Integration of the health consequence rating with incident
potential rating), the Monsanto Philippines, Inc. rated the activities of the phases of project
a very low incident/exposure potential rating.
3. Scientific pieces of evidences from provided references i.e. literatures show that
regulated article applied for direct use is as safe as its conventional counterpart and shall
not pose any significant risk on human health, animal health and on the environment.
In its very long history of safe use and utilization, the assessors accepted that corn
MON88017 is not a source of toxicants. They also accepted that it is not a source of
common allergen although some case studies reported that individuals could have allergic
reaction to corn due to presence of a 9 kilodalton (kd) lipid transfer protein, 16 kd trypsin
inhibitor and zeins. These reported allergic effects for maize include skin, gastrointestinal
and respiratory complaints. However, clinical relevance of these findings is uncertain
(Hefle, 1996 and OECD, 2002 p. 29).
EN
MON88017 is not a source of toxicants. They also accepted that it is not a source of
common allergen although some case studies reported that individuals could have allergic
reaction to corn due to presence of a 9 kilodalton (kd) lipid transfer protein, 16 kd trypsin
inhibitor and zeins. These reported allergic effects for maize include skin, gastrointestinal
and respiratory complaints. However, clinical relevance of these findings is uncertain
(Hefle, 1996 and OECD, 2002 p. 29).
The levels of anti-nutrient in MON88017 are compositionally equivalent to that of
the conventional corn. Processing may lower the level of anti-nutrient in MON 88017 as
same amount as it reduces the level in the conventional corn. PPSSD site examples that
processing may lower the level of anti-nutrient. The raffinose can be removed in corn by
soaking, cooking, enzyme or solvent treatment and by irradiation. On the other hand,
phytic acid is present in maize and binds about 60-75% of the phosphorus in the form of
phytate (NRC, 1998). Bioavailability of phosphorus in maize is 15% for non-ruminants.
Ruminants utilize considerably more phosphorus and can produce phytase that breaks
down the phytate and releases phosphorus (Ensminger et al., 1990). Processing of maize,
fresh and dry for the production of various traditional products results in the loss of phytic
acid. Fresh mature corn contains less phytic acid (1.71 g kg−1) than dry corn (7.15–7.60 g
kg−1). The loss of phytic acid varies from 18.1 to 46.7% for fresh maize and from 11.5 to
52.6% for dry maize respectively among the heat treatments given (Khan et al., 1991).
EN
the conventional corn. Processing may lower the level of anti-nutrient in MON 88017 as
same amount as it reduces the level in the conventional corn. PPSSD site examples that
processing may lower the level of anti-nutrient. The raffinose can be removed in corn by
soaking, cooking, enzyme or solvent treatment and by irradiation. On the other hand,
phytic acid is present in maize and binds about 60-75% of the phosphorus in the form of
phytate (NRC, 1998). Bioavailability of phosphorus in maize is 15% for non-ruminants.
Ruminants utilize considerably more phosphorus and can produce phytase that breaks
down the phytate and releases phosphorus (Ensminger et al., 1990). Processing of maize,
fresh and dry for the production of various traditional products results in the loss of phytic
acid. Fresh mature corn contains less phytic acid (1.71 g kg−1) than dry corn (7.15–7.60 g
kg−1). The loss of phytic acid varies from 18.1 to 46.7% for fresh maize and from 11.5 to
52.6% for dry maize respectively among the heat treatments given (Khan et al., 1991).
The STRPs together with BAI and PPSSD unanimously find the scientific evidence provided
by the applicant is sufficient in showing that the regulated article being applied for direct
use is as safe for human and animal health, and the environment, as its conventional
counterpart.
EN
by the applicant is sufficient in showing that the regulated article being applied for direct
use is as safe for human and animal health, and the environment, as its conventional
counterpart.
DENR suggested that BPI ensure the following:
a) development of guidelines on the EMP in coordination with DENR;
b) implementation of the EMP by the traders/importers involved in the import,
handling, processing and transport of viable Corn MON88017 commodity
products; and
c) Strict monitoring of the regulated article from port of entry to the
trader's/importer's storage/warehouse (Section 32 of the JDC No. 1 s.2016);
DOH suggested that BPI ensure the following:
a. Strict monitoring of the regulated article from port of entry to the trader’s/
importers storage/warehouse as stated in Section 32 of the JDC No. 1 series,
2016.
b. The BPI to include in the issuance of permit for the release of this product the
following conditions:
b.1. Any spillage (during unloading and loading/hauling and transport unloading
and storage) shall be collected and cleaned up immediately.
b.2. Transportation of the consignment from the port of entry to any destination
within the country shall be in closed containers.
b.3. There shall be a clear labeling of the product from importation down to all levels
of marketing stating that it is only for the purpose of direct use as food and feed
or processing and is not to be used as planting materials.
EN
a) development of guidelines on the EMP in coordination with DENR;
b) implementation of the EMP by the traders/importers involved in the import,
handling, processing and transport of viable Corn MON88017 commodity
products; and
c) Strict monitoring of the regulated article from port of entry to the
trader's/importer's storage/warehouse (Section 32 of the JDC No. 1 s.2016);
DOH suggested that BPI ensure the following:
a. Strict monitoring of the regulated article from port of entry to the trader’s/
importers storage/warehouse as stated in Section 32 of the JDC No. 1 series,
2016.
b. The BPI to include in the issuance of permit for the release of this product the
following conditions:
b.1. Any spillage (during unloading and loading/hauling and transport unloading
and storage) shall be collected and cleaned up immediately.
b.2. Transportation of the consignment from the port of entry to any destination
within the country shall be in closed containers.
b.3. There shall be a clear labeling of the product from importation down to all levels
of marketing stating that it is only for the purpose of direct use as food and feed
or processing and is not to be used as planting materials.
The STRPs together with BAI and PPSSD unanimously find the scientific evidence provided
by the applicant is sufficient in showing that the regulated article being applied for direct
use is as safe for human and animal health, and the environment, as its conventional
counterpart.
EN
by the applicant is sufficient in showing that the regulated article being applied for direct
use is as safe for human and animal health, and the environment, as its conventional
counterpart.
This application is not for propagation of the Corn MON88017. This LMO will be directly used for food, feed and for processing.
EN
Quantitative diagnostic lateral flow strips, ELISA and PCR for routine quantitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR may be used.
EN
Corn MON88017 is intended for direct use as food, feed and for processing.
All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members, BAI, PPSSD, DENR, DOH and SEC Expert during the evaluation of this event.
EN
All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members, BAI, PPSSD, DENR, DOH and SEC Expert during the evaluation of this event.
- ISAAA [ English ]
